Prezcobix (darunavir and cobicistat)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved January 2015

Specific Treatments:

HIV-1 infection

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General Information

Prezcobix is a once-daily, fixed-dose combination containing darunavir, a protease inhibitor, and the pharmacokinetic enhancing or boosting agent cobicistat.

Prezcobix is specifically indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). 

Prezcobix is supplied as a tablet (800 mg of darunavir and 150 mg of cobicistat) for oral administration. The recommended dose is one tablet taken once daily with food.

Clinical Results

FDA Approval

The FDA approval of Prezcobix was based on a bioequivalence study evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations. The tolerability profile of the fixed dose-combination is similar to that of the two agents taken separately. The efficacy of Prezcobix is based on efficacy demonstrated in clinical trials of darunavir co-administered with ritonavir and pharmacokinetic trials showing similar exposures of darunavir when boosted with cobicistat compared to darunavir boosted with ritonavir. 

Side Effects

Adverse effects associated with the use of  darunavir may include, but are not limited to, the following:

  • diarrhea
  • nausea
  • rash
  • headache
  • abdominal pain
  • vomiting

Mechanism of Action

Prezcobix is a once-daily, fixed-dose combination tablet containing darunavir, a protease inhibitor, and the pharmacokinetic enhancing or boosting agent cobicistat.

Additional Information

For additional information regarding the use of Prezcobix or HIV-1, please visit http://www.prezcobix.com/