Scientific Publications by FDA Staff

Clin Pharmacol Ther 2015 Oct;98(4):394-402

Direct-acting antiviral drugs for the treatment of chronic hepatitis C virus infection: interferon free is now.

Florian J, Mishra P, Arya V, Harrington P, Connelly S, Reynold KS, Sinha V

Chronic hepatitis C (CHC) is a serious, global and life-threatening disease. Virologic response at 12 weeks (SVR12) signifies a durable virologic response and is currently the primary efficacy endpoint used in registrational trials. This change led to more rapid clinical development and earlier approvals of highly effective and well-tolerated therapies, facilitating access to those in need. CHC virus (HCV) infection is a therapeutic area where mathematical modeling has proven helpful in understanding drug mechanism and characterizing viral kinetics to inform therapy decisions. The availability of direct acting antivirals (DAAs) provides various treatment options for HIV/HCV co-infected patients, the complexity of predicting- and managing DDIs presents a unique challenge. Real-world experience or non-interventional studies can provide insight regarding the safety and use of therapeutics that may not be readily available from traditional clinical trials. This paper provides a brief overview of the development of promising drugs for the treatment of CHC.