FDA Approves HIV-1 Infection Treatment

Bristol-Myers Squibb announced today the US Food and Drug Administration (FDA) has granted approval for Evotaz tablets in combination with other antiretroviral agents for an innovative treatment option for adults suffering from HIV-1 infection — delivering proven suppression through 48 weeks.

Evotaz is coformulated as one pill, once-daily, combining the protease inhibitor (atazanavir 200 mg/300 mg), Reyataz capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences, Inc.

The use of Evotaz in patients who had undergone previous HIV medication should be guided by their baseline resistance to protease inhibitors.

Experts noted Evotaz and Reyataz do not cure HIV-1 infection or AIDS. Evotaz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the product components and in combination with certain drugs.

“We are pleased to provide physicians and patients with an important new option to treat HIV; atazanavir with cobicistat delivers sustained efficacy and safety through 48 weeks, as demonstrated through its rigorous clinical development plan, including a head-to-head Phase III trial,” expressed Murdo Gordon, Head of Worldwide Markets, Bristol-Myers Squibb, in a news release.

Evotaz is the first and only protease inhibitor pharmacoenhanced by cobicistat that had been supported by comparative Phase III trial data. Researchers conducted a randomized, double-blind, clinical trial (N=692) evaluating the efficacy and safety of Reyataz 300 mg with cobicistat 150 mg (n=344) versus Reyataz 300 mg with ritonavir 100 mg (Reyataz/ritonavir) (n=348), another pharmacokinetic enhancing agent. This was combined with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults.

The study results detected zero protease inhibitor resistance through 48 weeks. Researchers were pleased to find no patients developed tenofovir‐associated resistance, and only 2 patients in the Evotaz arm developed emtricitabine‐associated resistance.

Additionally, the most common moderate to severe adverse events reported in the Evotaz arm and Reyataz/ritonavirarm were: rashes (5%, 4%), jaundice (5%, 3%), ocular iterus (3%, 1%), and nausea (2%, 2%).

“Maintaining sufficient drug concentrations inhibits viral replication and prevents the development of resistance, which are critical considerations in treating patients with HIV,” said study investigator Joel Gallant, associate medical director of Specialty Services at Southwest CARE Center in Santa Fe, New Mexico, and adjunct professor of medicine in the Division of Infectious Diseases at the Johns Hopkins University School of Medicine.

Gordon commented, “Evotaz increases the possibility of providing HIV suppression by combining reduced pill burden with a low rate of virologic failure (6% Evotaz arm; 4%Reyataz/ritonavir arm) and zero protease inhibitor mutations.”