FDA Approves Once-Daily Nevirapine for HIV Infection

Emma Hitt, PhD

April 11, 2011

April 11, 2011 — The US Food and Drug Administration (FDA) has approved once-daily nevirapine extended-release tablets (Viramune XR; Boehringer Ingelheim Pharmaceuticals Inc) for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults.

"With the approval of once-daily [nevirapine extended release], patients in the US now have the benefit of a new HIV treatment option for use in combination with their other HIV medications," said Joseph Gathe, Jr., MD, with the Department of Internal Medicine, Baylor College of Medicine, Houston, Texas, and lead investigator of the VERxVE clinical trial.

"Physicians in the US can now switch their current [nevirapine] patients to a once-daily product with demonstrated comparable safety and efficacy," Dr. Gathe adds.

The 48-week phase 3 VERxVE trial demonstrated that once-daily extended-release nevirapine (400 mg) achieved a virologic response noninferior to twice-daily immediate-release nevirapine (200 mg) in treatment-naive HIV-1 infected adults. Both versions of the drug were taken in combination with emtricitabine and tenofovir (Truvada). The drug safety and tolerability were comparable between the treatment groups.

A separate phase 3, randomized, open-label trial, TRANxITION, also demonstrated that HIV-1 infected adults could safely and efficiently be switched from twice-daily immediate release nevirapine to once-daily extended release nevirapine.

The recommended dose for extended release nevirapine is a single 400-mg tablet taken once daily, with or without food, in combination with other antiretroviral agents.

The potential for lethal hepatotoxicity associated with nevirapine limits the drug's use in females with CD4+ cell counts greater than 250 cells/mm3 and males with CD4+ cell counts greater than 400 cells/mm3.

The frequency of rash reported when introducing nevirapine can be reduced by a lead-in dose of 200 mg immediate release once a day for 14 days before moving onto the extended-release version. Adults switching from immediate-release nevirapine twice daily require no lead-in dosing and have no CD4+ cell count limitations.