Approved by the FDA on June 28, sofosbuvir/velpatasvir is the first single-tablet therapy regimen to treat all six major HCV genotypes. “This drug has two huge advantages,” said Gary Rice, RPh, MBA, Diplomat’s senior vice president for Clinical, Education and Human Resources, in an interview with SPC. “First, it is a 12-week therapy for all patients across all genotypes, even for those with decompensated cirrhosis. For those patients, instead of elongating the regimen, you just add ribavirin. This makes it more predictable, which is important for providers and for payors; you don’t have some patients on 12 weeks of therapy, some on eight and some on 24.”
Sofosbuvir/velpatasvir is also the first regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. “With other regimens, you still need to add ribavirin, which presents additional complexities as far as patient management and adverse events,” Mr. Rice said. The only other option for genotype 2 is the combination of daclatasvir (Daklinza, Bristol-Myers Squibb) and sofosbuvir (Sovaldi, Gilead), which can cost in excess of $145,000 based on 12- or 24-week therapy. “This adds a much more cost-effective option, and really simplifies therapy for these patients.”
These unique advantages haven’t led to an increase in price over existing therapies. Gilead has set the list price for sofosbuvir/velpatasvir at $74,760—less than the $84,000 it charges for sofosbuvir alone. Whether Gilead’s contracting strategy for the new combination will include rebates is unknown at this point. “There has not been a lot of information yet in the public domain on the contracting strategy,” said Mr. Rice. “They may feel they don’t need to have as much of a contracting strategy with regard to rebates because of the uniqueness of the product.” Company representatives did not respond to requests for comment by press time.
Epclusa carries a warning for patients and health care providers that symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral agent. Coadministration of amiodarone with Epclusa is not recommended.