Neukam, KarinEspinosa, NuriaCollado, AntonioDelgado-Fernández, MarcialJiménez-Aguilar, PatriciaRivero-Juárez, AntonioHontañón-Antoñana, VictorGómez-Berrocal, AnaRuiz-Morales, JosefaMerino, DoloresCarrero, AnaTéllez, FranciscoRíos, María JoséHernández-Quero, Joséde Lagarde-Sebastián, MaríaPérez-Camacho, InésVera-Méndez, FranciscoMacías, JuanPineda, Juan A2016-08-102016-08-102016-05-19Neukam 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):e0155842http://hdl.handle.net/10668/2349Journal Article;OBJECTIVES 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. METHODS 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. RESULTS 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). CONCLUSION 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.enBilirrubinaProtocolos clínicosCoinfecciónInfecciones por VIHHepacivirusCirrosis hepáticaEstudios retrospectivosTransaminasasMedical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Azoles::Pyrroles::Tetrapyrroles::Bile Pigments::BilirubinMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Clinical ProtocolsMedical Subject Headings::Diseases::Bacterial Infections and Mycoses::Infection::CoinfectionMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Control GroupsMedical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Follow-Up StudiesMedical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::HIV InfectionsMedical Subject Headings::Organisms::Viruses::Hepatitis Viruses::HepacivirusMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Diseases::Digestive System Diseases::Liver Diseases::Liver CirrhosisMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studies::Retrospective StudiesMedical Subject Headings::Geographicals::Geographic Locations::Europe::SpainMedical Subject Headings::Chemicals and Drugs::Pharmaceutical Preparations::Dosage Forms::TabletsMedical Subject Headings::Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Transferases::Nitrogenous Group Transferases::Transaminasesresearch article27195797open access10.1371/journal.pone.01558421932-6203PMC4873169