Darunavir and cobicistat

(Prezcobix®)

Darunavir and cobicistat

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Drug updated on 5/17/2024

Dosage FormTablet (oral; darunavir/cobicistat 800 mg/150 mg)
Drug ClassHIV-1 protease inhibitors and CYP3A inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of HIV-1 infection in treatment-na├»ve and treatment-experienced adults and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).

Summary
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  • Darunavir and cobicistat (Prezcobix) is recommended for the management of HIV-1 infection in both individuals who are initiating treatment and those who have previously received treatment, as well as in pediatric patients weighing at least 40 kg without darunavir resistance-associated substitutions. The medication is designed for once-daily intake.
  • Two randomized controlled studies provided information on Prezcobix's safety, effectiveness, population pharmacokinetics (PK), exposure levels, comparison to other regimens, and subgroup considerations.
  • These studies employed a population PK approach to detail the pharmacokinetics of darunavir (DRV) and tenofovir alafenamide (TAF). DRV and TAF exposure levels were found to be consistent with historical data across various patient groups, irrespective of age, race, or gender. Lower plasma concentrations were not linked to reduced virologic response or an increased risk of virologic rebound.
  • In one study, the EMERALD, transitioning from a boosted protease inhibitor regimen to D/C/F/TAF demonstrated equivalent efficacy and safety, while preserving virologic suppression across different subgroups based on demographic characteristics, previous treatment experience, and baseline antiretroviral regimen. Adverse event rates were similarly low in both groups, highlighting its favorable safety profile.
  • Subgroup analysis indicated that the effectiveness and safety of switching to D/C/F/TAF were consistent across a broad range of demographics, including age, gender, race, previous antiretroviral use, history of virological failure, baseline bPI & boosting agents, suggesting its broad applicability.
  • Darunavir/cobicistat combined with emtricitabine/tenofovir alafenamide provides an advantageous alternative compared to traditional regimens involving boosted protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate, without compromising either efficacy or safety. It also offers improvements in renal and bone health markers, which may influence the choice of treatment in patient populations at risk for or concerned with long-term complications related to these parameters.

Product Monograph / Prescribing Information

Document TitleYearSource
Prezcobix (darunavir and cobicistat) Prescribing Information.2023Janssen Products, LP, Horsham, PA

Randomized Controlled Trials

Clinical Practice Guidelines