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Survey: Sofosbuvir (Sovaldi) Dominates Hepatitis C Market

Many specialists unaware of investigational sofosbuvir/ledipasvir combo

Decision Resources Group, a health care research firm located in Burlington, Mass., finds that, for the treatment of hepatitis C virus (HCV) infections, regimens containing sofosbuvir (Sovaldi, Gilead) account for more than half of the patient share across key genotypes at 3 months after the drug’s launch, establishing sofosbuvir as the market-leading therapy.

According to surveyed specialists, nearly 20% of their currently treated genotype-1 patients are receiving a regimen containing simeprevir (Olysio, Janssen), with most of these patients being prescribed the off-label combination of simeprevir and sofosbuvir with or without ribavirin. A trending analysis found that off-label prescribing of this combination had more than doubled, with 30% of specialists reporting having prescribed the regimen.

Surveyed hepatologists were more likely to prescribe both the sofosbuvir- and simeprevir-based regimens than were gastroenterologists and infectious disease specialists. A large proportion of actively treated genotype-1 patients under the care of gastroenterologists and infectious disease specialists were receiving a first-generation protease inhibitor, whereas hepatologists were treating most of their genotype-1 patients with sofosbuvir- and/or simeprevir-containing regimens.

Analyst Brenda Perez-Cheeks, PhD, observed: “Given the uptake of the off-label Olysio and Sovaldi combination regimen, which serves as an effective interferon-free and possibly ribavirin-free therapy for the genotype 1 population, Janssen’s ongoing phase III clinical trials and supplemental new drug application submission for this regimen is a sensible strategic move for the Olysio marketer; however, given the high cost of both agents, it will remain to be seen if payers — who are already cost-sensitive — will provide wide access to this regimen following an FDA approval. Additionally, it will be interesting to see if this regimen will be able to compete with other lower-priced regimens that are expected to enter the market in the near future.”

In the survey, specialists continued to note increases in the number of patients they were actively treating. The percentage of surveyed specialists reporting an increase in the number of patients on active treatment significantly increased from 49% 2 months ago to 75% in the current study.

A significant proportion of surveyed specialists were unaware of the investigational fixed-dose combination of sofosbuvir and ledipasvir (Gilead). However, among physicians with an awareness of this emerging regimen, most were expecting to warehouse patients or were intentionally delaying treatment in anticipation of marketing authorization for this new therapy.

“Despite the continuous stream of media coverage and information about clinical development of key regimens, approximately one-third of HCV-treating physicians had no awareness of Gilead’s co-formulated sofosbuvir/ledipasvir therapy, which represents the first of the next wave of HCV therapies likely to enter the market,” Cheeks said. “The low awareness is likely not limited to Gilead’s investigational regimens, but also has implications for marketers of other therapies vying to penetrate this space within the next year.”

Source: BioTrends Research Group; May 19, 2014.

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