Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study
Liver International Dec 07, 2019
Asselah T, Pol S, Hezode C, et al. - Researchers performed this partially randomized, open-label multicenter study in France, to assess the safety as well as the effectiveness of elbasvir/grazoprevir given for 8 and 12 weeks in participants with hepatitis C virus (HCV) genotype (GT) 4 infection. Randomization 2:1 of treatment-naive participants with GT4 infection and F0-F2 fibrosis to receive elbasvir (50 mg)/grazoprevir (100 mg) for 8 or 12 weeks was done. Allocation of treatment-naive participants with F3-F4 fibrosis and all treatment-experienced cases (F0-F4) to elbasvir/grazoprevir was done for 12 weeks. Sustained virologic response (SVR) 12 weeks following the completion of treatment was regarded as the primary endpoint. The attainment of SVR by 94% (50/53) and 96% (26/27) of those taking elbasvir/grazoprevir for 8 or 12 weeks, respectively, was noted among treatment-naive participants with F0-F2 fibrosis, with relapse in 4 participants. The achievement of SVR by 95% (35/37) and relapse in 2 cases was reported in the 12-week arm. Overall, elbasvir/grazoprevir 12 weeks was proved efficacious in treatment-experienced people with HCV GT4 infection and those with advanced fibrosis. An 8-week regimen appeared effective for treating treatment-naive people with mild fibrosis.
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