title: A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus.
abstract: In Korea, patients with chronic hepatitis C virus (HCV) infection are typically treated with pegylated interferon-alpha plus ribavirin, but interferons are contraindicated in many patients and are often poorly tolerated, particularly by the elderly and those with advanced liver disease. No interferon-free treatment regimens are approved in Korea. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV nonstructural 5B RNA polymerase. It is approved in the USA, European Union and Japan for treating a number of HCV genotypes, including genotype 2. Genotype 2 has a seroprevalence of 38-46% in Korea. This single-arm, phase 3b study (NCT02021643) examined the efficacy and safety of sofosbuvir plus ribavirin (12-week duration) in chronic genotype 2 HCV-infected treatment-naive and treatment-experienced Korean patients with and without cirrhosis. The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 97% (125/129), with 96% (101/105) of treatment-naive and 100% (24/24) of treatment-experienced patients achieving SVR12. Two patients experienced virologic failure (n = 1, on-treatment failure; n = 1, relapse). No patient discontinued study treatment due to an adverse event (AE). The most common treatment-emergent AEs were headache (18%, 23/129) and pruritus (15%, 19/129). Few patients had grade 3 AEs (5%, 6/129) or grade 3 laboratory abnormalities (12%, 15/129). No grade 4 AE was reported. These data suggest that 12 weeks of treatment with the all-oral, interferon-free regimen of sofosbuvir plus ribavirin is effective and well tolerated in Korean patients with chronic genotype 2 HCV infection.
authors: Yonsei University College of Medicine, Seoul-Korea, South Korea.
authors: S H
authors: SH
authors: Ahn
authors: Asan Medical Center, University of Ulsan College of Medicine, Seoul-Korea, South Korea.
authors: Y S
authors: YS
authors: Lim
authors: Gangnam Severance Hospital, Yonsei University Health System, Seoul-Korea, South Korea.
authors: K S
authors: KS
authors: Lee
authors: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul-Korea, South Korea.
authors: S W
authors: SW
authors: Paik
authors: Pusan Paik Hospital, Inje University, Busan-Korea, South Korea.
authors: Y J
authors: YJ
authors: Lee
authors: Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-Korea, South Korea.
authors: S H
authors: SH
authors: Jeong
authors: Gachon University Gil Hospital, Incheon-Korea, South Korea.
authors: J H
authors: JH
authors: Kim
authors: Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul-Korea, South Korea.
authors: S K
authors: SK
authors: Yoon
authors: Korea University Ansan Hospital, Ansan-si, Gyeonggi-do-Korea, South Korea.
authors: H J
authors: HJ
authors: Yim
authors: Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, South Korea.
authors: W Y
authors: WY
authors: Tak
authors: Dong-A University Medical Center, Busan-Korea, South Korea.
authors: S Y
authors: SY
authors: Han
authors: Gilead Sciences Inc., Foster City, CA, USA.
authors: J C
authors: JC
authors: Yang
authors: Gilead Sciences Inc., Foster City, CA, USA.
authors: H
authors: H
authors: Mo
authors: Gilead Sciences Inc., Foster City, CA, USA.
authors: A
authors: A
authors: Mathias
authors: Gilead Sciences Inc., Foster City, CA, USA.
authors: L
authors: L
authors: Han
authors: Gilead Sciences Inc., Foster City, CA, USA.
authors: S J
authors: SJ
authors: Knox
authors: Gilead Sciences Inc., Foster City, CA, USA.
authors: D M
authors: DM
authors: Brainard
authors: Seoul National University Hospital, Seoul National University College of Medicine and Liver Research Institute, Seoul, Korea.
authors: Y J
authors: YJ
authors: Kim
authors: Korea University Guro Hospital, Seoul-Korea, South Korea.
authors: K S
authors: KS
authors: Byun
authors: Soonchunhyang University Bucheon Hospital, Bucheon-Korea, South Korea.
authors: Y S
authors: YS
authors: Kim
authors: Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, Korea.
authors: J
authors: J
authors: Heo
authors: Yonsei University College of Medicine, Seoul-Korea, South Korea.
authors: K H
authors: KH
authors: Han
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: Korea; hepatitis C virus (HCV); phase 3; ribavirin; sofosbuvir