Dual raltegravir/etravirine combination in virologically suppressed HIV-1-infected patients on antiretroviral therapy.

Background: The combination of raltegravir (RAL) and etravirine (ETR) represents a novel antiretroviral treatment option in patients with toxicity or long-term exposure to standard therapies including protease inhibitors (PI) and nucleoside reverse transcriptase inhibitors (NRTI). The objective of this study was to evaluate the capacity of dual RAL/ETR therapy to maintain virological suppression in HIV-1 patients under effective antiretroviral therapy (ART). Methods: Using the Nadis database we retrospectively identified all patients in our centre who were switched from different ART regimens to ETR 200 mg twice daily plus RAL 400 mg twice daily prior to February 2010, having a suppressed HIV-1 plasma viral load (pVL<200 copies/ml) at the moment of switch. Patients already on RAL or ETR at baseline were not excluded from the study. Treatment failure was defined as two consecutive pVL>50 copies/ml or discontinuation of RAL/ETR for any reason. Results: A total of 18 patients were included. Median baseline characteristics were: age 48 years (IQR 45-56), duration of ART 14 years (IQR 13-16), duration of viral suppression 6 years (IQR 5-9), duration of NRTI exposure 11 years (IQR 8-14) and PI exposure 6 years (IQR 3-9). In intent-to-treat analysis, the efficacy at 6 months of follow-up was 94.4% (n= 17/18, 95% Cl 74.2, 99%) and 83.3% (n= 15/18, 95% Cl 60.7, 94.1%) at 12 months. In per-protocol analysis, the efficacy at 12 months was 100% (n= 15/15, 95% Cl 80.6, 100%). No tolerabilityrelated treatment discontinuation was recorded. Conclusions: This study, although on a limited number of patients, suggests that raltegravir plus etravirine represents a potential option of NRTI/PI-sparing strategy, deserving further investigation in randomized studies.