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, French ANRS CO22 Hepather Cohort
Аннотация
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.