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Report: All-Oral, IFN-Free Regimen Is Major Unmet Need in HCV Patients

Sofosbuvir/ledipasvir/ribavirin combo has advantages over current therapies (May 2)

Decision Resources, a research and advisory firm located in Burlington, Mass., finds that surveyed gastroenterologists in the U.S. 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 the interferon (IFN)-free regimen of the nucleoside polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir plus ribavirin (Gilead) has advantages over the current sales-leading regimen in terms of efficacy, safety, and delivery attributes. For the treatment of HCV, the current sales-leading regimen is telaprevir (Incivek, Vertex; Incivo, Johnson & Johnson) in combination with pegylated IFN-alpha (Pegasys, Roche; PegIntron, Roche/Merck) and ribavirin (Copegus, Roche; Rebetol, Merck; generics).

The report also finds that surveyed U.S. and European gastroenterologists and pharmacy directors at managed care organizations (MCOs) consider that an all-oral, IFN-free regimen is one of the greatest unmet needs in treatment-naïve HCV patients. Clinical data and thought leader opinion indicate that several emerging regimens — such as sofosbuvir plus lepidasvir plus ribavirin (Gilead), ritonavir-boosted ABT450 plus ABT-333 plus ABT-267 plus ribavirin (AbbVie), and faldaprevir plus BI-207127 plus ribavirin (Boehringer-Ingelheim) — 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 IFN-free and ribavirin-free if it achieved an SVR rate that is up to 10% lower than that of a comparably priced regimen that is free of IFN but not of ribavirin. This finding suggests that emerging regimens that dispense with both IFN and ribavirin will face a less stringent reimbursement review and/or will receive a 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 analyst Seamus Levine-Wilkinson, PhD. “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.”

Source: Decision Resources; May 2, 2013.

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