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.
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.
authors.affiliation: Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.
authors.forename: Karin
authors.initials: K
authors.lastname: Neukam
authors.affiliation: Service of Infectious Diseases, Hospital Universitario Virgen del Rocío, Seville, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Espinosa
authors.affiliation: Unit of Infectious Diseases, Hospital Torrecárdenas, Almeria, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Collado
authors.affiliation: Unit of Infectious Diseases, Hospital Regional de Málaga. Malaga, Spain.
authors.forename: Marcial
authors.initials: M
authors.lastname: Delgado-Fernández
authors.affiliation: Unit of Infectious Diseases, Hospital Universitario Puerto Real, Puerto Real, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Jiménez-Aguilar
authors.affiliation: Unit of Infectious Diseases, Hospital Universitario Reina Sofía, Instituto de Investigación Biomédica de Córdoba (IMIBIC), Cordoba, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero-Juárez
authors.affiliation: HIV Unit, Service of Internal Medicine, Hospital Universitario La Paz/IdiPAZ, Madrid, Spain.
authors.forename: Victor
authors.initials: V
authors.lastname: Hontañón-Antoñana
authors.affiliation: Service of Internal/Infectious Medicine, Hospital Universitario de la Princesa, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Gómez-Berrocal
authors.affiliation: Unit of Infectious Diseases, Hospital Universitario Virgen de la Victoria, Malaga, Spain.
authors.forename: Josefa
authors.initials: J
authors.lastname: Ruiz-Morales
authors.affiliation: Unit of Infectious Diseases, Complejo Hospitalario de Huelva, Huelva, Spain.
authors.forename: Dolores
authors.initials: D
authors.lastname: Merino
authors.affiliation: Unit of Infectious Diseases/HIV, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Carrero
authors.affiliation: Unit of Infectious Diseases, Hospital La Línea, AGS Campo de Gibraltar, La Linea de la Concepcion, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Téllez
authors.affiliation: Unit of Infectious Diseases, Hospital Virgen Macarena, Seville, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Ríos
authors.affiliation: Unit of Infectious Diseases, Hospital Universitario San Cecilio, Granada, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Hernández-Quero
authors.affiliation: HIV Unit. Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: María
authors.initials: M
authors.lastname: de Lagarde-Sebastián
authors.affiliation: Tropical Medicine Unit, Hospital Poniente, El Ejido, Spain.
authors.forename: Inés
authors.initials: I
authors.lastname: Pérez-Camacho
authors.affiliation: Infectious Medicine Section, Hospital Universitario Santa Lucia, Cartagena, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Vera-Méndez
authors.affiliation: Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Macías
authors.affiliation: Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.
authors.forename: Juan A
authors.initials: JA
authors.lastname: Pineda
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage; D000998:Antiviral Agents / Q000008:administration & dosage*; D001663:Bilirubin / Q000378:metabolism; D016022:Case-Control Studies; D060085:Coinfection / Q000188:drug therapy / Q000821:virology; D004359:Drug Therapy, Combination; D000068679:Emtricitabine / Q000008:administration & dosage*; D005260:Female; D005355:Fibrosis / Q000188:drug therapy; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D016174:Hepacivirus; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy*; D006760:Hospitalization; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000068696:Rilpivirine / Q000008:administration & dosage*; D013030:Spain; D013607:Tablets; D000068698:Tenofovir / Q000008:administration & dosage*; D000637:Transaminases / Q000378:metabolism
chemical_list: D044966:Anti-Retroviral Agents; D000998:Antiviral Agents; D013607:Tablets; D000068698:Tenofovir; D000637:Transaminases; D000068696:Rilpivirine; D000068679:Emtricitabine; D001663:Bilirubin