Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan

被引：24

作者：

Toyoda, Hidenori ^{[1
]}

Atsukawa, Masanori ^{[2
]}

Takaguchi, Koichi ^{[3
]}

Senoh, Tomonori ^{[3
]}

Michitaka, Kojiro ^{[4
]}

Hiraoka, Atsushi ^{[4
]}

Fujioka, Shinichi ^{[5
]}

Kondo, Chisa ^{[2
]}

Okubo, Tomomi ^{[6
]}

Uojima, Haruki ^{[7
]}

Tada, Toshifumi ^{[1
]}

Yoneyama, Hirohito ^{[8
]}

Watanabe, Tsunamasa ^{[9
]}

Asano, Toru ^{[10
]}

Ishikawa, Toru ^{[11
]}

Tamai, Hideyuki ^{[12
]}

Abe, Hiroshi ^{[13
]}

Kato, Keizo ^{[13
]}

Tsuji, Kunihiko ^{[14
]}

Ogawa, Chikara ^{[15
]}

Shimada, Noritomo ^{[16
]}

Iio, Etsuko ^{[17
,18
]}

Deguchi, Akihiro ^{[19
]}

Itobayashi, Ei ^{[20
]}

Mikami, Shigeru ^{[21
]}

Moriya, Akio ^{[22
]}

Okubo, Hironao ^{[23
]}

Tani, Joji ^{[24
]}

Tsubota, Akihito ^{[25
]}

Tanaka, Yasuhito ^{[17
,18
]}

Masaki, Tsutomu ^{[8
]}

Iwakiri, Katsuhiko ^{[2
]}

Kumada, Takashi ^{[1
]}

机构：

[1] Ogaki Municipal Hosp, Dept Gastroenterol, 4-86 Minaminokawa, Ogaki, Gifu 5038502, Japan

[2] Nippon Med Sch, Dept Internal Med, Div Gastroenterol & Hepatol, Tokyo, Japan

[3] Kagawa Prefectural Cent Hosp, Dept Hepatol, Takamatsu, Kagawa, Japan

[4] Ehime Prefectural Cent Hosp, Gastroenterol Ctr, Matsuyama, Ehime, Japan

[5] Okayama Saiseikai Gen Hosp, Dept Gastroenterol, Okayama, Japan

[6] Chiba Hokusoh Hosp, Div Gastroenterol, Dept Internal Med, Nippon Med Sch, Inzai, Japan

[7] Kitasato Univ, Sch Med, Dept Gastroenterol, Internal Med, Sagamihara, Kanagawa, Japan

[8] Kagawa Univ, Sch Med, Dept Gastroenterol & Neurol, Kida, Japan

[9] St Marianna Univ, Sch Med, Dept Internal Med, Kawasaki, Kanagawa, Japan

[10] Tokyo Metropolitan Bokutoh Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Tokyo, Japan

[11] Saiseikai Niigata Daini Hosp, Dept Hepatol, Niigata, Japan

[12] Wakayama Rosai Hosp, Dept Hepatol, Wakayama, Japan

[13] Shinmatusdo Cent Gen Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Matsudo, Chiba, Japan

[14] Teine Keijinkai Hosp, Ctr Gastroenterol, Sapporo, Hokkaido, Japan

[15] Takamatsu Red Cross Hosp, Dept Gastroenterol & Hepatol, Takamatsu, Kagawa, Japan

[16] Otakanomori Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Kashiwa, Chiba, Japan

[17] Nagoya City Univ, Grad Sch Med Sci, Dept Virol, Nagoya, Aichi, Japan

[18] Nagoya City Univ, Grad Sch Med Sci, Liver Unit, Nagoya, Aichi, Japan

[19] Kagawa Rosai Hosp, Dept Gastroenterol, Marugame, Japan

[20] Asahi Gen Hosp, Dept Gastroenterol, Asahi, Japan

[21] Kikkoman Gen Hosp, Div Gastroenterol, Dept Internal Med, Noda, Chiba, Japan

[22] Mitoyo Gen Hosp, Dept Gastroenterol, Kannonji, Japan

[23] Juntendo Univ, Dept Gastroenterol, Nerima Hosp, Tokyo, Japan

[24] Yashima Gen Hosp, Dept Internal Med, Takamatsu, Kagawa, Japan

[25] Jikei Univ, Core Res Facil Basic Sci, Sch Med, Tokyo, Japan

来源：

JOURNAL OF GASTROENTEROLOGY | 2018年 / 53卷 / 12期

关键词：

Chronic hepatitis C; Genotype; 1; Elbasvir; Grazoprevir; Efficacy; Safety; Real world; DACLATASVIR PLUS ASUNAPREVIR; ALL-CAUSE MORTALITY; HEPATOCELLULAR-CARCINOMA; INTERFERON THERAPY; HISTOLOGIC IMPROVEMENT; COMBINATION THERAPY; SUSTAINED RESPONSE; FIBROSIS; RISK; DACLATASVIR/ASUNAPREVIR;

D O I：

10.1007/s00535-018-1473-z

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

BackgroundThe real-world virological efficacy and safety of an interferon (IFN)-free direct-acting antiviral (DAA) therapy with elbasvir (EBR) and grazoprevir (GZR) were evaluated in Japanese patients chronically infected with hepatitis C virus (HCV) genotype 1.MethodsThe rate of sustained virologic response (SVR) and safety were analyzed in patients who started the EBR/GZR regimen between November 2016 and July 2017. SVR rates were compared based on patient baseline characteristics.ResultsOverall, 371 of 381 patients (97.4%) achieved SVR. Multivariate analysis identified a history of failure to IFN-free DAA therapy and the presence of double resistance-associated substitutions (RASs) in HCV non-structural protein 5A (NS5A) as factors significantly associated with failure to EBR/GZR treatment. The SVR rates of patients with a history of IFN-free DAA therapy and those with double RASs were 55.6 and 63.6%, respectively. In all other subpopulations, the SVR rates were more than 90%. There were no severe adverse events associated with the treatment.ConclusionsThe EBR/GZR regimen yielded high virological efficacy with acceptable safety. Patients with a history of failure to IFN-free DAA therapy or with double RASs in HCV-NS5A remained difficult to treat with this regimen.

引用

页码：1276 / 1284

页数：9

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