title: Ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin is safe and effective in HCV-infected patients in a real-life cohort from Latin America.
abstract: Information about the use of ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin (OBV/PTV/r/DSV ± RBV) in real-clinical practice in Latin America is scarce. We aimed to confirm safety and effectiveness of OBV/PTV/r/DSV ± RBV therapy in real-world setting. We analyzed a cohort of patients with genotype 1 infection treated with OBV/PTV/r/DSV ± RBV. Data on demographics, clinical features, safety, and virological response were retrospectively collected from 21 centers in Latin America. A total of 96 patients received OBV/PTV/r/DSV, associated with RBV in 68% of the cases. Most were genotype 1b (80%), 56 (58%) had cirrhosis, and 45 (47%) failed prior HCV treatment. Adverse events occurred in 62% of patients. The most common adverse events were pruritus (21%), hyperbilirubinemia (17%), and asthenia (17%). Five patients discontinued therapy prematurely due to hepatic decompensation, three of them were Child-Pugh B at baseline and one patient died due to multi-organ failure. Follow up HCV-RNA 12 weeks after completion of therapy was evaluated in all the patients and sustained virologic response rate was 97%. No virologic breakthrough was detected. Our study confirms that OBV/PTV/r/DSV treatment is highly effective in patients with chronic HCV without cirrhosis or with Child-Pugh A cirrhosis in non-European populations. Adverse events were often mild and rarely led to treatment discontinuation except for patients with Child-Pugh B cirrhosis or with previous history of hepatic decompensation. These results can support the development of public strategies to expand the access of OBV/PTV/r + DSV and other DAAs combinations in order to reduce the burden of HCV infection in our region.
authors.affiliation: Unidad de Hígado y Trasplante Hepático, Hospital Universitario Austral, Pilar, Argentina.|Latin American Liver Research Educational and Awarness Network (LALREAN).
authors.forename: Manuel
authors.identifier: 0000-0002-7026-9908
authors.initials: M
authors.lastname: Mendizabal
authors.affiliation: Sección Hepatología, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
authors.forename: Leila
authors.initials: L
authors.lastname: Haddad
authors.affiliation: Fundación Sayani, San Salvador de Jujuy, Argentina.
authors.forename: Patricia E
authors.initials: PE
authors.lastname: Gallardo
authors.affiliation: Instituto Chileno Japonés de Enfermedades Digestivas, Hospital San Borja Arriaran, Santiago, Chile.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Ferrada
authors.affiliation: Latin American Liver Research Educational and Awarness Network (LALREAN).|Departamento de Gastroenterología, Pontificia Universidad Católica de Chile, Santiago, Chile.
authors.forename: Alejandro A
authors.initials: AA
authors.lastname: Soza
authors.affiliation: Latin American Liver Research Educational and Awarness Network (LALREAN).|Unidad de Hepatología, Centro de Hepatología, La Plata, Argentina.
authors.forename: Raul
authors.initials: R
authors.lastname: Adrover
authors.affiliation: Instituto Chileno Japonés de Enfermedades Digestivas, Hospital San Borja Arriaran, Santiago, Chile.
authors.forename: Edmundo
authors.initials: E
authors.lastname: Aravena
authors.affiliation: Instituto Chileno Japonés de Enfermedades Digestivas, Hospital San Borja Arriaran, Santiago, Chile.
authors.forename: Juan P
authors.initials: JP
authors.lastname: Roblero
authors.affiliation: Clínica Universitaria Colombia y Centro de Enfermedades Hepáticas y Digestivas (CEHYD), Bogotá, Colombia.
authors.forename: Jhon
authors.initials: J
authors.lastname: Prieto
authors.affiliation: Unidad de Hepatitis Virales de FUNCEI, Buenos Aires, Argentina.
authors.forename: Claudia
authors.initials: C
authors.lastname: Vujacich
authors.affiliation: Sección Hepatología, Hospital Dr. Carlos B. Udaondo, Buenos Aires, Argentina.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Romero
authors.affiliation: Sección Hepatología, Hospital Dr. Carlos B. Udaondo, Buenos Aires, Argentina.
authors.forename: Alberto
authors.initials: A
authors.lastname: Muñoz
authors.affiliation: Unidad de Hígado y Trasplante Hepático, Hospital Alemán, Buenos Aires, Argentina.
authors.forename: Margarita
authors.initials: M
authors.lastname: Anders
authors.affiliation: Clínica de Gastroenterología, Hospital de Clínicas, Montevideo, Uruguay.
authors.forename: Nelia
authors.initials: N
authors.lastname: Hernández
authors.affiliation: Latin American Liver Research Educational and Awarness Network (LALREAN).|Unidad de Hepatología, Centro de Hepatología, La Plata, Argentina.
authors.forename: Daniel
authors.initials: D
authors.lastname: Coccozella
authors.affiliation: Hepatología y Trasplante Hepático, Hospital Universitario Fundación Favaloro, Buenos Aires, Argentina.
authors.forename: Fernando
authors.initials: F
authors.lastname: Gruz
authors.affiliation: Latin American Liver Research Educational and Awarness Network (LALREAN).|Sección Hepatología, Hospital del Centenario, Rosario, Argentina.
authors.forename: Maria V
authors.initials: MV
authors.lastname: Reggiardo
authors.affiliation: FUNDIEH y HPR-Grupo Gamma, Rosario, Argentina.
authors.forename: Andres E
authors.initials: AE
authors.lastname: Ruf
authors.affiliation: Fundación Cardioinfantil, Instituto de Cardiología, Bogotá, Colombia.
authors.forename: Adriana
authors.initials: A
authors.lastname: Varón
authors.affiliation: Sección Hepatología, Hospital Dr. Carlos B. Udaondo, Buenos Aires, Argentina.
authors.forename: Mariano
authors.initials: M
authors.lastname: Cartier
authors.affiliation: Trasplante Hepático, Hospital Italiano de Mendoza, Mendoza, Argentina.
authors.forename: Roberto
authors.initials: R
authors.lastname: Pérez Ravier
authors.affiliation: Unidad de Hígado y Trasplante Hepático, Hospital Universitario Austral, Pilar, Argentina.|Latin American Liver Research Educational and Awarness Network (LALREAN).|CEMIC, Buenos Aires, Argentina.
authors.forename: Ezequiel
authors.initials: E
authors.lastname: Ridruejo
authors.affiliation: Unidad de Hígado, Hospital Francisco J. Muñiz, Buenos Aires, Argentina.
authors.forename: Mirta
authors.initials: M
authors.lastname: Peralta
authors.affiliation: Sección Hepatología, Sanatorio Municipal Dr. Julio Méndez, Buenos Aires, Argentina.
authors.forename: Daniel
authors.initials: D
authors.lastname: Poncino
authors.affiliation: Universidad Nacional de Rosario, Rosario, Argentina.
authors.forename: Julio
authors.initials: J
authors.lastname: Vorobioff
authors.affiliation: Sanatorio Mitre, Buenos Aires, Argentina.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Aballay Soteras
authors.affiliation: Unidad de Hígado y Trasplante Hepático, Hospital Universitario Austral, Pilar, Argentina.|Latin American Liver Research Educational and Awarness Network (LALREAN).
authors.forename: Marcelo O
authors.initials: MO
authors.lastname: Silva
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects* / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007843:Latin America; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents
keywords: antiviral agents; disease control; hepatitis C virus; public policy