FDA approves HIV drug for adults who are resistant, intolerant of other treatments
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The FDA announced approval of lenacapavir, a new antiretroviral medication for adults with HIV type 1 who cannot be treated with other therapies because of resistance, intolerance or safety concerns.
According to an FDA press release, lenacapavir (Sunlenca, Gilead Sciences) is the first among a new class of drugs — capsid inhibitors — to receive approval for treating HIV-1. The drug initially is administered via oral tablets and subcutaneous injections, followed by maintenance injections every 6 months. It can be given in combination with other antiretroviral medications.
“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” Debra Birnkrant, MD, director of the division of antivirals in the FDA Center for Drug Evaluation and Research, said in the release. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”
The approval comes after promising results from a multicenter clinical trial that evaluated 72 patients with HIV infection who were resistant to various HIV treatment options, the release stated. In the randomized study cohort, researchers reported virus reduction during the first 14 days of treatment in 87.5% of patients receiving lenacapavir compared with 16.7% of patients receiving placebo.
In addition, 81% of patients who received lenacapavir in combination with other antiretroviral drugs reached HIV RNA suppression after 26 weeks of treatment, an outcome reported in 83% of treated patients after 52 weeks, according to the release.
The FDA reported that the most common adverse reactions associated with lenacapavir include nausea and injection site reactions.
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