There may be a brand new glimmer of hope in HIV prevention. Recent results from a Phase 3 trial show that a twice-yearly injection of the drug used to treat AIDS is 100% effective in stopping recent infections.
In a landmark Attempt A study of 5,000 young women and adolescent girls in South Africa and Uganda found not a single case of HIV infection amongst those that received two doses of lenacapavir from the drug manufacturer Gilead.
Participants were randomly assigned to receive either a lenacapavir injection every 26 weeks or a each day oral HIV medication resembling emtricitabine-tenofovir alafenamide (F/TAF) or emtricitabine-tenofovir disoproxil fumarate (FTC/TDF). The study was double-blind, so participants didn’t know which treatment they were receiving.
The outcomes showed that about 2% of people that took the pills each day became infected with HIV from infected partners, highlighting the effectiveness of lenacapavir in comparison with each day oral medications.
“With zero infections and 100% efficacy, lenacapavir has demonstrated its potential as a very important recent tool for stopping HIV infection when administered twice a yr. We sit up for further results from the continued PURPOSE clinical program and to moving closer to our goal of helping to finish the HIV epidemic for everybody, all over the place.” said Dr. Merdad Parsey, chief medical officer of Gilead Sciences.
About 69% of participants experienced injection site reactions, compared with 35% within the placebo group, but researchers reported that no safety concerns were identified.
Lenacapavir, sold under the name Sunlenca, is already a prescription drug used to treat HIV. Following the successful completion of the PURPOSE 1 trial, researchers are looking forward to the outcomes of the PURPOSE 2 trial, which is able to evaluate the effectiveness of twice-yearly lenacapavir injections in stopping HIV in several populations and regions.
“These data confirm that twice-yearly lenacapavir for HIV prevention is a breakthrough with great public health potential. If approved and distributed – quickly, inexpensively and equitably – to those that need or want it, this long-acting treatment could help speed up global progress in HIV prevention. We’re all grateful to the 1000’s of young women in South Africa and Uganda who’ve volunteered to participate on this trial,” said Sharon Lewin, President of the IAS – the International AIDS Society – in a Press release.
“We now eagerly await the outcomes of PURPOSE 2, which is able to study twice-yearly lenacapavir for HIV prevention in other populations and countries. Within the meantime, all stakeholders must work together to speed up the equitable delivery of existing HIV prevention options and do more to arrange for future options resembling lenacapavir for PrEP,” Lewin said.
