Generics for the Treatment of Hepatitis C in Monoinfected and HIV-coinfected Patients: Pros and Cons.

The treatment of hepatitis C virus in monoinfected and HIV-coinfected patients has greatly changed over recent years as a result of the introduction of direct-acting antiviral agents (DAAs), which have revolutionized clinical outcomes and led to sustained virological response rates above 90-95%. The discovery of new molecules and the subsequent competition between pharmaceutical companies, together with the negotiated price policies pursued by many national health systems, have led to a gradual reduction in the cost of DAAs, and expand their use to an increasing number of patients, including those with mild liver damage. However, the cost of branded DAAs is still too high for many developing countries, and many patients are still left without therapy. In this context, the availability of generic DAAs certainly provides a major opportunity for further cost savings in industrialized countries and will ensure broader access to treatment elsewhere. However, their more widespread use must not lead to a reduction in pharmaceutical quality because this could result in serious clinical consequences, including high rat failures, and selection of drug resistance. It is therefore essential that all generic formulations of DAAs are pre-qualified by the World Health Organization, and that real-life studies are carried out to verify their pharmacokinetic bioequivalence (ideally in patients, and not just in healthy volunteers) and clinical effectiveness. In this regard, lessons from expanding access programs in the HIV field would be very helpful.