ViiV Healthcare, the global specialist HIV company has announced that an independent data safety monitoring board (DSMB) recommended the early unblinding of the HIV Prevention Trials Network (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 with the current standard of care for women, daily oral emtricitabine/tenofovir disoproxil fumarate 200mg and 300mg (FTC/TDF) tablets. The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP).
The early study unblinding for superior efficacy in this prevention trial in women follows results reported earlier this year from a companion study (HPTN 083) that also established long-acting cabotegravir’s superiority to daily oral PrEP in preventing HIV among men who have sex with men and transgender women who have sex with men.
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. If approved, long-acting cabotegravir will provide an option that reduces the number of annual dosing days from 365 to six. In addition, long-acting cabotegravir can be discretely administered and may empower women to reduce their risk of HIV acquisition without the need for negotiation with their sexual partner. The results of HPTN 084 confirm long-acting cabotegravir’s potential as an HIV prevention option that can meet these needs.”
The HPTN 084 study, with 3,223 participants in 20 sites across seven countries in sub-Saharan Africa (Botswana, Kenya, Malawi, South Africa, eSwatini, Uganda and Zimbabwe), is the first study of long-acting injectable therapy for HIV prevention among women. The data showed that there was a statistically significant advantage for the women who received cabotegravir compared with the women who received FTC/TDF. While both were highly effective at preventing HIV in the study population, cabotegravir was superior.
The HPTN 084 study is a phase III double blind safety and efficacy study designed to evaluate the safety and efficacy of the long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in 3,223 women who are at increased risk of HIV acquisition. HPTN 084 opened to enrolment in November 2017 and is being conducted at research centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe.
Image credit: Sam Moqadan
