Introduction:
Hepatitis C virus (HCV) is an attractive target for drug
developers: more than 25 drug candidates are in Phase II development or beyond,
representing 9 drug classes. Most of these classes represent novel mechanisms
of action for targeting HCV. About half of HCV-infected patients fail
treatment, and these HCV treatment nonresponders have few options for
subsequent treatment. Thus, an ever-growing portion of HCV-infected patients
are sidelined from treatment and await novel therapies that can effectively
treat them. Moreover, because the only option for second-line therapy is
another round of treatment (with the same therapies that failed the first time)
and because of the low relative risk of death associated with HCV, the HCV
treatment nonresponder patient population has steadily grown larger over time.
Thus, tremendous market potential awaits drugs that can demonstrate improved
efficacy in the treatment of this HCV patient subpopulation.
Questions Answered in This Report:
*
A drug’s performance on at least two efficacy end points,
including sustained virologic response, in HCV treatment nonresponders is
important for regulatory approval and uptake.
What are the key primary and
secondary clinical trial end points with which new therapies are evaluated by both regulatory agencies and prescribing
clinicians? How do U.S. and European gastroenterologists weight efficacy
measures and other drug attributes in their prescribing decisions for treatment
of HCV nonresponders?
*
Peg-IFN-α-2a (Roche’s
Pegasys) plus ribavirin (Merck’s Rebetol, Roche’s Copegus, generics) is the
2008 major-market sales leader for the treatment of HCV nonresponders.
How
will emerging therapies fare against peg-IFN-α-2a/ribavirin? Will emerging
therapies offer improvements in the efficacy end points and drug attributes that
are most influential in physician prescribing decisions? Which emerging
therapies are best positioned to challenge the market-leading status of
peg-IFN-α-2a/ribavirin?
*
In 2013, Vertex/Tibotec/Mitsubishi Tanabe Pharma’s telaprevir
(in combination with peg-IFN-α-2a/ribavirin)
will emerge as the gold-standard therapy in our Drug Comparator Model because
of its superior clinical profile over the current therapies evaluated in this
study.
On what clinical attributes is telaprevir most differentiated from
its competitors?Scope:
Key drug development opportunity tested in our target
product profiles for HCV treatment nonresponders: an HCV-specific antiviral
that, when used in combination with peg-IFN-α-2a/ribavirin/telaprevir for
24 weeks, achieves a better SVR than a peg-IFN-α-2a/ribavirin/telaprevir
regimen alone for the treatment of nonresponders infected with HCV genotype 1.
Physicians surveyed for this study: 60 U.S. and 32
European gastroenterologists.
Comprehensive List of Therapies Included in Our Research and Modeling
Current Therapies
- Pegylated IFN-α-2a
(Roche’s Pegasys)
- Pegylated IFN-α-2b
(Merck’s PegIntron)
- IFN-α-con-1 (Three
Rivers Pharmaceuticals’ Infergen, Astellas Pharma’s Advaferon)
- Ribavirin (Merck’s Rebetol, Roche’s Copegus, generics)
Emerging Therapies
- Alb-IFN-α-2b
(Novartis/Human Genome Sciences’ Zalbin/Joulferon)
- Telaprevir (Vertex/Johnson &
Johnson/Misubishi Tanabe Pharma)
- Boceprevir (Merck)
- R-7128 (Roche/Pharmasset)
- TMC-435 (Tibotec)