Clinical Corner: Harvoni’s FDA Approval

Last week, Gilead’s combination Genotype I Hepatitis C product, now officially named Harvoni, was approved by the FDA[1]. The drug is a combination of Gilead’s Sovaldi with a second antiviral agent, ledipasvir, in a single tablet. It will cost ~$94,500 per 12-week treatment course, in contrast to Sovaldi’s $84,000 cost per 12-week treatment course. Unlike Sovaldi, however, an 8-week treatment course costing $63,000 will also be possible for certain patients receiving Harvoni.

Why is this drug’s launch so important?

94% of treatment-naïve patients who received Harvoni for 8 weeks, and 96% of treatment-naïve patients for 12 weeks achieved sustained viral response (SVR). This means the virus could not be detected in the patient following the course of treatment [2]. Although some physicians may have been withholding pharmaceutical treatment in anticipation of the approval of Harvoni, it is unlikely that the spike in utilization that will follow Harvoni’s approval will be as material as the spike in utilization that followed Sovaldi’s approval. There is potential for Harvoni to replace Sovaldi as the treatment of choice for these patients [3]. Harvoni launched as the first oral, combination product to be approved for the treatment of Hepatitis C and this category is changing rapidly.

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