 DecisionBase PDFs --
2008
 Overview:
Drug development for hepatitis C virus (HCV) has been highly
active in the past decade, with a broad pipeline of innovative new therapeutics
under study. Current treatment is effective in only approximately 50% of
patients, leaving a sizable pool of patients who have failed first-line therapy
(i.e., nonresponders) that is accumulating over time. Indeed, efficacious
therapies in treatment nonresponders represents one of the most commercially
and medically compelling opportunities in HCV clinical management. We expect
the introduction of several emerging therapies from high-profile novel drug
classes—HCV protease inhibitors, second-generation long-acting IFN-alpha
therapies, and second-generation ribavirin analogues—to offer significant
improvements in efficacy, safety and tolerability, and delivery over current
HCV therapeutics.
Questions Answered in This Report:
 Viral clearance, reducing liver inflammation, and improving
liver fibrosis are key goals in the treatment of HCV. What are the key primary
and secondary clinical trial end points with which new therapies are evaluated?
How do gastroenterologists and hepatologists weight specific efficacy end
points and other drug attributes in their prescribing decisions for HCV?
Pegylated interferon-alpha-2a (peg-IFN-alpha-2a) (Roche’s
Pegasys) plus ribavirin (Roche’s Copegus, generics) is the 2006 major-market
sales-leading regimen for HCV. How will peg-IFN-alpha-2a plus ribavirin and
other current therapies fare against emerging therapies? Will emerging
therapies offer improvements in the efficacy end points and drug attributes
that are most influential in physician prescribing decisions? If so, which
drugs will suffer the most from entry of these new agents?
By 2011, albinterferon-alpha-2b
plus ribavirin plus telaprevir 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 albinterferon-alpha-2b
plus ribavirin plus telaprevir most differentiated from its competitors? Which
current therapies are at greatest risk of being replaced by albinterferon-alpha-2b plus ribavirin plus telaprevir?
Scope:
Key drug development opportunity tested in our target
product profiles for hepatitis C virus: A protease inhibitor that has a
significantly higher SVR rate than current therapies among
treatment-nonresponders when used as a second-line therapy in combination with
a long-acting IFN-alpha and ribavirin for the treatment of HCV.
Physicians surveyed for this study: 60 U.S. gastroenterologists and hepatologists.
Comprehensive List of Therapies Included in Our Research and
Modeling
Current therapies:
- Peg-IFN-alpha-2a (Roche’s Pegasys)
- Peg-IFN-alpha-2b (Schering-Plough’s Peg-Intron)
- IFN-alpha-con-1 (Three Rivers Pharmaceuticals’ Infergen,
Astellas’s Infergen/Advaferon)
- Ribavirin (Roche’s Copegus, Schering-Plough’s Rebetol,
generics)
Emerging therapies:
- Albinterferon-alpha-2b (Novartis/Human Genome Science’s
Albuferon)
- Taribavirin (Valeant Pharmaceuticals’ Viramidine)
- Telaprevir (Vertex/Tibotec [Johnson & Johnson])
- Boceprevir (Schering-Plough)
About DecisionBase
Hepatitis C Virus: Blockbuster Sales Potential for Protease
Inhibitor That Is Effective in Treatment Nonresponders is a DecisionBase 2008 study
from Decision Resources. DecisionBase 2008 combines market forecasts with
clinical and commercial end points to assess market share projections in 35
indications. These outputs are driven by quantitative and qualitative primary
research. DecisionBase 2008 provides detailed market share, patient share, and
price-per-day projections for emerging drugs in development. The market share
projections are based on prescriber surveys that compare physicians’
expectations of a potential target product profile with an emerging product
profile of the leading drugs in development.
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