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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
An open label, multi-centre retrospective study of 103 patients, who were switched from tenofovir to entecavir between March 2008−October 2015 due to kidney dysfunction, described four men and a woman (aged 58−71 years), who developed kidney dysfunction during treatment with tenofovir disoproxil fumarate, and further developed resistance to entecavir while being treated for hepatitis-B [routes and outcomes not stated; not all durations of treatments to reactions onsets stated].
A 67-year-old man, who had chronic hepatitis-B infection, and who was resistant to lamivudine, had been receiving tenofovir disoproxil fumarate at 245 mg/72hrs. He subsequently developed kidney dysfunction, which was suspected to be drug-induced. Therefore, his antiviral therapy was switched to entecavir....
- Vigano M, et al. Effectiveness and safety of switching to entecavir hepatitis B patients developing kidney dysfunction during tenofovir. Liver International 39: 484-493, No. 3, Mar 2019. Available from: URL: http://doi.org/10.1111/liv.14017 - Italy