Disease Progression in Patients With Hepatitis C Virus Infection Treated With Direct-Acting Antiviral Agents.

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.

• Authors: Manuel Mendizabal, Federico Piñero, Ezequiel Ridruejo, Fernando Herz Wolff, Margarita Anders, Virginia Reggiardo, Beatriz Ameigeiras, Ana Palazzo, Cristina Alonso, María Isabel Schinoni, María Grazia Videla Zuain, Federico Tanno, Sebastián Figueroa, Luisa Santos, Mirta Peralta, Alejandro Soza, Cecilia Vistarini, Raúl Adrover, Nora Fernández, Daniela Perez, Nelia Hernández, Claudio Estepo, Andres Bruno, Valeria Descalzi, Marcela Sixto, Silvia Borzi, Daniel Cocozzella, Alina Zerega, Alexandre de Araujo, Adriana Varón, Fernando Rubinstein, Hugo Cheinquer, Marcelo Silva, Latin American Liver Research, Educational and Awareness Network (LALREAN)
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 18 Issue 11 Pg. 2554-2563.e3 (10 2020) ISSN: 1542-7714 [Electronic] United States
• PMID: 32113892 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antiviral Agents

Topics

• Antiviral Agents (therapeutic use)
• Carcinoma, Hepatocellular (drug therapy, epidemiology)
• Cohort Studies
• Disease Progression
• Hepacivirus
• Hepatitis C, Chronic (complications, drug therapy)
• Humans
• Liver Cirrhosis (drug therapy, epidemiology)
• Liver Neoplasms (drug therapy, epidemiology)
• Prospective Studies
• Risk Factors
• Sustained Virologic Response