Long-Term Benefits of Nevirapine-Containing Regimens: Multicenter Study with 506 Patients, Followed-Up a Median of 9 Years

S.      Moreno; J.      Sanz; I.      Santos; L.      Force; P.      Barrufet; J.      Lopez-Aldeguer; J.      A. Garcia-Henarejos; J.      L. Gomez-Sirvent; C.      Villalonga; E.      Ribera; T.      Puig; D.      Podzamczer; J.      C. Lopez Bernaldo de Quiros; M.      Leal; S.      Echevarria; A.      Castro; E.      Casas; M.      A. Cardenes; J.      Curto; J.      Mallolas; J.      M. Tiraboschi

doi:10.2174/157016212802429820

Abstract

Objective: To evaluate long-term outcomes in patients maintaining a nevirapine (NVP)-based regimen.

Methods: Retrospective, multicenter, cohort study including patients currently receiving an NVP regimen that had been started at least 5 years previously. Demographic, clinical, and analytical variables were recorded.

Results: Median follow-up was 8.9 (5.7-11.3) years. Baseline characteristics: 74% men, 47 years old, 36% drug users, 40% AIDS, 40% HCV+, 51.4% detectable HIV-1 viral load, CD4 count 395 (4-1,421)/μL, 19% CD4 <200/μL, 27% ALT grade 1-2, 36% AST grade 1-2. Thirty percent ART-naïve, 83% received NVP associated with 2 nucleoside analogues during the study period, and 17% a protease inhibitor.

A significant improvement was observed in general health status markers, including hemoglobin, platelets, and albumin, regardless of HCV coinfection. CD4 cell gain was +218 and +322/μL after 6 and 9 years, respectively (+321 and +391 in naive patients). Triglycerides significantly decreased in pretreated patients, whereas the percentage of patients with HDLc <1.03 mmol/L and LDL-c >3.37 mmol/L significantly decreased in a subsample with available values. A significant decrease in transaminases, alkaline phosphatase, and Fib4 score was observed, mainly in HCV+ and ARV-naive patients.

Conclusions: In patients who tolerate NVP therapy, (even those with HCV coinfection), long term benefits may be significant in terms of a progressive improvement in general health status markers and CD4 response, a favorable lipid profile, and good liver tolerability.

Keywords: Nevirapine, antiretroviral therapy, long term benefits, tolerability, liver outcome, NVP, NNRTI, CD4, naive patients, regimens.