Considerations for Formulatory Strategy and Management of
Hepatitis C
A Payer’s Perspective
Chris Anderson, PharmD, BCPS
Alex James, PharmD
Fran Gregory, PharmD, MBA
Tyler Whisman, PharmD, BCOP
Humana
The authors report no financial conflicts with any products discussed in this paper.
It is estimated that 3.2 million Americans are
chronically infected with the Hepatitis C virus (HCV)1.
Underdiagnoses of HCV infection continues to be
a concern due to slow disease progression and
the primarily asymptomatic nature of the disease
course. As a result, approximately 1.6 million or half
of the estimated HCV cases, remain undiagnosed2.
In response, the Center for Disease Control and
Prevention (CDC) now recommends that all U.S.
citizens born between 1945 and 1965 be tested for
the presence of HCV1.
HCV infection remains the leading cause of chronic
liver disease, hepatocellular carcinoma (HCC), liver
transplantation, and death due to liver disease3. Of
those chronically infected, 5% to 20% will eventually
develop cirrhosis in the 20 to 30 years after infection
and up to 5% will die from consequences of chronic
infection such as HCC or cirrhosis1. The HCV
treatment market has undergone rapid changes
over the last several years. There has been an
unprecedented expansion in HCV treatment options
and guideline recommendations have reflected this
shift in the treatment paradigm. The goal of therapy
remains a clinical cure also known as a sustained
viral response (SVR), but shorter treatment durations
and more effective therapies continue to drive market
competition.
In 2011, an HCV treatment milestone was achieved
with the approval of the first direct-acting antiviral
(DAA) agents for HCV. Prior to the approval of
boceprevir and telaprevir in 2011, the standard of
care was the combination of pegylated interferon and
ribavirin. Boceprevir and telaprevir are both NS3/4A
protease inhibitors which used in combination
with pegylated interferon and ribavirin provide a
substantial improvement in SVR rates.
2013 also saw radical changes in the way HCV
was treated. Simeprevir, another NS3/4A protease
inhibitor, and sofosbuvir, a novel NS5B polymerase
inhibitor, were approved late in 2013. As a result,
the American Association for the Study of Liver
Diseases (AASLD) updated their guidelines to reflect
the changing treatment landscape. Boceprevir and
telaprevir are now no longer recommended and, to
the surprise of many, interferon free regimens are now
an option for patients intolerant to interferon based
treatments.
There is a robust HCV treatment pipeline dominated
by combinations of polymerase inhibitors, NS5A
inhibitors, and protease inhibitors which will provide
both payers and patients with numerous all oral,
interferon-free treatment options. Approval of several
of these options is expected in 2014 or 2015 and
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