Simplification of protease inhibitor-containing regimens with efavirenz, @entity5198 or XXXX : safety and efficacy outcomes.

@entity1 @entity137 @entity404 @entity22208 @entity645 @entity16333 @entity5198 @entity791
OBJECTIVE: To describe the immunological and virological outcome, and the factors associated to discontinuation in @entity1 switching to a regimen containing efavirenz (EFV), @entity5198 ( @entity16333 ) or @entity22208 (ABC) after long-term viral suppression under protease inhibitor-including HAART. DESIGN: Observational study at three outpatient clinics for @entity645 care in Italy. METHODS: @entity1 with @entity645 RNA <80 copies/ml and @entity404 >200 cells/ml for at least 6 months on a protease inhibitor-containing treatment who switched to NVP, EFV or ABC were included in the study. End-points were immunological failure, virological failure and discontinuation due to @entity137 . Survival analyses were performed to find out any independent variables predictive of reaching the end-points. RESULTS: 177 @entity1 were enrolled; 85 started EFV, 54 NVP and 38 ABC as part of the simplification regimen. 16/159 @entity1 experienced immunological failure: the variables associated to @entity404 count decrease were @entity645 RNA set point value (HR 2.32 for each log10 copies more, P=0.040) and intolerance/ @entity137 as reason for simplification (HR 3.96, P=0.05). 13/151 subjects showed virological failure; an @entity791 diagnosis (HR 6.04, P=0.021) and the use of NVP (HR 7.98, P=0.027) were associated to a worse virological outcome, while @entity1 naive before HAART showed a lower risk of failure (HR 0.008, P=0.007). 16/177 @entity1 discontinued simplification regimen due to @entity137 ; longer HAART duration before switch was associated to risk reduction (HR 0.92, P=0.004). CONCLUSIONS: Simplification is safe and effective, but it should be offered to @entity1 with shorter treatment duration, and in good clinical and immunovirological conditions.
