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Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection
Author(s) -
Kumada Hiromitsu,
Suzuki Yoshiyuki,
Ikeda Kenji,
Toyota Joji,
Karino Yoshiyasu,
Chayama Kazuaki,
Kawakami Yoshiiku,
Ido Akio,
Yamamoto Kazuhide,
Takaguchi Koichi,
Izumi Namiki,
Koike Kazuhiko,
Takehara Tetsuo,
Kawada Norifumi,
Sata Michio,
Miyagoshi Hidetaka,
Eley Timothy,
McPhee Fiona,
Damokosh Andrew,
Ishikawa Hiroki,
Hughes Eric
Publication year - 2014
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.27113
Subject(s) - daclatasvir , medicine , ribavirin , adverse effect , hepatology , gastroenterology , interferon , sofosbuvir , hepatitis c virus , virology , virus
All‐oral combinations of direct‐acting antivirals may improve efficacy and safety outcomes for patients with hepatitis C virus (HCV) infection, particularly those who are poor candidates for current interferon/ribavirin‐based regimens. In this open‐label, phase 3 study, 135 interferon‐ineligible/intolerant and 87 nonresponder patients with chronic HCV genotype 1b infection were enrolled at 24 centers in Japan. Patients received daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily for 24 weeks. The primary endpoint was sustained virologic response 24 weeks after treatment (SVR 24 ). This study is registered with ClinicalTrials.gov (NCT01497834). SVR 24 was achieved by 87.4% of interferon‐ineligible/intolerant patients and 80.5% of nonresponder (null and partial) patients; rates were similar in cirrhosis (90.9%) and noncirrhosis (84.0%) patients, and in patients with IL28B CC (84.5%) or non‐CC (84.8%) genotypes. Fourteen patients in each group (12.6%) discontinued dual therapy, mainly due to adverse events or lack of efficacy. Nine nonresponder patients received additional treatment with peginterferon/ribavirin per protocol‐defined criteria. The rate of serious adverse events was low (5.9%) and varied among patients. The most common adverse events were nasopharyngitis, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST), headache, diarrhea, and pyrexia. Conclusion : Interferon‐free, ribavirin‐free all‐oral therapy with daclatasvir and asunaprevir for 24 weeks is well tolerated and can achieve a high rate of SVR in patients with HCV genotype 1b who were ineligible, intolerant, or had not responded to prior interferon‐based therapy. (H epatology 2014;59:2083–2091)