An independent data safety monitoring board (DSMB) indicated that cabotegravir for HIV prevention in women met the primary objective of demonstrating superiority compared with the current standard of care for women: daily oral emtricitabine/tenofovir disoproxil fumarate 200-mg and 300-mg (FTC/TDF) tablets.

Further, the study results showed that cabotegravir was 89% more effective than daily oral FTC/TDF for preexposure prophylaxis (PrEP).

The early study unblinding for superior efficacy in this prevention trial in women follows results reported 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.

The HPTN 083 study includes 3223 participants in 20 sites across 7 countries in sub-Saharan Africa and 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.

Although both were highly effective at preventing HIV in the study population, cabotegravir was superior, according to a statement.


ViiV Healthcare announces superiority of cabotegravir for PrEP in global HIV prevention in study in women. GCI Health [email]. Sent November 9, 2020.