DecisionBase

April 2013

Hepatitis C Virus

Introduction:

Substantial Opportunity and Fierce Competition Await Developers of Interferon-Free Therapies for Treatment-Naive Patients

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-α/ribavirin dual therapy), they are associated with significant new toxicities and must be taken in combination with peg-IFN-α and ribavirin, which have their own serious side effects, to avoid treatment failure. Indeed, many patients are ineligible for treatment with peg-IFN-α/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.

Questions Answered in This Report:

  *   A drug’s performance on at least eight efficacy end points, including SVR24 rate in HCV genotype-1a-infected patients, is important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European gastroenterologists weight efficacy measures and other drug attributes in their prescribing decisions for treatment-naive HCV?

  *   Improved SVR rate in the absence of ribavirin and all-oral regimens are key areas of unmet need for treatment-naive HCV, according to the insights of surveyed U.S. and European gastroenterologists. Which therapies in development for treatment-naive disease are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  *   By 2016, sofosbuvir plus ledipasvir plus ribavirin will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is sofosbuvir plus ledipasvir plus ribavirin most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by sofosbuvir plus ledipasvir plus ribavirin?

Scope:

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:

Current Therapies

- 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)

Emerging Therapies

- 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)


Search Reports

Mentioned in this report:

  • - AbbVie
  • - Boehringer Ingelheim
  • - Bristol-Myers Squibb
  • - Gilead
  • - Johnson & Johnson
  • - Merck
  • - Mitsubishi Tanabe Pharma
  • - Roche
  • - Vertex
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