Briefly Sep+Oct 2024

On August 14, the World Health Organization (WHO) declared that a recent and significant rise in mpox cases in Africa “constitutes a public health emergency of international concern (PHEIC).” Mpox cases have occurred due to different viruses called clades, the agency wrote in a press statement.

WHO reported that director-general Tedros Adhanom Ghebreyesus said there was “transmission of the so-called clade 1b virus in the Democratic Republic of the Congo [DRC] last year which was caused mainly ‘through sexual networks.’ This clade is reportedly deadlier and more easily transmitted from person to person. Clade 1 has been circulating in the DRC for years while clade 2 was responsible for the global outbreak of 2022 which was declared an international public health emergency.”

In a perspective piece published August 28 in the New England Journal of Medicine (NEJM), Lawrence O. Gostin, JD; Ashish K. Jha, MD, MPH; and Alexandra Finch, LLM; write, “The previous day, the Africa Centers for Disease Control and Prevention (Africa CDC) declared a Public Health Emergency of Continental Security (PHECS)—the organization’s first-ever declaration of a regional health emergency. This regional declaration and the WHO’s early response—issued without waiting for mpox to affect high-income countries—could offer a historic opportunity to mobilize lifesaving resources according to the principles of solidarity and equity.”

The perspective article continues to explain that, “Human-to-human transmission has primarily occurred within households, in health care settings and by means of sexual contact, with the greatest risk seen among men who have sex with men (MSM) and sex workers. Evidence suggests that clade 1b is more likely to be lethal than clade 2b—the clade that drove the global mpox outbreak in 2022, affecting primarily MSM and causing nearly 100,000 cases and 208 deaths in 116 countries. Tragically, most cases and deaths in the current mpox outbreak have occurred in children, indicating that transmission is occurring by routes other than sexual contact.

“The WHO previously declared a PHEIC for the clade 2b mpox global outbreak in 2022. Yet endemic [basically, a condition that has become common in an area] mpox has not garnered the same attention and investment—a disparity that the concurrent regional and global emergency declarations should help to rectify. The rapid international spread of a new mpox subtype is of enormous concern. Though all countries should fortify their preparedness, the priority must be coordinated action and investments focused on response efforts in Africa,” Gostin and colleagues write.

The August 28 issue of NEJM has a separate perspective piece addressing mpox and pregnancy. The article includes a detailed trajectory of mpox spread, above and beyond the needs and means to protect pregnant people and their unborn child.

WHO reported that mpox cases have been spreading throughout many countries in Africa, particularly the DRC, and neighboring Burundi, Kenya, Rwanda and Uganda. The potential for further spread in Africa is worrying, Tedros said. “In addition to other outbreaks of other clades of mpox in other parts of Africa, it’s clear that a coordinated international response is essential to stop these outbreaks and save lives,” the director-general added.

There have been more than 14,000 reported cases of the virus this year with 524 deaths, a significant increase in reported cases from last year.

GO TO bit.ly/4ehL4Xr,

GO TO bit.ly/3XndgBF.

Doctors Without Borders/Médecins Sans Frontières (MSF) provided several informational pieces on mpox and its outbreaks, including Q&As and the organization’s efforts to combat mpox, including vaccination. GO TO doctorswithoutborders.org.

Doxy-PEP from Ryan White

The HIV/AIDS Bureau from the Health Resources and Services Administration (HRSA HAB) issued a program letter to recipients of the Ryan White HIV/AIDS Program (RWHAP) urging them to provide doxy-PEP, an antibacterial strategy used to prevent STIs following a potential exposure. The recommendation followed establishment of doxy-PEP guidelines from the U.S. Centers for Disease Control and Prevention (CDC) in June.

GO TO cdc.gov/mmwr/volumes/73/rr/rr7302a1.htm.

“Specifically, we encourage you to use RWHAP funds to purchase doxycycline for your eligible clients and for RWHAP Part B AIDS Drug Assistance Programs [ADAPs] to add doxycycline to their formularies to ensure access and coverage,” said HRSA HAB associate administrator Laura Cheever, MD, and colleague Heather Hauck in a note to Ryan White recipients notifying them of the letter.

The July 31 letter also points out that, “Awareness of current mpox vaccination and testing recommendations, especially for the immunocompromised, is vital to prevent future outbreaks. The mpox vaccine is now accessible commercially at locations where other vaccines are offered.”

GO TO bit.ly/4dXsft7.

HRSA HAB has an mpox webpage; GO TO ryanwhite.hrsa.gov/resources/mpox.

Legal primer for aging with HIV

The Center for HIV Law and Policy (CHLP), a national prison abolitionist and legal policy organization based in New York, in August published the legal guide Aging and HIV: An Introduction to Legal Issues Facing People Living and Aging with HIV (PLAHIV).

“The focus of this primer is to help PLAHIV identify and overcome the legal barriers to aging with dignity,” CHLP writes.

According to the primer, people living with HIV (PLWH) are affected not just by their HIV status, but by discrimination dominated by ageism, anti-Black racism, homophobia and transphobia. CHLP hopes the guide can help advocates with policy efforts.

“People living with HIV deserve to age with dignity and to have that ability fully supported and funded by government resources,” the guide states. “They deserve to have their rights protected in both public and private spheres and not face stigma and discrimination. This primer provides as much information as possible about ways that the law supports the ability of PLAHIV to age with dignity while highlighting some of the limitations and flaws of America’s aging support systems.”

The primer is divided into three categories:

• Federal laws (such as the Americans with Disabilities Act)
• HIV criminalization
• Barriers to, and remedies for, protecting personal decisions for health and medical care

Using clear writing, the primer takes you not just through the law, but through the sociopolitical realities that often affect people living with, or groups most affected by, HIV. For example, PLWH and LGBTQ+ individuals are more likely to experience incarceration than the general population. As one result, they are more likely to have difficulties building a job history or credit.

The 76-page guide covers a lot of territory and contains dozens of links to other publications and articles.

“Just as there are myriad forms of discrimination and administrative roadblocks faced by PLAHIV to aging with dignity with unhampered decision-making capacity, there are accessible tools that they can utilize to best prepare for their future,” said Kae Greenberg, CHLP staff attorney and author of the guide.

GO TO hivlawandpolicy.org.

CHLP’s definition of aging with HIV includes Dandelions, the group of people born with the virus. “Dandelions” comes from a poem of the same title by poet and performance artist and activist (artivist) Mary Bowman, who died in 2019 at the age of 30. Hear her performance of the poem at bit.ly/3BbBS8L.

PrEP your booty

That may not be what researchers say (most of them, anyway) but that’s what advocates titled a new study and their recent webinar on the upcoming trial that will test a rectal douche for preventing HIV.

Known as the REV UP trial from the HIV Prevention Trials Network (HPTN), HPTN 106 will observe the safety and acceptability of a tenofovir-based douche for use by cisgender men and transgender women who have sex with men.

Different forms of the drug tenofovir are contained in the two current oral HIV prevention medications on the market, Truvada for PrEP and Descovy. “PrEP” stands for pre-exposure prophylaxis.

An August 29 webinar features presentations by HPTN 106 researchers Craig Hendrix, MD; and Mark Marzinke, PhD; of Johns Hopkins University. It includes a history of rectal microbicides for HIV prevention and of PrEP in general. PrEPWatch, a data and news tracking initiative from the prevention advocacy organization AVAC, along with co-sponsor HPTN, hosted the program. For a recording and slides, GO TO bit.ly/4ebDON6. The page links to several articles on PrEP and microbicides.

AIDS 2024 international conference

Organized by the International AIDS Society (IAS), the 25th International AIDS Conference (AIDS 2024) took place July 22–26 in Munich, Germany. IAS calls the conference “the premier global platform to advance the HIV response.”

“As the world’s largest conference on HIV and AIDS, it sits uniquely at the intersection of science, advocacy and human rights, bringing together scientists, policy makers, healthcare professionals, people living with HIV, funders, media and communities,” IAS writes. “Since its start in 1985, the conference has served as an opportunity to strengthen policies and programs that ensure an evidence-based response to HIV and related epidemics.”

Following are but a few of the reports coming out of AIDS 2024. GO TO iasociety.org.

Maine reports first infant HIV case in five years

The state of Maine issued a health alert in June after an infant tested positive for HIV. “This is a rare event and an opportunity to reinforce HIV testing recommendations to prevent future cases,” said the state’s Center for Disease Control and Prevention (Maine CDC) in a statement.

According to the report, “The last infant in Maine with HIV infection attributed to perinatal transmission was born in 2019. Perinatal HIV infections are rare, with 21 cases of HIV attributed to perinatal transmission in the U.S. in 2021, the last year for which data are available. Perinatal HIV in the U.S. has fallen by more than 95% since the early 1990s. Perinatal HIV [previously referred to as “vertical”] transmission occurs when HIV is passed from a pregnant person to their child during pregnancy, childbirth or breastfeeding/chestfeeding. Having an undetectable viral load in pregnancy, and throughout the duration of breastfeeding/chestfeeding, lowers the risk of perinatal transmission of HIV to less than 1%. Most pregnant people living with HIV can have vaginal deliveries: for people with a high viral load (greater than 1,000 copies/mL) near the time of delivery, a scheduled cesarean delivery can reduce the risk of perinatal HIV transmission.”

Maine health officials recommend that people get tested for HIV at the time of pregnancy. In fact, a test is required by state law for perinatal care. A second test during the third trimester should be given to anyone with “ongoing risk.” “Maine CDC recommends testing all people with ongoing risk factors for HIV infection (e.g., shared syringes, needles or other injection drug equipment, exchanged sex for drugs or money or more than one sex partner since their last HIV test) at least every three months. This interim recommendation is related to the [recent] HIV cluster occurring in Penobscot County.”

A rapid HIV test should be given to anyone without a test result at the time of delivery. An infant born having a potential exposure to HIV should be given HIV therapy immediately, “ideally within 6 hours after delivery.”

The Maine report included a list of U.S. CDC recommendations for HIV testing: at least once for everyone between 13–64 years old, but at least once a year for the following groups that may experience a heightened level of potential exposure:

• Men who have sex with men
• People who have had anal or vaginal sex with someone living with HIV
• People who have had more than one sex partner since their last HIV test
• People who have shared syringes, needles or other injection drug equipment
• People who have exchanged sex for drugs or money
• People who have been diagnosed with or treated for another sexually transmitted infection (STI)
• People who have been diagnosed with or treated for hepatitis or tuberculosis (TB)
• People who have had sex with anyone with the above risk factors or anyone whose sexual history they don’t know

To find the June 13 notice, GO TO bit.ly/4gfscud.

‘Addicts are everywhere, and we look just like you’

That’s what Lori Lynne Armstrong says about telling her story in Someday I Will Not Be Ashamed: A Memoir, released in August.

“Many people have conscious or unconscious ideas of how a junkie looks or talks. I look nothing like that, and I talk like the love child of a poet and a psychologist,” Armstrong said in a press release for the book. “Addicts are everywhere, and we look just like you. And we who live with mental illness are everywhere, too. Anyone you meet who looks confident on the outside may be battling symptoms or drowning in a swamp of shame.”

Armstrong’s challenges included an eating disorder, chronic pain, hospitalization for mental illness and an addiction to painkillers. She holds master’s degrees in molecular biology and counseling psychology and writes prose and poetry on the subjects of mental health and addiction. Armstrong has also written the poetry compilation Poppytown: Love Songs from the Opioid Epidemic.

GO TO lorilynnearmstrong.com, or connect with Armstrong on Facebook (bit.ly/3ZihFIr), X (@LLArmstrong) and Instagram (lorilynnearmstrong).    

WHO updates its PEP guidelines

Not enough people receive the medicines that can prevent them from acquiring HIV after a potential sexual exposure

The science is here to prevent HIV with medicine. The science has been here to prevent HIV with medicine. And, it continues to get better.

Yet, PEP—medication taken one to three days after a potential exposure to HIV—remains unknown to far too many people.

“Despite advancements in testing and treatment, over one million people became infected with HIV in 2022. This warrants a need for a revitalized focus on proven HIV prevention interventions such as HIV post-exposure prophylaxis (PEP),” the World Health Organization (WHO) reported.

For AIDS 2024, WHO presented its updated PEP guidelines. WHO added two new recommendations that would expand the reach of this prevention strategy:

• Allow more places, beyond the clinic, that can make PEP available (including mobile clinics, drop-in centers, pharmacies, online delivery and community-based organizations)
• Allow more individuals (including pharmacists and trained lay and peer health workers) to provide it

“While HIV PEP is an effective HIV prevention intervention that has been recommended by WHO for all potential HIV exposures, access to and uptake of PEP is still sub-optimal, leading to missed opportunities to prevent new HIV transmissions,” the international agency’s guidelines explain. “There has been huge interest and increased programming and uptake of pre-exposure prophylaxis (PrEP) over the past 10 years. In contrast PEP, which also has been recommended for a decade, has received little attention and limited use, even though, with expanded PrEP access, PEP has important additional prevention benefits. Expanding access to PEP after all potential exposures through sexual and injecting drug use is needed.”

According to the updated guidelines, greater access to PEP may help “to mitigate barriers such as stigma and to ensure timely access post exposure.”

The international agency stressed that, “Timely access to PEP is the most crucial factor in PEP effectiveness. PEP is most effective when initiated as soon as possible, ideally within 24 hours and no later than 72 hours after exposure.”

WHO noted that, “While a PEP regimen of two drugs can be effective, three drugs are preferred. It is recommended that people be given a 28-day prescription for PEP.” The guidelines include recommended regimens for adults, adolescents and children.

Outdated policies are restricting access, WHO noted, such as limiting it to cases of sexual assault or to workplace use (primarily needlestick injuries experienced by clinic staff). WHO states that, “Anyone with a known or suspected exposure to HIV should be offered PEP.” Further, PEP knowledge is low among providers, and so is access to the medications that can be used. At the community level, groups or locations with the highest level of HIV transmission also have a low level of awareness about PEP.

And PEP has only a brief time for it to work: people need to get the medicines within three days at the most—preferably within a day. A flowchart of suggested labwork and follow-up steps appears on page 8 of the guidelines. Also, while HIV testing may be desirable, its availability varies from place to place; to be clear: “If HIV tests are unavailable but the person is suspected to have been exposed to HIV, PEP should be started regardless.”

“Therefore, PEP services need to be close at hand when needed,” WHO writes.

A recognized benefit of PEP is linking people with a potentially greater need for prevention to PrEP; a discussion of transitioning PEP users to PrEP appears on page 7. PrEP may be especially beneficial for people who use PEP multiple times.

To read the guidelines, GO TO bit.ly/3B1U4lg.

Preferred PEP medications in the U.S.

The following HIV medications are recommended for PEP according to expert opinion. Biktarvy and all the combinations are to be used once a day for at least 28 days, within 1 to 3 days (24 to 72 hours) of a potential exposure to HIV, but the sooner the better. A one-month prescription is probably the easiest way to go to avoid a pharmacy snafu. These regimens are for adults and adolescents ages 13 and older.

There are different recommended regimens for children under the age of 13 and for individuals with kidney problems (defined as creatinine clearance less than or equal to 59 mL/min), found in the PEP guidelines from the U.S. Centers for Disease Control and Prevention (CDC), 2016 update. The newest update is expected soon.

Preferred regimen

A three-drug regimen consisting of one of the following three combinations:

• Biktarvy (single-tablet regimen) or
• raltegravir (Isentress or Isentress HD) plus Truvada or Descovy or
• Tivicay (dolutegravir) plus Truvada or Descovy

Alternative regimen

A three-drug regimen consisting of 800 mg of darunavir (Prezista) boosted by Norvir (ritonavir, taken as a 100 mg tablet) plus Truvada or Descovy

Note: Generic versions of Norvir, Prezista and Truvada are available.

The recommendations are technically referred to as “nPEP” for “non-occupational post-exposure prophylaxis.” GO TO bit.ly/4d52equ. SEE also the International AIDS Society-USA (IAS-USA) HIV treatment and prevention guidelines, which already list Biktarvy for PEP use. GO TO bit.ly/3N2fQZ7.

HHS updates OI guidelines on MAC

The U.S. Department of Health and Human Services (HHS) in August updated its opportunistic infection (OI) guidelines for treating MAC (Mycobacterium avium Complex). The bacterial disease is most commonly associated with tuberculosis (TB). As an opportunistic infection in advanced HIV disease, MAC takes advantage of a weakened immune system that has difficulty fighting back.

The revised Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV from HHS now have:

• “Updated information to prioritize the initiation of effective antiretroviral therapy (ART) and to refrain from primary prophylaxis [prevention] for [MAC] except for people with HIV who are not receiving ART, remain viremic [have a detectable viral load] on ART or have no options for a fully suppressive [achieving undetectable viral load] ART regimen.
• “Added new information indicating that drugs demonstrating substantive in vitro [test tube] activity against MAC might be considered for the treatment of refractory MAC disease (e.g., bedaquiline, tedizolid, linezolid and omadacycline), acknowledging that there is insufficient observational or clinical trial data to support formal recommendations in this setting.
• “Updated information on drug–drug interactions between anti-MAC therapies, particularly rifabutin, and antiretroviral drugs and provided a link to the Adult and Adolescent Antiretroviral Guidelines on drug–drug interactions.”

GO TO clinicalinfo.hiv.gov.

Children’s Investment Fund to promote the HIV prevention vaginal ring

The Children’s Investment Fund Foundation (CIFF), in partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund), announced an initiative to provide up to $2 million over the 2024–2025 period for about 150,000 dapivirine vaginal rings. A form of long-acting HIV PrEP, the ring has shown efficacy in stopping the virus.  

CIFF said the DapiRing is manufactured by Sever Pharma Solutions in Sweden for the Population Council. The one-month ring costs approximately $12.80, but a three-month ring in development is expected to cost $16.

“The Global Fund is committed to drive equitable access to quality assured and affordable HIV prevention tools and is working with partners and the industry to shape and create a sustainable market, including injectable lenacapavir,” said Hui Yang, who heads Supply Operations at the Global Fund, in a press release.

According to the release, the PrEP ring has received a positive opinion from the European Medicines Agency (EMA) and has received regulatory approval in Botswana, Eswatini, Kenya, Lesotho, Malawi, Namibia, Rwanda, South Africa, Uganda, Zambia and Zimbabwe.

It is hoped that the ring donation will help promote prevention and bridge the gap until a lower-cost three-month ring or an African-manufactured ring becomes available, “which will lead to lower prices over the long-term.”

An independent philanthropic organization with offices in Addis Ababa, Beijing, London, Nairobi and New Delhi established in 2002, CIFF “works with a wide range of partners to create a healthy, fair and safe world for children. Areas of work include child health and nutrition, sexual and reproductive health and rights, opportunities for girls and young women, child protection, and catalyzing climate action.” GO TO bit.ly/47qnSUH.

New IAS president: Beatriz Grinsztejn

The International AIDS Society elected Beatriz Grinsztejn of Brazil as their new president. An infectious disease physician and researcher, Grinsztejn co-founded FIOCRUZ HIV/AIDS Service, the largest care provider in Rio de Janeiro. She has served as director of the HIV/AIDS Clinical Research Unit at the Evandro Chagas National Institute of Infectious Diseases-FIOCRUZ for 25 years and was director of the first established trans health clinic in Rio.

“As a lesbian from Latin America and the director of the first sexual and gender minorities’ health clinic in Rio de Janeiro, I witness firsthand every day how we are still failing the most marginalized people,” she said. “In Brazil, new HIV acquisitions are rising among young black men who have sex with men, illustrating the structural gender-related violence and racism fueling the epidemic.”

Dr. Grinsztejn is a leader in clinical research for the development of new HIV prevention tools, including the HPTN 083 study evaluating long-acting injectable cabotegravir in HIV-negative trans women and men who have sex with men. A pioneering champion of LGBTQ+ rights, she also led efforts to introduce gender-affirming care in Brazil. As a professor of the Infectious Diseases Clinical Research Postgraduate Program at FIOCRUZ, she has mentored more than 25 master’s and PhD students.

Kenneth Ngure from Kenya was selected as president-elect. Sharon Lewin from Australia assumed the role of Immediate Past President.

GO TO bit.ly/3MHMZc8.

PEPFAR: Millions of lives saved

HIV.gov conducts video reports from most major HIV conferences. Its AIDS 2024 coverage began with a brief overview from John Nkengasong, the ambassador to the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR).

“Just think of where we were 25 years ago, when HIV meant death,” said Nkengasong, calling the program “a game-changing initiative.”

“PEPFAR has transformed that, and offered hope to individuals, offered hope to the community, and offered hope to the countries that we supported,” Nkengasong continued. “We recognized 25 years ago also that a disease threat anywhere in the world was a disease threat everywhere in the world. And look at where we are today. Over 25 million lives have been saved. About 5.5 million children have been born free of HIV/AIDS. But we need to sustain those gains. We need to make sure that we accelerate our efforts so that by the year 2030 we can bring HIV/AIDS to an end as a public health threat.”

Nkengasong said there needs to be continued awareness that HIV is not over, and that prevention is crucial to reaching the goal of ending the epidemic by 2030, particularly with a long-acting injectable drug showing success in clinical trials (lenacapavir). Financial commitment must therefore continue, and complacency must be overcome.

“It’s very easy for us to be vulnerable to our own success,” said Nkengasong.

To hear ambassador Nkengasong’s brief comments, GO TO bit.ly/3B4hFly.

The webpage connects to other video reports that include HIV criminalization, research updates and U=U (undetectable equals untransmittable, in which a person living with HIV is unable to transmit the virus to sexual partners after reaching and maintaining undetectable viral load). HIV.gov also posts videos on its Facebook page.

Advocates call for lower cost, greater access to new injectable PrEP drug

What should be the price for lenacapavir?

by Rick Guasco

When Gilead Sciences announced in June the unprecedented results of a phase 3 HIV prevention clinical trial, it made headlines (see page XX). Lenacapavir, which is injected once every six months, had a 100% success rate protecting cisgender women from HIV in the PURPOSE 1 study. For the first time in a prevention study, not a single new HIV diagnosis was reported among the 2,134 women who received lenacapavir. Now, as more studies are underway, advocates are urging Gilead to make lenacapavir more accessible by cutting its price.

At AIDS 2024, UNAIDS executive director Winnie Byanyima was among the voices calling for lenacapavir to be licensed in low- and middle-income countries through the Medicines Patent Pool, a UN-backed organization that helps development of and access to life-saving medications in those countries.

Marketed under the brand name Sunlenca, lenacapavir is used in combination with other antiretrovirals as an HIV treatment. It has not been FDA approved for HIV prevention, known as PrEP. Sunlenca’s list price is $42,250 a year. In comparison, Gilead also manufactures Descovy, the leading brand name oral PrEP medication, which lists for $26,000 a year. Apretude, the brand name of cabotegravir, sold as another long-acting PrEP drug injected every two or three months and made by rival ViiV Healthcare, lists for $23,000.

“The list price sets the ceiling from which the complex set of drug distribution players in the U.S. negotiate a lower price,” says PrEP4All in a commentary released on August 26. “Start high and even with discounts, we’ll end high. For a drug with such public health significance as PrEP, the high list price also hamstrings the ability of state and local public health departments that perennially struggle with anemic budgets—some of whom qualify for discounts and some of whom do not—to purchase the drug and get it out to uninsured, low-income and vulnerable populations.”

Written by PrEP4All executive director Jeremiah Johnson and consultant Amy Killelea, the commentary appeared in the online journal Health Affairs. PrEP4All is an advocacy organization promoting the development of a national PrEP program and wider access to PrEP medications.

“We have been down this road before,” the commentary says. “It was not so long ago that the very same drug manufacturer released similarly jaw dropping clinical trial results first for Truvada and then Descovy, the first two medications approved for the prevention of HIV; it led to widespread speculation of the end of HIV as an epidemic. And yet, more than a decade after the first approval for PrEP in the United States, we still see significant disparities in getting PrEP to communities of color and cisgender women in the U.S.”

The commentary adds, “…there is still always the potential for an alternative future here. We can envision a scenario in which Gilead—perhaps facing significant pressure from the U.S. advocacy community and the U.S. government—commits to working with existing public health programs and, eventually, a national PrEP program to set a public health price point for lenacapavir to ensure a simple, transparent and intuitive pathway for uninsured populations. This would be a new, bold approach—not a repeat of past charitable and donation programs that fail to provide an integrated approach to PrEP delivery. Instead, it would be a true, significantly lower price point that empowers public programs and health departments to come up with simple and comprehensive financing and delivery mechanisms that are highly accessible for end users. Only then will we stop repeating the same pattern in which the bang of a big scientific breakthrough is followed by the whimper of inaccessibility.”

Several other PURPOSE clinical trials are underway or are being planned that will look at how well lenacapavir works in specific groups of people including men who have sex with men, trans men and people who inject drugs. Results of at least one of these PURPOSE studies are expected by early next year, if not sooner, before the drug is submitted for FDA approval.

To read the complete commentary on Health Affairs, GO TO bit.ly/3z8mEkx.

With reporting from Enid Vázquez