New Therapies and Screening for Hepatitis C Are Changing Treatment Landscape

The American Journal of Managed Care (AJMC) recently convened an expert panel that analyzed the implications of recommendations by the US Preventive Services Task Force that all Americans born between 1946 and 1964 be screened for the hepatitis C virus (HCV). Widespread screening, along with new therapies that move patients from a chronic condition to a cure, is changing the landscape in treatment of hepatitis C, said the AJMC panel, according to a press release.

An estimated 3.2 million people have HCV, but the vast majority are unaware they have it, the AJMC noted in the press release. HCV gained steam in the early 1980s, before blood products were routinely screened for its presence. Screening people for HCV would allow candidates for treatment to rid themselves of the disease early, before complications become difficult and expensive to treat. Targeting the baby-boomer generation before most of them retire would allow those found to be carrying the virus to obtain treatment under commercial insurers, rather than Medicare. The cost of treatment to cure HCV, which may be possible in 90 to 94% of cases with new therapies, must be weighed against the cost of caring for what was once an expensive, long-term chronic condition, noted one of the panelists.

New therapies are available, with others in development. FDA recently granted breakthrough therapy designation to Bristol Myers-Squibb’s (BMS) investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection, BMS announced in a press release. The designation is based on data from the company’s ongoing Phase III clinical trial program evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin. BMS also recently announced that the European Medicines Agency validated the company’s marketing authorization application for the use of daclatasvir for the treatment of adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4. The application seeks the approval of daclatasvir for use in combination with other agents for the treatment of chronic hepatitis C and will be reviewed under an accelerated regulatory review.