Manuel Mendizabal1, Federico Piñero2, Ezequiel Ridruejo3, Fernando Herz Wolff4, Margarita Anders5, Virginia Reggiardo6, Beatriz Ameigeiras7, Ana Palazzo8, Cristina Alonso2, María Isabel Schinoni9, María Grazia Videla Zuain10, Federico Tanno6, Sebastián Figueroa11, Luisa Santos12, Mirta Peralta13, Alejandro Soza14, Cecilia Vistarini7, Raúl Adrover15, Nora Fernández16, Daniela Perez8, Nelia Hernández17, Claudio Estepo18, Andres Bruno18, Valeria Descalzi19, Marcela Sixto20, Silvia Borzi21, Daniel Cocozzella15, Alina Zerega22, Alexandre de Araujo23, Adriana Varón13, Fernando Rubinstein24, Hugo Cheinquer4, Marcelo Silva2. 1. Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Argentina. Electronic address: mmendiza@cas.austral.edu.ar. 2. Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Argentina. 3. Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Argentina; Centro de Educación Médica e Investigaciones Clínicas, CEMIC, Ciudad de Buenos Aires, Argentina. 4. Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. 5. Hospital Alemán, Ciudad de Buenos Aires, Argentina. 6. Hospital Provincial del Centenario, Rosario, Argentina. 7. Hospital Ramos Mejía, Ciudad de Buenos Aires, Argentina. 8. Hospital Padilla, Tucumán, Argentina. 9. Universidade Federal do Bahia, Salvador do Bahia, Brazil. 10. Hospital Zubizarreta, Ciudad de Buenos Aires, Argentina. 11. Hospital Arturo Oñativia, Salta, Argentina. 12. Fundación Cardioinfantil, Bogotá, Colombia. 13. Hospital Francisco J. Muñiz, Ciudad de Buenos Aires, Argentina. 14. Hospital Pontificia Universidad Católica de Chile, Santiago, Chile. 15. Hospital San Roque, La Plata, Argentina. 16. Hospital Británico, Ciudad de Buenos Aires, Argentina. 17. Hospital de Clínicas, Montevideo, Uruguay. 18. Hospital Cosme Argerich, Ciudad de Buenos Aires, Argentina. 19. Fundación Favaloro, Ciudad de Buenos Aires, Argentina. 20. Hospital Jose María Cullen, Santa Fe, Argentina. 21. Hospital Rossi, La Plata, Argentina. 22. Sanatorio Allende, Córdoba, Argentina. 23. Hospital de Clínicas de Porto Alegre, Brazil. 24. Instituto de Efectividad Clínica Sanitaria, Buenos Aires, Argentina.
Abstract
BACKGROUND & AIMS: Little is known about how a sustained virologic response (SVR) to treatment of hepatitis C virus infection with direct-acting antivirals (DAAs) affects patient mortality and development of new liver-related events. We aimed to evaluate the incidence of disease progression in patients treated with DAAs. METHODS: We performed a prospective multicenter cohort study of 1760 patients who received DAA treatment at 23 hospitals in Latin America, from May 1, 2016, through November 21, 2019. We excluded patients with a history of liver decompensation, hepatocellular carcinoma (HCC), or solid-organ transplantation. Disease progression after initiation of DAA therapy included any of the following new events: liver decompensation, HCC, liver transplantation, or death. Evaluation of variables associated with the primary outcome was conducted using a time-dependent Cox proportional hazards models. RESULTS: During a median follow-up period of 26.2 months (interquartile range, 15.3-37.5 mo), the overall cumulative incidence of disease progression was 4.1% (95% CI, 3.2%-5.1%), and after SVR assessment was 3.6% (95% CI, 2.7%-4.7%). Baseline variables associated with disease progression were advanced liver fibrosis (hazard ratio [HR], 3.4; 95% CI, 1.2-9.6), clinically significant portal hypertension (HR, 2.1; 95% CI, 1.2-3.8), and level of albumin less than 3.5 mg/dL (HR, 4.1; 95% CI, 2.3-7.6), adjusted for SVR achievement as a time covariable. Attaining an SVR reduced the risk of liver decompensation (HR, 0.3; 95% CI, 0.1-0.8; P = .016) and de novo HCC (HR, 0.2; 95% CI, 0.1%-0.8%; P = .02) in the overall cohort. CONCLUSIONS: Treatment of hepatitis C virus infection with DAAs significantly reduces the risk of new liver-related complications and should be offered to all patients, regardless of disease stage. Clinicaltrials.gov: NCT03775798.
BACKGROUND & AIMS: Little is known about how a sustained virologic response (SVR) to treatment of hepatitis C virus infection with direct-acting antivirals (DAAs) affects patient mortality and development of new liver-related events. We aimed to evaluate the incidence of disease progression in patients treated with DAAs. METHODS: We performed a prospective multicenter cohort study of 1760 patients who received DAA treatment at 23 hospitals in Latin America, from May 1, 2016, through November 21, 2019. We excluded patients with a history of liver decompensation, hepatocellular carcinoma (HCC), or solid-organ transplantation. Disease progression after initiation of DAA therapy included any of the following new events: liver decompensation, HCC, liver transplantation, or death. Evaluation of variables associated with the primary outcome was conducted using a time-dependent Cox proportional hazards models. RESULTS: During a median follow-up period of 26.2 months (interquartile range, 15.3-37.5 mo), the overall cumulative incidence of disease progression was 4.1% (95% CI, 3.2%-5.1%), and after SVR assessment was 3.6% (95% CI, 2.7%-4.7%). Baseline variables associated with disease progression were advanced liver fibrosis (hazard ratio [HR], 3.4; 95% CI, 1.2-9.6), clinically significant portal hypertension (HR, 2.1; 95% CI, 1.2-3.8), and level of albumin less than 3.5 mg/dL (HR, 4.1; 95% CI, 2.3-7.6), adjusted for SVR achievement as a time covariable. Attaining an SVR reduced the risk of liver decompensation (HR, 0.3; 95% CI, 0.1-0.8; P = .016) and de novo HCC (HR, 0.2; 95% CI, 0.1%-0.8%; P = .02) in the overall cohort. CONCLUSIONS: Treatment of hepatitis C virus infection with DAAs significantly reduces the risk of new liver-related complications and should be offered to all patients, regardless of disease stage. Clinicaltrials.gov: NCT03775798.
Authors: Lauren E Ball; Bernice Agana; Susana Comte-Walters; Don C Rockey; Henry Masur; Shyam Kottilil; Eric G Meissner Journal: J Viral Hepat Date: 2021-08-19 Impact factor: 3.728