FDA Approves Treatment for Patients With Multidrug-Resistant HIV

The US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir) for the treatment of adults with HIV whose HIV has not been successfully treated previously due to intolerance, resistance, or safety considerations.

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” said Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, in a press release.

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection—helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives,” Dr Murray added.

Rukobia is to be taken 2 times per day by mouth. Nausea was the most commonly reported adverse reaction to Rukobia. Severe adverse reactions were elevated in liver enzymes among participants who also had hepatitis B or C virus infections, and immune reconstitution syndrome.

—Christina Vogt

FDA approves new HIV treatment for patients with limited treatment options. News release. US Food and Drug Administration. July 2, 2020. Accessed July 6, 2020.