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

Autor: Bing Gao, Tsung-Hui Hu, Steven J. Knox, Jia-Horng Kao, Horng-Yuan Wang, Kimberly L. Garrison, Wan-Long Chuang, Jenny C. Yang, I-Shyan Sheen, Phillip S. Pang, Hongmei Mo, Cheng Yuan Peng, Yu-Chun Hsu, Ting-Tsung Chang, Gin-Ho Lo, Jyh-Jou Chen, Chi-Jen Chu, Rong-Nan Chien
Rok vydání: 2016
Předmět:
Zdroj: Journal of Gastroenterology and Hepatology. 31:1323-1329
ISSN: 0815-9319
DOI: 10.1111/jgh.13305
Popis: 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 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-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 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.
Databáze: OpenAIRE
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