GlaxoSmithKline plc (GSK,GSK.L) said Monday that its majority-owned specialist HIV company ViiV Healthcare has revealed interim analysis from HPTN 084 study that showed that investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women.
An independent data safety monitoring board or DSMB recommended the early unblinding of the HIV Prevention Trials Network or HPTN 084 study evaluating the safety and efficacy of investigational, long-acting, injectable cabotegravir for HIV prevention in women.
Following a pre-specified interim analysis, the DSMB indicated that cabotegravir met the primary objective of demonstrating superiority when compared to the current standard of care for women, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg or FTC/TDF tablets.
The study showed that long-acting injectable cabotegravir administered every two months is 89% more effective than daily pills in preventing HIV acquisition in women.
If approved, long-acting cabotegravir will provide an option that reduces the number of annual dosing days from 365 to six, the company noted.
The latest findings follow data from HPTN 083, a partner HIV prevention study in men who have sex with men and transgender women, which also demonstrated long-acting injectable cabotegravir was superior to daily oral pills for PrEP
Kimberly Smith, Head of Research & Development at ViiV Healthcare said, “It’s thrilling to collaborate with the NIH and the Bill & Melinda Gates Foundation to conduct such an important study in HIV prevention in women and deliver ground-breaking results confirming the superior efficacy of long-acting cabotegravir for PrEP. Women need more effective choices for HIV prevention.”
HPTN 084 was jointly funded by the U.S. NIAID, and the National Institute of Mental Health, both part of the NIH, the Bill & Melinda Gates Foundation and ViiV Healthcare, and was conducted by the HPTN.
Study product was provided by ViiV Healthcare and Gilead Sciences.
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