Briefly | February + March 2024

“The Dovato blister pack is designed to help address some of the challenges we hear from the HIV community, which include stigma and convenience, and offers a discreet package which may fit more seamlessly into people’s daily routines,” said Lynn Baxter, head of ViiV’s North American operations.

The FDA approved Dovato’s blister pack on Nov. 23, 2023. It is available now in the U.S. and will be offered in some European markets later this year. Dovato will continue to be available in a 30-pill bottle.

Dovato is a once-daily, single-pill, two-drug combination of dolutegravir, an integrase strand transfer inhibitor (INSTI) and lamivudine, a nucleoside analog reverse transcriptase inhibitor (NRTI).

ViiV is majority owned by pharmaceutical company GSK, with Pfizer and Shionogi as shareholders.

—Rick Guasco

New guidelines protect positive hearts

The large, international REPRIEVE study found a 35% reduction in major adverse cardiovascular events for people living with HIV (PLWH) who used pitavastatin compared to the individuals who took a placebo (fake pill). It is now recommended that PLWH ages 40–75 with a low-to-intermediate 10-year risk of atherosclerotic cardiovascular disease (ASCVD) start “at least moderate-intensity statin therapy” consisting of:

1. pitavastatin 4 mg once daily (AI recommendation—the highest available in the guidelines) or
2. atorvastatin 20 mg once daily (AI) or
3. rosuvastatin 10 mg once daily (AII)

The updated HIV treatment guidelines from the U.S. Department of Health and Human Services (HHS) were published as this issue went to press. GO TO bit.ly/3Pi2CsD.

Biktarvy now also FDA-approved for common type of drug resistance

The U.S. Food and Drug Administration (FDA) has approved a new, expanded usage (indication) for Biktarvy to include people who are virally suppressed (a viral load of less than 50 copies/mL, often known as “undetectable”) with a confirmed or suspected form of drug resistance known as M184V/I.

One of the most common, the M184V/I resistance mutation has been found in a range (22–63%) of people living with HIV (PLWH) having a pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes, including one of the two in Biktarvy.

The label update is based on week 48 data from Study 4030, which evaluated the efficacy, safety and tolerability of Biktarvy in a broad range of people living with HIV-1 (the most common HIV type in the U.S.) with or without pre-existing NRTI resistance, including M184V/I resistance.

In the phase 3, randomized, double-blind trial, participants were on a baseline regimen of dolutegravir (DTG + either emtricitabine/tenofovir alafenamide [FTC/TAF] or emtricitabine/tenofovir disoproxil fumarate [FTC/TDF]). They were then randomly switched—284 participants onto Biktarvy and 281 onto DTG+FTC/TAF.

Out of the Biktarvy group, 47 had HIV with pre-existing M184V/I resistance. The primary endpoint included the proportion of individuals with HIV RNA greater than or equal to 50 copies/mL at week 48. About 89% remained suppressed and 11% did not have virologic data at week 48, according to the results.

No one with M184V/I who received Biktarvy and had virologic data had HIV RNA of 50/mL or greater. There were also no cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance in the final analysis population.

Overall, the safety profile in virologically suppressed participants in Study 4030 was similar to other studies of Biktarvy in people who are treatment naïve (individuals taking HIV antivirals for the first time).

“This label update builds on the established high resistance barrier of Biktarvy by showing that it’s effective in [PLWH] who may have certain forms of pre-existing resistance or a history of past treatment failure,” said Paul E. Sax, MD, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School.

Approved by the FDA in 2018, Biktarvy is now the first and only integrase strand transfer inhibitor- (INSTI-) based single-tablet regimen that is FDA approved and recommended by the U.S. Department of Health and Human Services (HHS) for PLWH who are undetectable and have M184V/I resistance.

—Rick Guasco

Stopping HIV in the streets

The success of the Boston Health Care for the Homeless Program in pushing back against HIV was detailed in an interview with the city’s public radio station in January.

The Boston Department of Public Health reported a rise in new HIV cases beginning in 2019 for people who experienced homelessness, especially among people who also used injection drugs. By early 2022, there were nearly 170 new cases in this group.

Working with the homeless agency, however, there were 20 new cases for all of 2022 and five in 2023.

What helped? Among other things, simple testing and treating. The treatment of HIV, which prevents transmission to other people when it’s successful, was often innovative in that medications were taken out to individuals instead of having them go to a clinic. There was also respectful support and fighting the stigma that the group constantly faces.

Preventing transmission by bringing down HIV viral load to undetectable levels with medication is called Treatment as Prevention (TasP) or U = U (Undetectable Equals Untransmittable).

Hear Jennifer Brody, MD, MPH, director of HIV services at Boston Health Care for the Homeless Program, talk about the city’s outbreak and its response, in conversation with host Arun Rath on WGBH during NPR’s All Things Considered afternoon news show; GO TO bit.ly/49QPy5m.

A transcript is available.

Using hospitals to prescribe PrEP

For many years now, prevention advocates have pointed to the limited promotion of HIV pre-exposure prophylaxis (PrEP), a medication that can stop the virus in its tracks.

At the University of California-San Francisco (UCSF) hospital, Sarah Flynn, MD, MPhil, and colleagues took an innovative approach to addressing the problem. Noting that PrEP information in the health field (such as it is) is mainly provided to outpatients, they set up a study program for people being admitted to the hospital. Their institution is San Francisco’s “main safety-net hospital,” they wrote, with many patients experiencing one or more factors that may expose them to HIV.

Through the study, providers were educated about HIV PrEP and becoming comfortable with screening for HIV, providing prevention counseling and prescribing PrEP. In the first nine months of the initiative, 14 hospital patients were started on PrEP during their admission. In the year following their discharge from the hospital, six of them (42.9%) continued on PrEP prescriptions through their outpatient care providers.

Interventions at the hospital included new workflows for staff to start PrEP inquiry, counseling and prescription.

“PrEP was initiated in particularly vulnerable populations: 85% of patients were experiencing homelessness and 64% injected drugs. … This project required a substantial culture change since PrEP initiation was considered an outpatient intervention in our healthcare system,” Dr. Flynn and colleagues wrote in their journal paper published in Volume 13, Issue 1 online BMJ Journals. GO TO bit.ly/3v84OMv.

Cancer now the leading cause of death in HIV

The American Cancer Society (ACS) reported that cancer is now the leading cause of death among people living with HIV.

The organization’s report, Cancer Facts and Figures 2024, notes that while the virus does not cause cancer, it contributes to a greater chance for it to occur. Ironically, it states that successful HIV treatment allows people to live longer and thus become more likely to develop cancer as they age. Several cancers are especially more likely with HIV, including cancer of the liver, lungs and cervix.

Released in January, the report is produced in conjunction with Cancer Statistics 2024, and is published in ACS’s journal, CA: A Cancer Journal for Clinicians.

The report includes a special section addressing the LGBTQ+ community. The report notes that CancerCare.org, which helps provide emotional, physical and financial resources, has an LGBTQ+ section; GO TO cancercare.org/tagged/lgbtq+. It also directs people to the National LGBT Cancer Network; GO TO cancer-network.org.

ACS also reported that cancer diagnoses in 2024 are expected to climb above 2 million in the United States, a record high.

TO READ the ACS report, GO TO amercancer.co/cff24.

Acting director Capt. Robyn Fanfair, MD, MPH, becomes permanent head of CDC’s HIV prevention division

Having served as acting director since August 2022, Capt. Robyn Neblett Fanfair, MD, MPH, has been named the permanent director of the Division of HIV Prevention (DHP) of the National Center for HIV, Viral Hepatitis, STD and Tuberculosis Prevention (NCHHSTP) of the Centers for Disease Control and Prevention (CDC). The DHP oversees much of the CDC’s HIV prevention efforts; its mission is to prevent HIV and to reduce HIV-related illness and death.

“During her time as acting director, Dr. Fanfair demonstrated her dedication to collaborating with the HIV workforce to gain a better understanding of suggested solutions and strategies for HIV prevention,” said Leisha McKinley-Beach, founder and CEO of the Black Public Health Academy. “While we commemorate her deserving appointment, it’s important to recognize that she is navigating a system with its own obstacles related to racism and discrimination. Nonetheless, Robyn shines as an exceptional guiding light, a catalyst for change, and as a woman committed to positively impacting the lives of others.”

Dr. Fanfair began her career in Baltimore as an HIV prevention researcher, clinician and public health worker. She served as a primary care provider for people living with HIV (PLWH) at the Moore Clinic of Johns Hopkins Hospital. She was a clinical research track fellow at Hopkins’ Division of General Internal Medicine, conducting research into sexual networks and HIV and aging. A board-certified internist, she is also a primary care provider at the Atlanta VA Medical Center for veterans living with HIV.

In 2012, she joined NCHHSTP as a medical epidemiologist in the Division of STD Prevention, working on projects focused on syphilis, mycoplasma and herpes. She joined DHP in 2015, leading a randomized clinical trial to assess a collaborative data-to-care model to improve HIV care continuum outcomes. Becoming team lead of the DHP’s Treatment Research Team in 2018, she led research efforts to improve engagement and retention in HIV care, increase viral suppression and improve health and life equity for PLWH. She also led DHP’s Treatment pillar workgroup, supporting the Ending the HIV Epidemic in the U.S. initiative (EHE). She was named DHP’s principal deputy director in November 2021, becoming acting division director the following August.

Dr. Fanfair is also a captain in the U.S. Public Health Service (USPHS), active in emergency preparedness and response, deploying to provide support for efforts around Ebola, Zika, COVID-19 and hurricanes Irma and Maria.

She received her bachelor’s degree from Brown University, her Doctor of Medicine from NYU and her master’s in public health from Johns Hopkins. She trained at Cornell-New York Presbyterian Hospital in internal medicine.

Announcement of Dr. Fanfair’s permanent position was made Feb. 12 by Jonathan H. Mermin, MD, MPH, director of the NCHHSTP.

—Rick Guasco

New report: Transwomen and HIV

The first report of the National HIV Behavioral Surveillance Among Transgender Women (NHBS-Trans) was released in January.

NHBS-Trans was established in 2017 by the U.S. Centers for Disease Control and Prevention (CDC). The agency noted that while transgender women experience HIV out of proportion to their numbers in the country, there has been no HIV surveillance research devoted to them.

NHBS-Trans focuses on three areas:

• Behavioral risk factors
• Prevention usage
• HIV prevalence

Surveys were conducted in seven urban areas—Atlanta, Los Angeles, New Orleans, New York City, Philadelphia, San Francisco and Seattle.

Nevertheless, the comprehensive 73-page report for 2019–2020 data covers wide territory, including reports from many research studies that have included transgender people.

Of the 1,608 women who participated in the survey:

• 902 were HIV-negative
• 706 were living with HIV

“The disproportionate effect of HIV infection among transgender women is the result of a complex layering of syndemics,” the CDC noted, “and more remains to be understood. NHBS-Trans highlights the social and economic factors that are contributing to this disparity.” The report explains that, “Syndemic theory posits that epidemics are produced by both diseases and social conditions. The theory emphasizes how structural factors (e.g., experiencing homelessness and incarceration) and psychosocial factors (e.g., sexual violence and polydrug use) jointly increase risk for HIV acquisition and transmission.”

Syndemics specifically examined in the report are

• structural and psychosocial syndemic conditions and condomless anal intercourse
• nonprescription hormone use
• homelessness
• discrimination and employment discrimination as it relates to healthcare access
• social support and the association between certain forms of violence and harassment and suicidal ideation

In a separate section on the use of pre-exposure prophylaxis (PrEP) for the medical prevention of HIV, the CDC reports that half of the HIV-negative women had discussed PrEP with their provider during the past year and a third had used it.

According to the report, “Although transgender women who reported sexual behaviors that are associated with HIV acquisition were more likely to have PrEP discussions with their healthcare provider and use PrEP, many who could benefit from PrEP were not using it. Because transgender women are one of the groups most affected by HIV, providing access to PrEP is critical to reducing HIV acquisition risk among transgender women and to reaching the goals for Ending the HIV Epidemic in the United States. Use of gender-affirming care was associated with having discussions about PrEP with a healthcare provider and PrEP use. Improving access to gender-affirming care for transgender women and training healthcare providers that serve transgender women to incorporate HIV prevention, including PrEP, into their services are strategies that might help increase PrEP use among transgender women.”

TO SEE the report published in the January 25 issue of the CDC’s Morbidity and Mortality Weekly Report (MMWR), GO TO cdc.gov/mmwr/volumes/73/su/pdfs/su7301-H.pdf.

Helping women envision PrEP

The MOSAIC project has issued a strategy brief sharing its findings on how to communicate HIV biomedical prevention to young women in Africa.

Communicating the PrEP Category to Adolescent Girls and Young Women (AGYW) reports on insights the project has gained from talking with girls and young women. For example, they don’t want the facts around taking PrEP to be sugar coated and they don’t want to be dictated to. In this last insight, “Prescriptive instructions are less effective than personal stories, examples and honest conversations.”

In another insight, “AGYW don’t want to feel that they are being singled out or stigmatized.” An action step states, “Even though the focus is on supporting AGYW’s PrEP use, include images of people of all ages, genders and ethnicities so the communities around them know that PrEP is for everyone.” As the report notes elsewhere, “This is not a story about HIV. This is a story about young women in Africa.”

To “brand” PrEP—promote it—MOSAIC reports that “PrEP is a way for young women to prioritize their physical health and mental well-being, to live a life uninterrupted by HIV. It affirms that self-love is strength.” It should also be noted as a source of peace of mind and something that provides the girls and women with a measure of control.

MOSAIC—Maximizing Options to Advance Informed Choice for HIV Prevention—is a five-year (2021–2026) global project funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID) to help AGYW and other women prevent HIV acquisition by accelerating introduction and scale-up of new and emerging biomedical prevention products.

Published in November 2023, the report notes that PrEP now includes oral (pill) options, an injectable and the dapivirine vaginal ring, with more choices on the way. The full-color report contains many beautiful photos and the extensive graphic design work belies its clinical title. MOSAIC has other beautiful and comprehensive reports to its credit.

TO SEE the seven-page brief, GO TO bit.ly/3uQOkbj.

Long-acting injectable is superior to daily pills, study says

Data from a phase 3 clinical trial show that, for people who have challenges with adherence, monthly injections of the HIV medication Cabenuva are superior to a daily pill regimen.

Comprised of the anti-HIV drugs cabotegravir and rilpivirine, Cabenuva is a long-acting injectable antiretroviral therapy (ART) that is administered every four or eight weeks.

The finding came during a regularly scheduled interim review by an independent Data and Safety Monitoring Board (DSMB) looking at data from the ongoing LATITUDE study.

“The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome,” said Kimberly Smith, MD, MPH, head of research and development at drugmaker ViiV Healthcare. “There are many reasons why people may find it challenging to stay on daily oral treatment and the LATITUDE study shows cabotegravir and rilpivirine injectable treatment can help them keep their virus suppressed, which benefits their overall health. Optimizing therapy for all people living with HIV, including those with adherence challenges, is critical to the effort to end the HIV epidemic.”

LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) is an ongoing study at 31 sites across the United States including Puerto Rico. It focuses on people who have challenges with adhering to a daily oral regimen. Participants were tested to ensure the HIV in their blood was not resistant to the study drugs. They then underwent “comprehensive and incentivized adherence support” using daily oral HIV meds to achieve viral suppression—that is, their viral load was too low to be measured by most tests. Participants were then randomized into two groups, either continuing daily meds or receiving the long-acting injectable medication.

After reaching its findings on February 12, the DSMB recommended that study participants be offered the opportunity to switch to Cabenuva. All participants will be monitored for another year.

While there are other long-acting injectable HIV medications, Cabenuva is the only FDA-approved long-acting complete regimen. For now, it is approved only for people whose viral load is undetectable. About 70% of people living with HIV in the United States who take oral ART are virally suppressed, according to the Centers for Disease Control and Prevention (CDC).

The two-drug injectable combo was approved by the FDA in 2021. Cabotegravir is an integrase strand transfer inhibitor (INSTI), which inhibits HIV replication by preventing the virus’s DNA from integrating into the genetic material of human immune cells (T cells). Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), interferes with an enzyme, reverse transcriptase, that the virus uses to multiply.

LATITUDE was launched in 2019 by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is conducted by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), the world’s largest HIV clinical trials network. Additional support was provided by the National Institute of Mental Health, the National Institute on Drug Abuse and by cabotegravir maker ViiV Healthcare and the Janssen Pharmaceutical Companies of Johnson & Johnson, manufacturer of rilpivirine.

—Rick Guasco

Special issue on LGBTQ+ aging

The American Society on Aging (ASA) has devoted a special issue of its Generations Journal to topics related to the LGBTQ+ community. The ASA worked with SAGE, a national organization devoted to improving the lives of LGBTQ+ elders.

“Our essay collection analyzes ageism as a systemic bias—like racism and sexism—and explores its deep links to ableism, given that bias about age is often linked to bias about disability,” writes SAGE CEO Michael Adams. “The essays reflect a reality that is often overlooked: that aging, ageism and ableism affect different socio-economic groups differently. That’s why organizations like ours exist.”

Other articles include one on women with HIV; “The Power and Limits of Law to Fight Structural Ageism, Ableism and Racism” by Gelila Selassie and Denny Chan and “With Age, Blacks Fall Into Poverty as Their Health Worsens,” by Rodney A. Brooks.

TO READ the special edition of Generations Journal 2023, GO TO bit.ly/3UZTH2M.

Keeping people on Medicaid

An online hub showing Medicaid renewal requirements state-by-state was created early this year by the U.S. Department of Health and Human Services (HHS). The intention is to help people figure out how to maintain their Medicaid coverage. The resource is available in Spanish, Mandarin, Hindi, Korean and Tagalog among additional languages. GO TO hiv.gov/blog/hhs-launches-new-medicaid-chip-resource-hub-help-keep-people-covered.

HHS also created a blog post addressing HIV service organizations and others working with the community about helping people living with HIV maintain their Medicaid coverage. GO TO hiv.gov/blog/the-medicaid-unwinding-period-a-message-for-the-hiv-community-09-01-2023. The post also contains links to information for pediatrics and people living with hemophilia.

Positive Women’s Network welcomes new executive team

The Positive Women’s Network-USA (PWN-USA) announced a new leadership team—Keiva Lei Cadena and Marnina Miller became joint executive directors in January.

“We can’t imagine a better team to lead PWN-USA into its bright future,” said board of directors co-chairs LaTrischa Miles and Pat Migliore in a press release. “Keiva Lei and Marnina have been a part of the PWN family for many years and are talented, brilliant and emotionally intelligent leaders; this represents a natural next step in PWN herstory.”

Keiva Lei Cadena is a nationally recognized advocate, activist, speaker and a Native Hawaiian cultural practitioner with extensive experience in HIV services, harm reduction and transgender rights. She is a graduate of PWN’s R.I.S.E. (Resist, Inspire, Sustain through Education) Gender Justice Training Academy, and was later welcomed back as faculty in the same program.

“It’s such a privilege to join PWN’s staff as co-director; this network played a role in my understanding the importance and power of having BIPOC trans women living with HIV advocating for ourselves fearlessly—the effects impact our entire community,” said Cadena. “I’m so proud to be a Native Hawaiian woman of trans experience holding this type of role at the national level. We don’t often see Native people lifted up in this way. PWN continues to be groundbreaking in our efforts to empower our communities. I will continue to strive for the dignity and quality of life we deserve, with the best group of sisters by my side.”

Marnina “the Queen” Miller is a highly accomplished human rights activist, speaker, trainer and social media strategist with “a profound commitment to fostering positive change in society.” She has been part of PWN’s Greater Houston Area chapter and has served on PWN-USA’s Board of Directors since 2018.

“I am honored to co-lead PWN as a young Black woman living with HIV, keeping in minds and hearts our shared values of sisterhood, solidarity and meaningful involvement of people living with HIV,” Miller said. “In this unique journey, let us forge pathways of change, shatter barriers and create a future where our voices not only matter but shape policies that support and empower every woman living with HIV.”

Cadena and Miller follow on the heels of founding director Naina Khanna, who stayed on to help them during a transition period.

Under Khanna’s leadership, PWN-USA grew from a group of 28 founding members to a national organization with seven regional chapters and an organizing presence in more than a dozen states over the past sixteen years. PWN declared in a press release that it has “successfully advanced demands to uplift human rights and dignity for people living with HIV—from changes to the National HIV/AIDS Strategy to increasing the focus on gender responsive services and programs to protecting abortion access and reproductive justice at the ballot box.”

“Keiva Lei and Marnina jointly bring years of community organizing and advocacy, grounded in PWN’s values of Black liberation, trans liberation and meaningful involvement of communities impacted by HIV,” said Khanna, who is pursuing a PhD in medical sociology at the University of California-San Francisco. “Their brilliance, courage, conviction and compassion are urgently needed in this political and cultural moment and will serve as a beacon to the whole HIV field.”

READ MORE about Cadena and Miller at bit.ly/3OV9lZl.

Remembering Hydeia Broadbent

Hydeia Broadbent was a young child when she began speaking on behalf of people living with HIV, but especially on behalf of children like herself who were born with HIV. She died in her home in Las Vegas February 20 at the age of 39. Her father, Loren Broadbent, announced, “With great sadness, I must inform you that our beloved friend, mentor and daughter Hydeia, passed away today after living with AIDS since birth. Despite facing numerous challenges throughout her life, Hydeia remained determined to spread hope and positivity through education about HIV/AIDS.” Cause of death was not immediately given.

In her extensive work on behalf of people living with HIV, Broadbent made many TV appearances. At age 7, she participated in a Nickelodeon special with Magic Johnson. At age 11, she discussed her AIDS status on the Oprah show. She appeared in an episode of the ABC News program 20/20 and on Good Morning America as well as other TV shows. She was presented with an award by Mariah Carey in an Essence Awards ceremony and she won a Black Achievement Award from Jet magazine. Broadbent spoke at the 1996 Republican National Convention. She made appearances through the Elizabeth Glaser Pediatric AIDS Foundation. Broadbent also worked with the Let’s Stop HIV Together campaign of the Centers for Disease Control and Prevention (CDC) and started the Hydeia Broadbent Foundation. Again and again, she raised awareness around HIV and spoke out against stigma.

Patricia and Loren Broadbent adopted Hydeia when she was a baby. Born in 1984, she had been left at a hospital by her birth mother. It wasn’t until age 3 that she was found to have HIV and doctors predicted she would not live past age 5. The family wrote her story in a book, You Get Past the Tears.

Hydeia Broadbent lived her life succeeding beautifully against the odds.