Viiv Healthcare, a United States-based pharmaceutical company, has received approval from the United States Food and Drug Administration (FDA) for its Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing around 35kg (77lbs) for pre-exposure prophylaxis (PrEP) to decrease the risk of sexually acquired HIV, it was reported on Monday.

The product is administered first as two initiation injections, injected one month apart, and then every two months thereafter. Patients can choose to start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to evaluate how well they tolerate the drug.

The safety and efficiency of Apretude to decrease the risk of acquiring HIV were assessed in two randomised, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behaviour for HIV infection. Trial 2 also included uninfected cisgender women at risk of acquiring HIV.

Participants who were administered Apretude commenced the trial with cabotegravir (oral, 30mg tablet) and a placebo daily for up to five weeks, subsequent to Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet. Subjects administered with Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, subsequent to the oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.

Trial 1 showed participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada. Trial 2 showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

Apretude was granted a Priority Review and Breakthrough Therapy Designation.