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- Title
Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus.
- Authors
Chuang, Wan‐Long; Chien, Rong‐Nan; Peng, Cheng‐Yuan; Chang, Ting‐Tsung; Lo, Gin‐Ho; Sheen, I‐Shyan; Wang, Horng‐Yuan; Chen, Jyh‐Jou; Yang, Jenny C.; Knox, Steven J.; Gao, Bing; Garrison, Kimberly L.; Mo, Hongmei; Pang, Phillip S.; Hsu, Yu‐Chun; Hu, Tsung‐Hui; Chu, Chi‐Jen; Kao, Jia‐Horng
- Abstract
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-naïve; n = 43, treatment-experienced) with chronic genotype 1 HCV infection (±compensated cirrhosis) received 12 weeks of ledipasvir/sofosbuvir fixed-dose combination tablet. The primary efficacy end point was the proportion of patients with sustained virologic response 12 weeks 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-naïve 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 12 weeks 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.
- Subjects
FLAVIVIRAL diseases; HEPATITIS C; INFLAMMATION; GENOMES; LIVER diseases
- Publication
Journal of Gastroenterology & Hepatology, 2016, Vol 31, Issue 7, p1323
- ISSN
0815-9319
- Publication type
Article
- DOI
10.1111/jgh.13305