Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection

An open-label, phase 3 trial

Masao Omata, Shuhei Nishiguchi, Yoshiyuki Ueno, Hitoshi Mochizuki, Namiki Izumi, Fusao Ikeda, Hidenori Toyoda, Osamu Yokosuka, Kazushige Nirei, Takuya Genda, Takeji Umemura, Tetsuo Takehara, Naoya Sakamoto, Yoichi Nishigaki, Kunio Nakane, Nobuo Toda, Tatsuya Ide, Mikio Yanase, Keisuke Hino, Bing Gao & 10 others Kimberly L. Garrison, Hadas Dvory-Sobol, Akinobu Ishizaki, Masa Omote, Diana Brainard, Steven Knox, William T. Symonds, John G. McHutchison, Hiroshi Yatsuhashi, Masashi Mizokami

Research output: Contribution to journalArticle

126 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)762-768
Number of pages7
JournalJournal of Viral Hepatitis
Volume21
Issue number11
DOIs
Publication statusPublished - Nov 1 2014

Fingerprint

Ribavirin
Virus Diseases
Hepacivirus
Genotype
Japan
Fibrosis
Sofosbuvir
Nasopharyngitis
Therapeutics
Chronic Hepatitis C
Standard of Care
Headache
Liver Diseases
Anemia

Keywords

  • direct-acting antiviral agents
  • HCV genotype 2
  • Hepatitis C virus
  • nucleotide polymerase inhibitor

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology
  • Medicine(all)

Cite this

Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection : An open-label, phase 3 trial. / Omata, Masao; Nishiguchi, Shuhei; Ueno, Yoshiyuki; Mochizuki, Hitoshi; Izumi, Namiki; Ikeda, Fusao; Toyoda, Hidenori; Yokosuka, Osamu; Nirei, Kazushige; Genda, Takuya; Umemura, Takeji; Takehara, Tetsuo; Sakamoto, Naoya; Nishigaki, Yoichi; Nakane, Kunio; Toda, Nobuo; Ide, Tatsuya; Yanase, Mikio; Hino, Keisuke; Gao, Bing; Garrison, Kimberly L.; Dvory-Sobol, Hadas; Ishizaki, Akinobu; Omote, Masa; Brainard, Diana; Knox, Steven; Symonds, William T.; McHutchison, John G.; Yatsuhashi, Hiroshi; Mizokami, Masashi.

In: Journal of Viral Hepatitis, Vol. 21, No. 11, 01.11.2014, p. 762-768.

Research output: Contribution to journalArticle

Omata, M, Nishiguchi, S, Ueno, Y, Mochizuki, H, Izumi, N, Ikeda, F, Toyoda, H, Yokosuka, O, Nirei, K, Genda, T, Umemura, T, Takehara, T, Sakamoto, N, Nishigaki, Y, Nakane, K, Toda, N, Ide, T, Yanase, M, Hino, K, Gao, B, Garrison, KL, Dvory-Sobol, H, Ishizaki, A, Omote, M, Brainard, D, Knox, S, Symonds, WT, McHutchison, JG, Yatsuhashi, H & Mizokami, M 2014, 'Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: An open-label, phase 3 trial', Journal of Viral Hepatitis, vol. 21, no. 11, pp. 762-768. https://doi.org/10.1111/jvh.12312
Omata, Masao ; Nishiguchi, Shuhei ; Ueno, Yoshiyuki ; Mochizuki, Hitoshi ; Izumi, Namiki ; Ikeda, Fusao ; Toyoda, Hidenori ; Yokosuka, Osamu ; Nirei, Kazushige ; Genda, Takuya ; Umemura, Takeji ; Takehara, Tetsuo ; Sakamoto, Naoya ; Nishigaki, Yoichi ; Nakane, Kunio ; Toda, Nobuo ; Ide, Tatsuya ; Yanase, Mikio ; Hino, Keisuke ; Gao, Bing ; Garrison, Kimberly L. ; Dvory-Sobol, Hadas ; Ishizaki, Akinobu ; Omote, Masa ; Brainard, Diana ; Knox, Steven ; Symonds, William T. ; McHutchison, John G. ; Yatsuhashi, Hiroshi ; Mizokami, Masashi. / Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection : An open-label, phase 3 trial. In: Journal of Viral Hepatitis. 2014 ; Vol. 21, No. 11. pp. 762-768.
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AU - Mochizuki, Hitoshi

AU - Izumi, Namiki

AU - Ikeda, Fusao

AU - Toyoda, Hidenori

AU - Yokosuka, Osamu

AU - Nirei, Kazushige

AU - Genda, Takuya

AU - Umemura, Takeji

AU - Takehara, Tetsuo

AU - Sakamoto, Naoya

AU - Nishigaki, Yoichi

AU - Nakane, Kunio

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AU - Ide, Tatsuya

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AU - Brainard, Diana

AU - Knox, Steven

AU - Symonds, William T.

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AU - Yatsuhashi, Hiroshi

AU - Mizokami, Masashi

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N2 - 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.

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