Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort.
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Laurain Anne, Metivier Sophie, Haour Georges, Larrey Dominique, Dorival Céline, Hezode Christophe, Zoulim Fabien, Marcellin Patrick, Bourliere Marc, Zarski Jean-Pierre, Thabut Dominique, Alric Laurent, Ganne-Carrie Nathalie, Cales Paul, Bronowicki Jean-Pierre, Riachi Ghassan, Geist Claire, Causse Xavier, Abergel Armand, Chazouilleres Olivier, Mathurin Philippe, Guyader Dominique, Samuel Didier, Tran Albert, Loustaud-Ratti Véronique, Petrov-Sanchez Ventzislava, Diallo Alpha, Luzivika-Nzinga Clovis, Fontaine Hélène, Carrat Fabrice, Pol Stanislas, ANRS/AFEF HEPATHER study group
Аннотация
METHODS: Demographics and history of liver disease were collected at entry in the cohort. Clinical, adverse events, and virological data were collected throughout treatment and post-treatment follow-up. The choice of treatment duration or addition of ribavirin was left up to the physician.
RESULTS: Five hundred ninety-nine HCV (467 genotype 1 and 132 genotype 4) mono-infected, naïve for all oral-DAAs regimen patients were given sofosbuvir/simeprevir with (n = 63) or without ribavirin (n = 536) for 12 or 24 weeks; 56% had cirrhosis (4% decompensated) and 71% had prior treatment failure to interferon-based regimen. 7 patients (1.16%) were lost to follow-up. The overall SVR12 rate was 92.6%. The SVR12 was 90% in GT1a, 94.2% in GT1b and 91.6% in GT4 with no significant difference for genotype, treatment duration or ribavirin addition. Severity of liver disease was not associated with a lower SVR12 rate on multivariate analysis but was associated with a higher rate of severe side effects. Early treatment discontinuations were rare; no new safety signals were reported.
CONCLUSION: In this real life, observational, prospective cohort study, the 12-week sofosbuvir/simeprevir+/-ribavirin combination appears to be efficient and safe.
TRIAL REGISTRATION: Trial registration with ClinicalTrials.gov NCT01953458 .