Gilead’s experimental twice-yearly HIV prevention medicine, lenacapavir, has proven to be 100% effective in a late-stage trial, the company announced Thursday. An interim analysis of the trial showed that none of the approximately 2,000 women who received the lenacapavir shot had contracted HIV. This prompted the independent data monitoring committee to recommend Gilead unblind the Phase 3 trial and offer the treatment to all participants, including those who had been receiving standard daily pills.
This success marks a significant step forward for Gilead in its efforts to introduce a new form of pre-exposure prophylaxis (PrEP) and expand its HIV treatment portfolio. The company’s shares rose by about 7% following the announcement. Jared Baeten, Gilead’s vice president of clinical development for HIV, emphasized the importance of offering more PrEP options to meet individual needs and preferences.
Before seeking approval from the Food and Drug Administration, Gilead plans to replicate these results in another Phase 3 study involving men who have sex with men. Data from this study is expected to be shared later this year or early next year. If the results are positive, lenacapavir could be available on the market as soon as late 2025.
Gilead’s Truvada was the first approved PrEP drug over a decade ago, targeting people without HIV who are at high risk of acquiring the virus. While daily pills currently dominate the market, there is a growing focus on developing longer-acting shots. PrEP, when taken correctly, reduces the risk of getting HIV from sex by 99% and from injected drug use by 74%. However, only about one-third of the people in the U.S. who could benefit from PrEP actually take it, according to the Centers for Disease Control and Prevention.
Health policymakers and advocates hope that longer-acting options will reach individuals who are unable or unwilling to take a daily pill, thereby improving prevention efforts. Bruce Richman, founding executive director of the nonprofit Prevention Access Campaign, stressed the need for more options to effectively combat the epidemic.
The FDA approved the first injectable PrEP, Apretude, in 2021. Apretude, administered every other month, has about 11,000 users according to its manufacturer, ViiV. Some individuals, like 28-year-old public health worker Tim Oliver, prefer the convenience of injections, while others favor daily pills. A longer-acting option like lenacapavir could attract more patients.
RBC Capital Markets analyst Brian Abrahams predicts that Gilead’s shot will significantly boost the number of people interested in preventive HIV medicine, estimating peak sales of nearly $2 billion. Gilead’s newer PrEP pill, Descovy, generated about $2 billion in revenue last year.
Activists have called on Gilead to ensure that lenacapavir is accessible in low- and middle-income countries, where HIV incidence rates are high. Gilead has faced criticism over the pricing of its HIV medicines, with Descovy listed at $26,000 per year. In response, Gilead stated that it plans to address access issues in these countries and will provide updates on its strategy.
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