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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 case series, two male patients, aged 65 and 56 years respectively were described, who developed grade III hepatocellular carcinoma (HCC) during treatment with daclatasvir, ombitasvir, paritaprevir, ribavirin, ritonavir, simeprevir or sofosbuvir [not all dosages stated] for hepatitis-C virus infection.
Case 1: A 65-year-old man, who had been diagnosed with hepatitis-C virus infection (HCV), started receiving oral antiviral therapy with ritonavir (50mg), ribavirin, paritaprevir (75mg) and ombitasvir (12.5mg) in August 2015 for 3 months. However, HCV relapsed 6 months later. Subsequently, he started therapy with ribavirin, daclatasvir (60mg) and sofosbuvir (400mg) in October 2016 for 6 months, but HCV relapsed again. In 2017, he started receiving ribavirin, simeprevir (150mg)...
- Wahab MA, et al. Hepatic resection for two giant hepatocellular carcinoma after oral direct-acting antiviral therapy: Is there a relationship?. Journal of Solid Tumors 8: 32-38, No. 2, Jan 2018. Available from: URL: http://doi.org/10.5430/jst.v8n2p32 - Egypt