Drug updated on 4/16/2024
| 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
- 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 resistanceassociated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
Summary
- Darunavir and cobicistat (Prezcobix) is indicated for the treatment of HIV-1 infection in both treatment-naïve and treatment-experienced adults, as well as pediatric patients weighing at least 40 kg who do not have any darunavir resistance-associated substitutions.
- One Randomized Controlled Trial was reviewed to gather information about this drug's effectiveness and safety profile.
- The trial involved two phase III studies named AMBER (NCT02431247) and EMERALD (NCT02269917), which included a total of 1106 HIV-infected patients receiving Prezcobix along with emtricitabine/tenofovir alafenamide.
- According to the study results, there were no apparent relationships between exposure levels of darunavir or tenofovir alafenamide with efficacy parameters such as virologic response or safety outcomes including metabolic, cardiac, liver, gastrointestinal skin bone renal pancreas lipid events.
- Furthermore, it was found that even in patients with low plasma concentrations of these drugs there was no risk of decreased virologic response or rebound suggesting good tolerance across different patient profiles.
- These findings support the use of a once-daily single-tablet regimen containing darunavir/cobicistat/emtricitabine/tenofovir alafenamide for treating HIV-1 infections irrespective age race gender body weight lean body weight α₁-acid-glycoprotein levels indicating broad applicability without subgroup considerations.
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 |
Sex Distribution:
Year:
2021
Source:The AAPS Journal