Abstract
BackgroundIn HCV-infected patients with advanced liver disease, the direct antiviral agents-associated clinical benefits remain debated. We compared the clinical outcome of patients with a previous history of decompensated cirrhosis following treatment or not with direct antiviral agents from the French ANRS CO22 HEPATHER cohort.MethodsWe identified HCV patients who had experienced an episode of decompensated cirrhosis. Study outcomes were all-cause mortality, liver-related or non-liver-related deaths, hepatocellular carcinoma, liver transplantation. Secondary study outcomes were sustained virological response and its clinical benefits.Results559 patients met the identification criteria, of which 483 received direct antiviral agents and 76 remained untreated after inclusion in the cohort. The median follow-up time was 39.7 (IQR: 22.7–51) months. After adjustment for multivariate analysis, exposure to direct antiviral agents was associated with a decrease in all-cause mortality (HR 0.45, 95% CI 0.24–0.84, p = 0.01) and non-liver-related death (HR 0.26, 95% CI 0.08–0.82, p = 0.02), and was not associated with liver-related death, decrease in hepatocellular carcinoma and need for liver transplantation. The sustained virological response was 88%. According to adjusted multivariable analysis, sustained virological response achievement was associated with a decrease in all-cause mortality (HR 0.29, 95% CI 0.15–0.54, p < 0.0001), liver-related mortality (HR 0.40, 95% CI 0.17–0.96, p = 0.04), non-liver-related mortality (HR 0.17, 95% CI 0.06–0.49, p = 0.001), liver transplantation (HR 0.17, 95% CI 0.05–0.54, p = 0.003), and hepatocellular carcinoma (HR 0.52, 95% CI 0.29–0.93, p = 0.03).ConclusionTreatment with direct antiviral agents is associated with reduced risk for mortality. The sustained virological response was 88%. Thus, direct antiviral agents treatment should be considered for any patient with HCV-related decompensated cirrhosis.Trial registration: ClinicalTrials.gov registry number: NCT01953458.
Highlights
In hepatitis C virus (HCV)-infected patients with advanced liver disease, the direct antiviral agents-associated clinical benefits remain debated
Direct antiviral agents treatment should be considered for any patient with HCV-related decompensated cirrhosis
Among the HCV patients included in this cohort between August 2012 and December 2015, we identified those who had experienced an episode of decompensated cirrhosis before or at the time of study inclusion, including ascites, jaundice, encephalopathy, and haemorrhage
Summary
In HCV-infected patients with advanced liver disease, the direct antiviral agents-associated clinical benefits remain debated. We compared the clinical outcome of patients with a previous history of decompensated cirrhosis following treatment or not with direct antiviral agents from the French ANRS CO22 HEPATHER cohort. Direct-acting antiviral agents (DAAs) have transformed the clinical course of HCV-infected patients, even in those with advanced liver disease [3,4,5]. The clinical benefit of treatment has been assessed at large by the evolution of Child–Pugh and MELD prognostic scores during a short period from baseline to posttreatment week 12, as well as by patient delisting from liver transplant waiting lists. The DAA-associated benefits, including the reduction of mortality or other hepatic complications, remain debated [6]. Among the various studies published on the evaluation of the efficacy of DAA in the most severe patients, decompensated cirrhosis has been defined either by: (1) Child–Pugh score > B7 without taking complications into account, or (2) a past or current clinical event reflecting decompensation, such as ascites, digestive haemorrhage, and encephalopathy
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