Drug updated on 5/17/2024
Dosage Form | Tablet (oral; darunavir/cobicistat 800 mg/150 mg) |
Drug Class | HIV-1 protease inhibitors and CYP3A inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of HIV-1 infection in treatment-naïve 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).
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Summary
- 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 Title | Year | Source |
---|---|---|
Prezcobix (darunavir and cobicistat) Prescribing Information. | 2023 | Janssen Products, LP, Horsham, PA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Population pharmacokinetic analysis of darunavir and tenofovir alafenamide in HIV-1-infected patients on the darunavir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen (amber and emerald studies). | Data not availableSubjects F: null% M: null% | 2021 | The AAPS Journal |
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study. | 1,141Subjects F: 18% M: 82% | 2019 | AIDS Research and Therapy |
Sex Distribution:
![No Data](/img/Nodata_Icon.png)
Year:
2021
Source:The AAPS Journal
Sex Distribution:
F:18%
M:82%
1141Subjects
Year:
2019
Source:AIDS Research and Therapy
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. | 2023 | National Institute of Health |
Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2023 | National Institute of Health |
European AIDS clinical society guidelines v10.1 October 2020. | 2020 | European AIDS Clinical Society |