TUESDAY December 21, 2021 (HealthDay News) – The United States Food and Drug Administration has approved the first long-acting injectable treatment for HIV pre-exposure prophylaxis, which is given every two months and offers an alternative to drugs oral daily, the agency announced Monday.
Apretude (cabotegravir prolonged-release suspension for injection) is approved for use in adults and at-risk adolescents weighing at least 35 kg (77 lbs). Patients who initiate Apretude begin with two initiation injections given one month apart and then receive injections every two months thereafter. The FDA notes that patients can start treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate Apretude.
The approval was based on safety and efficacy data from two randomized, double-blind trials comparing Apretude to the once-daily oral drug Truvada. The first trial involved 4,566 non-HIV-infected transgender men and women who have sex with men and behave at high risk for HIV, while the second trial involved 3,224 uninfected cisgender women at risk for HIV infection. HIV. Participants randomly assigned to Apretude began with cabotegravir (30 mg tablet) and placebo daily for up to five weeks, then at months 1 and 2 and every two months thereafter received 600 mg injections. of Apretude in addition to a daily dose of Apretude. placebo tablet. In Trials 1 and 2, respectively, researchers found that participants randomly assigned to Apretude had a 69 and 90% reduced risk of becoming infected with HIV compared to participants randomly assigned to Truvada.
Side effects occurred more frequently with Apretude than with Truvada and included injection site reactions, headache, fever, fatigue, back pain, myalgia and rash. A boxed warning on the Apretude label indicates that the medicine should not be used unless a negative HIV test is confirmed immediately before starting the medicine and before each injection.
“This injection, given every two months, will be critical in tackling the HIV epidemic in the United States, including helping those at high risk and certain groups where adherence to daily medications has been a major challenge or no. That’s not a realistic option, ”Debra Birnkrant, MD, director of the antivirals division of the FDA’s Center for Drug Evaluation and Research, said in an agency press release.
Approval was granted to Viiv.