Open AccessLong‐term safety and tolerability of nevirapine and efavirenz‐containing regimens in HIV/HCV‐coinfected patients
Author(s) -
Mauelshagen A,
Horst H,
Stellbrink H,
Hoffmann C
Publication year - 2012
Publication title -
journal of the international aids society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.724
H-Index - 62
ISSN - 1758-2652
DOI - 10.7448/ias.15.6.18416
Subject(s) - efavirenz , medicine , nevirapine , tolerability , discontinuation , regimen , adverse effect , population , viral load , human immunodeficiency virus (hiv) , virology , antiretroviral therapy , environmental health
Purpose There is some controversy about the hepatic safety of nevirapine (NVP) and current US guidelines discourage NVP use in HCV‐coinfected patients. We evaluated the long‐term safety and tolerability of antiretroviral therapies containing NVP or efavirenz (EFV) in this difficult‐to‐treat population. Methods This retrospective observational cohort study included all HIV/HCV‐coinfected patients who initiated a regimen including NVP or EFV between January 2000 and July 2011 in two HIV centers. A detailed analysis of the HIV/HCV status at the time of NNRTI start was performed as well as of the reason for NNRTI discontinuation. Results In total, 195 cases were identified (121 on EFV, 74 on NVP). Mean age was 38 years, 77% were men and intravenous drug use (59%) was the most frequent mode of transmission. In 66%, HCV infection was viremic while 34% had an aviremic infection. The estimated median time on NNRTI was 5.2 years. During a total of 566 patient‐years, no NNRTI‐associated fatal event was observed. Treatment was discontinued due to adverse events (AEs) in 23.1% patients on EFV and 23.0% in patients on NVP. The main AE leading to discontinuation were CNS side effects in patients on EFV (20.7%) and hepatic events in patients on NVP (21.6%, grade 3 or 4 events: 9.5%). The majority of AEs in patients on NVP occurred during the first 12 months while AEs in patients on EFV were observed continuously during the observation period (Figure). Discontinuations due to hepatotoxicity were not more frequent in patients viremic for HCV compared to aviremic patients. Pre‐treatment levels of ALT, GGT or CD4 cells were also not predictive for discontinuation of ART due to an hepatic event. Conclusions Antiretroviral regimens, including NVP or EFV, were generally safe in HIV/HCV‐coinfected patients. Severe AEs were rare. However, 23% of the patients discontinued their NNRTI regimen due to AEs. Discontinuations of NVP due to hepatotoxicity were not more frequent in patients viremic for HCV compared to aviremic patients.