Suchergebnisse

BackgroundIEtravirine (ETR) was approved in France in Sept 2008, to be used in combination with a ritonavir‐boosted protease inhibitor (bPI) and others antiretrovirals (ARV) in HIV‐infected pre‐treated patients.ObjectivesTo describe in a real life setting efficacy and tolerability of ETR‐including regimen and factors associated with virologic response.MethodIn the French DatAIDS cohort including 18,647 patients, we selected patients who initiated an ETR‐including regimen between September 2008 and July 2013. Demographic data and clinico‐biological data were collected from the standardized electronic medical record Nadis®. Analyses were done in patients starting ETR and sub‐analyses were performed in pre‐treated patients starting ETR for virologic failure (VF) or maintenance (MT) therapy, with or without bPI.Results2083 patients (ARV‐naïve n=77, VF n=1014, MT n=992) were included: median age 47 years, 73.3% male, median duration of HIV infection 15.7 years, CDC stage C 38.7%, HBV/HCV co‐infection 25.7%. In pre‐treated patients, 75.5% previously received NNRTIs (median duration on EFV and NVP of 480 and 396 days, respectively), 94.3% bPIs, 30.8% raltegravir (RAL) and 19.4% enfuvirtide. The most frequent ARVs associated with ETR were two NRTIs in 37.2% of the cases (21.9% in VF, 52.9% in MT), 1 bPI+RAL in 10.1% (13.5% in VF, 6.6% in MT), RAL in 6.2% (2% in VF, 10.5% in MT). Median duration on ETR was 3.7 and 2.2 years in the VF and MT group, respectively. In the VF group, HIV RNA was <50 c/ml in 71.7% (71.1% without bPI, 72% with bPI) of the patients at M12, 72.8% (71% without bPI, 73.3% with bPI) of the patients at M24. In the MT group, HIV RNA was<50 c/ml in 90.5% of the patients at M12 and 93.1% at M24. ETR was discontinued in 8.8% of the patients (12.8% in VF, 5.4% in MT) for adverse events in 23.9% of cases (21.5% in VF, 29.5% in MT), treatment failure in 15.2% (16.2% in VF, 7.4% in MT) or simplification in 5.4% (4.6% in VF, 7.4% in MT). In the VF group, factors associated with virologic failure in multivariate analysis were a longer duration of HIV infection (OR 2.6; 95% CI 1.7–4.0) and baseline HIV RNA >5 log10 c/ml (OR: 2.0; 95% CI 1.3–3.2) but not the association with a bPI.ConclusionThis large study shows that in ARV‐pre‐treated patients ETR is well tolerated with a high efficacy when combined with other active drugs, even when the regimen does not include a bPI.