RT Journal Article
T1 Hepatic Safety of Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Single-Tablet Regimen in HIV-Infected Patients with Active Hepatitis C Virus Infection: The hEPAtic Study.
A1 Neukam, Karin
A1 Espinosa, Nuria
A1 Collado, Antonio
A1 Delgado-Fernández, Marcial
A1 Jiménez-Aguilar, Patricia
A1 Rivero-Juárez, Antonio
A1 Hontañón-Antoñana, Victor
A1 Gómez-Berrocal, Ana
A1 Ruiz-Morales, Josefa
A1 Merino, Dolores
A1 Carrero, Ana
A1 Téllez, Francisco
A1 Ríos, María José
A1 Hernández-Quero, José
A1 de Lagarde-Sebastián, María
A1 Pérez-Camacho, Inés
A1 Vera-Méndez, Francisco
A1 Macías, Juan
A1 Pineda, Juan A
K1 Bilirrubina
K1 Protocolos clínicos
K1 Coinfección
K1 Infecciones por VIH
K1 Hepacivirus
K1 Cirrosis hepática
K1 Estudios retrospectivos
K1 Transaminasas
AB OBJECTIVESThe aim of this study was to evaluate the frequency of transaminase elevations (TE) and total bilirubin elevations (TBE) during the first year of therapy with a single tablet regimen including RPV/FTC/TDF (EPA) in HIV/hepatitis C virus (HCV)-coinfected subjects in clinical practice.METHODSIn a retrospective analysis, HIV/HCV-coinfected subjects who started EPA at 17 centres throughout Spain were included as cases. Subjects who started an antiretroviral therapy (ART) other than EPA during the study period at the same hospitals were randomly selected as controls in a 1:2 ratio. Primary outcome variables were grade (G) 3-4 TE and G4 TBE.RESULTSOf the 519 subjects included, 173 individuals started EPA. Nine (5.2%) subjects of the EPA group and 49 (14.2%) controls were naïve to ART. The median (Q1-Q3) follow-up was 11.2 (9.7-13.9) months. TE was observed in 2 [1.2%; 95% confidence interval (CI): 0.14%-4.1%] subjects receiving EPA and 11 (3.2%; 95%CI: 1.6%-5.6%) controls (p = 0.136), all events were G3. No patient discontinued ART due to TE. One (0.6%; 95%CI: 0.01%-3.1%) subject on EPA and 8 (2.3%; 95%CI: 1%-4.5%) subjects in the control group developed TBE (p = 0.141), without developing any other hepatic event during follow-up. Three (2.3%) subjects with cirrhosis versus 10 (3.1%) without cirrhosis showed G3-4 TE (p = 0.451).CONCLUSIONThe frequency of severe liver toxicity in HIV/HCV-coinfected subjects receiving EPA under real-life conditions is very low, TE were generally mild and did not lead to drug discontinuation. All these data suggest that EPA can be safely used in this particular subpopulation.
PB Public Library of Science
YR 2016
FD 2016-05-19
LK http://hdl.handle.net/10668/2349
UL http://hdl.handle.net/10668/2349
LA en
NO Neukam K, Espinosa N, Collado A, Delgado-Fernández M, Jiménez-Aguilar P, Rivero-Juárez A, et al. Hepatic Safety of Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Single-Tablet Regimen in HIV-Infected Patients with Active Hepatitis C Virus Infection: The hEPAtic Study. PLoS ONE. 2016; 11(5):e0155842
NO Journal Article;
DS RISalud
RD Apr 7, 2025