ViiV Healthcare has announced that its long-acting injectable cabotegravir for HIV prevention demonstrated superiority compared to the current standard of treatment for women.
The GlaxoSmithKline subsidiary announced that an independent data safety monitoring board (DSMB) recommended the early unblinding of the HIV Prevention Trials Network (HPTN) 084, which had been evaluating the safety and efficacy of cabotegravir for HIV prevention in women.
The DSMB recommended the early study finish after cabotegravir met the primary objective of demonstrating superiority to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets – the current standard of care for women.
According to ViiV, the study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP).
Emtricitabine/tenofovir disoproxil fumarate is sold by Gilead under the brand name Truvada, among others.
Earlier this year, ViiV also reported results 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.
“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,” said Kimberly Smith, head of research & development at ViiV Healthcare.
“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,” she added.
The HPTN -84 study was jointly funded by the US National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Mental Health – both part of the National Institutes of Health – the Bill & Melinda Gates Foundation and ViiV Healthcare.