Briefly May + Jun 2023

Doxy-PEP cuts STI cases

But study adds that possible resistance merits a closer look

The oral antibiotic doxycycline reduced the acquisition of sexually transmitted infections (STIs) by two-thirds among men who have sex with men and among transgender women when taken within 72 hours of condomless sex as a form of post-exposure prophylaxis (PEP), a study reported in the New England Journal of Medicine. However, the study also found a slight increase in antibacterial resistance.

Researchers at the University of California at San Francisco and at the University of Washington, Seattle, recruited 501 participants who were age 18 years or older who were on HIV treatment or were taking PrEP for HIV prevention, and who had been diagnosed with gonorrhea, chlamydia or syphilis within the past year. In the open-label, randomized study, two-thirds of the study participants were given 200 mg of doxycycline (often referred to as “doxy”) to take within 72 hours of condomless sex; the remaining third were given standard care without doxy. All participants were tested quarterly for STIs to monitor rates of acquisition.

Among the 327 participants on PrEP for HIV prevention who were given doxy-PEP, 10.7% were diagnosed with an STI during their quarterly screenings, compared to 31.9% for those on standard care.

Among the 174 people living with HIV (PLWH) taking post-exposure doxy, 11.8% were diagnosed with an STI; the PLWH group who were on standard care had a rate of 30.5%.

Gonorrhea was the most often diagnosed STI. Diagnoses among the doxy-PEP group were about 55% lower than in the standard care group. Chlamydia and syphilis were each reduced by more than 80%.

However, researchers discovered that the doxy-PEP group had a slightly higher percentage of tetracycline-resistant Staphylococcus aureus living in the nose after 12 months. It was found in 38.5% of the doxy-PEP group who were diagnosed with an STI, compared to 12.5% in the standard care group. Doxycycline is used for treating methicillin-resistant Staphylococcus aureus skin and tissue infections. Additional research and longer follow-up periods will be needed to determine how intermittent use of doxy-PEP might affect antimicrobial resistance.

“Given its demonstrated efficacy in several trials, doxy-PEP should be considered as part of a sexual health package for men who have sex with men and transwomen if they have an increased risk of STIs,” according to Annie Luetkemeyer, MD, professor of infectious diseases at Zuckerberg San Francisco General Hospital at UCSF, and co-principal investigator of the study, in a press announcement. “It will be important to monitor the impact of doxy-PEP on antimicrobial resistance patterns over time and weigh this against the demonstrated benefit of reduced STIs and associated decreased antibiotic use for STI treatment in men at elevated risk for recurrent STIs.”

Of the 501 participants, 67% were White, 7% Black, 11% Asian or Pacific Islander and 30% Hispanic or Latinx. The study was funded by the National Institutes of Health. For more information, GO TO clinicaltrials.gov, study number NCT03980223. Read the NEJM article at bit.ly/NEJM-doxy-pep-study-2023.

—Rick Guasco

AMA elects gay man as president

Jesse M. Ehrenfeld, MD, MPH, was set to be inaugurated in June as the first openly gay doctor to lead the American Medical Association (AMA). Dr. Ehrenfeld is a senior associate dean, tenured professor of anesthesiology and director of the Advancing a Healthier Wisconsin Endowment at the Medical College of Wisconsin. He has served on the AMA board of trustees since 2014. A combat veteran who deployed to Afghanistan during both Operation Enduring Freedom and Resolute Support Mission, he conducts research focused on understanding how information technology can improve surgical safety and patient outcomes; he also teaches and conducts a clinical practice. He is a longtime advocate for LGBTQ rights and health care. Dr. Ehrenfeld and his husband have two children.

Honoring the mother-son connection

The bond between a son and his mother or a maternal figure is unique. A new campaign, “Mother to Son,” launched by ViiV Healthcare, celebrates this special relationship and the importance it can play in affirming the health of Black and Latinx gay, bisexual, trans and queer men.

“Whether biological or chosen, maternal support is essential to getting men connected, engaged and retained in HIV care and other health services,” the website states. “It is a mother’s love, support, patience and compassion that combats learned self-hate that can lead these men to unhealthy decisions, behaviors and practices. It’s a mother’s love that empowers these men to see themselves as whole, worthy and valuable.”

The campaign features a series of mother-son portraits such as writer and advocate Darnell Moore with his mother Diane, stylist Ty Hunter with his mother Connie, and Blair Khan with legendary ballroom icon Luna Luís-Ortiz, among others.

“I want her to see me as I am: self-assured, family-oriented, big hearted and queerly happy,” says Moore about his mother.

A booklet of the portraits, along with comments by the sons and their mothers, includes a series of questions meant to inspire dialogue and can be viewed and downloaded at the campaign’s website:

viivhealthcare.com/en-us/supporting-the-hiv-community/positive-action/mother-to-son/. A version in Spanish is also available: viivhealthcare.com/content/dam/cf-viiv/viivhealthcare/en_US/pdf/ms-booklet-spanish.pdf.

The campaign draws its name from From Mother to Son, a poem by the Black American poet and social activist Langston Hughes, who was a leader of the Harlem Renaissance.

—Rick Guasco

Status neutral, please

HIV treatment and prevention are in bed together more than ever, so to speak. They both use some of the same medications and are affected by the same negative social forces, such as stigma and unstable housing.

Appropriately then, the U.S. Centers for Disease Control and Prevention (CDC) now promotes a status neutral approach to HIV prevention and care to bring the two together.

“A status neutral approach continually addresses the healthcare and social service needs of all people affected by HIV so that they can achieve and maintain optimal health and well-being. …Ultimately, status neutral approaches promote health equity by putting client needs above HIV status to improve care and eliminate stigma,” the CDC stated March 1 in announcing a training module for medical and service providers.

The training takes off from the CDC’s Issue Brief, “Status Neutral HIV Care and Service Delivery: Eliminating Stigma and Reducing Health Disparities,” posted on November 28, 2022.

Status neutral care begins with an HIV test and goes from there. The CDC notes, however, that services should not be denied because a person hasn’t taken an HIV test.

“How can we evolve the institutional structures that maintain a ‘serodivide’ in service delivery and that may maintain that same ‘serodivide’ and resulting stigma in the lives of people affected by HIV?” wrote Demetre C. Daskalakis, MD, an infectious disease expert on loan from the CDC to the White House for the national mpox response, in the Spring 2023 issue of HIV Specialist. “People don’t care who funds their services. They are concerned with getting the services they need to support their health and well-being. ‘Statusing’ a place or a service may be aversive to people who could benefit from that place or service.”

Status neutral HIV prevention and care was first introduced by the New York City Department of Health and Mental Hygiene, where Dr. Daskalakis championed the concept and led the city to the lowest number of new diagnoses seen in years.

GO TO cdc.gov/hiv/effective-interventions/prevent/status-neutral-hiv-prevention-and-care/index.html for the training page. GO TO cdc.gov/hiv/policies/data/status-neutral-issue-brief.html to read the issue brief.

For Black HIV/AIDS Awareness Day (February 7), Chicago-based The Qube devoted a podcast series to Black HIV in the South: How Did We Get Here? According to a press statement, the Qube “takes a deep dive into the complicated historical intertwinings of how systemic racism, economics and culture within the healthcare system contributed to the nearly 52% of new infection rates of Black people living in impoverished communities, particularly in the Bible Belt.” Co-hosts radio personality Anna DeShawn and photographer Duane Cramer and their guests brought a down-home family feel to their talk. DeShawn and Cramer are also the co-founders of The Qube, which presents a streaming platform of music and podcasts produced by and for Black, brown and queer and trans people of color. The series showcased four topics:

• The History of Black HIV in the South
• The Fear of Black HIV in the South
• The Community of Black HIV in the South
• The Solutions to Black HIV in the South

Find The Qube at http://theqube.app.

Report offers data on PLWH in state and federal prisons

The number of people incarcerated in state and federal prisons who are living with HIV decreased in 2021 for the 23rd consecutive year, down to 11,810, according to a U.S. Department of Justice report that was released in March. The 2021 figure dropped by 2% from the previous year, a downward trend that has continued since data were compiled in 1991.

Issued by the U.S. Department of Justice’s Bureau of Justice Statistics (BJS), HIV in Prisons, 2021–Statistical Tables is a by-the-numbers look at people living with HIV who were in state and correctional facilities in 2021.

“While about one percent of persons in state and federal prison were living with HIV, testing and monitoring remain important to assess long-term trends,” said BJS director Alex Piquero, PhD.

The 2021 report cites data from 49 states and the federal Bureau of Prisons. Not included in BJS figures, however, are people held in privately run prisons. Among the statistics presented in the report:

• Of the estimated 11,810 persons living with HIV (PLWH) who were in custody at the end of 2021, 1,216 were in federal facilities and 10,600 were in state custody. The two states with the largest numbers of PLWH were Florida (1,863) and Texas (1,583).
• By year’s end in 2021, 0.9% of individuals in federal custody were living with HIV; 1.2% of people in state custody were PLWH. The states with the highest proportions of PLWH in custody were Florida (2.8%), Louisiana (2.5%) and Mississippi (2.5%).
• Of the 50 jurisdictions whose HIV testing practices were cited in the report, 16 conducted mandatory testing during intake. HIV testing was offered during routine medical examination by 18 jurisdictions, up from 11 in 2017. HIV testing at the person’s request was the most commonly reported testing practice during discharge in 29 jurisdictions in 2021, compared to 27 in 2017.

Since the federal prison system began collecting HIV data, one to four jurisdictions a year have not provided numbers. To produce national and state totals on the number of PLWH in prison, data are imputed for non-reporting jurisdictions.

Statin drug significantly cuts cardio risk for people living with HIV

A review of data found that a daily statin medication cut the risk of cardiovascular disease among people living with HIV by 35% compared to a placebo. The findings were so conclusive, the REPRIEVE study, which had been ongoing for eight years, came to an abrupt end.

The significant reduction prompted the study’s independent Data Safety and Monitoring Board to recommend that REPRIEVE be stopped early, and that the participants who had been on the placebo be switched to the statin.

The rate was “more than we hypothesized,” said the study’s principal investigator, Steven Grinspoon, MD, of Harvard University and Massachusetts General Hospital.

People living with HIV have “higher than expected risk of cardiovascular disease and this is occurring often in younger patients who have relatively low to only moderate traditional cardiovascular risk,” Grinspoon said. “In other words, they don’t typically have high cholesterol and other risk factors, and typically they wouldn’t be recommended for statin therapy.”

The largest randomized HIV study in progress, REPRIEVE began in 2015, enrolling 7,769 participants ages 40–75 living with HIV from 12 countries in Africa, Asia, Europe, North America and South America. All participants were on stable antiretroviral therapy, had CD4+ T cell counts of over 100 cells/mm³ and were at low to moderate risk for cardiovascular disease. Nearly one-third of the participants were women.

Statin drugs reduce cholesterol, and have been shown to lower the risk for heart attack and cardiovascular disease in most people, but it was uncertain whether they would benefit PLWH. Participants were given either a 4 mg pitavastatin Livalo pill or a placebo pill once daily. They were monitored for major cardiovascular events such as myocardial infarction, chest pains and stroke or having stents or coronary bypass surgery. Side effects and drug-drug interactions were monitored, although pitavastatin is believed to be safe with HIV medications.

“These latest findings represent the culmination of an unprecedented eight-year effort to generate evidence that can help clinicians better support the unique cardiovascular health needs of people living with HIV,” said Gary H. Gibbons, MD, director of the National Heart, Lung and Blood Institute (NHLBI). “REPRIEVE is important because there are limited existing interventions to help prevent adverse cardiovascular outcomes in this population.”

Participants were notified of the findings and will continue to be monitored for several months, according to the National Institutes of Health (NIH).

REPRIEVE was primarily funded by by the National Institute of Allergy and Infectious Diseases (NIAID) and the NHLBI with additional funding from the NIH Office of AIDS Research. The AIDS Clinical Trials Group conducted the study.

Read the REPRIEVE abstract on the New England Journal of Medicine website: bit.ly/nejm-reprieve-abstract

—Rick Guasco

HIV activist couple pass within hours of each other

Hard-core HIV/AIDS activists Mary Lucey and wife Nancy MacNeil died February 11 within hours of each other. The two women dedicated their lives to fighting on behalf of women and people living with HIV who are incarcerated, among other struggles. MacNeil died of natural causes, but Lucey’s cause of death has yet to be reported.

“It is with great sadness that I report that both Mary and Nancy died over the weekend,” wrote long-time HIV activist and former Positively Aware writer Susan Forrest in an email sent February 13. “They did so much for incarcerated women and women living with HIV locally [the Los Angeles area] and nationally.” She attached each woman’s bio, provided by ACT UP L.A. (the AIDS Coalition to Unleash Power) and reprinted below.

Forrest said that Mary Lucey “died of a broken heart.”

GO TO “ACT UP/LA’s Mary Lucey & Nancy MacNeil’s legacy of compassion” by Karen Ocamb at losangelesblade.com/2023/02/27/act-up-las-mary-lucey-nancy-macneils-legacy-of-compassion, which contains vintage photos of the HIV activism movement; also, “R.I.P. Lesbian AIDS Activists Mary Lucey and Nancy Jean MacNeil” by Trent Straube at poz.com/article/rip-lesbian-hiv-aids-activists-mary-lucey-nancy-jean-macneil-act-up-. GO TO www.poz.com/article/cure-life-love-loss-mary-lucey-nancy-macneil#search-query=cure%20life%20love%20loss%20Mary%20lucey for a personal story about the couple by friend Keiko Lane.

Mary Lucey

“In 1989, Mary Lucey was fighting drug addiction while simultaneously pregnant and diagnosed HIV positive. She had also recently completed an 18-month sentence at California Institute for Women, Frontera.

“After nearly 10 years into the epidemic there was only one medication that was available to Lucey, the highly toxic AZT which she had to take around the clock. She boldly faced the discrimination, stigma and fear associated with an HIV/AIDS diagnosis, which at the time was still considered a death sentence.

“In 1990 Lucey got a handle on her addiction, met her future wife Nancy MacNeil, and found her voice in ACT UP Los Angeles. She joined the group after they attended the first Women’s Caucus meeting in June of 1990.

“Lucey, a loud and proud lesbian, was among the first HIV positive women in Los Angeles to be out about her status. Fueled by a sense of outrage at AIDSphobia, she fought for several years in ACT UP to expand the CDC’s definition of AIDS to include women’s opportunistic infections and for healthcare for incarcerated women with AIDS. In 1992 Lucey’s advocacy work for compassionate release for women in prison with AIDS led to the first U.S. of release of such a prisoner, Judy Cagle, enabling her to die at home with dignity.

“Lucey became more powerful, fearlessly outspoken, and willing to confront government officials at every level. She was often asked by ACT UP to provide testimony to government agencies and legislators: the National Commission on AIDS, the CDC [Centers for Disease Control and Prevention], the NIH [National Institutes of Health], the Department of Health and Human Services, congressmen and state senators. Following ACT UP LA demonstrations Lucey was often interviewed for numerous newspapers and magazines, such as the Orange County Register, the LA Weekly, the Lesbian News, the Weekly Reader, Glamour and Time magazine.

“In 1994 Lucey worked as the first woman City AIDS Coordinator on an interim basis where she, along with other staff, funded the first needle exchange program from the City of Los Angeles. This program, an offshoot of ACT UP LA originally called Clean Needles Now, is currently known as the LA Community Health Project. It was calculated to prevent 12,000 new HIV infections each year.

“Lucey also founded the first peer support group for positive women in 1990 and co-founded Women Alive, a support and advocacy group. She raised money for and organized the 1997 National Conference on Women and AIDS held at the Convention Hall of the Los Angeles Staples Center. It was the largest gathering of positive women in the country at that time.”

Lucey continued to stay involved as a community activist. She won a position on her local community services board representing the town of Oceano, serving for two consecutive terms. As a long-term survivor, she often asked, “Where is our vaccine? Where is our cure? And why on earth are people still getting infected?”

Nancy MacNeil

Nancy MacNeil was born in Los Angeles and grew up running the Avenues of Highland Park. In the Vietnam War era, Nancy organized sit-ins and walk-outs with fellow students at risk for the draft in high school. She continued to attend peace rallies, marches, and pickets. She joined the Black Panther Party [BPP] to fight against police brutality and helped with their breakfast programs in downtown LA. (The BPP encompassed Black people and poor Whites.)

MacNeil was labeled an ‘outside agitator’ on California college campuses, enduring multiple encounters with vicious men cloaked in police uniforms while protesting against war and police brutality. Engaged on various levels with People’s Park in Berkeley and the Isla Vista Uprising in Santa Barbara, she witnessed the infamous burning of the Bank of America in protest of the use of napalm in North Vietnam.

She attended the Institute for The Study of Non-violence in Palo Alto and visited federal prisons housing the boys who said ‘no’ to the draft. She passed out flyers at the L.A. induction center every Tuesday morning, encouraging draftees to resist going to war and assisted Peace House in Pasadena, helping young men file papers for conscientious objector status.

Employed at the [U.S. Postal Service], MacNeil was a steward for the American Postal Workers Union, Venice Local, negotiating union contracts between management and the rank and file. She filed numerous grievances for blatant violations of contractual agreements on behalf of persecuted employees.

In the ’70s and ’80s she became active in the gay and lesbian community, joined several women’s rights groups as well as the Lavender Left. MacNeil organized for queer liberation, civil rights and protested police harassment. In May of 1979 she participated in the ‘White Night’ riots in San Francisco when the verdict of voluntary manslaughter was announced acquitting Dan White of first-degree murder for the killing of Supervisor Harvey Milk. MacNeil was again brutalized by police and sustained multiple injuries from whirling billy clubs.

From the onset of AIDS, while it was still being referred to as gay cancer or GRID [gay-related immune deficiency], MacNeil was losing friends to the disease. Her first friend to die of AIDS was Julian Turk in 1982. He’d been diagnosed by Dr. Michael Gottlieb at UCLA, [the doctor] who was the first to report the disease that would come to be known as HIV and AIDS. She was exhaustively surrounded and saddened by the weekly loss of so many close and dear friends. This compelled her to try and turn the tables. She joined ACT UP in 1990 after attending the first Women’s Caucus meeting. She also joined the Prisoners with AIDS subcommittee and the ACT UP National Network. MacNeil attended the AIDS Clinical Trials Group in Washington, D.C. to confront researchers about scientific and ethical questions surrounding women in the government-funded treatment studies. Dosages and effects of AIDS medications on women’s bodies were still unknown and inclusion of women in clinical trials was urgently needed.

MacNeil joined fellow activists as they perpetually disseminated information, analyzed clinical data, wrote letters and postcards, zapped the opposition with faxes and phone calls and helped to organize demonstrations. She also helped to organize enormous die-ins to illustrate mass deaths to shock and shame the government and media into publicizing the AIDS crisis that was being ignored.

MacNeil became the founding executive director of Women Alive, an organization by and for HIV-positive women with a membership of over 500. She established a treatment-focused newsletter (quarterly distribution of 10,000), the first National women’s AIDS hotline and empowered women with AIDS to become their own advocates.

She identified as a “situational pacifist dedicated to fighting for social justice [who] sincerely believes that women and queers will save the world.” She said that it was “written in my heart.”

Nanoparticle looks promising in early vaccine trial

An experimental nanoparticle vaccine has been shown to be safe in its first in-human trial. The results of the early phase study were published in the journals Science Translational Medicine and in Science. While the vaccine is not intended to provide HIV protection by itself, researchers found that it prompted a robust immune response in 35 of the study’s 36 adult participants.

Results showed that the engineered outer domain germline targeting version 8 60-mer nanoparticle—or, eOD-GT8 60-mer—increased production of a rare type of antibody-producing immune B cell that is capable of producing broadly neutralizing antibodies (bNAbs) to protect against diverse strains of HIV.

This is significant because the human immune system is often overwhelmed and outsmarted by HIV. The virus mutates rapidly, producing new and different versions of itself that the immune system eventually fails to recognize. For a vaccine to work, it will most likely need to induce the body’s production of bNAbs that will be able to identify multiple strains of HIV. Only a handful of people living with HIV—the Berlin patient and the London patient, for example—have been cured, and often only through treatment that was torturous and not scalable. Still, they are proof that the immune system can do the job.

The first step of what would be a multi-step vaccination regimen is to prime the immune system to make more bNAb-precursor B cells. That’s where the eOD-GT8 60-mer protein nanoparticle comes into the picture. It “teaches” the immune system to identify and target HIV.

In the study, eOD-GT8 60-mer was administered by injections eight weeks apart; participants received doses of either 20 or 100 mcg. Additionally, antigen-specific CD4 T helper responses were observed in 84% and 93% of vaccine recipients, respectively. Participants reported mild to moderate side effects that disappeared within a couple of days. The study also showed that the vaccine bolstered B cell production; subsequent booster shots could further coax B cells into making HIV-protective bNAbs.

“[W]e found that induction of vaccine-specific peripheral CD4 T cells correlated with expansion of eOD-GT8-specific memory B cells,” concluded researchers in their abstract. “Our findings demonstrate strong human CD4 T cell responses to an HIV vaccine candidate priming immunogen and identify immunodominant CD4 T cell epitopes that might improve human immune responses either to heterologous boost immunogens after this prime vaccination or to other human vaccine immunogens.”

Principal investigator was Kristen W. Cohen, of Seattle’s University of Washington and the Fred Hutchinson Cancer Center, as well as William J. Fulp, Allan C. deCamp and Andrew Fiore-Gartlan.

—Rick Guasco

Advocates take to Capitol Hill for 30th annual AIDSWatch

More than 350 HIV advocates from 37 states came to the U.S. Capitol in late March for the 30th annual AIDSWatch, the largest ever constituent-led HIV advocacy event. The advocates met with lawmakers and their staffs in 182 congressional offices.

AIDSWatch is produced by AIDS United, the U.S. People Living with HIV Caucus and the Center for Health Law and Policy Innovation at Harvard Law School.