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