Gilead touts 96 percent HIV risk reduction with twice-yearly PrEP, eyes regulatory filings
Gilead Sciences on Thursday released interim results from the Phase III PURPOSE 2 study, demonstrating that an investigational long-acting formulation of its antiretroviral drug lenacapavir drastically reduced the risk of contracting HIV.
PURPOSE 2—which enrolled cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth—showed that a twice-yearly injection of lenacapavir cut HIV infections by 96% versus its background incidence. Of the 2,180 study participants, only two contracted HIV indicating that 99.9% percent of patients were free of the infection at the time of the interim analysis.
Twice-yearly lenacapavir also bested a daily Truvada (emtricitabine/tenofovir) regimen for HIV pre-exposure prophylaxis (PrEP), according to Gilead.
An independent data monitoring committee confirmed that at the interim analysis PURPOSE 2 achieved its key efficacy endpoint and recommended that the pharma end the blinded phase of the trial and offer open-label lenacapavir to all study participants.
Gilead CEO Daniel O’Day in a statement called Thursday’s results “remarkable,” noting that lenacapavir has “demonstrated the potential to transform the prevention of HIV and help to end the epidemic.” The pharma will “work urgently with regulatory, government, public health and community partners” to make twice-yearly lenacapavir broadly available for PrEP worldwide, if approved, O’Day said.
Gilead is set to start global regulatory filings by the end of the year, with an eye toward initial launch in 2025, according to the company.
Reuters
