PREZCOBIX

What it is

PREZCOBIX is a fixed-dose combination of darunavir and cobicistat film-coated tablets. PREZCOBIX 800/150 mg tablets contain 800 mg of darunavir and 150 mg of cobicistat. PREZCOBIX consists of the HIV protease inhibitor darunavir and the pharmacokinetic enhancer cobicistat.

Approved indications

PREZCOBIX, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus-1 (HIV-1) infection in: — Antiretroviral treatment-naive patients — Antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL — Antiretroviral treatment-experienced but HIV protease inhibitor-naive patients for whom HIV-1 genotype testing is unavailable

Dosing overview

The recommended dose regimen in adults is PREZCOBIX one tablet taken once daily with food. The type of food does not affect the exposure to PREZCOBIX.

Key safety warnings

Severe skin reactions have been reported, including Stevens Johnson Syndrome which has been rarely reported, and during post-marketing experience toxic epidermal necrolysis, Drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported very rarely. PREZCOBIX should be discontinued immediately if signs or symptoms of severe skin reactions develop, which can include severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia. Darunavir contains a sulfonamide moiety and PREZCOBIX should be used with caution in patients with a known sulfonamide allergy. New onset diabetes mellitus, hyperglycaemia, or exacerbation of existing diabetes mellitus has been reported in patients receiving antiretroviral therapy including HIV protease inhibitors, and in some of these patients the hyperglycaemia was severe and in some cases also associated with ketoacidosis. Consideration should be given to measurement of fasting serum lipids and blood glucose, and lipid disorders should be managed as clinically appropriate. Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe hepatic adverse events, and appropriate laboratory testing should be conducted prior to initiating therapy with PREZCOBIX and patients should be monitored during treatment.

Contraindications

PREZCOBIX is contraindicated in patients with hypersensitivity to darunavir, cobicistat or to any of the excipients. PREZCOBIX should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life threatening events, examples include alfuzosin, astemizole, apixaban, cisapride, colchicine (in patients with renal and/or hepatic impairment), dapoxetine, dronedarone, elbasvir/grazoprevir, ivabradine, lomitapide, lovastatin, lurasidone, oral midazolam, naloxegol, pimozide, ranolazine, ergot alkaloids and sildenafil (when used for treatment of pulmonary arterial hypertension), simvastatin, terfenadine, and triazolam and antiarrhythmic drugs. Patients taking PREZCOBIX should not use products containing potent CYP3A inducers such as carbamazepine, phenobarbital, phenytoin, rifampin or St. John's wort.

PBS listing

PREZCOBIX darunavir/cobicistat 800 mg/150 mg is listed on the ARTG. The PBAC recommended the Section 100 Highly Specialised Drugs Program listing in March 2016 for the treatment of HIV infection, with special arrangements under the HSD Community Access Program as Authority Required (Streamlined).

Regulatory history

PREZCOBIX darunavir/cobicistat 800 mg/150 mg film coated tablet was first listed on the ARTG on 24 September 2015. In March 2016, the PBAC recommended the Section 100 Highly Specialised Drugs Program listing of darunavir with cobicistat fixed dose combination for the treatment of HIV.