The use of generics to treat chronic hepatitis C: not quite ready for the big stage.
Recently developed direct acting antivirals have been highly effective in treating patients with chronic hepatitis C infection. Due to their expense, there has been development of generic formulations of these medications in many countries. However, there has been controversy regarding the bioequivalence of generics when compared to brand name medications. Inactive ingredients, which may differ in generic medications, can alter the bioequivalence of the active ingredient as well as provoke intolerance or confusion among patients. There is also concern regarding the quality control and assessment of the manufacturing process of generics. When taken together these issues have the potential to lead to treatment failure. The use of generics to treat chronic hepatitis C will remain controversial, until these issues are adequately addressed.
Division of Liver Diseases, Deparment of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Dost
D
Sarpel
Division of Liver Diseases, Deparment of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Douglas
D
Dieterich
D000998:Antiviral Agents / Q000592:standards / Q000627:therapeutic use*; D004345:Drug Industry / Q000592:standards; D016568:Drugs, Generic / Q000592:standards / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D013810:Therapeutic Equivalency
D000998:Antiviral Agents; D016568:Drugs, Generic
Direct-acting antivirals; generics; hepatitis c