And women will need easy access to vaccines every eight weeks, which must be administered by a healthcare professional. During the clinical trial, due to the restrictions introduced during the pandemic, “there was a rush to ensure these women could continue to receive their injections on time,” said Dr Smith of ViiV Healthcare. Researchers in the trial sent the transport for the women and managed to retain 98% of the participants, she said.
The randomized, double-blind clinical trial was conducted by the HIV Prevention Trials Network, an international collaboration funded by the National Institutes of Health. The trial compared the injected drug, called cabotegravir, with Truvada in 3,223 participants at 20 sites in seven countries in sub-Saharan Africa.
Of the women who received Truvada, 34 were infected with HIV during the trial, compared with only four of the women who received the injections; two of those four women had stopped taking the injections, Dr Smith said.
After an interim analysis showed the long-acting injection to be 89% more effective than Truvada, an independent data safety oversight committee recommended that the trial be stopped prematurely.
“I am extremely excited with the results of this study and have to admit I was on a knife edge while waiting for these results,” said Dr. Monica Gandhi, HIV specialist at the University of California, San Francisco, who was not involved in the trial.
A previous trial tested the drug in nearly 4,600 cisgender men and transgender women who have sex with men and found it to be 66% more effective than Truvada in this population. This trial was scheduled to continue until 2022, but was halted in May for similar reasons.