Affecting at least 170 million people worldwide, chronic
hepatitis C virus (HCV) infections are a serious public health problem. Many
patients exhibit progressively more-severe liver fibrosis, leading in many
cases to decompensated liver disease, liver transplantation, hepatocellular
carcinoma, and eventually death. In 2011, the first two HCV-specific protease
inhibitors—telaprevir (Vertex’s Incivek, Johnson & Johnson’s Incivo,
Mitsubishi Tanabe Pharma’s Telavic) and boceprevir (Merck/Roche’s
Victrelis)—received marketing approval. Although the drugs were welcomed
because they greatly increase the efficacy of treatment compared with the
previous standard of care (peg-IFN-a/ribavirin dual therapy), they are
associated with significant new toxicities and must be taken in combination
with peg-IFN-a and ribavirin, which have their own serious side effects,
to avoid treatment failure. Indeed, many patients are ineligible for treatment
with peg-IFN-a/ribavirin because of the serious toxicities associated with
these agents, and many patients deemed eligible for treatment discontinue early
as a result of the side effects. For these reasons, there is substantial market
opportunity for developers that can launch the first IFN-free therapy for
chronic HCV infection. This opportunity is widely recognized and has prompted
many drug developers to make significant investments in all-oral, IFN-free
treatments for HCV.
Attributes included in conjoint analysis-based assessment of target product profiles for treatment-naive HCV:
- Genotype-1 sustained virological response (SVR) (% of patients).
- Genotype-2/3 SVR (% of patients).
- Treatment duration (weeks).
- Dosing frequency (daily number of doses).
- Percentage of patients discontinuing treatment due to adverse effects.
- Number of drugs in regimen.
- Price per full course of treatment
Attributes included in assessment of U.S. payers’ receptivity to new therapies for treatment-naive HCV:
- Improved effect on SVR rate: IFN-free regimens.
- Improved effect on SVR rate: ribavirin-free and IFN-free regimens.
- Improved treatment duration in treatment-naive patients.
- Lower rate of early discontinuations due to side effects.
Physicians surveyed: 60 U.S. and 30 European gastroenterologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Pegylated-interferon-alpha-2a (Roche’s Pegasys)
- Pegylated-interferon-alpha-2b (Merck’s PegIntron)
- Telaprevir (Vertex’s Incivek, Johnson & Johnson’s Incivo, Mitsubishi Tanabe Pharma’s Telavic)
- Boceprevir (Merck/Roche’s Victrelis)
- Ribavirin (Roche’s Copegus, Merck’s Rebetol, generics)
- Ritonavir (AbbVie’s Norvir)
- AbbVie’s ABT-267
- AbbVie’s ABT-333
- AbbVie’s ABT-450
- Boehringer Ingelheim’s faldaprevir (BI-201335)
- Boehringer Ingelheim’s BI-207127
- Bristol-Myers Squibb’s daclatasvir (BMS-790052)
- Bristol-Myers Squibb’s asunaprevir (BMS-650032)
- Bristol-Myers Squibb’s BMS-791325
- Gilead’s sofosbuvir (GS-7977)
- Gilead’s ledipasvir (GS-5885)