Clinical outcomes after treatment with direct antiviral agents: beyond the virological response in patients with previous HCV-related decompensated cirrhosis

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Pageaux, Georges‐philippe | Nzinga, Clovis Lusivika | Ganne, Nathalie | Samuel, Didier | Dorival, Céline | Zoulim, Fabien | Cagnot, Carole | Decaens, Thomas | Thabut, Dominique | Asselah, Tarik | Mathurin, Philippe | Habersetzer, François | Bronowicki, Jean‐pierre | Guyader, Dominique | Rosa, Isabelle | Leroy, Vincent | Chazouilleres, Olivier | de Ledinghen, Victor | Bourliere, Marc | Causse, Xavier | Cales, Paul | Metivier, Sophie | Loustaud-Ratti, Véronique | Riachi, Ghassan | Alric, Laurent | Gelu-Simeon, Moana | Minello, Anne | Gournay, Jérôme | Geist, Claire | Tran, Albert | Abergel, Armand | Portal, Isabelle | D’alteroche, Louis | Raffi, François | Fontaine, Hélène | Carrat, Fabrice | Pol, Stanislas

Edité par CCSD ; BioMed Central -

International audience. BACKGROUND: 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. METHODS: We 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. RESULTS: 559 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). CONCLUSION: Treatment 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.

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