EVOTAZ

What it is

EVOTAZ is a film coated tablet containing atazanavir and cobicistat 300 mg/150 mg. Atazanavir is indicated for the treatment of HIV 1 infection, in combination with other antiretroviral agents.

Approved indications

— HIV 1 infection, in combination with other antiretroviral agents.

Dosing overview

The equi-effective dose of atazanavir 300 mg with cobicistat 150 mg is equivalent to atazanavir 300 mg with ritonavir 100 mg. EVOTAZ tablets must be taken with food.

Key safety warnings

Most patients taking atazanavir experience asymptomatic elevations in indirect (unconjugated) bilirubin, which may be associated with scleral icterus and jaundice in some patients. This isolated hyperbilirubinemia is reversible upon discontinuation of the medicine. Atazanavir has been shown to prolong the PR interval of the electrocardiogram in some patients. In healthy volunteers and in patients, abnormalities in atrioventricular (AV) conduction were asymptomatic and generally limited to first-degree AV block. In controlled clinical trials, rash (all grades, regardless of causality) occurred in 21% of patients treated with atazanavir. Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of initiating therapy. In most patients, rash resolves within 2 weeks while continuing therapy. Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions including drug rash, eosinophilia, and systemic symptoms (DRESS) syndrome have been reported in patients receiving atazanavir. Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance. The medicine should be used with caution, particularly in those patients with other risk factors for chronic kidney disease.

Contraindications

Hypersensitivity to atazanavir or to any of the excipients. EVOTAZ is contraindicated in patients with severe hepatic insufficiency. EVOTAZ is contraindicated when coadministered with drugs that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows. Coadministration may result in competitive inhibition of the metabolism of these drugs and create the potential for serious and/or life-threatening adverse events such as cardiac arrhythmia (e.g., cisapride, pimozide), prolonged sedation or respiratory depression (e.g., orally administered midazolam, triazolam), or other events (e.g., ergot derivatives).

PBS listing

EVOTAZ 300 mg/150 mg is listed on the Pharmaceutical Benefits Scheme with Section 100 HSD Authority Required (streamlined) restriction on a cost-minimisation basis with atazanavir plus ritonavir.

Regulatory history

EVOTAZ atazanavir/cobicistat 300 mg/150 mg film coated tablets was first registered on the ARTG on 23 September 2015. In November 2015, the PBAC recommended listing for HIV infection.