Long‐term efficacy and safety of atazanavir/ritonavir treatment in a cohort of treatment‐naïve HIV patients: an interim analysis of the REMAIN study

Abstract

PurposeCombined antiretroviral therapy has dramatically improved HIV‐infected individuals survival. Long‐term strategies are currently needed to achieve the goal of durable virologic suppression. However, long‐term available data for specific antiretrovirals (ARV) are limited. In clinical trials, boosted atazanavir (ATV/r) regimens has shown good efficacy and tolerability in ARV‐naïve patients for up to 4 years. The REMAIN study aimed to evaluate the long‐term outcomes of ATV/r regimens in ARV‐naïve patients in a real life setting.MethodsNon‐comparative, observational study conducted in Germany, Portugal and Spain. Historical and longitudinal follow‐up data was extracted six monthly from the medical record of HIV‐infected, treatment‐naïve patients, who initiated an ATV/r‐regimen between 2008 and 2010. The primary endpoint was the proportion of patients remaining on ATV treatment over time. Secondary endpoints included virologic response (HIV‐1 RNA <50 c/mL and <500 c/mL), reasons for discontinuation and long‐term safety. The duration of treatment and time to virologic failure (VF) were analyzed using the Kaplan‐Meier method. Data from an interim analysis including patients with at least one year of follow‐up are reported here.ResultsA total of 411 patients were included in this interim analysis [median (Q1, Q3) follow‐up: 23.42 (16.25, 32.24) months]: 77% male; median age 40 years [min, max: 19, 78]; 16% IDUs; 18% CDC C; 18% hepatitis C. TDF/FTC was the most common backbone (85%). At baseline, median (Q1, Q3) HIV‐RNA and CD4 cell count were 4.91 (4.34, 5.34) log10 c/mL and 256 (139, 353) cells/mm3, respectively. The probability of remaining on treatment was 0.84 (95% CI: 0.80, 0.87) and 0.72 (95% CI: 0.67, 0.76) for the first and second year, respectively. After 2 years of follow‐up, 84% (95% CI: 0.79, 0.88) of patients were virologically suppressed (<50 c/mL). No major protease inhibitors mutations were observed at VF. Overall, 125 patients (30%) discontinued ATV therapy [median (Q1, Q3) time to discontinuation: 11.14 (6.24, 19.35) months]. Adverse events (AEs) were the main reason for discontinuation (n = 47, 11%). Hyperbilirubinaemia was the most common AE leading to discontinuation (14 patients). No unexpected AEs were reported.ConclusionsIn a real life clinical setting, ATV/r regimens showed durable virologic efficacy with good tolerability in an ARV‐naïve population. Data from longer follow‐up will provide additional valuable information.