Twice a Year PrEP One Step Closer to Being a Reality
Julie Holt
6/27/20242 min read
A New Milestone in PrEP HIV Prevention: Twice-Yearly Lenacapavir Shows 100% Efficacy
As today is National HIV Testing day and we gear up for Pride Celebrations this weekend there’s exciting news from Gilead Sciences for PrEP options. Their current clinical study results for their twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, (i.e. injectable PrEP that would be taken every 6 months) demonstrated 100% efficacy in preventing HIV.
This is the first Phase 3 HIV Prevention Trial Ever to Show Zero Infections. This is exciting news to prevent HIV and give options for those who face barriers to taking daily medications and accessing clinics for PrEP prescriptions.
Key Findings from the Trial
The Phase 3 PURPOSE 1 trial, involving over 5,300 cisgender women and adolescent girls in South Africa and Uganda, showed that lenacapavir outperformed the current daily oral Truvada®. In the lenacapavir group, there were zero HIV infections, a remarkable result compared to the 16 infections in the Truvada group. The trial's success led the independent Data Monitoring Committee to recommend offering lenacapavir to all participants, highlighting its potential as a new, highly effective PrEP option. Gilead additional trial PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals is still in progress, with results expected in late 2024/early 2025. The results from both trials will be used for the regulatory filing to obtain approval from the FDA to ensure lenacapavir for PrEP can be approved for multiple populations and communities most in need of additional HIV prevention options.
“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
Isn't taking a daily pill is easier?
Some individuals face barriers to accessing traditional PrEP options; taking daily pills and physical access to providers to ensure regular prescriptions for PrEP can be a challenge. Last year we completed an analysis of access to AP-PrEP sites in California where geographical access to free clinics was limited in counties with higher rates of HIV infections within Latinx populations. (To see that Geospatial analysis and more info on PrEP in California check it out here).
Lenacapavir’s twice-yearly dosing could significantly help with these barriers, providing a discreet and less frequent alternative. An injection provides “invisible” protection especially for those who may face stigma and are fearful of family members, co-workers, or partners seeing their PrEP medications. Getting access twice a year reduces the appointment burden for those who need to travel longer distances.
There is an injectable option available now, cabotegravir (brand name Apretude®) but requires a dose every month for the first three months, followed by every two months afterwards making accessing this schedule difficult for some.
Future results will determine the broad regulatory approval for lenacapavir, so there is still a ways to wait before expecting this option at your local clinic, but the exciting results so far are promising!
Above all wishing everyone a safe and happy Pride this weekend! 🌈
References
https://www.hiv.gov/events/awareness-days/hiv-testing-day
https://www.gilead.com/news-and-press/press-room/press-releases/2024/6/gileads-twiceyearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention
https://apretude.com/about-apretude/what-is-apretude/?cc=ps_83LE9DHGC01JJWG2109389&utm_source=google&utm_medium=cpc&utm_term=apretude&gad_source=1&gclid=CjwKCAjwvvmzBhA2EiwAtHVrb8LFbQ1xZnCsaX9Crd5zaLuADx2FwodJ_ns1oHehj2iE4NbY5N11ExoCc0YQAvD_BwE&gclsrc=aw.ds
Contact
info@hghconsult.com
Subscribe to our newsletter
Holt & Associates Global Health Consulting Inc.
See our Privacy Policy for more information