Evotaz Combo Pill Approved for HIV-1 in Adults

Troy Brown, RN

Disclosures

January 29, 2015

The US Food and Drug Administration (FDA) has approved atazanavir and cobicistat (Evotaz, Bristol-Myers Squibb) for treatment of adults with human immunodeficiency virus (HIV-1) infection.

Atazanavir/cobicistat is a fixed-dose combination tablet that contains 300 mg of atazanavir and 150 mg of cobicistat. It is intended for use in combination with other antiretroviral drugs.

Clinicians should base decisions about its use in treatment-experienced patients on "the number of baseline primary protease inhibitor resistance substitutions," according to an FDA news release. The recommended dosage is one tablet taken orally once daily with food.

In a study of 62 healthy adults, one tablet provided comparable atazanavir exposures (90% confidence interval [CI], 80% to 125%) to one 300-mg atazanavir capsule plus one 150-mg cobicistat tablet, after single-dose administration with a light meal.

The FDA decision follows a review of data from a randomized, double-blind, active-controlled trial (study 114) in 692 treatment-naïve patients with HIV-1 infection and baseline estimated creatinine clearance above 70mL/min. Patients were randomly assigned in a 1:1 ratio to take either atazanavir 300 mg coadministered with cobicistat 150 mg once per day or atazanavir 300 mg coadministered with ritonavir 100 mg once per day.

All patients were treated concomitantly with tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg once daily, in a single tablet. The proportion of patients with HIV-1 RNA < 50 copies/mL was 85% for those in the group that took atazanavir 300 mg coadministered with cobicistat 150 mg + emtricitabine/tenofovir disoproxil fumarate and 87% for those in the group that took atazanavir 300 mg coadministered with ritonavir 100 mg + emtricitabine/tenofovir disoproxil fumarate (treatment difference -2.2%; 95% CI, -7.4% to 3.0%).

A phase 2 trial (study 105) and a phase 3 trial (study 114) established the safety of atazanavir and cobicistat coadministered as single agents. A pooled analysis looked at data from 771 antiretroviral treatment-naïve adults infected with HIV-1 who received for at least 48 weeks:

  • atazanavir coadministered with cobicistat and emtricitabine/tenofovir disoproxil fumarate (N=394) or

  • atazanavir coadministered with ritonavir and emtricitabine/tenofovir disoproxil fumarate (N=377).

The most frequently reported adverse reactions observed in >10% of patients in the group that received atazanavir coadministered with cobicistat were jaundice (13%), ocular icterus (15%), and nausea (12%). The most frequently reported adverse reactions in the group that received atazanavir coadministered with ritonavir were jaundice (11%), ocular icterus (17%), nausea (11%), and diarrhea (11%).

In both treatment groups, 7% of patients discontinued study treatment because of adverse events, regardless of severity.

Product labeling information will be available soon at Daily Med .

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