Young-Suk Lim1, Sang Hoon Ahn2, Kwan Sik Lee3, Seung Woon Paik4, Youn-Jae Lee5, Sook-Hyang Jeong6, Ju-Hyun Kim7, Seung Kew Yoon8, Hyung Joon Yim9, Won Young Tak10, Sang-Young Han11, Jenny C Yang12, Hongmei Mo12, Kimberly L Garrison12, Bing Gao12, Steven J Knox12, Phillip S Pang12, Yoon Jun Kim13, Kwan-Soo Byun14, Young Seok Kim15, Jeong Heo16, Kwang-Hyub Han17. 1. Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 2. Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. 3. Department of Gastroenterology and Hepatology, Gangnam Severance Hospital, Yonsei University Health System, Seoul, South Korea. 4. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. 5. Department of Infectious Diseases, Gastroenterology, and Hepatology, Inje University, Pusan Paik Hospital, Busan, South Korea. 6. Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea. 7. Department of Internal Medicine, Gachon University Gil Hospital, Incheon, South Korea. 8. Department of Gastroenterology, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea. 9. Department of Internal Medicine, Korea University Ansan Hospital, Ansan-si, Gyeonggi-do, South Korea. 10. Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, South Korea. 11. Department of Internal Medicine, Dong-A University Medical Center, Busan, South Korea. 12. Gilead Sciences, Inc, Foster City, CA, USA. 13. Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine and Liver Research Institute, Seoul, South Korea. 14. Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea. 15. Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea. 16. Department of Internal Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, South Korea. 17. Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. gihankhys@yuhs.ac.
Abstract
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.
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.
Entities:
Keywords:
Genotype 1; Hepatitis C virus (HCV); Korea; Ledipasvir; Sofosbuvir
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