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E.C. approves Bristol-Myers Squibb’s Evotaz for HIV-1 infection in adults

Friday, July 17, 2015

The E.C. has approved Bristol-Myers Squibb’s Evotaz (atazanavir 300mg and cobicistat 150mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.

Coformulated to be one pill, once-daily, Evotaz combines the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir) capsules, and cobicistat, a pharmacokinetic enhancer marketed as Tybost by Gilead Sciences. The approval allows for the marketing of Evotaz in all 28 Member States of the E.U. and offers patients living with HIV an innovative treatment option that delivers proven suppression through 144 weeks. The marketing authorization follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in May 2015. The FDA approved Evotaz in the U.S. in January 2015.

Evotaz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to the active substances or to any of the excipients of Evotaz, in combination with certain drugs, and in patients with moderate to severe hepatic impairment. Evotaz and Reyataz do not cure HIV-1 infection or AIDS.

There are 2.2 million people living with HIV in the European region, according to recent estimates from UNAIDS and WHO, and between 2004 and 2013, more than 300,000 people were newly infected. Only one-third of diagnosed patients (35%) in the eastern European region were receiving antiretroviral therapy in 2012, a number that is significantly below the 80% coverage goal set by WHO for 2015. Virologic suppression, or the reduction of HIV viral load to undetectable amounts in the blood, is the goal of antiretroviral treatment in all patients.

“HIV remains a significant public health concern throughout the world, and the increase in new infections in recent years in Europe means that it is more important than ever to continue to deliver new treatment options to help patients achieve virologic suppression,” said Murdo Gordon, head of Worldwide Markets, Bristol-Myers Squibb. “By combining reduced pill burden with a low rate of virologic failure and no protease inhibitor mutations, Evotaz increases the possibility of suppressing HIV, and we are pleased to bring it to physicians and patients in the E.U.”

Evotaz is the first and only fixed-dose combination (FDC) of a protease inhibitor pharmacoenhanced by cobicistat that is supported by comparative phase III trial data. The E.C.’s approval is based on data from Gilead’s Study 114, a randomized, double-blind clinical trial (N=692) evaluating the safety and efficacy of Reyataz 300mg with cobicistat 150mg (the components of Evotaz) (n=344) versus Reyataz 300mg with ritonavir 100mg (Reyataz/ritonavir) (n=348), another pharmacokinetic enhancing agent, in combination with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults.

At 48 weeks, 85% of patients in the Reyataz/cobicistat arm achieved virologic success (HIV-1 RNA levels of /ritonavir arm. Low rates of virologic failure (HIV-1 RNA ≥50 copies/mL: 6% Reyataz/cobicistat arm; 4% Reyataz/ritonavir arm) also were observed at 48 weeks. The long-term data at week 144 also confirmed these results, with virologic success and failure rates of 72% and 8%, respectively, in the Reyataz/cobicistat arm, and 74% and 5%, respectively, in the Reyataz/ritonavir arm.

Virologic failure, which occurs when therapies are unable to completely suppress HIV, may be caused in part by drug resistance. Limited data are available on the development of resistance to Reyataz/cobicistat. However, in the clinical trial, no patients taking Reyataz/cobicistat who had virologic failure developed protease inhibitor resistance through 48 weeks. Specifically, zero patients developed tenofovir-associated resistance K65R, and two patients developed emtricitabine resistance M184V. In the Reyataz/ritonavir arm, zero resistance was observed.

Reyataz/cobicistat also demonstrated a safety profile comparable to Reyataz/ritonavir. The most common moderate to severe adverse events (AEs) in both treatment arms were jaundice, ocular iterus, and nausea. There were similar low rates of discontinuation due to AEs with Reyataz/cobicistat as compared to Reyataz/ritonavir at 48 weeks (6% and 7%, respectively). 

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