A clinical trial led by researchers at Emory University demonstrated that twice-yearly injections can transform HIV prevention, providing 96% greater protection than current standard treatments. This study represents a major step forward in making HIV prevention more accessible to communities most affected by the virus.
Published in New England Medical Journal |Estimated reading time: 5 minutes
In a comprehensive phase 3 clinical trial across multiple countries, researchers found that injections of lenacapavir every 26 weeks dramatically reduced HIV infection rates compared to daily oral medication . The study, which involved 3,265 participants at 88 sites around the world, showed remarkable results. Only two participants in the lenacapavir group became infected with HIV, compared to nine in the control group who took the oral medication daily.
This double-blind, randomized study, sponsored by Gilead Sciences, divided participants in a 2:1 ratio to receive lenacapavir subcutaneously every 26 weeks versus emtricitabine tenofovir disoproxil fumarate ( F/TDF) was assigned to a group that received daily oral administration. The results were surprising: HIV infection rates in the lenacapavir group were 0.10 per 100 person-years compared to 0.93 per 100 person-years in the F/TDF group. Its effectiveness becomes even clearer when compared to the background HIV incidence rate of 2.37 per 100 person-years in the screened population.
Dr Colleen KellyLead author and professor at Emory University School of Medicine emphasizes that these findings represent a significant advance in medicine. The nearly 100% efficacy rate is especially important for people who have difficulty with daily oral medication regimens. As co-director of the Emory AIDS Research Center and associate dean for research at Grady College at Emory, Dr. Kelly’s perspective is important to the field.
This study directly addresses one of the most persistent challenges in HIV prevention: medication adherence. Current prevention methods require daily oral medication, which can be difficult to maintain. Studies show that about half of people who start daily oral PrEP discontinue it within a year due to a variety of factors, including barriers to healthcare access. The introduction of a twice-yearly injection option could significantly improve adherence rates and, as a result, preventive efficacy.
The trial’s diversity and inclusion efforts were particularly noteworthy. Dr. Valeria CantosAn associate professor at Emory University School of Medicine and principal investigator at the Grady Research Institute, he emphasized efforts to represent underserved populations. The study included participants from Peru, Brazil, Argentina, Mexico, South Africa, Thailand, and the United States, provided materials in multiple languages, and had bilingual staff at various locations. This comprehensive approach was critical because the same populations disproportionately affected by HIV often have limited access to PrEP.
Recent statistics highlight the urgency of these discoveries. In 2022, more than half of new HIV infections in the United States will occur among cisgender gay men, and 70% will occur among people of Black or Hispanic descent. The development of a twice-yearly injection option could help address these disparities by removing barriers to daily medication adherence and reducing the frequency of visits to a health care provider from every 3 months to twice a year. There is.
Lenacapavir’s safety profile also proved promising during trials. Some participants experienced injection site reactions, leading to discontinuation in 1.2% of participants in the lenacapavir group compared to 0.3% in the F/TDF group, but no significant safety concerns were identified. It was. Dr. Carlos del Rio, chair of the department of medicine at Emory University School of Medicine, emphasizes that while these results are promising, the real challenge lies in ensuring equitable access to these new prevention tools.
With Phase III clinical trials now complete and under review by the FDA, researchers are optimistic about the possibility of approval by 2025. This development could represent an important turning point in HIV prevention efforts, especially for communities most vulnerable to infection.
Glossary
- PrEP (pre-exposure prophylaxis): Medications taken to prevent HIV infection before contracting the virus
- Lena Kapabil: A long-acting injection drug administered twice a year to prevent HIV.
- Phase 3 clinical trial: Large-scale trial of efficacy and safety of treatment in humans
TEST YOUR KNOWLEDGE
How often should lenacapavir be given for HIV prevention?
Lenacapavir is administered by subcutaneous injection every 26 weeks (twice a year).
What percentage of participants in the lenacapavir group remained HIV negative during the study?
Ninety-nine percent of participants in the lenacapavir group did not develop an HIV infection during the study.
How does lenacapavir efficacy compare to background HIV prevalence in the screened population?
The incidence rate ratio was 0.04 (95% CI, 0.01 to 0.18), representing a 96% reduction in the risk of HIV infection compared with background incidence.
How did the infection rates compare in terms of infections per 100 person-years between the lenacapavir group and the F/TDF group?
The number of infections in the lenacapavir group was 0.10 per 100 person-years, while the number of infections in the F/TDF group was 0.93 per 100 person-years.
Enjoy this story? Subscribe to our newsletter scienceblog.substack.com.
