- 42 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:Drug interaction
* congenital anomaly
* other medically important event
A 66-year-old woman developed rhabdomyolysis and myositis following concomitant administration of ledipasvir/sofosbuvir, atorvastatin and colchicine. Additionally, atorvastatin and colchicine individually contributed to the occurrence of myositis [routes not stated].
The woman had a history of stage III chronic kidney disease (CKD) related to hypertensive nephropathy, coronary artery disease, gout, chronic hepatitis C virus (HCV) infection and compensated liver cirrhosis. She started receiving ledipasvir/sofosbuvir (sofosbuvir/ledipasvir) 90/400mg tablet along with ribavirin 200mg twice daily for 12 weeks for HCV infection. Her baseline laboratory data 2 weeks prior to the treatment initiation was unremarkable. She had been receiving colchicine 0.6mg and...
- Patel S, et al. An unexpected interaction between sofosbuvir/ledipasvir and atorvastatin and colchicine causing rhabdomyolysis in a patient with impaired renal function. Case Reports in Medicine 2016: 3191089, Jan 2016. Available from: URL: http://doi.org/10.1155/2016/3191089 - USA