Gilead's Twice-Yearly Lenacapavir Shows 100% Efficacy and Superiority in HIV Prevention Trials
In a groundbreaking development, Gilead Sciences announced that its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. This marks the first Phase 3 HIV prevention trial to show zero infections.
The independent data monitoring committee (IDMC) recommended that Gilead stop the blinded phase of the PURPOSE 1 trial at interim analysis and offer open-label lenacapavir to all participants. The IDMC made this recommendation based on superiority of twice-yearly lenacapavir over daily Truvada for HIV prevention, as none of the women who received the lenacapavir shot had contracted HIV.
Gilead's announcement brings it closer to introducing a new form of pre-exposure prophylaxis (PrEP) and broadening its HIV business. The company plans to share an update on how it intends to address access in countries with high incidence rates of HIV.
According to multiple sources, including CNBC and Bloomberg, the Phase 3 trial involved roughly 2,000 women who received either lenacapavir or daily pills. None of the women in the lenacapavir group had contracted HIV by an interim analysis.
The IDMC's recommendation to unblind the trial and offer open-label lenacapavir to all participants was based on superiority of twice-yearly lenacapavir over daily Truvada for HIV prevention. This development is significant as it represents a potential game changer in the field of HIV prevention.
Gilead Sciences, Inc. (Nasdaq: GILD) shares rose about 7% following the announcement, reflecting investor optimism about the potential impact of lenacapavir on its business and the broader HIV market.
