Twice-a-year PrEP may be available by summer
FDA accepts new drug application for long-acting injectable lenacapavir for HIV prevention
A new drug for HIV prevention that’s used only twice a year may become available as early as this summer. Long-acting injectable lenacapavir (LEN) for PrEP (pre-exposure prophylaxis) is administered as just two injections taken every six months. The latest HIV prevention med, made by Gilead Sciences, was granted a New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA) on February 18.
The FDA decision whether to approve lenacapavir for PrEP is scheduled for June 19 under a priority review. It has also been submitted for approval in Europe.
“Today, we are one step closer to introducing the first-ever twice-yearly HIV prevention choice that could, if approved, help transform the landscape for individuals who need or want additional prevention options that better fit into their lives,” Gilead's chief medical officer Dietmar Berger said in a press release. “We’re excited about the potential of lenacapavir to make a real difference in HIV prevention in the U.S. and around the world, supporting the broader goal of ending the HIV epidemic for everyone, everywhere.”
Gilead made headlines last year with the success of lenacapavir for PrEP in cisgender women and adolescent girls in the PURPOSE 1 clinical trial, conducted in South Africa and Uganda. (SEE “Injectable lenacapavir 100% effective at preventing HIV in cis women” by Larry Buhl, SEP+OCT 2024.)
Additional PURPOSE studies are examining the use of the PrEP medication in other groups of people. PURPOSE 2 is studying cisgender and transgender men, transgender women and non-binary people who have sex with men. Study sites include Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States. PURPOSE 3 is studying lenacapavir for PrEP in cisgender women in the U.S. PURPOSE 4 is determining efficacy for injection drug users.
With its enrollment of cis women in sub-Saharan Africa, the PURPOSE 1 demographics are significant: the region represents an estimated two-thirds of people with HIV worldwide. According to UNAIDS, approximately 4,000 teen girls and young women in Africa acquire HIV every week.
Science magazine designated the PrEP medication Science Breakthrough of the Year in December 2024.
The FDA granted a Breakthrough Therapy Designation to lenacapavir for PrEP in October 2024. According to the FDA website, “Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”
Lenacapavir would become the fourth drug FDA approved for PrEP. Gilead produced the first PrEP medication to come to market, Truvada for PrEP, in 2012. Later it brought out Descovy for PrEP. In late 2021, cabotegravir, manufactured by ViiV, began the first long-acting injectable form of PrEP—two shots administered every two months—under the brand name Apretude. All four medications—Truvada, Descovy, cabotegravir and lenacapavir are also prescribed as components of HIV treatment regimens. Under the brand name Sunlenca, lenacapavir for HIV treatment is a twice-yearly (every six months) injection that is taken with other HIV medications.
When PURPOSE 1 results were made public during last year’s International AIDS Conference, AIDS 2024, advocates called on Gilead to lower the drug’s cost to make it more accessible. Access, access, access. Battles have begun over access issues such as cost and supply.
National Black HIV/AIDS Awareness Day
“Year after year, the disparities in healthcare outcomes for our Black communities remain glaring. We cannot afford inaction while Black communities face disproportionately high rates of HIV/AIDS illness and limited access to life-saving resources,” said Illinois state Rep. Carol Ammons (D-Urbana) speaking out on National Black HIV/AIDS Awareness Day (NBHAAD), February 7.
The Illinois Department of Health has declared racism to be a public health issue, as have many other health departments and organizations around the country.
Rep. Ammons, who is the chair emerita of the Illinois Black Caucus Foundation (ILBCF), joined Black Leadership Advocacy Coalition for Healthcare Equity (BLACHE) in a press conference for Black HIV/AIDS Awareness Day to address the disproportionate impact of HIV/AIDS in African American communities across the state.
The theme of this year’s National Black HIV/AIDS Awareness Day was Engage, Educate, Empower: Uniting to End HIV/AIDS in Black Communities.
“This observance is a day to acknowledge how HIV disproportionately affects Black people,” says HIV.gov. “Black communities have made great progress in reducing HIV. Yet racism, discrimination, and mistrust in the healthcare system may affect whether Black people seek or receive HIV prevention services. These issues may also reduce the likelihood of engaging in HIV treatment and care.”
Find all HIV/AIDS Awareness Days at hiv.gov/events/awareness-days.
Congressional representatives Mark Pocan (WI-2), who is chair of the Congressional HIV/AIDS Caucus, Robin Kelly (IL-2) and Bonnie Watson Coleman (NJ-12) recognized NBHAAD with a press statement: “As our country observes National Black HIV/AIDS Awareness Day, it is important for Congress and the Administration to recognize the progress of the Black community’s fight against HIV and to continue Ending the HIV Epidemic by fully funding the nation’s HIV programs.
“We cannot turn our backs when our national prevention efforts are finally having an impact on the number of new infections for Black communities,” Rep. Pocan said in the press release. “This ongoing crisis has underscored the systemic inequities people living with HIV and AIDS face in accessing healthcare. Now is the time for the government to fulfill its commitment to ending the HIV epidemic, not for the Trump administration to halt critical care programs and put peoples’ lives at risk.”
The representatives quoted Leisha McKinley-Beach, a member of PrEP in Black America (PIBA) and CEO of the Black Public Health Institute: “PrEP can be a game-changer for Black communities, but only when it’s powered by the right forces—Black leadership, research, and access. Without that, it’s just another unused tool, sitting idle in the toolbox.”
Organized by PrEP4All, the #SaveHIVFunding is a campaign comprised of a coalition of activists and advocacy organizations that include AVAC (formerly the AIDS Vaccine Advocacy Coalition), the HIV Medicine Association (HIVMA) and NASTAD (National Alliance of State and Territorial AIDS Directors). “Thanks to the support of advocates and community members who supported the #SaveHIVFunding campaign in 2023, we were able to successfully avert $767 million in domestic HIV funding cuts proposed by Congress, as well as lift up calls for a National PrEP Program,” NASTAD writes.
“With your support, we were able to build bipartisan support in the Senate to fund HIV prevention and treatment services for another year. Unfortunately, we are again dealing with half a billion in proposed cuts to HIV funding by Congress as we get closer to the 2030 federal deadline for ending the HIV epidemic.” GO TO nastad.org/savehivfunding.
Improving blood samples sent through the mail
“In parts of the world where traveling to a clinic for routine blood tests is a financial and logistical challenge, HIV patients increasingly have the option to collect and ship a drop of their blood in paper-based devices that absorb the sample and store it for analysis in far-away labs,” writes Joseph Caputo for TuftsNow, an online newsletter of Tufts University.
“While this technology is helpful for tracking an individual’s adherence to their drug regimen or monitoring disease progression, the most frequently used devices don’t control how much blood they collect, potentially leading to inaccurate readings of a person’s infection,” Caputo reports.
Associate professor Charlie Mace of the university’s Chemistry Department, along with colleagues in the U.S. and in South Africa, tested a new paper-based product with wax-printed patterns that could improve the collection of samples.
Read the story at now.tufts.edu/2025/02/18/new-paper-based-device-boosts-hiv-test-accuracy-dried-blood-samples. The research team’s findings were published February 18 in the Proceedings of the National Academy of Sciences.
PEPFAR freeze
A 90-day funding freeze was placed on PEPFAR (the U.S. President’s Emergency Plan for AIDS Relief) and all other foreign aid in January by the new presidential administration. Established in 2003, PEPFAR has been credited with saving more than 25 million lives around the world, more than any other health program. HIV treatment and prevention advocates began gearing up after the November elections to fight funding cuts, including concerns over U.S. efforts such as the Ryan White HIV/AIDS Program.
“PEPFAR is the largest commitment by any nation to address a single disease in history, enabled by strong bipartisan support across 10 U.S. congresses and four presidential administrations, and through the American people’s generosity. PEPFAR shows the power of what is possible through compassionate, cost-effective, accountable, and transparent American foreign assistance,” according to NIH.gov. GO TO hiv.gov/federal-response/pepfar-global-aids/pepfar.
The Journal of the International AIDS Society (JIAS) on February 18 published an overview of the freeze effects on PEPFAR. GO TO onlinelibrary.wiley.com/doi/full/10.1002/jia2.26423.
“Apart from the court battles to preserve foreign aid, PEPFAR is at the mercy of several deadlines as Congress wrangles with the federal budget,” writes PA editor-in-chief Rick Guasco online. Read his interview with former PEPFAR chief of staff Jirair Ratevosian at positivelyaware.com/articles/future-pepfar-and-us-hiv-programs.
“I think we’re facing a future where we’re not going to be able to put every person who needs HIV treatment on treatment,” says Ratevosian. “We're not going to be able to rapidly broaden PrEP access in the way it needs to. These will be missed opportunities as a result of a shortsighted foreign aid freeze.”
Anal cancer screening, for men and women
Last year, anal cancer screening recommendations were added to the opportunistic infections guidelines in HIV, produced by the Department of Health and Human Services (HHS).
But understanding the recommendations remains somewhat complicated. Brian R. Wood, MD, helps put things into perspective with a commentary published in TheBodyPro.com.
“I believe the barriers that will have the most impact include the low number of providers trained to perform high-resolution anoscopy; long wait times for those who have completed the training; low awareness of the potential benefits of screening among patients; and difficulty integrating a new screening strategy into primary care practices that are already very busy,” Dr. Wood writes in his report. He provides some recommendations of his own.
The guidelines are an important step forward in HIV care, he notes, since people living with the virus are at an increased risk of acquiring anal cancer. GO TO clinicalinfo.hiv.gov.
It doesn’t matter whether people have anal sex or not, since the virus that leads to most cases of anal cancer, human papilloma virus (HPV), is not only extremely common in the U.S., but is spread by skin-to-skin contact and can move from the front genital area to the anus.
Dr. Wood is an associate professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington. He also serves as a faculty trainer for the Mountain West AIDS Education and Training Center (MWAETC) and is the medical director for the MWAETC Project ECHO Telehealth Program. His article provides insight into preparing providers and clinics to take on screening, and he discusses the readiness of people with HIV to embrace it as well.
“My experience has been that for some patients, such as older men who have sex with men who have seen friends or partners struggle with or die of anal cancer, the new guidelines recommendations are easy to accept,” Dr. Wood writes.
“However, for others—such as cisgender women over age 45 years—the new recommendation for additional anal cancer screening is a surprise, and may be met with reluctance. It may well take a number of conversations for some individuals to feel comfortable with it, and I think we need further research to confirm the optimal interval for repeating screening, because yearly testing will be a burden on both providers and patients,” he explains.
He notes that, “The other challenge with yearly screening is a potential overload of referrals for high-resolution anoscopy. I believe we need better guidance on who to prioritize for screening. For example, certain clinical factors—such as older age, more significant immunosuppression (as indicated by a nadir CD4 count below 200 cells/mL or persistent low CD4/CD8 ratio), as well as longer duration of HIV infection—are associated with a higher risk of anal HSIL [high-grade squamous intraepithelial lesions] and anal cancer. Additional factors, such as tobacco smoking, also increase the persistence of HPV infection and the likelihood of developing anal cancer.”
To read the February 18 commentary, GO TO thebodypro.com/hiv/hiv-anal-cancer-screening-guidelines-2024-update-commentary.
The U.S. Centers for Disease Control and Prevention (CDC) recommends HPV vaccination for adolescents beginning at ages 11 to 12 and as young as 9 (two injections), and for young people up to the age of 25 (three injections). Vaccination is less effective above this age due to the common acquisition of HPV by that point, but some groups are still better served by vaccination than others. GO TO cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html.
More data on HIV in Korea
“Despite the relatively low prevalence of HIV/AIDS in Korea, the incidence of HIV is steadily increasing, centering on same-sex sexual contact among men in their 20s and 30s. However, in Korean society, where acceptance of homosexuality is low, LGBTQ + research is lacking and there is little empirical data on HIV transmission,” researcher Minsoo Jung, of the Department of Health Science, College of Natural Science, Dongduk Women’s University, writes in a recently published study.
Jung established a survey for gay and bisexual men through a website that serves them.
According to the conclusion, “This study found that young non-heterosexual men in South Korea are more likely to engage in condomless anal sex while living with HIV [and] STDs. As a result, primary partners are at higher risk of infection, and bisexual individuals are more likely to transmit HIV [or] STDs due to similar sexual contexts.”
The study, published February 19 by BMC Public Health, is available free online. GO TO bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-21751-2.
Treatment interruption
The concept of treatment interruption (also known as “drug holidays”) seems like a thing of the past. It was commonly discussed when earlier HIV therapies had side effects and other complications that made taking them difficult for many people, at a time when the benefits were not as clear as they became later.
Treatment interruptions never went away, however. People still stop taking their HIV medication for various reasons.
A comprehensive article in CATIE News published online February 18 reviews studies examining treatment interruption from Canada, the U.S. and Switzerland.
The latest treatment interruption data from the Swiss HIV Cohort Study found that about 19% of participants monitored for at least 10 years had interrupted therapy. This group of nearly 15,000 individuals spans from 1996. The ’90s were difficult years for therapy, however, despite the amazing turnaround at that point when it meant that AIDS was no longer a death sentence.
“Over time, the risk for interrupting clinic visits and/or ART [antiretroviral therapy] decreased and remained lower in the years 2005 to 2009 (compared to 1996 to 1999) and it did not further decrease after this time,” wrote author Sean R. Hosein.
Nearly half of the people who interrupted their therapy went back on treatment at some point.
Interruptions were associated with these negative effects:
- Twelve percent of the people who interrupted treatment returned to care with a new AIDS-related infection.
- The most common of these infections were pneumocystis pneumonia (PCP), thrush in the mouth and throat (esophageal candidiasis), Kaposi’s sarcoma (KS, a cancer), and toxoplasmosis.
- A longer interruption was associated with a greater risk of experiencing an infection.
- “For instance,” Hosein explained, “among participants who interrupted ART for 14 months, there was a 7% risk of developing a life-threatening complication. The figure rose to 17% for those who interrupted ART for more than 60 months.”
In terms of effects on the immune system, as reflected by CD4+ T cell counts:
- The average T cell count for the people who went back into care after an average of 12 months had gone down from 374 to 250.
- For individuals who took longer to return to care, 60 months, T cell counts had decreased to an average of 185, considered part of an AIDS diagnosis.
- The people who had stayed in care experienced an average T cell count of 600.
The article also discusses findings around people who were able to maintain suppressed virus—control HIV—while on treatment interruption.
“The studies from Switzerland, Canada and the U.S. suggest that adherence is an issue for some, perhaps many, people with HIV,” writes Hosein. “Long-acting regimens, such as Cabenuva (injectable cabotegravir + rilpivirine), that are ultimately injected once every two months, are one potential solution for some patients. However, even with Cabenuva, clinic and laboratory visits are required. Clinics need additional funding to engage in studies of adherence and ways to support patients so that the impressive survival benefits of ART can be maintained.”
“CATIE”—the Canadian AIDS Treatment Info Exchange—is a program devoted to information on hepatitis C as well. GO TO catie.ca/catie-news/swiss-study-explores-trends-in-interruption-and-re-engagement-in-hiv-care.
The Black community and HIV history
A recent profile of historian Dan Royles tells of his longtime work around the Black community’s response to HIV/AIDS, as well as stories from the LGBTQ+ community. Royles, an associate professor of history at Binghamton University, part of the State University of New York system, runs an oral history project and online archive on Black activism around HIV.
“We think of HIV/AIDS as an epidemic, but it is also a symptom of the inequities that persist in our society,” Royles tells Ethan Knox for BingUNews, published online February 19.
Royles is the author of the book To Make the Wounded Whole: The African American Struggle Against HIV/AIDS. He is currently working on a new book about Claude Brown, author of Manchild in the Promised Land.
“If everything has a history, that means that whatever we don’t like about the world we live in can be changed and we have the power to change it,” Royles says. To read the profile, GO TO binghamton.edu/news/story/5373/tracing-the-past-shaping-the-future.