Author(s): Allavena C, Katlama C, Cotte L, Roger PM, Delobel P, , Allavena C, Katlama C, Cotte L, Roger PM, Delobel P,
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Abstract BACKGROUND: IEtravirine (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. OBJECTIVES: To describe in a real life setting efficacy and tolerability of ETR-including regimen and factors associated with virologic response. METHOD: In 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. RESULTS: 2083 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. CONCLUSION: This 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.
This article was published in J Int AIDS Soc
and referenced in Journal of AIDS & Clinical Research