You are here
DRV/R/3TC FDC FOR HIV-1 TREATMENT NAÏVE PATIENTS: WEEK 48 RESULTS OF THE ANDES STUDY
María I. Figueroa1, Omar G. Sued1, Ana M. Gun1, Waldo Belloso2, Diego M. Cecchini3, Gustavo Lopardo4, Daniel Pryluka5, Maria J. Rolon1, Valeria I. Fink1, Santiago Perez Lloret6, Pedro Cahn1
1Fundación Huésped, Buenos Aires, Argentina,2Hospital Italiano de Buenos Aires, Buenos Aires, Argentina,3Hospital Argerich, Buenos Aires, Argentina,4Centro de Estudios Infectológicos, Buenos Aires, Argentina,5Consultorio Infectológico, Buenos Aires, Argentina,6University of Buenos Aires, Buenos Aires, Argentina
Dual therapy has been explored in different studies. A generic fixed dose combination (FDC) of DRV800/ritonavir100 mg is available in Argentina. We designed a study to compare efficacy and safety of this FDC plus 3TC to standard-of care HAART based on the same drugs plus tenofovir. ClinicalTrials.gov Identifier: NCT02770508
ANDES is a randomized, open-label, phase IV study, designed to compare dual therapy (DT) with DRV/RTV (800/100 mg) FDC, plus 3TC (300 mg), to triple therapy (TT) with DRV/RTV (800/100 mg) plus 3TC/TDF (300/300mg),FDC in treatment-naïve HIV-1 infected patients. Primary endpoint: proportion of patients with viral load (pVL) <50 copies/mL at week 48 (FDA snapshot -ITTe analysis) Preplanned week 24 analysis was presented at IAS 2017.Week 48 results are reported here.
Out of 182 patients screened, 145 were randomized to receive: DT (n75) or TT (n70). At baseline 92% were on CDC stage A: 24% had pVL> 100,000 copies/mL. At week 48, 93% of patients on DT and 94% on TT achieved pVL <50 copies/mL, difference (95% CI): -1.0% (-7.5; 5.6%). Patients with baseline pVL>100,000 copies/mL showed 92% response in TT arm and 91% in DT. One patient presented virological failure at week 48 (TT arm).Per-protocol analysis: 99% were responders in TT arm and 100% in DT arm. Median CD4+ change between BSL and week 48 was similar in both arms. Thirty six grade 2-4; possible/probable related adverse events (AEs) were reported among 28 patients(TT:17;DT:11),most frequent were gastrointestinal (TT:14%;DT: 7%;p:0.17) and rash (TT:7%;DT: 8%;p:0.95). Laboratory abnormalities were similar in both arms except regarding total cholesterol (TT: 4%; DT: 19%; p: 0.01).LDL-cholesterol and triglycerides showed a non-significant trend in favor of TT( TT: 6%/DT 14% and TT: 14%/DT: 25% respectively). AEs leading to discontinuation were rare and similar between arms. No related SAEs or deaths were reported
A generic FDC of DRV/RTV plus 3TC showed non-inferiority to a standard of care triple drug regimen with ritonavir-bosted Darunavir in FDC plus TDF/3TC at 48 weeks. This study adds further evidence about the efficacy of drug-sparing regimens in treatment-naïve patients