UGANDA: In a groundbreaking development for HIV prevention, Gilead Sciences reported 100 per cent efficacy of its innovative anti-HIV drug, lenacapavir, in the PURPOSE 1 study. Conducted among 2,134 young women and adolescent girls in South Africa and Uganda, the trial revealed zero HIV infections among participants who received twice-yearly injections of lenacapavir as pre-exposure prophylaxis (PrEP).
Lenacapavir’s remarkable efficacy prompted the study’s Data Monitoring Committee to close the trial early. The drug’s performance was compared to daily oral PrEP medications, tenofovir alafenamide/emtricitabine (Descovy) and tenofovir disoproxil/emtricitabine (Truvada), which showed significantly lower efficacy rates.
The PURPOSE 1 study involved 5,338 women divided into three groups: lenacapavir injections plus dummy Descovy pills, lenacapavir plus dummy Truvada, and dummy lenacapavir injections plus either Descovy or Truvada. Real or dummy lenacapavir pills were also administered initially to rapidly build the drug’s concentration to preventative levels.
With no placebo-only arm, the study compared infection rates to the background HIV incidence (bHIV) of 2.4 per cent. While the lenacapavir group saw zero infections, the Descovy and Truvada groups reported 39 and 16 infections, respectively, translating to incidence rates of 2.0 per cent and 1.7 per cent.
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The study’s success underscores lenacapavir’s potential as a game-changing HIV prevention measure. Dr. Andrew Hill from the University of Liverpool commented, “This drug is the closest we have ever been to a vaccine against HIV.”
Despite its efficacy, lenacapavir’s high cost remains a barrier. The current list price in the US is $40,000 per year, compared to the much cheaper generic tenofovir disoproxil/emtricitabine pills. Advocacy groups, including the People’s Medicines Alliance and the AfroCAB network, are urging Gilead to license lenacapavir via the Medicines Patent Pool to ensure affordable access.
Gilead has pledged to deliver lenacapavir swiftly and sustainably to high-incidence, resource-limited countries. The company is negotiating contracts to expedite access to low-cost versions of the drug.
As the world sees 1.3 million new HIV infections annually, the urgency for an effective and easily-administered prevention measure like lenacapavir is critical. The results from PURPOSE 1 may add political and ethical pressure on Gilead to make the drug widely accessible.
