You are here
AGE, GENDER, AND RACE ANALYSES OF D/C/F/TAF IN HIV-1 TREATMENT NAÏVE PATIENTS
Bruce Rashbaum1, Cheryl McDonald2, Cristina Mussini3, Christoph D. Spinner4, John Jezorwski5, Eric Y. Wong6, Kimberley Brown6
1Capital Medical Associates, Washington, DC, USA,2Tarrant County Infectious Disease Associates, Fort Worth, TX, USA,3University of Modena and Reggio Emilia, Modena, Italy,4Technical University of Munich, Munich, Germany,5Janssen Research & Development, Pennington, NJ, USA,6Janssen Scientific Affairs, LLC, Titusville, NJ, USA
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is the only single-tablet regimen in development for HIV-1 infection that contains darunavir and F/TAF. AMBER evaluated the efficacy and safety of D/C/F/TAF 800/150/200/10 mg versus control (D/C+F/tenofovir disoproxil fumarate [TDF]) in antiretroviral treatment (ART)-naïve, HIV-1–infected adults. We present Week 48 results based on age, gender, and race.
In AMBER, a phase 3, randomized (1:1), non-inferiority trial, the primary endpoint was proportion of patients with virologic response (viral load [VL] <50 copies[c]/mL; FDA snapshot) at Week 48. Patients with baseline resistance-associated mutations to agents other than D, F, or TDF could be included. Safety was assessed by adverse event (AE) rates and changes in bone mineral density and eGFR from baseline to Week 48. Subgroups evaluated were: age ≤50 versus >50 y, men versus women, and non-black/African American (AA) versus black/AA race.
A total of 725 patients were randomized and treated; 68 (9.4%) were >50 y, 85 (11.7%) women, and 80 (11.5%) black/AA. Overall, virologic response rates were 91.4% for D/C/F/TAF and 88.4% for control (difference, 2.7%; 95% confidence interval, –1.6% to 7.1%); response rates with D/C/F/TAF were similar to control across age, gender, and race subgroups (Table). In the total population, patients in the D/C/F/TAF and control arms had similar rates of discontinuation due to an AE (1.9% vs 4.4%, respectively), worst grade 3-4 AEs (5.2% vs 6.1%), and serious AEs (4.7% vs 5.8%). Similarly, there were no clinically relevant differences across subgroups; in general, there were numerically fewer AEs in the D/C/F/TAF arm versus control (Table). There were no deaths. Improvement in bone (bone loss/atrophy AEs, bone mineral density) and renal (eGFR) safety parameters were observed for D/C/F/TAF versus control across subgroups, consistent with results in the total population.
D/C/F/TAF achieved high virologic response rates that were overall non-inferior to control, as well as favorable bone and renal outcomes, and demonstrated consistent results across subgroups by age, gender, and race through 48 weeks in ART-naïve, HIV-1–infected patients.