A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus

• Published in: Hepatology international 2016-11, Vol.10 (6), p.947-955
• Main Authors: Lim, Young-Suk, Ahn, Sang Hoon, Lee, Kwan Sik, Paik, Seung Woon, Lee, Youn-Jae, Jeong, Sook-Hyang, Kim, Ju-Hyun, Yoon, Seung Kew, Yim, Hyung Joon, Tak, Won Young, Han, Sang-Young, Yang, Jenny C., Mo, Hongmei, Garrison, Kimberly L., Gao, Bing, Knox, Steven J., Pang, Phillip S., Kim, Yoon Jun, Byun, Kwan-Soo, Kim, Young Seok, Heo, Jeong, Han, Kwang-Hyub
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; Colorectal Surgery; Drug Administration Schedule; Female; Fluorenes - administration & dosage; Fluorenes - adverse effects; Genotype; Hepacivirus - genetics; Hepatitis C virus; Hepatitis C, Chronic - drug therapy; Hepatology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Original Article; Republic of Korea; Surgery; Sustained Virologic Response; Tablets; Treatment Outcome; Uridine Monophosphate - administration & dosage; Uridine Monophosphate - adverse effects; Uridine Monophosphate - analogs & derivatives; Young Adult
• ISSN: 1936-0533; 1936-0541
• DOI: 10.1007/s12072-016-9726-5

Background The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection. Methods This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis. Results The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-naïve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment. Conclusions These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.