Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus

被引：26

作者：

Chuang, Wan-Long ^{[1
]}

Chien, Rong-Nan ^{[4
]}

Peng, Cheng-Yuan ^{[5
]}

Chang, Ting-Tsung ^{[6
]}

Lo, Gin-Ho ^{[2
]}

Sheen, I-Shyan ^{[8
,9
]}

Wang, Horng-Yuan ^{[10
]}

Chen, Jyh-Jou ^{[7
]}

Yang, Jenny C. ^{[15
]}

Knox, Steven J. ^{[15
]}

Gao, Bing ^{[15
]}

Garrison, Kimberly L. ^{[15
]}

Mo, Hongmei ^{[15
]}

Pang, Phillip S. ^{[15
]}

Hsu, Yu-Chun ^{[14
]}

Hu, Tsung-Hui ^{[3
]}

Chu, Chi-Jen ^{[11
,12
]}

Kao, Jia-Horng ^{[13
]}

机构：

[1] Kaohsiung Med Univ Hosp, Kaohsiung Med Univ, Kaohsiung, Taiwan

[2] E Da Hosp, Dept Med, Kaohsiung, Taiwan

[3] Chang Gung Med Fdn, Kaohsiung, Taiwan

[4] Chang Gung Mem Hosp Keelung, Liver Res Unit, Keelung, Taiwan

[5] China Med Univ, Sch Med, Dept Internal Med, Taichung, Taiwan

[6] Natl Cheng Kung Univ Hosp, Dept Internal Med, Tainan, Taiwan

[7] Chi Mei Hosp, Dept Internal Med, Tainan, Taiwan

[8] Chang Gung Univ, Chang Gung Mem Hosp, Taoyuan, Taiwan

[9] Chang Gung Univ, Coll Med, Taoyuan, Taiwan

[10] Mackay Mem Hosp, Dept Internal Med, Taipei, Taiwan

[11] Taipei Vet Gen Hosp, Dept Med, Taipei, Taiwan

[12] Natl Yang Ming Univ, Sch Med, Taipei, Taiwan

[13] Natl Taiwan Univ, Coll Med & Hosp, Taipei, Taiwan

[14] Changhua Christian Hosp, Dept Gastroenterol, Changhua, Taiwan

[15] Gilead Sci Inc, 353 Lakeside Dr, Foster City, CA 94404 USA

来源：

JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY | 2016年 / 31卷 / 07期

关键词：

hepatitis C virus (HCV); infection; ledipasvir; sofosbuvir; Taiwan; ALPHA-2A PLUS RIBAVIRIN; VIROLOGICAL RESPONSE; HEPATOCELLULAR-CARCINOMA; TREATMENT DURATION; RANDOMIZED-TRIAL; TREATMENT-NAIVE; CHRONIC HCV; INFECTION; LEDIPASVIR; SOFOSBUVIR;

D O I：

10.1111/jgh.13305

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background and Aim:Pegylated-interferon-alpha plus ribavirin is the current standard-of-care regimen for treating chronic hepatitis C virus (HCV) infection in Taiwan; however, interferon-based regimens can be poorly tolerated. The interferon-free, two-drug, fixed-dose combination tablet ledipasvir/sofosbuvir is approved in Europe, the USA, and Japan for treating chronic genotype 1 HCV infection. Little is known about its efficacy/safety in Taiwanese patients. Methods:In this multicenter, open-label, phase 3b (NCT02021656) study, 85 Taiwanese patients (n=42, treatment-naive; n=43, treatment-experienced) with chronic genotype 1 HCV infection (compensated cirrhosis) received 12weeks of ledipasvir/sofosbuvir fixed-dose combination tablet. The primary efficacy end point was the proportion of patients with sustained virologic response 12weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were collected. Results:The overall SVR12 rate was 98% (83/85), with 100% (42/42) and 95% (41/43) of treatment-naive and treatment-experienced patients, respectively, achieving SVR12. There were no on-treatment virologic failures. One patient relapsed after treatment discontinuation; one patient withdrew consent on day 2. The most common treatment-emergent adverse event (AE) was headache (14%, 12/85). There was one grade 3 AE (small cell lung cancer unrelated to ledipasvir/sofosbuvir), no grade 4 AEs, and four grade 3-4 laboratory abnormalities. Only the patient with small cell lung cancer prematurely discontinued treatment. Two patients reported three serious AEs; none was considered related to ledipasvir/sofosbuvir. Conclusions:Data from this phase 3b study suggest that 12weeks of once-daily treatment with the interferon-free, ribavirin-free regimen ledipasvir/sofosbuvir is effective and well-tolerated in Taiwanese patients with chronic genotype 1 HCV infection, irrespective of treatment history.

引用

页码：1323 / 1329

页数：7

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