History

Dr. Friedman-Kien, whose clientele were primarily young men who identified as gay, said he was surprised at the finding that previously healthy men were developing Kaposi’s Sarcoma (KS), a rare cancer historically associated with elderly men of Eastern European or Mediterranean descent.

KS is also associated with people who have weakened immune systems, according to the U.S. National Institutes of Heath (NIH).  The disease often presents as a purple plaque on the skin or internal surface of the mouth.  KS can also manifest on internal organs, such as the lungs and gastrointestinal system.

Dr. Friedman-Kien told New York magazine:

“In February 1981, I saw a young man who was perfectly healthy except for a number of spots on his skin.  I’d never seen anything like it, so I did a biopsy.  Under the microscope, the cell structure was clear: it was Kaposi’s sarcoma.”

Dr. Friedman-Kien continued:  “A week later, another physician sent me another patient, also a gay man in his late thirties, also with disseminated KS.”

Later research would establish that AIDS-related KS is the second most common tumor in HIV patients with CD4 counts less than 200 cells, according to the NIH.  Up to 30% of HIV patients not taking high-activity antiretroviral therapy (HAART) will develop Kaposi sarcoma.

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Source:

New York magazine, “Fighting AIDS” by Janice Hopkins Tanne, January 12, 1987

POZ magaine, “A Look Back at the Year a Rare Cancer Was First Seen in Gay Men” by Joseph Sonnabend, M.D., July 13, 2020

The New York Times, “Rare Cancer Seen in 41 Homosexuals” by Lawrence K. Altman, July 3, 1981

The 35-year-old, white gay man from New York City was transferred from a Connecticut hospital to the NIH in Bethesda, Maryland after researchers at the National Cancer Institute, an NIH branch that studied immunodeficiency diseases, heard about his case.

Almost immediately after the new disease emerged on the medical scene, researchers recognized that patients with this unnamed syndrome often developed a rare cancer called Kaposi’s sarcoma as well as other tumors, such as high-grade B-cell lymphomas. As a result, some of the earliest AIDS patient care and research was performed by cancer specialists at the NIH and elsewhere.

The man admitted to the NIH was, for privacy purposes, referred to as “Patient D.”  He came to the NIH from Hartford Hospital, where he had been hospitalized for two months with neumocystis carinii pneumonia, lymphocytopenia, cytomegalovirus, herpes simplex II, Candida esophagitis, and Mycobacterium avium tuberculosis of the lung, bone marrow, and esophagus.

The patient had been healthy through adulthood until February 1981, when he began experiencing fatigue and weakness, followed by weight loss and fever.

Thomas A. Waldmann, M.D., one of the NIH doctors who was first to examine “Patient D” said in a 1990 NIH interview:

“The pattern that we observed in our patient was the kind of pattern one saw in Hodgkin’s disease patients who were profoundly anergic [i.e., a condition in which the body fails to react to an antigen], or in patients with a form of profound immunodeficiency called ‘severe combined immunodeficiency of infancy,’ where the patient cannot make an effective cellular or antibody immune response. What we were seeing was an acquired form of cell-mediated immunity.”

Dr. Waldmann said the medical team performed every test they could think of to try to determine the cause of Patient D’s condition, to no avail.

“We were all groping, trying to understand what was going on,” Dr. Waldmann recalled.  “In that era, one couldn’t be fatalistic, even when someone was in an apparently irreversible state. One had to assume that somehow one might be able to reverse the immunodeficiency and with that bring into control the infectious disease.”

Members of the NIH’s Metabolism Branch joined forces to study the patient’s cells in a variety of tests.  Once doctors determined that Patient D suffered from a rare case of cytomegalovirus retinitis, the National Eye Institute became involved, photographing and studying Patient D’s deteriorating eyesight.

In addition to the research, the doctors were scrambling to find a treatment that Patient D would respond to, but these treatments failed to reverse the course of the symptoms.  In fact, it would later be discovered that chemotherapy, the traditional treatment for many forms of cancer, would be ineffective for (and even harmful to) AIDS patients because of their weakened immune systems.

“At the end, the patient had massive cerebral necrosis and autolysis. We had a great number of people involved in treating all the different systems,” Dr. Waldmann said in 1990.  “His disease continued, and the patient finally died on October 28, 1981 of hypotension and respiratory failure, with multisystem involvement.”

An autopsy of the body revealed an even wider spectrum of infectious diseases, including massive necrosis, encephalitis, and degeneration of the brain.

AIDS researcher and early human immunodeficiency virus (HIV) drug developer Robert Yarchoan, M.D., recalled the gravity of the moment:

“AIDS showed us that something that no one ever worried about before suddenly could become a major problem for the country and for mankind.  And when HIV was identified as the cause of AIDS, it became apparent that, in addition to persons known to have AIDS, thousands of people in the United States were already infected with this new virus without knowing it.  Moreover, at this time, infection with HIV was in most cases fatal.”

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Sources:

National Cancer Institute, “How Cancer Research Led to AIDS Breakthroughs,” August 26, 2021

National Institutes of Health, “Dr Thomas Waldmann Oral History 1990,” interview of Dr. Waldmann on March 14, 1990 by interviewers Dennis Rodrigues, Program Analyst, and Dr. Victoria Harden, Director of the NIH Historical Office.

After completing a three-year fellowship at the University of California San Francisco, Dr. Volberding was ready to become a cancer specialist under renowned virologist Dr. Jay Levy.  Instead, he found himself on a lifelong journey of treating people living with HIV/AIDS and fighting the spread of the virus.

Dr. Volberding remembered his first patient with clarity.

“Twenty-two-year-old man, grew up in the Deep South, and as I recall he was estranged from his family,” Dr. Volberding told the San Francisco Examiner almost 35 years later. “He ended up in San Francisco working basically sex for food, and had innumerable previous sexually transmitted infections.”

The man died within a few months, without his family present, Dr. Volberding recalls.

Around this same time in the early summer of 1981, two doctors in the Bronx started to see HIV/AIDS symptoms in their own patients.  Dr. Gerald Friedland identified several cases of Pneumocystis pneumonia in injection drug users, and became one of the first to see the connection between IV-drug use and HIV transmission.

Pediatric immunologist Dr. Arye Rubenstein began to identify the immunodeficiency of his pediatric patients, the children of drug addicts, as a symptom of what would be eventually called AIDS.

Dr. Rubenstein, who had been seeing this particular kind of immunodeficiency in children and sometimes in their mothers in his Bronx practice since the late 1970s, was one of the first to connect pediatric cases to the new disease affecting homosexual men.

These doctors who treated some of the first known cases of HIV/AIDS went on to do important, transformative work in the fields of treatment, research and public health policy.

In 1983, Dr. Volberding established what would make San Francisco General Hospital the model for HIV care: the country’s first AIDS treatment center (Ward 86).  Later the same year, he joined the medical team at Ward 5B, the world’s first in-patient clinic for AIDS patients.

Dr. Volberding continued to treat HIV/AIDS patients until 2012, when he became director of the UCSF AIDS Research Institute.  Volberding would also become co-director of the Center for AIDS Research.

In the years to come, Dr. Friedland also dedicated his life to AIDS treatment and research.  Following 10 years of working with HIV/AIDS patients in the Bronx, Dr. Friedland became director of the HIV/AIDS Program at Yale and Professor of Medicine and Epidemiology and Public Health at Yale School of Medicine.

Dr. Friedland also became involved in HIV/AIDS international research aimed at providing access to antiretroviral therapy in developing regions of the world.  The major focus of his work became the integration of HIV and TB care and treatment in co-infected patients in South Africa.

In 2018, on the occasion of delivering the keynote address at the 13th annual International Conference on HIV Treatment and Prevention, Dr. Friedland told The Body PRO:

“Many of these people living with HIV, I have cared for, for decades.  I know them extremely well. They know me.  We have gone through this together and have this close collegial relationship as a partnership, so it’s a wondrous pleasure to continue to provide.”

The other doctor working in New York City in 1981, Dr. Rubenstein, would decide to remain in the Bronx, caring for children with HIV AIDS.  In 1983, he received a grant from the National Institutes for Health to study the incidence of AIDS in women and children. In 1986, Dr. Rubenstein established that transmission of AIDS can occur in utero, and his breakthrough findings were published in the journal Clinical Immunology and Immunopathology.

By this time, Dr. Rubsenstein had treated more than a hundred HIV-infected children, and in the summer of 1985, he opened a day care center for pediatric AIDS patients at Albert Einstein College of Medicine in the Bronx.  He became Chief of the Division of Allergy & Immunology at Children’s Hospital at Montefiore, and Professor of Pediatrics, Microbiology & Immunology at Albert Einstein College.

In a 1987 interview with New York magazine, he spoke fondly of the parents, many of them former IV-drug users, of his pediatric patients:

“Many come from a low socioeconomic group, they’re poor, the family may have broken up, they may have used drugs, and now their child has AIDS because they gave it to him.  You wouldn’t be surprised if they threw up their hands, but many don’t.  They become the best parents in the world.  They straighten out their lives, they spend hours with their kids. They give up longing for material things and look for spiritual and religious values.”

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Sources:

San Francisco Examiner, “Pioneering AIDS Doctor Reflects on First Cases in SF as City Strives to Eradicate Virus,” February 8, 2015

University of California San Francisco, UCSF Profile: Paul Volberding, M.D.

The New York Times, “For Doctors, Years of Grief and Daring,” December 23, 1997

New York magazine, “Fighting AIDS” by Janice Hopkins Tanne, January 12, 1987

Yale Medicine AIDS Care Program, website

Yale University, Yale Profile: Gerald H. Friedland, M.D.

The Body Pro, “HIV ‘Providers’ Aren’t Just Doctors: An Interview with Gerald Friedland, MD” by Stephen Hicks, June 19, 2018

The New York Times, ” Ideas & Trends: The Strain of Caring for the Littlest AIDS Victims” by Jane Gross, August 4, 1985

Shortly after MMWR description of five cases of Pneumocystis carinii pneumonia (PCP) among homosexual men in Los Angeles, additional cases of other life-threatening opportunistic infections and a malignancy, Kaposi sarcoma (KS), were reported to the CDC.

Upon learning of these first cases, the CDC formed the Task Force on Kaposi’s Sarcoma and Opportunistic Infections to begin surveillance and conduct epidemiologic investigations.  Despite budget constraints at the time, about 30 CDC officers and staff were assigned to the Task Force during the summer of 1981.  CDC Director William Foege, appointed epidemiologist James Curran to lead the task force.

The Task Force first worked to establish a case definition for surveillance and investigation of the outbreak.  Previously, KS was known as an infrequently-diagnosed cancer that was rarely life-threatening, typically occurring among elderly men.  The outbreak seemed to represent a new epidemiologic form of KS.

Between June 1, 1981, and May 28, 1982, CDC would receive 355 case reports of KS and/or serious opportunistic infections, especially Pneumocystis carinii pneumonia, occurring in previously healthy persons between 15 and 60 years of age. Of the 355, 281 (79%) were homosexual (or bisexual) men, 41 (12%) were heterosexual men, 20 (6%) were men of unknown sexual orientation, and 13 (4%) were heterosexual women.

Five states — California, Florida, New Jersey, New York, and Texas — accounted for 86% of the reported cases.

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Sources:

Centers for Disease Control and Prevention, “AIDS: The Early Years and the CDC’s Response” by James W. Curran, M.D., and Harold W. Jaffe, M.D., October 7, 2011

Global Health Chronicles, “Interview: Jim Curran,” video posted on YouTube on June 7, 2016

Morbidity and Mortality Weekly Report | Centers for Disease Control and Prevention, “Epidemiologic Notes and Reports Update on Kaposi’s Sarcoma and Opportunistic Infections in Previously Health Persons — United States,” June 11, 1982

Cosponsored by the National Cancer Institute and Centers for Disease Control and Prevention, the medical conference focused on Kaposi’s sarcoma and other opportunistic infections.  Researchers began to develop recommendations for further studies in epidemiology, virology, and treatment.

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Sources:

www.HIV.gov, “A Timeline of HIV and AIDS”

National Institutes of Health, “In Their Own Words: NIH Researchers Recall the Early Years of AIDS | Timeline (1981-1988)”

The mothers of at least three of the children disclosed that they used drugs and/or engaged in sex work.  Dr. Rubinstein recognized that the children were showing signs of the same illnesses affecting gay men, but his diagnoses were initially dismissed by his colleagues.

“This would ultimately prove to be the moment when AIDS emerged in the Black community, driven among men, women, and children by sexual contacts, injecting drug use, and mother-to-child transmission,” writes Michael Broder in his article for Positively Aware.

By 1987, pediatric AIDS cases would be on the rise, especially in New York and especially among minority groups.  Many babies would be orphaned, creating insurmountable challenges for social workers seeking foster care placements for them.

Although medical experts estimated the number of infected infants in the city to be as many as 3,000, the City of New York has only 241 recorded cases of pediatric AIDS by the end of 1987.  Of these cases, the racial breakdown was 59% Black, 32% Hispanic and 8% White.

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Sources:

Positively Aware magazine, “The Dawn of AIDS in 1981” by Michael Broder, May 30, 2021

The New York Times, “For Child With AIDS, Hospital Is Home” by Bruce Lambert, December 24, 1987

By this time, some researchers began to call the condition GRID (Gay-Related Immune Deficiency).  This terminology would have a negative influence on both the medical profession and the public, causing people to perceive the epidemic as limited to gay men.

This early misconception of the disease would have serious long-term consequences as it becomes evident that anyone could be infected with HIV, including women, heterosexual men, hemophiliacs, people who inject drugs, and children.

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Source:

www.HIV.gov, “A Timeline of HIV/AIDS”

Under the headline “New Homosexual Disorder Worries Health Officials,” the Times introduced its readers to “a serious disorder of the immune system” that had proved fatal in 136 people to date.

“It was colloquially referred to as GRID – ‘Gay Related Immune Deficiency’ or ‘Gay Related Immune Disease,’ as if there was something intrinsic about being gay that made people susceptible to it,” wrote Carla Tsampiras in The Conversation.

While the Times article identified 13 cases of the disease in heterosexual women, it went on to state, “Most cases have occurred among homosexual men, in particular those who have had numerous sexual partners, often anonymous partners whose identity remains unknown.”

Even once the disease was renamed HIV/AIDS, the stigmatization continued.  Early research elicited categories of people, referred to as “high-risk groups,” who were apparently at increased risk of having AIDS.  They were informally known as “the Four-H Club” — homosexuals, Haitians, hemophiliacs and heroin users.  Later, “hookers” were added to the list.

“As a result, AIDS avatars — such as The Homosexual, The Prostitute, and The Drug Abuser — were created, drawing on long histories of social and medical prejudice and othering of certain groups of people,” said Carla Tsampiras, Senior Lecturer in Medical Humanities at the University of Cape Town.  “The avatars drew on existing stereotypes and reinforced them, reflecting existing prejudices or social attitudes relating to sexuality, sexual orientation, race, class and gender.”

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Sources:

The New York Times, “New Homosexual Disorder Worries Health Officials” by Lawrence K. Altman, May 11, 1982

The Conversation, “AIDS: What Drove Three Decades of Acronyms and Avatars?” by Carla Tsampiras, June 4, 2015

The Sisters distributed 16,000 copies of Play Fair! during the San Francisco Gay & Lesbian parade in June 1982.

Written by Sister Florence Nightmare and Sister Roz Erection, who outside the Order were known as registered nurses Bobbi Campbell and Baruch Golden, Play Fair! was among the first guides promoting safe sex and raising awareness around sexually transmitted diseases.

The Sisters originated in 1979 with three gay men who wanted to combine radical politics, street theater, and high camp, according to Will Kohler.  Having obtained nuns’ habits from a community theater production of The Sound of Music, these men (a.k.a., Sister Vicious Power Hungry Bitch, Sister Missionary Position, and Sister Roz Erection ) turned heads as they strolled Castro Street on Easter Sunday.

By 1982, the Sisterhood had many members and promoted a lively campaign around sex-positivity through a combination of fundraising, community outreach and events.  With growing anxiety and concern around the spread of Kaposi’s sarcoma and other immune disorders among gay men, it was inevitable that the Sisters would incorporate AIDS awareness into its mission.

For over 40 years, the order of queer and trans nuns has been spreading its ministry across San Francisco, the U.S., and the world.  Each professed nun takes a religious name (usually irreverent and hilarious).  For example, cities, events and venues have been ministered to by Sisters Psychedelia, Hellen Wheels, Innocenta, Rhoda Kill, Lotti Da, and Hysterectoria.

Although originally founded as an “Order of Gay Male Nuns,” the group now includes gay, lesbian, bisexual, heterosexual, and transgendered men and women. Many of their rituals are influenced by Eastern religious practices and beliefs, as well as by Roman Catholicism. Their doctrine stresses universal joy and the expiation of guilt.

Members of the Sisters of Perpetual Indulgence who have died are referred by the Sisters as “Nuns of the Above.”

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Sources:

The Sisters Of Perpetual Indulgence, “Sistory”

The Abbey of St Joan, “Play Fair”

Back2Stonewall, “Gay History – April 15, 1979: San Francisco’s Sisters of Perpetual Indulgence Founded,” April 16, 2022

The Culture Trip, “Meet the Sisters of Perpetual Indulgence, San Francisco’s Order of Queer Nuns” by Deanna Morgado, July 3, 2019

GLBTQ Archive, “Sisters of Perpetual Indulgence” by Robert Kellerman, 2002

The CDC’s MMWR article is the first report of the AIDS-related condition of immunosuppression in patients with hemophilia who have no other known risk factors for AIDS.

By the time the MMWR article is published, two of the three subjects have died.

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Source:

Mortality and Morbidity Weekly Report, “Epidemiologic Notes and Reports Pneumocystis carinii Pneumonia among Persons with Hemophilia A,” July 16, 1982

CDC’s report, “Current Trends Acquired Immune Deficiency Syndrome (AIDS): Precautions for Clinical and Laboratory Staffs,” introduced precautions for medical personnel working with people exhibiting signs of AIDS.

The report noted that “airborne spread and interpersonal spread through casual contact do not seem likely.”

Those providing care to people with AIDS were advised the following:

1. 1. Extraordinary care must be taken to avoid accidental wounds from sharp instruments contaminated with potentially infectious material and to avoid contact of open skin lesions with material from AIDS patients.
   2. Gloves should be worn when handling blood specimens, blood-soiled items, body fluids, excretions, and secretions, as well as surfaces, materials, and objects exposed to them.
   3. Gowns should be worn when clothing may be soiled with body fluids, blood, secretions, or excretions.
   4. Hands should be washed after removing gowns and gloves and before leaving the rooms of known or suspected AIDS patients. Hands should also be washed thoroughly and immediately if they become contaminated with blood.
   5. Blood and other specimens should be labeled prominently with a special warning, such as “Blood Precautions” or “AIDS Precautions.” If the outside of the specimen container is visibly contaminated with blood, it should be cleaned with a disinfectant (such as a 1:10 dilution of 5.25% sodium hypochlorite (household bleach) with water). All blood specimens should be placed in a second container, such as an impervious bag, for transport. The container or bag should be examined carefully for leaks or cracks.
   6. Blood spills should be cleaned up promptly with a disinfectant solution, such as sodium hypochlorite (see above).
   7. Articles soiled with blood should be placed in an impervious bag prominently labeled “AIDS Precautions” or “Blood Precautions” before being sent for reprocessing or disposal. Alternatively, such contaminated items may be placed in plastic bags of a particular color designated solely for disposal of infectious wastes by the hospital. Disposable items should be incinerated or disposed of in accord with the hospital’s policies for disposal of infectious wastes. Reusable items should be reprocessed in accord with hospital policies for hepatitis B virus-contaminated items. Lensed instruments should be sterilized after use on AIDS patients.
   8. Needles should not be bent after use, but should be promptly placed in a puncture-resistant container used solely for such disposal. Needles should not be reinserted into their original sheaths before being discarded into the container, since this is a common cause of needle injury.
   9. Disposable syringes and needles are preferred. Only needle-locking syringes or one-piece needle-syringe units should be used to aspirate fluids from patients, so that collected fluid can be safely discharged through the needle, if desired. If reusable syringes are employed, they should be decontaminated before reprocessing.
   10. A private room is indicated for patients who are too ill to use good hygiene, such as those with profuse diarrhea, fecal incontinence, or altered behavior secondary to central nervous system infections. Precautions appropriate for particular infections that concurrently occur in AIDS patients should be added to the above, if needed.

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Source:

Mortality and Morbidity Weekly Report, “Current Trends Acquired Immune Deficiency Syndrome (AIDS): Precautions for Clinical and Laboratory Staffs,” November 4, 1982

In the MMWR article, “Epidemiologic Notes and Reports Possible Transfusion-Associated Acquired Immune Deficiency Syndrome (AIDS) — California,” CDC states that the infant was delivered via caesarian section on March 3, 1981 and received six blood transfusions over a four-day period.

It was subsequently discovered that the blood transfused to the baby came from a man who was infected with HIV.

“If platelet transfusion contained an etiologic agent for AIDS, one must assume that the agent can be present in the blood of a donor before onset of symptomatic illness and that the incubation period for such illness can be relatively long,” stated the CDC report in an editorial note.  “This model for AIDS transmission is consistent with findings described in an investigation of a cluster of sexually related AIDS cases among homosexual men in southern California.”

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Source:

Mortality and Morbidity Weekly Report, “Epidemiologic Notes and Reports Possible Transfusion-Associated Acquired Immune Deficiency Syndrome (AIDS) — California,” December 10, 1982

Ward 86 becomes the gold standard for treating patients living with HIV/AIDS.

The clinic attracted staff passionate about treating people with AIDS.  Over time, the clinic team developed the San Francisco Model of Care, which focused on treating patients with compassion and respect; providing an array of health and social services in one facility; and collaborating closely with the local health department and community organizations.

Founded by AIDS pioneers Drs. Paul Volberding, Donald Abrams and Constance Wofsy, the clinic would see thousands of patients annually, ranging in age from 18 to 82, in the coming years.

In June 1983, the inpatient HIV unit, 5B, would also open at San Francisco General Hospital.

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Sources:

University of California San Francisco, “SFGH’s Ward 86: Pioneering HIV/AIDS Care for 30 Years” by Tristan Cook, June 7, 2011

Bay Area Reporter, “Hospital’s HIV/AIDS Division Marks 25th Anniversary” by Seth Hemmelgarn, November 27, 2008

San Francisco Chronicle, “SF AIDS Ward 86 – 25 Years of Saving Lives” by Elizabeth Fernandez, December 1, 2008

“Epidemiologic Notes and Reports Immunodeficiency among Female Sexual Partners of Males with Acquired Immune Deficiency Syndrome (AIDS) — New York” includes the first cases of AIDS in women participating in a research study.

The MMWR article described the cases of two women who were sexual partners of men diagnosed with AIDS.

In one case, a 37-year-old Black woman began losing weight in June 1982 and had developed oral candidiasis and swollen lymph nodes a month later.  Tests revealed she had Pneumocystis carinii pneumonia (PCP), as well as lymphopenia and a depletion of T-helper cells.  She said she was not an intravenous drug user, but her sexual partner since 1976 had a history of IV drug abuse.  The woman’s partner died of AIDS in November 1982.

In the second case included in the report, a 23-year-old Hispanic woman developed swollen lymph nodes in early 1982.  Tests showed she had elevated immunoglobulin levels, lymphopenia, decreased T-helper cell numbers, and a depressed T-helper/T-suppressor cell ratio.  She had no previous illnesses or therapy associated with immunosuppression.  Since the summer of 1981, her only sexual partner was a bisexual male who had developed AIDS-related symptoms in 1981.

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Source:

Mortality and Morbidity Weekly Report, “Epidemiologic Notes and Reports Immunodeficiency among Female Sexual Partners of Males with Acquired Immune Deficiency Syndrome (AIDS) — New York,” January 7, 1983

In the Morbidity and Mortality Weekly Report (MMWR) issued on this date, the U.S. Centers for Disease Control and Prevention (CDC) pointed to four distinct groups of people in the U.S. who were “at increased risk for developing AIDS.”  According to the CDC, those groups were:

• homosexual men with multiple sexual partners,
• hemophiliacs,
• abusers of intravenous drugs (i.e., heroin), and
• Haitians (“especially those who have entered the country within the past few years”)

The groups in the report titled “Current Trends Prevention of AIDS: Report of Inter-Agency Recommendations were henceforth cited in every new medical article and media report, resulting in a stigmatizing association with AIDS for people who identified with any of these groups.

Many in the gay community co-opted the information, referring to it as “the 4H Club,” a sly redefining of its original meaning as a long-standing agricultural youth group.

The MMWR was published at a time when no effective treatment or cure for AIDS was available.  People diagnosed with AIDS often had a few years — and sometimes just a few months — left before the disease would kill them.

Two months after this MMWR, the French virologist Luc Montagnier and his team at the Pasteur Institute in Paris would announce their discovery of the virus that causes AIDS.  But at the time of this MMWR report, top U.S. researchers were still baffled by the disease and following leads that suggested that the deterioration of the immune system in AIDS patients was caused by a biological substance, likely passed from one person to another through blood.

“Available data suggest that the severe disorder of immune regulation underlying AIDS is caused by a transmissible agent,” the CDC states in its report.

The CDC goes on to recommend that members of high-risk groups refrain from donating blood or plasma.

“As long as the cause remains unknown, the ability to understand the natural history of AIDS and to undertake preventive measures is somewhat compromised,” the CDC report states.  “However, the above recommendations are prudent measures that should reduce the risk of acquiring and transmitting AIDS.”

Then the director of the National Institute of Allergy and Infectious Diseases, Dr. Fauci led a presentation that summarized what was currently known about AIDS.

The presentation’s corresponding paper was co-authored by Dr. Fauci with Abe Macher, M.D.; Dan Longo, M.D.; H. Clifford Lane, M.D.; Alain Rook, M.D.; Henry Masur, M.D.; and Edward P. Gelmann, M.D.  Among the conclusions the researchers made were:

– The cause AIDS was unknown but likely due to “a transmissible agent, most likely a virus.”

– AIDS was spread “by sexual contact, particularly homosexual activity.”

– Blood-borne transmission was “the other major recognized form of spread of the disease.”

– It was “highly likely” that the disease could not readily spread through casual, nonsexual, non-blood-borne routes.

The paper considers the possibility that the disease may kill all who are infected with it, and calls it “one of the most extraordinary transmissible diseases in history.”

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Source:

Annals of Internal Medicine | American College of Physicians, “Acquired Immunodeficiency Syndrome: Epidemiologic, Clinical, Immunologic, and Therapeutic Considerations” by Anthony S. Fauci, M.D., Abe M. Macher, M.D., Dan L. Longo, M.D., H. Clifford Lane, M.D., Alain H. Rook, M.D., Henry Masur, M.D., Edward P. Gelmann, M.D., January 1, 1984

In response to growing concerns about the potential for AIDS transmission in healthcare settings, CDC publishes occupational exposure precautions for healthcare workers and allied health professionals.

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Source:

At the workshop, researchers collaborated to develop recommendations for research on the epidemiology and natural history of AIDS, and exchange information and educate clinical investigators about epidemio logical study design.

Held over two days, the workshop featured several panel discussions and lectures, including “Summary of Epidemiological Research on AIDS Supported by the NIH” by Robert Edelman, MD, Clinical Professor of Medicine and Pediatrics, University of Maryland School of Medicine.

* * * * * *
Source:

WHO’s meeting in Geneva marked the first time health officials representing countries from around the world met to share knowledge on risk factors, possible causes, and the clinical and immunological picture of potential spread of the new disease.  Up until that point, only regional meetings of surveillance groups and researchers had convened in the U,S, and Europe to assess the problem and to exchange information, according to The Fourth Ten Years of the World Health Organization.

From the inaugural meeting on AIDS, preliminary recommendations were issued for prevention, diagnostic and screening tests, and clinical management of cases.  Health officials also proposed areas of research and agreed to open a WHO center in Paris to coordinate global surveillance of the disease.

Following the meeting, WHO began reporting on AIDS cases and shared information through its publications about disease patterns, the risks of acquiring the disease, and methods of prevention and control.

Heckler also announces the development of a diagnostic blood test to identify HTLV-3 and expresses hope that a vaccine against AIDS will be produced within two years.

Dr. Gallo and his research colleagues developed a process to mass-produce the retrovirus for the purpose of developing the tools needed to identify, treat and cure the disease that has afflicted more than 4,000 Americans to date.

The announcement follows the announcement by the Pasteur Institute in Paris of its discovery of LAV, which they say causes AIDS.

Heckler said she thought the two viruses ”will prove to be the same.”

The conference brought together AIDS researchers conducting studies on the human immunodeficiency virus (HIV), which was then a new discovery.

At the time, no effective antiviral drugs for HIV/AIDS existed and research subjects typically died of AIDS-related illnesses within 10 years of infection with the virus.  Researchers worldwide were scrambling to find a way to stop the AIDS virus from replicating within the body, according to the National Institutes of Health’s website for its Cancer Research Center.

The 1983 discovery of the AIDS virus by Luc Montagnier, M.D. at the Pasteur Institute in Paris (which was confirmed in 1984 by Robert Gallo, M.D. of the U.S. National Cancer Institute) had researchers all over the world searching for an effective treatment and cure to counter the quick spread of the new disease.  Still more scientists were engaged with developing a vaccine for HIV — something that still eludes them to this day.

In December 1984, scientists at the forefront of this research gathered in southern California to try to answer the life-and-death questions of the day:

• Was HIV alone responsible for AIDS, or was it activated by a combination with other factors in the way that other viruses — like Epstein-Barr virus or Cytomegalovirus — did.
• What was the relationship of HIV to Kaposi’s sarcoma (since Kaposi’s sarcoma in AIDS could not be explained on the basis of the underlying immune deficiency)?
• Where and how did the virus originate?
• What were the clinical, cellular, and/or serological markers that determined the outcome of HIV infection?

Conference presentations also included work on identifying characteristics of early-stage AIDS and various treatment theories, and the specific ways in which HIV and AIDS exhibited in infants.

The Los Angeles Times covered the conference in its “Orange County” section under the headline “AIDS May Not Always Kill, Experts Report at Conference.”

A positive result on ELISA (an enzyme-linked immunosorbent assay) must be confirmed by a second test for a person to receive a definitive diagnosis of HIV infection.

Today, many single-test options are available to test for HIV (Human Immunodeficiency Virus), including an FDA-approved, at-home test called OraQuick.  Approved in 2012 for sale to anyone age 17 and older, the OraQuick In-Home HIV Test tests fluid from the mouth and delivers results in 20 to 40 minutes.  The kit does not require sending a sample to a lab.

HIV screening is covered in the U.S. by health insurance without a co-pay, as required by the Affordable Care Act.  Some testing sites offer free tests for those without medical insurance coverage.

The FDA still regulates the tests that detect infection with HIV.  An estimated 1.1 million people in the U.S. are living with HIV, and about one in seven don’t know they have it, according to the CDC.

The CDC recommends that everyone between the ages of 13 and 64 years old be screened for HIV at least once as part of their routine health care. More frequent testing is recommended for people who have a higher risk of infection because of behaviors such as having sex without condoms, having sex with multiple partners, or injecting drugs using shared needles.

The CDC, which began investigating the mysterious and often-fatal disease in 1981, initially identified Haitian immigrants, intravenous drug users, hemophiliacs, and homosexual or bisexual men as groups at high risk for HIV/AIDS.

The CDC’s weekly reports of AIDS statistics included all four groups, but starting in April 1985, Haitians were no longer included as a separate listing.

The April 1985 report cited a total of 9,405 cases of AIDS reported in the U.S.  Of those cases, 285 (about 3%) were Haitians, said Dr. Walter Dowdle, director of the Center for Infectious Diseases. Previously the rate for Haitians had been as high as 5%. By contrast, about 75% of the cases were of males who identified as homosexual or bisexual.

”The Haitians were the only risk group that were identified because of who they were, rather than what they did,” he said.

The CDC’s Morbidity and Mortality Weekly Report recommends that HIV-infected women delay pregnancy until more is known about the risks of transmission, and advised new mothers to avoid breastfeeding.

Transmission of the virus during pregnancy or labor and delivery is demonstrated by two reported AIDS cases occurring in children who had no contact with their infected mothers after birth.

With studies on the subject of pediatric AIDS just beginning, the rate of perinatal transmission of HIV from infected pregnant women is unknown and the limited amount of available data suggests a high rate.

However, the report contends that perinatal transmission (from an infected mother to her newborn) is not inevitable.

Of three children born to women who became infected with HIV by artificial insemination from an infected donor, all were in good health and negative for antibody to the virus more than 1 year after birth.  Another child, born to a woman living with AIDS, was HIV-negative and healthy at birth and at 4 months of age.

In December 1985, a total of 217 cases of AIDS have been reported among children under age 13, and 60% of them have died.

The meeting’s main conclusion was that the risk of transmitting HIV by factor VIII or factor IX concentrates, commonly used to treat hemophilia, could be reduced or eliminated with proven methods of screening for HIV antibodies and inactivation, according to The Fourth Ten Years of the World Health Organization.

The meeting, which included scientists from 15 countries, also presented goals for WHO’s Program on AIDS, including the creation of a global surveillance system to monitor HIV infection as well as deaths from AIDS-related illness.

Representing the U.S. were Kenneth J. Bart, M.D., the health director for the U.S. Agency for International Development; William C. Bartley, the international health attaché for the U.S. Mission to the United Nations; and Walter R. Dowdle, Ph.D., director of infectious disease at the Centers for Disease Control and Prevention, according to the meeting report.

Created by the Robert Wood Johnson Foundation, the AIDS Health Services Program seeks to replicate Ward 86’s San Francisco Model of HIV Care nationwide — but with an emphasis on tailoring programs to meet the needs in local context.

The goals of the program are to develop community-based services for persons with AIDS and to determine factors that facilitate or impede service.

The foundation starts with nine projects located in 11 communities: Atlanta, Dallas, Fort Lauderdale, Miami, Nassau County (NY), New Orleans, Newark, Jersey City, Seattle, and West Palm Beach.

The AIDS epidemic in each site varies substantially.  Lack of health insurance represents a problem for the majority of clients in states having the most restrictive Medicaid policies (Atlanta, New Orleans, and Dallas) and in communities where a large proportion of clients enter the program before their condition progresses to AIDS (Miami, Fort Lauderdale, and West Palm Beach).

Between 1987 and 1990, the average annual population with AIDS in program sites increase 126% (with increases ranging from 91% to 175%). During that period, the average increase in the number of persons alive with an AIDS diagnosis in these eleven cities is 191%, ranging from 181% to 257%.

The men and women attempting to build a network of coordinated services for persons with HIV/AIDS find themselves with an extremely difficult task.  As the epidemic progresses, there is a substantial increase in the scope of the epidemic as well as change in the racial, sex, and risk-group composition of HIV-infected persons.

Program staff have to cope with confusing state and federal policy, complicated by changes in medical treatment and in the conceptualization of AIDS. In 1986, AIDS is still perceived as an acute, fatal illness, and policies for expanding terminal care benefits are the focus of discussion. However, soon the focus would shift to early intervention and ongoing treatment programs for a new chronic disease.

The report, titled Perspectives in Disease Prevention and Health Promotion: Public Health Service Guidelines for Counseling and Antibody Testing to Prevent HIV Infection and AIDS, reflects the strong stance by the CDC against the unauthorized disclosure of personal information and inappropriate discrimination against those who seek to be tested.

Per the guidelines, health agencies should endeavor to provide ready, confidential access to HIV testing to those most at risk of HIV infection.

As examples, the report cites programs offering counseling and testing to gay men, IV-drug users, persons with hemophilia, the sexual and/or needle-sharing partners of these persons, and patients of sexually transmitted disease clinics.

The report also addresses the issue of false-positive HIV test results and its impact, stating that most false-positives are due to human error and more precautions should be used by medical personnel to ensure the accuracy of results.

“All laboratories should anticipate the need for assuring quality performance of tests for HIV antibody by training personnel, establishing quality controls, and participating in performance evaluation systems,” the report advises.

In a response to reports that some doctors are refusing to treat patients who are HIV-positive , the AMA advises physicians that it is unethical to deny care in such situations if the care required is within the doctor’s normal range of practice.

AMA ethics council also tells physicians that if a patient carrying the AIDS virus refuses to discontinue dangerous sexual practices, a doctor should notify public health authorities and even take it upon himself to directly inform individuals who may be in danger of infection.

The new AMA strictures conflict with California law, under which it is illegal for a doctor, without the patient’s consent, to tell anyone a person has tested positive for the AIDS virus or has AIDS.

The AMA states that no evidence exists that large numbers of doctors have refused to treat patients who tested positive for the AIDS virus.

But an AMA spokesperson concedes, “There have been physicians who have chosen to make public statements that they will not treat HIV-positive people. Those statements have generated tremendous amounts of discussion and debate.”

In the study, published in the May issue of The Journal of the American Dental Association and reported widely in the media, the researchers tested saliva from three healthy men aged 35, 40 and 42. Researchers determined that the subjects were not infected by HIV and they were not known to be at high risk of infection.

The researchers said the finding might help explain why no cases have been documented in which the AIDS virus was transmitted from person to person through saliva.

The research was led by Philip Fox, M.D., who cautioned that the study results do not eliminate the possibility of HIV infection from oral sex or deep kissing.  Dr. Fox explained that the virus could enter the bloodstream through cuts in the mucous membranes that line the mouth or it might be able to infect cells on the surface of mucous membranes.

In 1999, researchers at the University of Texas Medical Branch at Galveston would conduct a study that confirmed the results of the 1988 research.

UT researchers Samuel Baron, Joyce Poast and Miles W. Cloyd sought to confirm the results of Fox’s 1988 study and subsequent studies that showed that proteins in saliva seem to neutralize or disable the AIDS virus, Published in the Archives of Internal Medicine, the UT study would indicate that saliva inactivates more than 90% of the HIV-infected blood cells by breaking the virus apart into non-infectious components.

NIH established the Office of AIDS Research (OAR), which then launched the AIDS Vaccine Evaluation Group (AVEG) to oversee the first study of an experimental AIDS vaccine.

At the time, researchers and the medical community were hopeful that a vaccine would be quickly developed and rolled out to the general public.  But in spite of the optimism expressed by many, Dr. Anthony Fauci published a Public Health Report that warned that developing a HIV vaccine would be difficult.  Dr. Fauci listed the following as issues that complicate the development of an effective AIDS vaccine:

– the lack of “an appropriate animal model for AIDS,”

– the absence of a defined protective immune response in persons infected with HIV,

– the long latent period between initial infection and the development of symptoms,

– the existence of multiple strains of HIV, and

– the spread of HIV by way of cell-associated virus.

“When HIV was discovered and established as the cause of AIDS in 1983–1984, many people believed that a vaccine would be easily developed and rapidly deployed.  After all, vaccinologists had been very successful in developing vaccines for a whole range of viral diseases,” José Esparza of the Bill and Melinda Gates Foundation wrote in 2013.  “However, the paradigm that allowed the development of most existing viral vaccines, which is based on the recreation of the protective immunity that develops after natural infection, does not work in the case of HIV.”

By 2003, the first wave of vaccine trials would end in negative results and failure.

Still today, scientists continue their quest to develop a vaccine.  Extensive studies are underway to determine how HIV is able to avoid the immune responses spurred by vaccines.  In an article for the Association of American Medical Colleges, David Diemert, M.D. explained the challenge.

“From the very second HIV infects a person, it starts to escape from the immune response,” said Dr. Diemert, clinical director of vaccine research at the George Washington University School of Medicine and Health Sciences.

Dr. Joseph Sonnabend, Callen’s doctor, would later write about treatment to prevent PCP with “a drug that had been known to prevent this kind of pneumonia since 1977.”

The doctor would blame NIH Director Dr. Anthony Fauci for the delay in this treatment being available on a widespread basis, saying that Dr. Fauci “wanted data from a clinical trial of Bactrim for PCP prophylaxis in AIDS before he would recommend its use.”

Dr. Sonnabend says he refuses to wait for the NIH to collect data and reach its conclusions, revealing that he is already prescribing Bactrim (also known as Septra, Septrin or co-trimoxazole) and Dapsone to patients he routinely deems to be at risk for PCP, with positive results in his patients.

Years later, looking back at this time, Dr. Sonnabend would write:  “People were dying of PCP at a terrifying rate; I and some other physicians could not wait for these recommendations.”

The guidelines recommend a regimen of two compounds to prevent the onset of PCP: trimethoprim-sulfamethoxazole and pentamidine.  The CDC bases its recommendations on a study of 60 adults living with AIDS, which suggest that those who received treatment have fewer episodes of PCP and lived longer, compared with untreated patients.

Trimethoprim-sulfamethoxazole, a combination of the antibiotics sulfamethoxazole and trimethoprim, commonly causes side effects in patients that include nausea, vomiting, diarrhea, and loss of appetite.

Pentamidine, given as an aerosol in a nebulizing device, commonly causes adverse effects including coughing, difficulty breathing, difficulty swallowing, and chest pain or congestion.

The Public Health Service recommends physicians to start this treatment with:

• any HIV-infected adult patient who has already had an episode of PCP, and
• those whose CD4+ cell count is less than 200/mm3 (or less than 20% of total lymphocytes).

CD4+ cells would soon be referred to as “T-helper” or “T4 cells,” because one of their main goals is to send signals to other kinds of immune cells, which then destroy infectious particples.

Patients with CD4+ cell counts of less than 100/mm3 (or less than 10%), as well as patients with oral thrush or persistent fever, are at particularly high risk for PCP, the report states.

According to HIV.gov, a healthy T cell count should be between 500 and 1,600 T cells per cubic millimeter of blood (cells/mm3).

In a front-page article by Gina Kolata in The New York Times, Dr. Fauci calls for a new system that would allow patients far greater access to experimental drugs.

This marks a major turnaround in government policy, which restricts access to experimental drugs with the reasoning that patients would have no reason to join a clinical trial if they could get a drugs by other means.

In a column by Victor F. Zonana, the LA Times publishes newly released data that indicate that AIDS cases and deaths are rising dramatically and reaching new populations.  New cases recorded between January and November 1989 (the most recent months data was available) of full-blown AIDS in Los Angeles County totaled 2,274, up 28% from a year earlier.

In addition, planning documents for LA County estimated that by 1992, the cumulative total number of cases would more than double, to at least 19,000, and could rise to as high as 44,000 cases.

Zonana, the LA Times columnist, posed the question:  “Will [LA County] go the way of San Francisco, widely praised as a model of compassionate and cost-effective AIDS care?  Or will Los Angeles resemble New York City, the third major center of the epidemic, where people are dying in the streets as the unchecked spread of the virus among drug addicts fills public and private hospitals beyond capacity?”

Zonana wrote that one of the unique challenges facing the LA community was the large population of Latinos, some of whom were undocumented and disconnected from health services, and the potentially adverse impact of Roman Catholic Church’s unyielding stand against the use of condoms.

Torie Osborn, then-director of the Gay and Lesbian Community Services Center (now the Los Angeles LGBT Center), expressed her concerns that members of the Latino community were particular at risk of HIV infection as a result of these church teachings.

“In the past two months, our clinic has found 45% (infection rates) among gay and bisexual Latinos,” said Osborn, compared to 17% among Anglo gays.  “The figure just leaps out at you … it is really alarming.”

The following are selected AIDS statistics through Sept. 30, 1989 for New York, Los Angeles and San Francisco, the three major centers of the epidemic which together accounted for 34.5% of the nation’s AIDS cases.

The data shows that Los Angeles has more than twice as many female cases and three times as many pediatric cases as San Francisco, even though its total caseload is only 11% higher.

New York

Total cases: 22,571
Total deaths: 12,246
Children under 13: 536
Adult women: 2,934
Gay/bisexual contact: 10,916
Heterosexual IV drug use: 6,166
Reported new cases: 4,081
Year-to-date Total White cases: 39%
Year-to-date Total Black cases: 33%
Year-to-date Total Latino cases: 27%
Projected net municipal outlay*: $229.6 million

Los Angeles

Total cases: 8,063
Total deaths: 5,306
Children under 13: 70
Adult women: 244
Gay/bisexual contact: 6,474
Heterosexual IV drug use: 325
Reported new cases: 1,928
Year-to-date Total White cases:65%
Year-to-date Total Black cases: 16%
Year-to-date Total Latino cases: 18%
Projected net municipal outlay*: $20.5 million

San Francisco

Total cases: 7,277
Total deaths: 4,706
Children under 13: 22
Adult women: 91
Gay/bisexual contact: 6,164
Heterosexual IV drug use: 159
Reported new cases: 1,458
Year-to-date Total White cases: 82%
Year-to-date Total Black cases: 7%
Year-to-date Total Latino cases: 8%
Projected net municipal outlay*: $19.9 million

*for AIDS prevention and care, current fiscal year; does not include private contributions, state and federal expenditures or payments from private insurers.

The sources for the LA Times data were the Department of Geography, California State University, Northridge and Los Angeles County Department of Health Services.

The CDC reports that from 1988 to 1989, AIDS cases caused by heterosexual transmission jumped 36%.  Of the infected heterosexuals who are women, many give birth to infants who are also infected.

”The heterosexual epidemic is no myth,” Dr. Jerome Groopman, head of the AIDS program at Harvard’s New England Deaconness Hospital, told The New York Times.  ”It is real.”

According to the CDC, about 128,319 cases of fully symptomatic AIDS were reported from 1981 through March 1990. Of those, CDC officials estimate that about 6,231 — 5% — have been cases in which the disease was transmitted by heterosexual sex.

The NYT article noted that federal statistics likely reflect an undercount of heterosexual transmission of AIDS, because the CDC’s reporting system is ”hierarchical,” meaning that AIDS cases were attributed to homosexual sex, intravenous drug use and all other risk categories first. Only those that did not fit into these categories were put in the “heterosexual transmission” category.

Thomas C. Quinn, an AIDS researcher at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, told the NYT that there is a rapid increase in heterosexually transmitted disease in several cities, especially those of the East Coast, including Newark, Philadelphia, Baltimore, Washington and Miami.

Dr. Quinn recently presented a paper at an AIDS conference at Johns Hopkins University, where he and his colleagues described syphilis as one of the key factors in spreading AIDS among heterosexuals in the inner city.

The NIAID researchers studied 4,863 patients in two inner city clinics in Baltimore that treat sexually transmitted diseases. Among the heterosexuals who said they did not use intravenous drugs, those who had syphilis were seven to nine times more likely to have AIDS than other patients at the clinic.

In December 1988, NIAID launched the Heterosexual AIDS Transmission Study (HATS) to collect data on male and female heterosexuals at high risk of AIDS who are not IV drug users.

The CDC report described what it considered to be the first known case of clinical transmission of HIV:  Kimberly Bergalis, a 19-year-old college student, underwent a molar extraction in December 1987.  About two years later, she tested positive for HIV and the CDC was able to match the virus’ strain to that of her dentist, Dr. Jeffrey Acer.

Dr. Acer, would be vilified in the press, even in the years following his death in September 1990.  He would be openly called a lunatic and a murderer, and accused of deliberately infecting his patients — which was in no way supported by facts.

Reported to the CDC by the Florida Department of Health and Rehabilitative Services (HRS), the case described Bergalis — who said she had never engaged in sexual intercourse — as having no identified risk factor for HIV infection and that, at some time following a wisdom tooth extraction performed by Dr. Acer, she became infected with HIV.

In an open letter to his patients, Dr. Acer wrote: “I am a gentle man, and I would never intentionally expose anyone to this disease. I have cared for people all my life, and to infect anyone with this disease would be contrary to everything I have stood for.”

The CDC suggested that during the dental procedures, “higher titers of virus may have been present in the dentist’s blood and he may have been more likely to transmit virus than earlier in the course of his HIV disease.”

Following the notification, two more of Acer’s former patients would test positive with a strain similar to his.  In addition, a third infected patient would be identified by the Florida health department and a fourth would contact the CDC directly to report that she was HIV-infected and a former patient of the dentist.

The Florida health department would then reach out to 1,100 additional persons who potentially were patients of Dr. Acer to offer counseling and HIV-antibody testing.  Of them, 141 were tested, and all results were negative.  In addition, none of the dentist’s 14 employees tested positive for HIV.

Staff members of the dental office told HRS officials that barrier precautions had been introduced into the practice by early 1987 and that all staff, including the dentist, wore latex gloves and surgical masks for patient-care activities. Staff reported that they changed gloves and washed their hands between most patient contacts; occasionally, however, they washed gloves rather than changed them between patient contacts.  Additionally, staff reported that by 1987, all surgical instruments were autoclaved.

Dr. Acer was diagnosed with symptomatic HIV infection in late 1986 and AIDS in September 1987.  While he was in practice, he had no record of peripheral neuropathy, dementia, thrombocytopenia or other bleeding disorder, hand dermatitis, or injury.

Dr. Acer closed his practice in 1989 after his T-cell (CD4 lymphocyte) count dropped under 200.  He would die on Sept. 30, 1990 at the Hospice of Palm Beach County at West Palm Beach with his parents at his side.

Kimberly Bergalis would spend her final years advocating for the mandatory testing of medical professionals.  She is described as “the one AIDS patient the AIDS community will not embrace, a frightening and hostile new public symbol of an epidemic the AIDS community thought it had tamed.”

Larry Gostin, professor of health law at Harvard University, would tell The Washington Post in September 1991, “What Kimberly Bergalis symbolizes is … that AIDS is to be feared and that it can be contracted easily in health-care settings. She has created fear.”

Still, Bergalis became a sympathetic victim to many, and would go on to testify to Congress in a 20-second statement that became the world’s headline:

“I’d like to say that AIDS is a terrible disease that you must take seriously. I did nothing wrong, yet I’m being made to suffer like this. My life has been taken away. Please enact legislation so that no other patient or health care provider will have to go through the hell that I have. Thank you.”

Bergalis would die of AIDS-related illness on Dec. 8, 1991 at the age of 23.

A report from the Centers for Disease Control announces that HIV infection emerged in the 1980s as a leading cause of death in the U.S., and now HIV infection is the number one cause of death among men aged 25-44 years.

The CDC bases this assessment on data obtained from death certificates filed in all 50 states and the District of Columbia.  Statisticians suspect the magnitude is greater than indicated in the report.

The report also notes that HIV infection is more severely advancing to death for blacks and hispanics than other racial/ethnic groups.

“These differences probably reflect social, economic, behavioral, or other factors rather than race/ethnicity directly,” the report states.  “The social and cultural context of HIV infection must be addressed through prevention efforts designed to meet the needs of specific communities.”

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The Women’s Interagency HIV Study establishes a multi-center, prospective, observational cohort study of women living in the U.S. who are either HIV-infected or at risk for HIV acquisition.

The program would play an important role in the National Institute of Allergy and Infectious Diseases’ effort to understand the current epidemiology of HIV infection, disease progression, treatment use and outcomes, and related co-morbidities among U.S. residents with HIV.

Understanding differences in HIV disease and treatment outcomes between women compared to men, and in different racial and ethnic groups, is a critical public health goal.  The clinical research consortium is an integral part of the NIAID portfolio of research on HIV in women.

The guidelines follow a report to the CDC about a case of HIV transmission from a screened, antibody-negative donor to several transplant recipients.

Titled, Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs. the report seeks to reduce “the already low risk of HIV transmission by transplantation of organs and tissues.”

FDA says the test, which uses fluid from the mouth instead of blood, will be available only from doctors and will be administered only by people trained to do so.

“As long as a positive test is followed up with a blood test and as long as there is appropriate counseling available, it is a reasonable thing to do,” Dr. Jeff Lawrence tells The New York Times.  Dr. Lawrence is a consultant to the American Foundation for AIDS Research.

Studies show that for every 100 people infected with HIV, the oral-fluid-based test will miss one or two, and for every 100 people who are not infected, test results will be incorrectly positive for approximately two people.

In a precursor to a full report that would be published in the August edition of Clinical Infectious Diseases, the CDC announces that healthcare providers can prevent opportunistic infections in HIV-positive people by adhering to a set of guidelines.

The set of recommendations are rated according to the strength of the recommendation and the quality of evidence supporting the recommendation.  The guidelines address prevention techniques for adults, adolescents and children.

In the CDC’s Morbidity and Mortality Weekly Report, the total number of persons in the U.S. reported to have AIDS climbs to 501,310.

According to the report, the rates per 100,000 population for reported AIDS cases in 1994 are:

• 48 in the Northeast,
• 31 in the South,
• 29 in the West, and
• 13 in the Midwest

However, during 1988-1992 and 1993-October 1995, the largest numbers of cases (65,926 and 86,462, respectively) were reported from the South, which also accounted for the largest proportionate increase of reported cases (31%).

The first international AIDS conference in two years, the event is one of the more eagerly anticipated scientific meetings in years. Data on promising new drug treatments for AIDS, insights into the ways HIV infects cells, and the mechanisms of “host resistance” to that attack are scheduled to top the agenda.

Remarkable gains in using combinations of costly new and old drugs promise to slow the progression of AIDS and to allow many people infected with HIV to live longer and healthier lives, conference presenters announce to attendees.

With 15,000 delegates, journalists and commercial exhibitors in attendance, it is the largest conference so far.  The theme is “One World, One Hope.”

While it seems that AIDS may finally become a managable disease in developed countries, less developed nations are struggling to scrape together the resources to provide necessary treatment and services to people with HIV and AIDS.

Data would be released at the conference that estimate a total of 21.8 million people to be currently living with HIV/AIDS, the vast majority of whom live in developing countries.

Ending the 16-year incline of cases, 1996 data shows that AIDS-related deaths dropped 23% from 1995 to 1996.

Experts credit the downturn with the availability of aggressive new therapies that keep infected patients healthier, as well as the possibility that fewer people are becoming infected in the first place.

The positive trends do, however, mask a troubling development: cases among women and heterosexuals who do not use drugs, particularly minorities, are on the rise.

African-American women are particularly at risk. In 1994, officials at the Centers for Disease Control reported that black women were almost 15 times as likely as white women to test positive for HIV.

”My new cases among women are often young women, coming in with a first pregnancy who are being tested as part of that pregnancy and finding out that they are HIV-positive,” said Dr. Mary Young, who treats AIDS patients at Georgetown University here.

“The gay community has done a wonderful job of getting the message out. But I don’t know that we target young African-American women very well.”

Unlike other antibody tests for HIV, this blood test can be stored at room temperature, requires no specialized equipment, and may be used outside of traditional laboratory or clinical settings, allowing more widespread use of HIV testing.

The new test provides a result in about 20 minutes, while the fastest test currently in use takes 90 minutes.  In practice, however, most people who seek AIDS testing aren’t given their results for a week or more after they provide a blood sample.

The OraQuick Test requires that a person prick his finger and use a wire loop to capture a drop of blood. The drop is then put in a vial containing a diluting solution.

Then a paper tab attached to a cap is lowered into the solution. A dark line appears on the tab if it makes contact with certain universal blood proteins. If antibodies to HIV are present, a second dark line appears.

Public health officials are hopeful that the test will substantially increase the number of people seeking testing, and decrease the fraction who, once tested, never return for the results.

FDA announces that it has approved the 100th antiretroviral drug under the President’s Emergency Plan for AIDS Relief (PEPFAR).  Of the more than 100 products that have received either full or tentative FDA approval under the program, 29 are branded drugs and 71 are generics.

This achievement reflects a five-year-old regulatory process designed to fast-track the delivery of cheap HIV drugs to the developing world through the PEPFAR program.

The FDA process was launched in May 2004, in response to a call from activists, clinicians and members of Congress to use the WHO’s pre-certification drug list to make purchases of generic medications for PEPFAR-funded programs.  Instead, a process was devised to allow the FDA to certify generic antiretrovirals (ARVs) for PEPFAR purchase, even if the branded drug was still protected by U.S. patent laws.

HHS Secretary Kathleen Sebelius said in a statement, “This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS.”

In an article published in the scientific journal Philosophical Transactions B titled “The Evolution of HIV-1 and the Origin of AIDS,” researchers Paul M. Sharp and Beatrice H. Hahn demonstrated that HIV-1 can be traced via evolutionary comparisons to SIV-infected chimps and gorillas in west central Africa.

Sharp and Hahn described in their paper the four lineages of HIV-1 that resulted from cross-species transmissions from chimps (and possibly gorillas) to humans.  Their research was supported by grants from National Institutes of Health and the Bristol Myers Freedom to Discover program.

“The conclusion that HIV-1 was derived from a virus infecting chimpanzees is particularly interesting, because chimpanzees and humans are so closely related,” Sharp and Hahn wrote. “This raises a number of questions, such as the origin of the chimpanzee virus, whether adaptation of SIVcpz to infecting chimpanzees rendered the virus more capable of infecting humans and whether SIVcpz infection of chimpanzees is pathogenic.”

In the January 2000 article “AIDS as a Zoonosis: Scientific and Public Health Implications,” Sharp, Hahn and two additional researchers theorized how the virus was able to be transmitted from chimpanzees to humans.  Since transmission requires “exposure to infected blood and body fluids,” they propose that it was likely that infection in humans occurred during the practice of hunting and butchering chimps.  Even though the opportunity for chimp-to-human transmission existed for hundreds of years, the Congo in the early 20th Century, then under colonization by the Dutch, had a set of circumstances that for the first time allowed the virus to spread from humans to other humans.

Since workers in the bushmeat industry usually operated in a remote area in the southeast corner of Cameroon, Sharp and Hahn were able to identify this region as the likely location of the first notable spread of the disease.  Around 1920, HIV infections occurred in humans in “at least a dozen independent transmissions” from chimps.  From there, these infected people spread the virus as they travelled by the Sangha River to the largest city to the south, the Congolese capital city of Kinshasa (which was then under Dutch colonization).

“During the early part of that century, the destabilization of social structures by invading colonial powers, the origin and rapid growth of major conurbations, and the widespread use of injections may all have contributed to provide an unprecedented opportunity for dissemination of blood-borne viruses,” Sharp and Hahn wrote.

In October 2018, historian Thomas F. McDow would reference much of Sharp and Hahn’s research in an article for Origins delving into how the spread of HIV was linked to the socio-political impact from Africa’s colonization and the globalization of the economy in the early 20th century.

In “A Century of HIV,” McDow wrote:  “The story of HIV is a story of globalization. The expanding connections of the 20th Century spread the disease, yet the limitations and inequalities of global public health allowed the disease to ravage populations even after scientists discovered effective drug treatments.”

McDow credited research scientists with being able to pinpoint the origin of HIV from blood samples and a lymph node dating back to the late 1950s and stored in a Congolese laboratory.

“This virus began its career in humans at a time when the forests and riverine landscapes of Equatorial Africa became increasingly connected to the global economy,” McDow wrote.  “While the people who lived in these forests had traded and been connected to wider regional networks for a very long time, the scope and scale of these interactions changed at the end of the nineteenth and beginning of the twentieth centuries.”

In 1884, major European nations convened the Berlin Conference (also known as the Congo Conference), and determined which countries would control the trade routes in Central Africa, according to McDow.  Eight of the 14 countries represented at the conference — Germany, Belgium, Spain, France, the United Kingdom, Italy, Portugal, and the Ottoman Empire — set about laying claim to various African territories.

Under the control of European companies, the Sangha river basin became the world’s main producer of ivory and rubber.  To support their industry, the European colonists modernized the infrastructure of their territories and built links to previously unconnected regions.  Two towns on opposite sides of the Congo River, Kinshasa and Brazzaville, attracted Africans from remote parts of the continent with the promise of work and wages.

Meanwhile, Africans continued to live in impoverished conditions and workers were brutally exploited for decades, according to McDow.  As indigenous African workers began to rebel and refuse to accept to be treated poorly by the colonists, more wealth and opportunity began to come their way — but just a little.

“In the 1940s and 1950s, the creative energies of these towns produced the lively sounds of rumba, music inspired in part by Latin American sound and driven by the distinctive Congolese guitar playing,” wrote McDow.  “But the same venues and impulses that attracted the youth to hear people like Wendo Kolosoy croon ‘Marie Louise’ created conditions for the spread of the virus through heterosexual intercourse.”

During this time, records showing the uptick in sexually transmitted diseases like Hepatitis B suggests that HIV was also likely spreading during this time.  Then came the 1960s, a time hailed as “The African Decade” when people in the colonized territories fought for and won their independence.

The United Nations Education, Science, and Cultural Organization (UNESCO) and the Congolese government responded the region’s lack of skilled workers among its indigenous people by recruiting teachers and doctors to work in the Congo, according to McDow.  Belgians and Haitians made up the largest groups of expatriate professionals.

“While in Congo, however, some contracted HIV and subsequently returned home with the deadly, unknown virus,” he wrote.  “The earliest cases of HIV in the United States are connected to Haiti, and the Haitian-Congo link seems to have helped the disease cross the Atlantic.”

All of these events leading up to the June 1981 Morbidity and Mortality Weekly Report by The Centers for Disease Control are the “pre-history of AIDS,” according to McDow.

“Looking back, doctors can see that a small number of unexplained medical cases in the west … were early cases of AIDS,” wrote McDow.

Among these early cases are:

• In 1939-1959, cases of Pneumocystis pneumonia were reported in Western Europe in infants born prematurely.  Researchers state that the most likely cause was a retrovirus closely related to HIV (or a mild version of HIV) brought to Europe and originating from Cameroon, a former German colony. The epidemic started in 1939 along the German-Polish border in the Free City of Danzig and then spread to nearby countries, like Germany, Switzerland and The Netherlands, in the 1940s and 1950s.
• On June 28, 1959, Antonio Ardouin, a 49-year-old Jamaican-American shipping clerk, died in New York City of Pneumocystis carinii pneumonia. Gordon Hennigar, who performed the postmortem examination of the man’s body, found the case to be so unusual, he preserved Ardouin’s lungs for later study. Hennigar has been quoted as saying that he believes Ardouin likely died of AIDS.
• On May 15, 1969, Robert Rayford, a 15-year-old Black youth, died at St. Louis City Hospital with no immune system to fight the infection that ravaged his body for more than a year.  An autopsy revealed widespread Kaposi’s sarcoma, and a 1988 test of autopsy tissue specimens showed evidence of nine distinct HIV proteins.
• In 1976, Arvid Noe, a Norwegian sailor, died; it was later determined that he contracted HIV/AIDS in Africa during the early 1960s.  His wife and daughter also died of AIDS-related illnesses.
• On June 28, 1978, a Portuguese man known as Senhor José (“Mr. Joseph”) died.  Later confirmed as the first known infection of HIV-2, he was believed to have been exposed to the disease in Guinea-Bissau in 1966.
• In 1978-79, eight people from New York and San Francisco participated in a Hepatitis B virus study, and about 40 years later, their reconstructed blood samples tested positive for HIV.  A 2016 re-testing of samples from the Hep B studies identified five HIV cases from New York and three from San Francisco.  From their data, researchers estimate the virus’ entry into the U.S. at about 1970.  “You see a very telltale pattern of extensive genetic diversity in New York City, suggesting that New York City was the key hub of diversification for the virus,” researcher Michael Worobey told PBS News Hour in 2016.  ““Restricted genetic diversity in San Francisco, suggesting San Francisco was a later dispersal out of this New York City hub.”
• In 1979, a five-year-old girl died in New Jersey after suffering from symptoms of AIDS since birth; later her stored tissues tested positive for HIV-1.  The girl’s mother was described as an intravenous-drug user who had multiple male sex partners.
• On December 24, 1980, Rick Wellikoff, a Brooklyn grade-school teacher, died at the age of 37 of various infections that overwhelmed his immune system.  Strong evidence suggests that he died of AIDS.
• On January 15, 1981, Nick Rock, a New York City bartender and friend of Rick Wellikoff, died after months of suffering from seizures, heart attacks and Kaposi’s sarcoma.

Dr. Pépin, an epidemiologist and HIV/AIDS expert based in Quebec, traced the AIDS virus back to a single bush hunter in Central Africa in 1921.  He used medical reports and technical data dating back to France’s colonization of African territories to piece together the beginnings of a disease that would eventually leap from continent to continent and kill more than 40 million people worldwide.

“Either a hunter got injured with his knife when he cut out the ape to bring the carcass back to the village so that the chimp’s blood became in contact with his own blood, or the same type of accident occurred during the actual cooking of chimpanzee meat,” he said in an interview with Cambridge University Press, the publisher of his book.

“Three other potential modes of transmission from chimp to man, which have been proposed over the years, can now be rejected,” he added, “since there is nothing to sustain these other hypotheses.”

In a 2012 interview with medical journalist Mark Cardwell for the Canadian magazine University Affairs/Affairs University, Dr. Pépin said he got the idea for The Origins of AIDS in 2008 when he was at the Méditerranée Infection Foundation in Marseilles, France to research sleeping sickness in the Central African Republic.

“On my first day there, to my amazement, I suddenly understood, while looking at the health systems annual reports, the scope of the colonial-era public health interventions that required the administration of massive amounts of IV drugs over the whole of central Africa and throughout several decades,” he said.

Dr. Pépin told Cardwell it took four years to research and write The Origin of AIDS, and an additional year to edit the manuscript with the publisher.

“The book sheds new light on the pivotal role French colonialism played in spreading HIV from likely a single bush hunter infected with a simian immunodeficiency virus in central Africa in the early 1920s to large swaths of Africa and beyond,” Cardwell wrote in his 2012 article “The Story of the Origins of AIDS.”

Dr. Pépin’s book describes the conditions in turn-of-the-century French West Africa that created the ideal petri dish for a new disease.

At the Berlin Conference of 1884-1885, France was one of several European countries to lay claim to colonial territories in Africa.  In the decades to come, the urbanization of central Africa, inferior health policies, and the rise of prostitution all led first to the persistence of HIV in the population in the 1930s-1950s, and then eventually to its spread.

After about 50 years of managing an enterprise that involved extracting the area’s natural resources while ruling over its indigenous peoples, the French introduced a medical program in the 1930s that routinely used unsterilized syringes and employed other shoddy practices in the treatment of tropical diseases.  Dr. Pépin contended that these were the conditions in which HIV was able to take hold and then propagate.

In The Origins of AIDS, Dr. Pépin also explained how the construction of a railroad line across the African jungle resulted in the creation of sprawling government-run camps that were unsanitary and dangerous. Among the camp residents, according to Dr. Pépin, were health-compromised workers and prostitutes from across the colonial territories.

Dr. Pépin said he took research results from molecular biologists working under Beatrice H. Hahn, M.D. and scientists led by Michael Worobey, M.D., and used this to inform his own research drawn from colonial archives and European libraries.

“I conducted epidemiological studies which documented that several blood-borne viruses were indeed transmitted during several medical interventions in different parts of Africa,” Dr. Pépin said.

Dr. Pépin started his career in the early 1980s as a medical officer in a Zaire bush hospital.  After returning to Canada to complete his education in medicine, he returned to Africa as a clinical researcher at the Medical Research Council Laboratories in a tiny West African country called The Gambia.  This is where he began researching HIV and its interaction with sexually transmitted diseases.

“In the course of my investigations, I met most of the few hundred Senegalese prostitutes who charged their Gambian brothers rock-bottom prices for a few moments of pleasure,” Dr. Pépin wrote in the forward of the 2021 edition of The Origins of AIDS.

Using statistical approaches applied to HIV-1 sequence data from central Africa, the international team of researchers showed that from the 1920s, Kinshasa (formerly known as the Dutch-colonized city Leopoldstad) was the site of early HIV transmission.  The researchers validated their location and dating estimates by using the earliest HIV-1 archival sample, also from Kinshasa.

From Kinshasa, the virus spread in the early 1960s to other areas of the Congo via rail links, according to the report titled “The early spread and epidemic ignition of HIV-1 in human populations.”  HIV then spread from Africa to Haiti when Haitian teachers, brought to the Congo in the 1960s and 1970s to assist with Congolese independence, returned home.

An estimated 4,500 Haitians were in the Congo in the 1960s, and that number grew in the 1970s, according to Thomas F. McDow, a historian of Africa and the Indian World at the Ohio State University. .

From those early events, a pandemic was born.

The Science article references much of the work presented in “Phylogeny and the origin of HIV-1,” published in April 2001 in Nature by researchers Andrew Rambaut, David L. Robertson, Oliver G. Pybus, Martine Peeters, and Edward C. Holmes.

Authors of the 2014 Science article included Rambaut, Pybus and Peeters, as well as Nuno R. Faria, Marc A. Suchard, Guy Baele, Trevor Bedford, Melissa J. Ward, Andrew J. Tatem, João D. Sousa, Nimalan Arinaminpathy, Jacques Pepin, David Posada, and Philippe Lemey.

Subsequent data releases show that early therapy for people living with HIV also prevents the onset of cancer, cardiovascular disease, and other non-AIDS-related diseases.

It will provide data on the use of newer HIV medications during pregnancy, helping to ensure that women living with HIV and their infants receive the best available treatments.

The research shows that early and sustained ART reduces the onset of AIDS-defining cancers and — to a lesser degree — other cancers in HIV-positive people.

But the long-term study, which followed nearly 150,000 veterans over the years of 1999-2015, also found that the cancer risk for HIV-positive patients with long-term viral suppression still was greater than the risk of cancer for HIV-negative patients.

The simulations are consistent with 840,000 actual HIV DNA sequences contained in a global public HIV database, according to the study published in Nature Microbiology.

The simulations could allow state health departments to track the spread of HIV and provide a powerful new tool to help prevent new HIV infections.

“We looked for special genetic patterns that we had seen in the simulations, and we can confirm that these patterns also hold for real data covering the entire epidemic,” said Thomas Leitner, a computational biologist at Los Alamos and lead author of the study.

HIV is particularly interesting to study in this manner, Leitner noted, as the virus mutates rapidly and constantly within each infected individual.  The changing “genetic signatures” of its code provide a path that researchers can follow in determining the origin and time frame of an infection, and the computer simulations are now proven to be successful in tracking and predicting the virus’s movements through populations.

The study followed 3,700 MSM in New South Wales, Australia, who were taking PrEP with high levels of adherence.

As the first empirical study to test PrEP’s population-level effectiveness, the program found that HIV infections declined in the study cohort and also statewide in Australia’s most populous state, New South Wales.

The report concludes that rapid, targeted, high-coverage PrEP implementation is effective to reduce new HIV infections at the population level.

Less than a year later, Andrew Grulich, MD, head of the HIV Epidemiology and Prevention Program at the Kirby Institute at UNSW Sydney, would present follow-up data supporting the initial study at the 10th International AIDS Society Conference on HIV Science in Mexico City.

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The research project seeks to examine the safety and use of two HIV prevention tools — PrEP and a vaginal ring — for young women and girls under the title “REACH” (Reversing the Epidemic in Africa with Choices in HIV prevention).

One in four new infections in sub-Saharan Africa were women and girls aged 15-24 – despite making up 10% of the population.

“Women in less-developed countries disproportionately bear the burden in terms of ill health when facing food insecurity or a shock or disaster like drought that impacts the ability to get food or harvest food,” said Kelly Austin, associate professor of sociology at Lehigh University.

Essentially, lack of resources can lead to sexual assault, marriages of economic necessity and the resultant transmission of HIV.

Conducted for 1.5 years, the study would go on to show that the vast majority (97%) of the 247 participants used the vaginal ring and daily oral PrEP some or all of the time.  Fewer than 3% of participants would use neither of the products, according to laboratory tests for adherence.

“In many ways, these results exceeded even our own expectations, yet at the same time, it’s not surprising to find that these young women have the capacity and desire to protect themselves against HIV,” explains Gonasagrie (Lulu) Nair, MBChB, MPH, REACH protocol chair, Centre for Medical Ethics and Law, Faculty of Medicine, at Stellenbosch University in South Africa.  “They simply need to feel empowered and have the agency to make choices based on what they feel is right for them.”

Nina Martinez, 35, is the living donor. She donated her kidney to an anonymous recipient after the friend she had hoped to give it to died last fall. Martinez acquired HIV when she was 6 weeks old through a blood transfusion and was diagnosed at age 8.

“I wanted to show that people living with HIV were just as healthy.” Martinez says in a news conference held to announce the medical break-through. “Someone needed that kidney, even if it was a kidney with HIV. I very simply wanted to show that I was just like anybody else.”

Martinez first learned of the opportunity for her to donate a kidney in 2013, when the HIV Organ Policy Equity Act (HOPE Act) passed in Congress.  Yet, until she saw a storyline on the medical drama Grey’s Anatomy a few months later, she didn’t realize where her own life would intersect with kidney donation.

The HOPE Act was introduced on February 14, 2013, in the Senate by Sens. Barbara Boxer (D-CA), Tammy Baldwin (D-WI), Tom Coburn (R-OK), and Rand Paul (R-KY) and in the House by Rep. Lois Capps (D-CA).  The Senate passed the legislation by unanimous consent, and about six months later, the House passed it by unanimous consent.

The doctors at Johns Hopkins say the recipient is doing well.

“This is the first time someone living with HIV has been allowed to donate a kidney, ever, in the nation, and that’s huge,” says Dorry Segev, M.D., Ph.D., professor of surgery at Johns Hopkins.  “A disease that was a death sentence in the 1980s has become one so well-controlled that those living with HIV can now save lives with kidney donation — that’s incredible.”

The FDA’s approval of Cabenuva (cabotegravir and rilpivirine, in an injectable formulation) made it the first time an injectable, extended release, complete HIV treatment regimen was available in the U.S.

For many HIV-infected adults who were virologically suppressed on a stable antiretroviral regimen, Cabenuva replaced their daily oral antiretroviral regimen with a once-a-month injection.

“This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”

The FDA also approved Vocabria (cabotegravir, tablet formulation), which is taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with Cabenuva, according to the FDA. Patients in both trials continued to show virologic suppression at the conclusion of each study.  Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA.

In March 2022, the FDA would approve the use of Cabenuva for adolescents, extending the treatment option to HIV-infected people as young 12 years old, as long as they weigh at least 77 pounds and are already on a stable antiretroviral regimen, with no history of treatment failure, nor known or suspected resistance to either cabotegravir or rilpivirine

President Joe Biden, HHS Secretary Xavier Becerra, and Secretary of State Antony J. Blinken release messages recognizing the 40th anniversary. Other events and activities are held across the country to remember the lives that were cut short by this terrible disease and celebrate the resilience and dignity of the more than 38 million people with HIV worldwide.

On this day, the Foundation for The AIDS Monument held its ceremonial groundbreaking at the future site of STORIES: The AIDS Monument in West Hollywood Park.  Among the community members who attend the event is Dr. Michael Gottlieb, one of the authors of the June 1981 CDC report announcing the first five cases of an illness subsequently defined as acquired immunodeficiency syndrome (AIDS).

The five men described in the report were between the ages of 29-36 and resided in the Los Angeles area, and by the time the report was published, two had already died.  The relatively brief report gave scant information about this new medical phenomenon, including the following:

• The patients did not know each other and had no known common contacts or knowledge of sexual partners who had had similar illnesses.
• Two of the five reported having frequent homosexual contacts with various partners.
• All five reported using inhalant drugs, and one reported parenteral drug use (i.e., injected or implanted drugs).

Up until this day, the vaccines available in the U.S. — made by Pfizer and BioNTech, Moderna, and Johnson & Johnson — have been authorized on “an emergency basis” but had yet to be fully approved.

A fully approved COVID vaccine was particularly important to members of the HIV community, because people with HIV have higher rates of certain underlying health conditions, particularly if they are aged 50 or older.

Older age and underlying health conditions can make people more likely to become seriously ill if they get COVID-19, according to the Centers for Disease Control and Prevention. This is especially true for people with advanced HIV or people with HIV who are not on treatment.

While the CDC determined that COVID-19 vaccines are safe for people with HIV, concerns about the general safety of the vaccine were common.

The Pfizer-BioNTech vaccine, which was marketed as Comirnaty, was the first COVID-19 vaccination to receive full review and approval from the U.S. regulatory agency. The FDA would approve the vaccine’s use in children aged 5-11 the following October.

The company’s clinical trial included approximately 44,000 participants and found the vaccine to be 91% effective in preventing COVID-19 disease.

Comirnaty was developed from technology licensed from the National Institutes of Health, according to a U.S. government website.

“National Institute of Allergy and Infectious Diseases (NIAID) inventors and their collaborators had already developed a stabilized prefusion coronavirus spike protein that could be used as a vaccine antigen to cause neutralizing antibody responses,” stated the NIH in its feature on Comirnaty.  “NIH’s ongoing research allowed for BioNTech/Pfizer to quickly develop a vaccine and bring it to market based on NIH technologies.”

Previously, in December 2020, the Pfizer-BioNTech vaccine was granted emergency use authorization by the FDA in response to the public health emergency posed by the coronavirus pandemic. That authorization involved a review of safety data on over 37,000 participants in a randomized, placebo-controlled study.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Dr. Janet Woodcock, the then acting FDA Commissioner. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The FDA’s approval came amidst the spread of the highly contagious COVID-19 delta variant across the country. It also represented a turning point in U.S.’s response to COVID-19, as more private and public entities began instating vaccination requirements to stem the spread of COVID-19.

“The new vaccine was the result of months of work, robust data evaluation and a thorough, comprehensive review process that has protected more than 100 million Americans from severe COVID-19 complications,” said the American Medical Association in its newsletter.  “It is a milestone and major step forward in the worldwide effort to end this pandemic.”

Among those who adopted vaccine mandates for employees in the wake of the Pfizer-BioNTech vaccine’s FDA approval were the Pentagon and the New York City school system.

People infected with this variant were also found to undergo a twice-as-fast deterioration of their immune system, setting them on a course to potentially develop AIDS years earlier than people with other versions of HIV, according to a report in Science magazine released on this day.

HIV-1 virulence is most commonly measured by viral loads (the concentration of viral particles in blood plasma) and CD4 counts (the concentration of T cells).  Successful treatment of HIV-1 with antiretroviral drugs is indicated by the suppression of the viral load and interruption of the decline in CD4 counts that would otherwise lead to AIDS.

The study of the 109 individuals in the Netherlands with subtype-B HIV-1 found that the new variant carries more than 500 mutations scattered across its genome — though it was unclear how the mutations were able to manifest as a more severe form of the disease.

The study also finds that this variant still responds to current HIV treatments.

“Our discovery of a highly virulent and transmissible viral variant … emphasizes the importance of access to frequent testing for at-risk individuals and of adherence to recommendations for immediate treatment initiation for every person living with HIV,” wrote the lead researcher for the study, Chris Wymant, the senior researcher in statistical genetics and pathogen dynamics at the Oxford Big Data Institute.

Individuals with the variant were mostly men who have sex with men (82%), similar to non-variant HIV-positive individuals (76%). Age at diagnosis was also similar for variant and non-variant individuals; neither ethnicity nor host genotype data were available, but the place of birth was mostly recorded as Western Europe for both groups (71% for non-variant individuals, 86% for variant individuals).

A genetic sequence analysis conducted by the researchers indicated that the variant emerged some time in the 1990s from de novo mutation (an alteration as a result of a mutation on the cellular level), not recombination (the process by which chromosomes exchange genetic material).

While the variant spread quickly during the 2000s, its infection rate has been declining since around 2010 — probably as a result of the country’s access to life-saving treatment and efforts to curb HIV transmission, Wymant told Nature magazine.

The emergence of a more virulent form of HIV is “a reason to stay vigilant,” but it’s not a public-health crisis, according to Joel Wertheim, an evolutionary biologist and molecular epidemiologist at the University of California San Diego who spoke with Nature magazine.

Montagnier’s work on HIV made it possible for scientists to develop diagnostic tests and treatments that have saved countless lives.

Montagnier worked in several laboratories before landing at the Pasteur Institute in Paris in 1972, according to Heidi Ledford’s article in Nature magazine.   After developing an expertise in virology, he began to specialize in retroviruses, which are viruses with an enzyme capable of making a complementary DNA copy of the viral RNA, and then integrating it into the host cell’s DNA.

This knowledge made Montagnier the right researcher in the right place in January 1983, when a colleague sent him lymph node tissue taken from a French fashion designer thought to be in the early stages of AIDS.

When other scientists began releasing studies showing the depletion of a class of immune cells (CD4⁺ T cells) in people with AIDS, Montagnier took note.  He knew of a retrovirus that infected CD4⁺ T cells, and it was transmitted through blood and sexual activity.  He had a hunch that AIDS was caused by a retrovirus, too.

Working on Montagnier’s instincts, Françoise Barré-Sinoussi was able to isolate a new retrovirus from the lymph node biopsy.  It  was a major breakthrough for Montagnier’s virology unit at the Pasteur Institute — they had found the cause of AIDS.

Montagnier’s team — which called the viral isolates LAV, for Lymphadenopathy Associated Virus — published its research  results in Science magazine on May 20, 1983.  Four months later, Montagnier presented the results to a skeptical audience at a small, late-night session of a scientific conference at Cold Spring Harbor Laboratory in New York organized by Robert C. Gallo, M.D. a top researcher at the National Institutes of Health’s National Cancer Institute.

“Mentally, most attendants were not prepared to accept the idea of a second family of retroviruses … existing in humans and causing immune deficiency, and having no counterpart in animals!” Montagnier wrote in 2008 in his Nobel prize biography.  “This situation is not infrequent in science, since new discoveries often raise controversy.”

About a year after the Cold Spring Harbor conference, Dr. Gallo announced that he had discovered the cause of AIDS in the family of T-cell lymphotropic viruses (HTLVs), in a virus he called HTLV-III. Later, this virus was found to be virtually identical to the Pasteur Institute’s LAV, according to the Mayo Clinic’s biography of Montagnier.

The separate claims of discovery by Montagnier and Gallo culminated in a lawsuit in December 1985.  Virology icon Dr Jonas E. Salk stepped in to mediate the conflict and the two researchers finally resolved their differences.

in 1986, the AIDS virus was officially designated as human immunodeficiency virus (HIV). Both researchers were recognized and honored by the Lasker Foundation and received the 1986 Albert Lasker Medical Research Award. The Foundation cited Montagnier for “discovery of the [AIDS] retrovirus later shown to be responsible for the major new threat to world health,” and Gallo was acknowledged as the originator of much human retrovirus research.

In March 1986, Montagnier and his team announced the discovery of HIV-II, another strain of the AIDS virus.  They reported further isolates from AIDS patients, including a heterosexual couple from Africa and later from hemophiliacs, according to Robin A. Weiss and Simon Wain-Hobson in Science magazine.

Using tissue samples from key clinical researchers, Montagnier’s team was successful in developing lab tests for HIV antibodies, which enabled the development of blood tests to diagnose HIV infection.

Montagnier received many awards, including a Chevalier de la Légion d’ Honneur in 1984 and the Commandeur de l’Order National du Mérite in 1986 as well as professional honors from Switzerland, Canada, and Japan. He was honored on a stamp issued by Bhutan in 2000.

According to Nature, Montagnier spent his later years dismantling his hard-won reputation as a top scientist by opposing vaccination during the COVID-19 pandemic.

Through an award from the U.S. Health Resources and Services Administration, Los Angeles County received $6,168,850 to help implement its initiative Ending the HIV Epidemic (EHE) in Los Angeles County.

The county’s EHE initiative was aligned with the federal EHE initiative, which sought to reduce the number of new HIV infections in the U.S. by at least 90% by 2030.  At the time, new HIV cases in LA County represented more than 5% of the total number of cases in the country.

“With this investment, we’re increasing our efforts to end the HIV epidemic,” said HHS Secretary Xavier Becerra. “Today’s awards reaffirm our Ryan White HIV/AIDS Program work in communities that need it most as we continue to ensure everyone with HIV receives the care they need to thrive.”

The funding arrives through the federal Ryan White HIV/AIDS Program, which provides services to low-income people living with and at risk for HIV, according to an HHS press release.  About 560,000 people with HIV in the U.S. receive services through the program.

“That’s nearly half of the 1.2 million people with the virus,” Trent Straube wrote in POZ magazine. “What’s more, 88% of people receiving care through the Ryan White program attain viral suppression. People with an undetectable viral load not only enjoy longer and healthier lives but also do not transmit HIV through sex.”

The Office of AIDS Research from National Institutes of Health announced updates to the federal HIV clinical practice guidelines, which previously discouraged HIV-positive people from breastfeeding/chestfeeding infants.

The updated guidelines refrained from taking a stand on whether to breastfeed/chestfeed, and instead sought to quantify the risk of HIV transmission against the risk of formula, so that people with HIV could weigh the risks themselves with the help of a healthcare professional, according to the NIH.

The updated guidelines note that:

• The risk of HIV transmission while breastfeeding is less than 1% (but not zero) for PWH on antiretroviral therapy (ART) with sustained undetectable viral load through pregnancy and postpartum.
• The risk of postnatal HIV transmission to an infant is zero with the use of safe replacement feeding. Properly prepared formula or pasteurized human donor milk from a milk bank eliminates risk of HIV transmission to the infant.
• Clinicians should support the choices of people with HIV to breastfeed (if they are virally suppressed) or to formula/replacement feed.
• It is inappropriate to engage Child Protective Services or similar services in response to infant feeding choices of a person with HIV.

“If you are a woman living with HIV in an area of the world where access to resources like clean water, refrigeration, and medical care are limited, the World Health Organization (WHO) recommends that you breastfeed if you are taking HIV drugs,” The Well Project stated in its article “Can I Breastfeed While Living With HIV?”

“A course of HIV drugs may also be recommended for the baby during breastfeeding. The reason for this recommendation is that, in such resource-limited settings (for instance, many areas of Africa or India), infants are more likely to develop diarrhea and other illnesses, and may die from these,” the article continued.

“Breast milk contains substances that protect and strengthen a child’s immune system, even after they stop breastfeeding. Because of this, breast milk may help children to survive these health conditions. Furthermore, formula feeding may not be an option in these areas due to lack of funds to purchase it, clean water to mix it with (if the formula is powdered), or refrigeration to keep it fresh. Health authorities have determined that the benefits of breastfeeding outweigh the risks of HIV in areas where resources are constrained in this way.”

The NIH-supported study indicated that statins reduce the risk of heart disease in HIV+ people by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population.

People living with HIV have a 50-100% increased risk for cardiovascular disease, according to the NIH.

“This research suggests that statins may provide an accessible, cost-effective measure to improve the cardiovascular health and quality of life for people living with HIV,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute. “Additional research can further expand on this effect, while providing a roadmap to rapidly translate research findings into clinical practice.”

For the double-blinded phase 3 trial, known as Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study, researchers randomized participants into either a treatment group where they received a daily statin (pitavastatin calcium) or a control group where they received a placebo. The researchers followed participants for about five years, but ended the trial early when they discovered the treatment benefits outweighed the potential risks.

Researchers required those enrolled in the trial to have normal liver and kidney function. Participants were also required to take antiretroviral therapy, which was considered by the researchers to be critical to reducing the risk of HIV complications and related illnesses, including cardiovascular disease.

STIs can increase a person’s risk of getting or transmitting HIV, and the number of STI cases in the U.S. rapidly increased in the early 2020s, according to the CDC. Doxy-PEP has demonstrated substantial benefit in reducing new chlamydia, gonorrhea, and syphilis infections, Dr. Leandro Mena, Director of the CDC’s Division of STD Prevention, stated.

The CDC’s draft guidelines provided an overview of monitoring for antibiotic use and antibiotic resistance that the agency will be considering to address potential risks.  An informational presentation about the draft guidelines is available online.

The 2021 CDC STI Treatment Guidelines included a systematic review of the available literature on STI PEP and concluded that further studies were necessary to determine whether it would be an effective strategy for bacterial STI prevention. Since that time, promising results from several randomized trials on STI PEP indicated the need to re-address this topic. The new guidelines will offer an important resource for healthcare providers to inform the use of Doxy-PEP for preventing bacterial STI infections.

Preliminary data published by the CDC publishes shows that in 2022, PrEP coverage is on the rise among Americans most likely to benefit from it.  PrEP (pre-exposure prophylaxis) is highly effective for preventing HIV when taken as prescribed.

PrEP is available as a pill (Truvada® and Descovy®) or shots (Apretude).  According to the CDC, people who can most benefit from PrEP meet any of the following conditions:

_ _ _ _ _

Source:

Centers for Disease Control and Prevention. Core indicators for monitoring the Ending the HIV Epidemic initiative (preliminary data): National HIV Surveillance System data reported through June 2023; and preexposure prophylaxis (PrEP) data reported through March 2023. HIV Surveillance Data Tables 2023;4(3).  https://www.cdc.gov/hiv/library/reports/surveillance-data-tables/. Published October 2023. Accessed February 21, 2024.

In the mid-1990s, retired gynecologist Dr. Gao Yaojie was providing medical care in a small village in rural China when one of her patients, a woman who was exhibiting advanced AIDS symptoms, tested positive for HIV.

Chinese officials had long held that HIV and AIDS was not a problem, because the country banned the importation of blood products.  So Dr. Gao reached out to someone who might give her the hard truth about AIDS in China, Dr. Wang Shuping, a researcher who was testing blood donations for hepatitis C and HIV.  Dr. Wang had found HIV in the blood supply, but her warnings to local officials were dismissed.

Drs. Gao and Wang decided to team up and launch a campaign to educate rural residents about HIV and AIDS, and the dangers inherent in the for-profit blood centers that paid for their plasma donations.

While Dr. Wang worked behind the scenes gathering facts and information, Dr. Gao became the public face of AIDS awareness in China, daring to publicly challenge China’s health system and government.  This proved to be a very dangerous endeavor.

Dr. Gao travelled to remote villages from her home in Zhengzhou, providing rudimentary medicine for fever, diarrhea and other symptoms of AIDS.  According to The New York Times, her stops included a village school where 20 children were left without parents due to AIDS.  She said she once came across a toddler who was clinging to the feet of his mother, who had hanged herself after her husband died of AIDS.  Dr. Gao also spent considerable time leafleting bus stations, health clinics and sex parlors with educational material about HIV/AIDS.

While Dr. Gao’s work on AIDS education in rural China later earned her international acclaim from world leaders including Hillary Clinton, her rising profile meant she also came under close state surveillance.  Chinese officials forbid her to grant interviews, but she would still find ways to share her experiences dispensing healthcare and information in rural China.

Her cohort Dr. Wang also found ways to continue their work.  After party officials shut down her research clinic, Dr. Wang took on a new job in Beijing as assistant to the chair of China’s National Committee on HIV/AIDS.  Her position allowed her to continue her medical research on the prevalence of HIV/AIDS in China and keep Dr. Gao up-to-date on the latest information to share with rural residents.

In April 1996, all the donation clinics in China were abruptly shut down, without any notice to donors that they had been exposed to HIV through the clinics’ unhygienic practices.  Later that year, clinics reopened with HIV testing for previous donors.  And still, Chinese leaders would not acknowledge the prevalence of HIV in the country’s blood supply or the existence of an AIDS crisis among its rural citizens.

In spite of this, word got out to the rest of the world that China was experiencing an AIDS crisis.  The epidemic in China was unique in that it was associated with the “bloodheads,” the commercial blood donation sites that proliferated in China after its 1986 ban on the importation of blood products.

On August 8, 2001, Chinese officials finally acknowledged that the country had been unsuccessful in quarantining itself against HIV, and announced a publicity campaign to educate its citizens about HIV and AIDS. However, Chinese officials claimed that the major causes of HIV transmission in China were drug use and sexual contact.  Drs. Gao and Wang disputed this, making the research-supported claim that the country’s blood products industry was to blame.

“I visited so many provinces, cities, and counties, and met with thousands of AIDS patients. But I never saw a drug user and found that sexually transmitted cases accounted for less than 10%,” Dr. Gao told Radio Free Asia. “There is a 100% certainty that transmission is occurring through blood transfusions.”

Disputing the government’s official position on the health crisis was dangerous.  Under Communist Party rule, Dr. Gao was able to continue providing care to people living with HIV and AIDS in rural China, and she was able to write books about it.  But government officials heavily edited her work and kept a close eye on her public presence.

Officials refused to issue Dr. Gao a passport in 2001 to travel to the U.S. to be honored by the Global Health Council with the “Jonathan Mann Award for Health and Human Rights.”  In 2003, government officials would again refuse to allow Dr. Gao to travel abroad to accept the Ramon Magsaysay Award for Public Service, which was presented at an event in Manila, Philippines.

In 2007, the Vital Voices Global Partnership invited Dr. Gao to Washington, DC to receive the Global Women’s Leadership Award for Human Rights at a March event.  On February 1, as Dr. Gao was leaving for Beijing to pick up her travel visa, she was intercepted by officers and placed under house arrest, according to The New York Times.  Officials turned off her phone service and prevented family members and friends from visiting her. Under duress from a party official who came to her apartment three times a day, Dr. Gao agreed to decline the invitation.

Dr. Gao didn’t realize that her house arrest was receiving worldwide attention in the media and many were outraged at China’s treatment of the 80-year-old activist.  Hillary Clinton, who was then the Senator from New York and a co-founder of the nonprofit women’s advocacy group Vital Voices, wrote a letter to then-President Hu Jintao, urging him to allow Dr. Gao to come to the U.S. to accept the honor that her organization wanted to bestow.  A few days later, he relented under the pressure.

In early March 2007, Dr. Gao made her first trip to the U.S. and was honored in Washington, DC.  At the Vital Voices Awards event, she expressed concern that when she returned to China, she would be targeted by government officials for criticizing their handling of the AIDS epidemic.

Later the same year, she received another honor, the Heinz R. Pagels Human Rights of Scientists Award from the New York Academy of Sciences.

In August 2009, at the age of 82, Dr. Gao fled China with the help of the Chinese rights watchdog China Aid Association, and received political asylum in the U.S.  She settled in the Harlem neighborhood of New York City, where she restored her writings to their pre-censored state and arranged to have them published.

For many years, she was visited by Chinese students and others who were aware of her human rights achievements.  In March 2019, Hillary Clinton — who called Dr. Gao “simply one of the bravest people I know” — came to the doctor’s Harlem apartment for a visit.

“We’ve met many times over the years, including my first trip to China as secretary of state,” Clinton posted on Facebook after visiting Dr. Gao in New York City.

Dr. Gao’s “end-of-life” statement included her wish to be cremated and her ashes to be scattered in China’s Yellow River with no ceremony.  Originating in the Bayan Har Mountains in western China, the river flows through nine provinces of China and empties into the Bohai Sea in the east.  The Yellow River basin is known as the birthplace of ancient Chinese civilization, earning the name as “the Mother River.”

“I want to float eastwards down the Yellow River, and basically disappear from this world,” she said.