In Treatment-Naive Hepatitis C Virus, Thought Leaders' Opinions and Clinical Data Indicate That Sofosbuvir plus Ledipasvir plus Ribavirin Has Advantages Over Current Therapies

An All-Oral/Interferon-Free Regimen is One of the Great Unmet Needs in Treatment-Naive HCV, According to a New Report from Decision Resources

May 02, 2013, 09:00 ET from Decision Resources

BURLINGTON, Mass., May 2, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed gastroenterologists in the United States and Europe agree that the percentage of genotype-1 hepatitis C virus (HCV) patients achieving a sustained virological response (SVR) is one of the attributes that most influences their prescribing decisions. Clinical data and interviewed thought leaders indicate that Gilead's interferon-free regimen of the nucleoside polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir plus ribavirin has advantages over the current sales-leading regimen on efficacy, safety and delivery attributes. For the treatment of HCV, the current sales-leading regimen is telaprevir (Vertex's Incivek, Johnson & Johnson's Incivo, Mitsubishi Tanabe Pharma's Telavic) in combination with peg-IFN-alpha (Roche's Pegasys or Roche/Merck's PegIntron) and ribavirin (Roche's Copegus, Merck's Rebetol, generics).


The Decision Base report entitled Substantial Opportunity and Fierce Competition Await Developers of Interferon-Free Therapies for Treatment-Naive Patients also finds that surveyed U.S. and European gastroenterologists and managed care organization (MCO) pharmacy directors consider an all-oral/interferon-free regimen is one of the greatest unmet needs in treatment-naive HCV. Clinical data and thought leader opinion indicate that several emerging regimens from developers such as Gilead (sofosbuvir plus lepidasvir plus ribavirin), AbbVie (ritonavir-boosted ABT450 plus ABT-333 plus ABT-267 plus ribavirin) and Boehringer-Ingelheim (faldaprevir plus BI-207127 plus ribavirin) have demonstrated the potential to fulfill this unmet need.

The report also finds that surveyed MCO pharmacy directors would reimburse a new HCV regimen that is ribavirin-free and interferon-free if it achieved a SVR rate that is up to 10 percent lower than a comparably priced regimen that is free of interferon but not of ribavirin. This finding suggests that emerging regimens that dispense with both ribavirin and interferon will face a somewhat less-stringent reimbursement review and/or receive more-favorable formulary status.

"Although U.S. gastroenterologists cited improved SVR in the absence of ribavirin as an area of high unmet need, they do not assign high weight to this attribute in making treatment decisions," said Decision Resources Analyst Seamus Levine-Wilkinson, Ph.D. "The low weight of this attribute is likely due to the current lack of highly efficacious ribavirin-free antiviral therapies for HCV infection. The high unmet need and lack of current treatment options indicates that this is an important area of differentiation that Bristol-Myers Squibb is seeking to capitalize on with their interferon- and ribavirin-free regimen of daclatasvir plus asunaprevir plus BMS-791325."

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