FDA issues HCV draft guidance

FDA issued draft guidance on developing direct-acting antivirals to treat chronic HCV. The agency said that until the first direct-acting antiviral is approved, the recommended design for initial registration of a product is demonstration of superiority as an add-on to standard of care (SOC) in a blinded comparison to placebo plus SOC. The primary endpoint for Phase III studies should be sustained virologic response (SVR) at 24 weeks after the end of treatment, according to the guidance. SOC consists of Pegasys peginterferon alfa-2a and Copegus ribavirin from Roche (SIX:ROG; OTCQX:RHHBY). The guidance also noted that in the future a superiority design also can include a new drug as part of a four-agent regimen compared to a three-agent regimen. FDA said patients who achieve SVR should be followed for at least three years, data for which can be provided as part of a postmarketing commitment following the initial application.

For trials of a combination of direct-acting antivirals, the guidance recommends using agents with different mechanisms of action, with provisions for demonstrating that each component of the combination therapy contributes to the desired effect. ...