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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective cohort study, consisting of 183 patients who were enrolled for treatment with sofosbuvir-based regimen for chronic hepatitis C virus (HCV) infection at Kyushu University Hospital between June 2015 and March 2016, four patients (three men and one woman) aged 60−69 years, were described who exhibited appearance of detectable residual Hepatitis B virus (HBV) DNA or HBV reactivation following treatment with sofosbuvir for HCV infection [dosages not stated].
A 60-year-old man exhibited appearance of detectable residual HBV DNA following treatment with sofosbuvir for HCV infection. The man presented with HCV genotype 2b infection and cirrhosis. His medical history was significant for previously resolved HBV infection with negative hepatitis B surface antigen...
- Ogawa E, et al. Potential risk of HBV reactivation in patients with resolved HBV infection undergoing direct-acting antiviral treatment for HCV. Liver International 38: 76-83, No. 1, Jan 2018. Available from: URL: http://doi.org/10.1111/liv.13496 - Japan