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The efficacy and safety of dual oral therapy with daclatasvir and asunaprevir for genotype 1b in Japanese real‐life settings
Author(s) -
Sezaki Hitomi,
Suzuki Fumitaka,
Hosaka Tetsuya,
Akuta Norio,
Fujiyama Shunichiro,
Kawamura Yusuke,
Kobayashi Masahiro,
Suzuki Yoshiyuki,
Saitoh Satoshi,
Arase Yasuji,
Ikeda Kenji,
Kobayashi Mariko,
Kumada Hiromitsu
Publication year - 2017
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.13384
Subject(s) - daclatasvir , medicine , discontinuation , adverse effect , gastroenterology , hepatitis c virus , immunology , virus , ribavirin
Background & Aims It is important to investigate the treatment outcomes in patients excluded from clinical trials ( CTR ). The aims of this study were to evaluate the efficacy and safety of a 24‐week daclatasvir ( DCV ) and asunaprevir ( ASV ) therapy for patients with chronic hepatitis C virus ( HCV )‐1b infection. Methods A total of 651 HCV ‐1b patients started dual oral therapy with DCV and ASV for 24 weeks in Toranomon Hospital, Tokyo. Among them, 276 patients met phase III CTR inclusion criteria. The sustained virological response ( SVR ) rate after treatment and the adverse events during therapy were compared between CTR ‐met (patients who met the inclusion criteria) and CTR ‐unmet (patients who did not meet the inclusion criteria) groups. Results SVR 12 was achieved in 87.0% (240/276) and 86.7% (325/375) in CTR ‐met and CTR‐unmet patients respectively. SVR 12 rate in simeprevir‐experienced patients was 52.9% (9/17). SVR 12 rate in patients without resistance‐associated variant ( RAV ) of NS 3 or NS 5A loci was 93.7% (416/444). However, the SVR 12 rates in patients with NS 3‐D168, NS 5A‐L31 and Y93 single RAV at baseline were 55.0% (11/20), 73.9% (17/23) and 65.6% (63/96) respectively. The safety profiles in both CTR ‐met and CTR‐unmet patients were similar. The discontinuation rate as a result of alanine aminotransferase ( ALT ) elevation was only 2.9%. Seven (2.5%) patients in CTR ‐met group and 20 (5.3%) in CTR ‐unmet group discontinued therapy because of adverse events other than the ALT elevation. Conclusions Dual oral therapy with DCV and ASV in real‐life settings was well tolerated with a similar safety profile and achieved similar SVR 12 rates as that of CTR .