Decompensated cirrhosis and liver transplantation negatively impact in DAA treatment response: Real‐world experience from HCV‐LALREAN cohort

Abstract

Introduction Although effectiveness of direct‐acting antivirals (DAAs) for the treatment of chronic hepatitis C (HCV) has been reported in real‐world settings, predictive factors of treatment failure are lacking. Therefore, we sought to explore baseline predictors of treatment response to DAAs. Methods This was a prospective multicenter cohort study from the Latin American Liver Research Educational and Awareness Network (LALREAN) including patients who received DAAs treatment from May 2016 to April 2019. A multivariate logistic regression model was conducted to identify variables associated to unachieved sustained virological response (SVR), defined as treatment failure [odds ratios (OR) and 95% confidence intervals (CI)]. Results From 2167 patients (55.2% with cirrhosis) who initiated DAAs therapy, 89.4% completed a full‐course treatment (n=1938). Median treatment duration was 12 weeks, and 50% received ribavirin. Definitive suspension due to intolerance or other causes was observed in only 1.0% cases (n = 20). Overall non‐SVR12 was 4.5% (CI 3.5;5.7). There were no significant differences in treatment failure according to HCV genotypes and degree of fibrosis. Independently associated variables with DAAs failure were liver function impairment according to the Child Pugh score B OR 2.09 (P= 0.06), Child Pugh C OR 11.7 (P <0.0001); and liver transplant (LT) recipient OR 3.75 (P=0.01). Conclusion In this real‐life setting, higher DAAs treatment failure rates were observed in patients with decompensated cirrhosis and in LT recipients. These predictive baseline factors should be addressed to individualize the appropriate time‐point of DAAs treatment. (NCT03775798; www.clinicaltrials.gov)