Biannual Injection Fully Protects Women Against HIV, Trial Finds

A new HIV drug, lenacapavir, requiring just two injections annually, has shown remarkable efficacy in preventing HIV infections among young women in Africa, according to recent trial results. Gilead Sciences Inc., the pharmaceutical company behind the medication, announced that lenacapavir demonstrated 100% effectiveness as a preventive measure against HIV.

This promising data marks the first set of results from Gilead's PURPOSE program, which encompasses five global HIV prevention trials. Dr. Merdad Parsey, Gilead's Chief Medical Officer, highlighted the significance of these findings in a news release, expressing optimism about lenacapavir's potential to become a pivotal tool in the fight against HIV. He emphasized the company's commitment to further investigation through ongoing trials to ultimately help eradicate the HIV epidemic worldwide.

The study, conducted in Uganda and South Africa, compared the efficacy of lenacapavir with that of two widely used daily HIV prevention pills. It involved a randomized controlled trial where participants received either two injections of lenacapavir per year or daily doses of Truvada or Descovy, both of which are commonly prescribed in high-income countries. The results were so compelling that an independent data review committee recommended halting the trial prematurely to offer lenacapavir to all participants, citing its superior protection against HIV.

None of the 2,134 women who received lenacapavir contracted HIV, whereas 16 out of 1,068 women on Truvada and 39 out of 2,136 women on Descovy were infected. This stark contrast underscores the potential of lenacapavir to revolutionize HIV prevention, especially for young women facing challenges such as limited access to healthcare facilities and stigma associated with taking daily medication. Lillian Mworeko, leader of the International Community of Women Living With HIV Eastern Africa, emphasized that a biannual injection could be a game-changer for women unable to maintain a daily pill regimen due to societal pressures or logistical difficulties.

However, the Gilead data has yet to appear in a peer-reviewed journal. Meanwhile, a second trial is underway in six additional countries, focusing on men who have sex with men, transgender individuals, and those who use injection drugs. A midterm review of these results is expected later this year.

While Truvada has been a popular choice among gay men in the United States and other affluent countries, its uptake in Africa has been limited, particularly among young women, who remain highly vulnerable to HIV. The hope is that the convenience of a twice-yearly injection will enhance adherence and offer more robust protection in these communities.

One critical issue remains: the accessibility of lenacapavir. In the United States, the drug is priced at $42,250 per patient per year, raising concerns about its affordability in low-income countries with high HIV rates. Gilead has pledged to ensure the drug is available at prices that facilitate widespread distribution in these regions, aiming to make a significant impact on global HIV prevention efforts.