Add‐on effects of fluvastatin in simeprevir/pegylated‐interferon/ribavirin combination therapy for patients with genotype 1 hepatitis C virus infection: A randomized controlled study
Background The Japan Society of Hepatology guidelines indicate that hepatitis C virus (HCV) protease inhibitor combination therapy with simeprevir (SMV), pegylated‐interferon (Peg‐IFN), and ribavirin (RBV) is a therapeutic option for patients who fail to respond to a direct direct‐acting antiviral‐c...
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Published in | Hepatology research Vol. 48; no. 3; pp. E146 - E154 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Netherlands
Wiley Subscription Services, Inc
01.02.2018
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Subjects | |
Online Access | Get full text |
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Summary: | Background
The Japan Society of Hepatology guidelines indicate that hepatitis C virus (HCV) protease inhibitor combination therapy with simeprevir (SMV), pegylated‐interferon (Peg‐IFN), and ribavirin (RBV) is a therapeutic option for patients who fail to respond to a direct direct‐acting antiviral‐containing regimen. However, treatment outcomes have room for improvement. Fluvastatin (FLV) add‐on treatment in Peg‐IFN and RBV combination therapy for HCV‐infected patients significantly improved the sustained virologic response (SVR), but the add‐on effect of FLV on SMV combination therapy is not well understood.
Methods
This was a prospective, randomized, multicenter study in which a total of 61 HCV genotype 1b‐infected patients were recruited and 60 eligible patients were randomly allocated to two groups that received 12 weeks of SMV/Peg‐IFN/RBV followed by 12 weeks of Peg‐IFN/RBV with or without 24 weeks of FLV. The SVR rate and adverse events were compared between the two groups.
Results
Thirty‐one patients were allocated to the FLV add‐on group and 29 patients were allocated to the control group. Baseline clinical factors, including median age, baseline platelet count, alanine aminotransferase level, HCV RNA titer, Fibrosis‐4 index, and rate of IL28B minor genotype, were all similar between the two groups. The rapid virologic response, end‐of‐treatment response rates, SVR rates at 24 weeks after treatment, and safety profiles were also similar between the two groups.
Conclusions
This prospective, randomized, multicenter study indicated that FLV had no add‐on effect when given with SMV/Peg‐IFN/RBV combination therapy for genotype 1b HCV‐infected patients. |
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Bibliography: | This study was supported in part by grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan and the Japan Agency for Medical Research and Development. Professor Naoya Sakamoto received lecture fees from Bristol Myers Squibb and Janssen Pharmaceutical, grants and endowments from MSD and Chugai Pharmaceutical Co., and a research grant from Gilead Sciences. Dr. Goki Suda received research grants from Bristol Myers Squibb. The other authors have no conflict of interest. Conflict of interest Financial support ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 1386-6346 1872-034X |
DOI: | 10.1111/hepr.12938 |