The US Food and Drugs Administration (FDA) has granted priority review to Gilead’s lenacapavir for the prevention of HIV as pre-exposure prophylaxis (PrEP).
Lenacapavir is an injectable HIV-1 capsid inhibitor currently approved in several countries for the treatment of adult patients with multi-drug resistant HIV.
While majority of antivirals only target one stage of viral replication, lenacapavir is designed to inhibit HIV at several phases of its life cycle and does not demonstrate any known cross-resistance to other drug classes in vitro.
Gilead’s new drug application is based on phase 3 studies coded PURPOSE-1 and PURPOSE-2 that showed significant efficacy of lenacapavir in HIV prevention.
In PURPOSE-1, data showed that twice-yearly administration of the drug led to zero infections with 100% risk reduction and superiority compared to background HIV incidence (bHIV).
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PURPOSE-2 on the other hand showed that 99.9% of participants in the lenacapavir group did not acquire HIV infection, a 96% risk reduction in HIV infections, and superiority compared to bHIV among a broad and geographically diverse range of cisgender men and gender-diverse people.
Additionally, in both trials, twice-yearly lenacapavir demonstrated superiority of prevention of HIV infections when compared with once-daily oral combination of emtricitabine 200mg and tenofovir disoproxil fumarate 300mg and was generally well-tolerated, with no significant or new safety concerns identified.
“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,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “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.”
At this stage, use of lenacapavir for HIV prevention is still investigational and its safety and efficacy as PrEP are yet to be conclusively ascertained.
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African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.
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