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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* Drug interaction
In a report, 2 patients were described, of whom, a 42-year-old woman developed acquired resistance following concomitant administration of cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide and calcium carbonate, and a 35-year-old woman developed acquired resistance following treatment with efavirenz/emtricitabine/tenofovir disoproxil fumarate and following concomitant administration of cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide and folinic acid. Additionally, the 35-year-old woman developed fever, transaminase elevation and diffuse morbilliform rash during treatment with clindamycin [not all routes stated; durations of treatments to reactions onsets not stated].
Case 1: The 42-year-old woman, who was diagnosed with cerebral...
- Kang-Birken SL, et al. HIV Viral Rebound Due to a Possible Drug-Drug Interaction between Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide and Calcium-Containing Products: Report of 2 Cases. Journal of the International Association of Providers of AIDS Care 18: 7 Jan 2019. Available from: URL: https://doi.org/10.1177/2325958218821653 - USA