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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 comprehensive analysis consisting of 12012 patients, 11 patients were described, who developed sofosbuvir or sofosbuvir/ledipasvir resistance leading to virological failure following treatment for hepatitis C virus (HCV) infection [age and sex not stated for all; routes and dosages not stated].
Patient 1: A 52-year-old woman developed sofosbuvir resistance leading to virologic failure following treatment for HCV infection. The woman, who had HCV genotype 2b infection, received treatment with sofosbuvir for 12 weeks. At 4 weeks post-treatment, her HCV relapsed. S282T was detected at a frequency of >99%. The frequency of S282T rapidly decreased to 27.6% at week 8 and <1% at week 12 post-treatment. She was retreated with sofosbuvir and ribavirin for 12 weeks. Twelve weeks...
- Gane EJ, et al. The emergence of NS5B resistance associated substitution S282T after sofosbuvir-based treatment. Hepatology Communications 1: 538-549, No. 6, Aug 2017. Available from: URL: http://doi.org/10.1002/hep4.1060 - New Zealand