Abstract
Background: Egypt has the largest hepatitis C virus (HCV) epidemic worldwide. Sofosbuvir is an antiviral drug acting by inhibition of the HCV NS5B polymerase. It has shown high efficacy in combination with several other drugs and has a low reported rate of side effects. Objective: The aim of this prospective cohort study was to assess the safety of sofosbuvir-based treatment regimens used to treat chronic hepatitis C infections and to detect any side effects of sofosbuvir not previously reported. Methods: We studied treatment side effects in 3,000 patients with chronic HCV infection treated with sofosbuvir and ribavirin for 24 weeks or treated by pegylated interferon, sofosbuvir, and ribavirin triple therapy for 12 weeks. The endpoint of the study was the end of treatment. Results: Hyperbilirubinemia occurred frequently during treatment in both groups. Treatment was discontinued in 72 cases due to hepatic decompensation and drug complications; 8 of the cases had deep vein thrombosis (DVT) and 7 had cerebral ischemia. Surprisingly, 177/3,000 (5.9%) patients presented with abnormal bleeding, 85 of whom had a vasculitic skin rash. Conclusion: We report the occurrence of previously nonrecorded side effects with sofosbuvir, namely D...Continue Reading
References
Aug 1, 1973·The British Journal of Surgery·R N PughR Williams
Aug 1, 1981·Clinical Pharmacology and Therapeutics·C A NaranjoD J Greenblatt
Feb 1, 1994·Arthritis and Rheumatism·J T Lie
Aug 1, 1996·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·P Bedossa, T Poynard
Oct 19, 1999·Arthritis and Rheumatism·P CacoubP Opolon
Feb 24, 2000·The Journal of Pathology·L Harper, C O Savage
Apr 13, 2001·Internal Medicine·T FujiwaraM Harada
Sep 25, 2001·The British Journal of Ophthalmology·K JainJ Heathcote
Oct 5, 2001·Lancet·M P MannsJ K Albrecht
Aug 15, 2006·Gut·M P MannsM Cornberg
Dec 16, 2006·Current Medicinal Chemistry·Stefan RussmannGiuseppe Palasciano
May 3, 2007·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Feng YuHai-Yan Wang
Aug 5, 2008·Rheumatology·Y GaoM-H Zhao
Dec 18, 2009·Liver International : Official Journal of the International Association for the Study of the Liver·Nabil AntakiPatrick Marcellin
Nov 26, 2010·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·D Lavanchy
Mar 5, 2011·Journal of Hepatology·UNKNOWN European Association for the Study of the Liver
Jun 18, 2011·Liver International : Official Journal of the International Association for the Study of the Liver·William SievertFrancesco Negro
Jun 24, 2011·The New England Journal of Medicine·Stefan ZeuzemUNKNOWN REALIZE Study Team
Apr 24, 2013·The New England Journal of Medicine·Eric LawitzEdward J Gane
May 14, 2014·Journal of Hepatology
Nov 26, 2014·Journal of Pharmacology & Pharmacotherapeutics·Harmeet Kaur BhatiaNavreet Kaur Natt
Apr 26, 2015·Journal of Hepatology·UNKNOWN European Association for Study of Liver
May 6, 2015·Journal of Hepatology·Wahid DossGamal Esmat
Nov 23, 2016·World Journal of Nephrology·Shilpa GaddeRubin Zhang