—Alan Franciscus, Editor-in-Chief
The abstract below (revised text) is from a study conducted in Japan
that treated HCV genotype 2 patients with sofosbuvir plus ribavirin.
The viral cure rates achieved were 94 to 98% among all of the patients
regardless of pre-existing negative predictors (treatment experienced,
cirrhotic, ≥ 65yo) of treatment response. The side effects were
minimal with no treatment discontinuations. AF.
Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open-label, phase 3 trial.
Omata et al.
J Viral Hepat. 2014 Sep 8. doi: 10.1111/jvh.12312. [Epub ahead of print]
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
Of the 153 patients enrolled and treated, 60% had
HCV genotype 2a, 11% had cirrhosis, and 22% were over the aged 65 or
older. The results are listed below:
- Overall, 148 patients (97%) achieved SVR12.
- 90 treatment-naïve patients, 88 (98%) achieved SVR12, and
- 63 previously treated patients, 60 (95%) achieved SVR12.
- 94% in patients with cirrhosis and in those aged 65 and older achieved SVR.
- No patients discontinued study treatment due to
adverse events. The most common adverse events were nasopharyngitis
(sore throat, runny nose, nasal congestion, sneezing), anemia and
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.
© 2014 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd.Share This Page