title: Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open-label, phase 3 trial.
abstract: Genotype 2 hepatitis C virus (HCV) accounts for up to 30% of chronic HCV infections in Japan. The standard of care for patients with genotype 2 HCV - peginterferon and ribavirin for 24 weeks - is poorly tolerated, especially among older patients and those with advanced liver disease. We conducted a phase 3, open-label study to assess the efficacy and safety of an all-oral combination of the NS5B polymerase inhibitor sofosbuvir and ribavirin in patients with chronic genotype 2 HCV infection in Japan. We enrolled 90 treatment-naïve and 63 previously treated patients at 20 sites in Japan. All patients received sofosbuvir 400 mg plus ribavirin (weight-based dosing) for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after therapy (SVR12). Of the 153 patients enrolled and treated, 60% had HCV genotype 2a, 11% had cirrhosis, and 22% were over the aged 65 or older. Overall, 148 patients (97%) achieved SVR12. Of the 90 treatment-naïve patients, 88 (98%) achieved SVR12, and of the 63 previously treated patients, 60 (95%) achieved SVR12. The rate of SVR12 was 94% in patients with cirrhosis and in those aged 65 and older. No patients discontinued study treatment due to adverse events. The most common adverse events were nasopharyngitis, anaemia and headache. Twelve weeks of sofosbuvir and ribavirin resulted in high rates of SVR12 in treatment-naïve and previously treated patients with chronic genotype 2 HCV infection. The treatment was safe and well tolerated by patients, including the elderly and those with cirrhosis.
authors.affiliation: Yamanashi Prefectural Hospital Organization, Yamanashi, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.forename: Shuhei
authors.initials: S
authors.lastname: Nishiguchi
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Ueno
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Mochizuki
authors.forename: Namiki
authors.initials: N
authors.lastname: Izumi
authors.forename: Fusao
authors.initials: F
authors.lastname: Ikeda
authors.forename: Hidenori
authors.initials: H
authors.lastname: Toyoda
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokosuka
authors.forename: Kazushige
authors.initials: K
authors.lastname: Nirei
authors.forename: Takuya
authors.initials: T
authors.lastname: Genda
authors.forename: Takeji
authors.initials: T
authors.lastname: Umemura
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Takehara
authors.forename: Naoya
authors.initials: N
authors.lastname: Sakamoto
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Nishigaki
authors.forename: Kunio
authors.initials: K
authors.lastname: Nakane
authors.forename: Nobuo
authors.initials: N
authors.lastname: Toda
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ide
authors.forename: Mikio
authors.initials: M
authors.lastname: Yanase
authors.forename: Keisuke
authors.initials: K
authors.lastname: Hino
authors.forename: Bing
authors.initials: B
authors.lastname: Gao
authors.forename: Kimberly L
authors.initials: KL
authors.lastname: Garrison
authors.forename: Hadas
authors.initials: H
authors.lastname: Dvory-Sobol
authors.forename: Akinobu
authors.initials: A
authors.lastname: Ishizaki
authors.forename: Masa
authors.initials: M
authors.lastname: Omote
authors.forename: Diana
authors.initials: D
authors.lastname: Brainard
authors.forename: Steven
authors.initials: S
authors.lastname: Knox
authors.forename: William T
authors.initials: WT
authors.lastname: Symonds
authors.forename: John G
authors.initials: JG
authors.lastname: McHutchison
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yatsuhashi
authors.forename: Masashi
authors.initials: M
authors.lastname: Mizokami
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; 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* / Q000821:virology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D000069474:Sofosbuvir; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D012254:Ribavirin; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: HCV genotype 2; Hepatitis C virus; direct-acting antiviral agents; nucleotide polymerase inhibitor