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 language | English |
|---|---|
| Pages (from-to) | 762-768 |
| Number of pages | 7 |
| Journal | Journal of Viral Hepatitis |
| Volume | 21 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - Nov 1 2014 |
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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 journal › Article
}
TY - JOUR
T1 - Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection
T2 - An open-label, phase 3 trial
AU - Omata, Masao
AU - Nishiguchi, Shuhei
AU - Ueno, Yoshiyuki
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
AU - Toda, Nobuo
AU - Ide, Tatsuya
AU - Yanase, Mikio
AU - Hino, Keisuke
AU - Gao, Bing
AU - Garrison, Kimberly L.
AU - Dvory-Sobol, Hadas
AU - Ishizaki, Akinobu
AU - Omote, Masa
AU - Brainard, Diana
AU - Knox, Steven
AU - Symonds, William T.
AU - McHutchison, John G.
AU - Yatsuhashi, Hiroshi
AU - Mizokami, Masashi
PY - 2014/11/1
Y1 - 2014/11/1
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.
AB - 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.
KW - direct-acting antiviral agents
KW - HCV genotype 2
KW - Hepatitis C virus
KW - nucleotide polymerase inhibitor
UR - http://www.scopus.com/inward/record.url?scp=84907997463&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84907997463&partnerID=8YFLogxK
U2 - 10.1111/jvh.12312
DO - 10.1111/jvh.12312
M3 - Article
VL - 21
SP - 762
EP - 768
JO - Journal of Viral Hepatitis
JF - Journal of Viral Hepatitis
SN - 1352-0504
IS - 11
ER -