PREZCOBIX - Safety Information - Sulfa Allergy

Summary

• There is no information regarding the number of patients with/without a sulfonamide allergy who received darunavir (DRV) and cobicistat (COBI) administered as single agents in the GS-US-216-0130 study.¹
• In the AMBER study, which compared PREZCOBIX + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) with the single-tablet regimen (STR) DRV/COBI/FTC/tenofovir alafenamide (TAF), 1 (0.3%) patient in the PREZCOBIX group who experienced 2 rash events had a history of sulfonamide allergy.^2-4

data FROM STUDIES with drv/cobi

GS-US-216-0130 Study

GS-US-216-0130 is a phase 3b, open-label, single arm, 48 week, multicenter US study evaluating the safety, tolerability, efficacy, and pharmacokinetics of DRV 800 mg + COBI 150 mg once daily (QD; administered as single agents) in combination with 2 fully active nucleoside reverse transcriptase inhibitors (NRTIs) in treatment-naïve and treatment-experienced (no DRV resistance-associated mutations [RAMs]) HIV-1-infected patients (N=313; n=295 treatment-naïve).¹

• There is no information regarding the number of patients with/without a sulfonamide allergy who received DRV and COBI in the GS-US-216-0130 study.

Data from Studies with drv/cobi/ftc/taf STR

HIV-1 Patients with No Prior Antiretroviral Treatment History

AMBER Study

The AMBER study is a phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of the STR DRV/COBI/FTC/TAF vs the fixed-dose combination PREZCOBIX co-administered with FTC/TDF in treatment-naïve HIV-1-infected adults (N=725). At week 48, patients in the PREZCOBIX group switched to the STR and data were collected until week 96.²

Rash-associated adverse events were evaluated separately in patients with or without a history of sulfonamide allergy. Through week 48, one (0.3%) patient in the PREZCOBIX group who experienced rash events (rash macular and drug eruption) had a history of sulfonamide allergy (Table: Overview of Rash Events by History of Sulfonamide Allergy at Week 48.³

• Between weeks 48 and 96, there were 7 additional rash events in the initial STR group and 6 in the PREZCOBIX + FTC/TDF group following switch to the STR; none occurred in patients with a history of sulfonamide allergy.⁴

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® databases (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 03 April 2025.