Summary

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• Prezcobix (darunavir and cobicistat) is 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).
• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• AMBER and EMERALD Studies: In HIV-infected patients, the estimated mean (SD) DRV C0h and AUC24h were 1899 (759) ng/mL and 87,909 (20,232) ngh/mL in AMBER and 1813 (859) ng/mL and 85,972 (22,413) ngh/mL in EMERALD, respectively. No apparent relationship was found between DRV or TAF exposure and virologic response, with no risk of decreased virologic response or virologic rebound in patients with low plasma concentrations.
• EMERALD Study: In treatment-experienced, virologically suppressed adults, the virologic rebound rates were 2.5% for D/C/F/TAF and 2.1% for the control group, with virologic response rates ranging from 91-97% for D/C/F/TAF and 89-99% for the control. Switching to D/C/F/TAF was highly effective, with comparable virologic rebound and response rates to the control group.
• Effectiveness Across Subgroups: No significant differences were observed in virologic rebound or response rates across subgroups based on demographic characteristics, prior treatment experience, or baseline antiretroviral regimen, indicating consistent effectiveness of D/C/F/TAF.
• Safety Outcomes in AMBER and EMERALD Studies: There was no apparent relationship between DRV or TAF exposure and safety parameters across various health events (metabolic, cardiac, liver, gastrointestinal, skin, bone, renal, pancreas, and lipid). The single-tablet regimen of D/C/F/TAF 800/150/200/10 mg was supported for use without major safety concerns.
• Safety Outcomes in EMERALD Study: Adverse event rates were low in both D/C/F/TAF and control groups. Improvements in renal and bone parameters were observed with D/C/F/TAF across demographic subgroups, indicating a favorable safety profile.
• There is no population type or subgroup information available in the reviewed studies.