ViiV Healthcare has announced positive data from an interim analysis of the HIV Prevention Trials Network (HPTN) 084 study that showed investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women.
An independent data safety monitoring board (DSMB) recommended the early unblinding of the HPTN 084 study evaluating the safety and efficacy of cabotegravir.
Cabotegravir is an integrase inhibitor being analysed as a long-acting formulation for intramuscular injection.
It is also evaluated as a once-daily oral tablet for use as a lead-in, to establish the tolerability of the therapy prior to injection.
The study, which has 3,223 participants in 20 sites in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe, is the first analysing long-acting injectable therapy for HIV prevention among women.
The Phase III, double-blind HPTN 084 study is analysing the safety and efficacy of the long-acting injectable cabotegravir administered every eight weeks as compared to daily oral FTC/TDF tablets (200mg/300 mg) in women who are at increased risk of HIV acquisition.
Data showed cabotegravir demonstrated superiority over current standard of care for women, daily oral emtricitabine/tenofovir disoproxil fumarate 200mg and 300mg (FTC/TDF) tablets, meeting the primary objective.
It was also found to be 89% more effective than daily oral tablets for pre-exposure prophylaxis (PrEP).
The early unblinding in the study comes after data from another study, HPTN 083, which established long-acting cabotegravir’s superiority over daily oral PrEP in preventing HIV among men and transgender women.
ViiV Healthcare Research & Development head Kimberly Smith 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.”