The FDA on Monday approved ViiV Healthcare's long-acting, injectable drug Apretude (cabotegravir) for use as pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents. Debra Birnkrant, director of the antivirals division at the FDA's Center for Drug Evaluation and Research, said "adherence to daily medication has been a major challenge or not a realistic option" for certain groups, so the approval of Apretude "adds an important tool…by providing the first option to prevent HIV that does not involve taking a daily pill."

The decision comes roughly a month before the FDA's January 24 decision deadline for the filing, which was assessed under a priority review. The application was based on data from two Phase IIb/III trials. The HPTN 083 study, which included HIV-uninfected men and transgender women who have sex with men and have high-risk behaviour, showed Apretude to be 69% more effective than Gilead Sciences' daily oral Truvada (emtricitabine/tenofovir disoproxil fumarate) at preventing HIV-1 acquisition.

Meanwhile, a companion study, dubbed HPTN 084, enrolled HIV-negative, sexually active women at risk for the infection across sub-Saharan Africa. Results here demonstrated that women who took Apretude had 89% less risk of contracting HIV infection than did those given daily oral Truvada PrEP. In either trial, side effects occurring more frequently with Apretude than with Truvada included headache, fever, fatigue, back pain, myalgia and rash.

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Injection given every two months

Apretude is given first as two initiation injections administered one month apart, and then every two months after that. The FDA noted that patients can either start their treatment with Apretude or take oral cabotegravir, which is sold as Vocabria, for four weeks to assess how well they tolerate the drug.

The agency also noted that Apretude comes with a boxed warning to not use the drug unless a negative HIV test is confirmed. "Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEP," the FDA said, adding that people who become infected while receiving Apretude must transition to a complete HIV treatment regimen.

Earlier this year, the FDA approved Cabenuva, a long-acting regimen for the treatment of HIV-1 infection in adults. The co-pack of two injectable medicines includes cabotegravir, which is an integrase strand transfer inhibitor, and Johnson & Johnson's non-nucleoside reverse transcriptase inhibitor rilpivirine. GlaxoSmithKline holds a majority stake in ViiV alongside minority investors Pfizer and Shionogi.