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Title: 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.
Authors: Neukam, Karin
Espinosa, Nuria
Collado, Antonio
Delgado-Fernández, Marcial
Jiménez-Aguilar, Patricia
Rivero-Juárez, Antonio
Hontañón-Antoñana, Victor
Gómez-Berrocal, Ana
Ruiz-Morales, Josefa
Merino, Dolores
Carrero, Ana
Téllez, Francisco
Ríos, María José
Hernández-Quero, José
de Lagarde-Sebastián, María
Pérez-Camacho, Inés
Vera-Méndez, Francisco
Macías, Juan
Pineda, Juan A
hEPAtic Study Group
metadata.dc.subject.mesh: Adult
Anti-Retroviral Agents
Antiviral Agents
Case-Control Studies
Drug Therapy, Combination
HIV Infections
Hepatitis C
Middle Aged
Retrospective Studies
Issue Date: 19-May-2016
Abstract: The 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. In 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. Of 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). The 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.
metadata.dc.identifier.doi: 10.1371/journal.pone.0155842
Appears in Collections:Producción 2020

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