While Gilead's Sovaldi Continues to Dominate the Hepatitis C Space, Janssen's Olysio Has Gained Market Share Driven by Off-label Prescribing

BURLINGTON, Mass., May 19, 2014 /PRNewswire/ -- Decision Resources Group finds that, for the treatment of hepatitis C virus (HCV) infections, regimens containing Gilead's Sovaldi account for over half of the patient share across key genotypes at three months after the drug's launch, rapidly establishing Sovaldi as the market-leading therapy. According to surveyed specialists, nearly 20 percent of their currently-treated genotype 1 patients are receiving a regimen containing Janssen's Olysio, with the majority of these patients being prescribed the off-label combination of Olysio plus Sovaldi with or without ribavirin. Trending analysis from the previous sampling period shows that off-label prescribing of this combination has more than doubled, with 30 percent of specialists in this study reporting having patients currently prescribed the regimen.

Other key findings from the report entitled LaunchTrends: Sovaldi and Olysio US Wave 2:

• Specialty-specific prescribing patterns: Surveyed hepatologists are more likely to prescribe both the Sovaldi- and Olysio-based regimens than gastroenterologists and infectious disease specialists. A notable share of actively-treated genotype 1 patients under the care of gastroenterologists and infectious disease specialists are on a first-generation protease inhibitor therapy, while hepatologists are treating the majority of their genotype 1 patients with Sovaldi- and/or Olysio-containing regimens.
• Treatment rates: Specialists continue to note increases in the number of patients they are actively treating. The percentage of surveyed specialists reporting an increase in the number of patients on active treatment significantly increased from 49 percent two months ago to 75 percent in the current study.
• Awareness of the sofosbuvir/ledipasvir regimen: A notable share of surveyed specialists are unaware of Gilead's investigational fixed-dose combination of sofosbuvir/ledipasvir. However, among physicians with awareness of this emerging regimen, most are expecting to warehouse patients or are currently intentionally delaying treatment of patients in anticipation of marketing authorization of this new therapy.

Comments from Decision Resources Group Director Brenda Perez-Cheeks, Ph.D.:

• "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."
• "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. 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."

About Decision Resources Group
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Decision Resources Group
Christopher Comfort
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SOURCE Decision Resources