On the eve of the FDA’s pending decision on Gilead’s sofosbuvir, a MedLIVE PULSE survey—conducted by WorldOne Interactive for MM&M of 48 US hepatologists—suggests doctors may not be ready to embrace the drug for all their HCV patients.
When compared against the current HCV landscape, their choice looks clear. Findings show that 88% of the 48 docs polled have “warehoused” patients in anticipation of the drug’s approval rather than use already available treatments like Vertex’s Incivek or Merck’s Victrelis.
However, the majority of hepatologists—83% (40 out of 48)—told researchers they would continue to warehouse their GT-1 patients in anticipation of an all-oral formulation, rather than immediately treat these patients with sofosbuvir and injected antivirals.
Barring any bombshells, approval seems highly likely this month. In an investor note, Leerink Swann analyst Alice Avanian pegged sofosbuvir’s approval chances at 80% for its upcoming PDUFA date on December 8. That estimate comes one week after EU advisors also recommended the drug’s approval, following in the footsteps of their US counterparts in October.
Sofosbuvir’s initial application promises a treatment upgrade for patients with the genotype 2 and 3 forms of the virus. For those with the GT-1 form, the drug will initially require use with interferon (an injected antiviral that can produce flu-like symptoms). And GT-1 is the most prolific subset of HCV infections in the US.
An all-oral regimen for use in that patient subtype consisting of sofosbuvir and ledipasvir, an NS5A protease inhibitor, is not likely to come until later. Current estimates suggest Gilead’s oral formulation for GT-1 will be available by the end of 2014, and another option from Merck about 18 months further down the line.
The majority of liver specialists also said price could play a significant factor in the treatment’s uptake. 66% of polled doctors said sticker shock could dampen enthusiasm for a new therapy that could cost between $60,000 to $100,000.
Janssen’s simeprevir, approved last month, carries a price tag of roughly $66,360 for a three-month course.
Patients, too, appear ready to greet new treatments, although they may not know what they’re embracing. When asked, only 11 of 42 doctors—or 26%—said that patients inquire specifically about sofosbuvir.
In the WorldOne survey, one doctor noted, “Most of my patients do not know sofosbuvir by name. My patients only know that there will soon be ‘better’ drugs for hepatitis C and that perhaps in a couple of years, interferon will not be needed,” and that there are “frequent questions, but little facts.”
Another added, “My very knowledgeable patients know about sofosubivr and that it is likely to be approved within days. Those that know about it are very hopeful.”
That lack of name recognition suggest awareness andeducation around this new wave of treatments will be necessary, with other HCV treatments on the horizon.