ViewPoints: Gilead Sciences' sofosbuvir will be used to treat a third of warehoused genotype 1 hepatitis C patients in 2014, indicate physicians

Gilead Sciences' sofosbuvir sailed through an AdCom review on Friday as most expected. Now anticipated to gain US approval by the end of the year, and European approval in early 2014, consensus forecasts indicate that sofosbuvir could generate sales of $2 billion next year as the first next-generation hepatitis C therapy that can offer certain patients treatment without interferon. Uptake is thus expected to occur mostly among the smaller genotype 2 and 3 patient populations, where treatment with sofosbuvir plus ribavirin has delivered compelling results in Phase III studies.

But what of the larger genotype 1 patient population where sofosbuvir will initially require co-administration with ribavirin and interferon? With only an estimated 12 months before interferon- and ribavirin-free therapies are potentially introduced, will a sizeable warehoused population remain intact?

Insight, Analysis & Opinion

Based on results from FirstWord's latest Physician Views poll (which surveyed 80 gastroenterologists/hepatologists and 81 infectious disease specialists based in the US and EU5), around two thirds of warehoused genotype 1 patients are likely to remain treatment free until more convenient therapies emerge.

That said, if the poll results are accurate in predicting that around 33 percent of genotype 1 patients are treated with a combination of sofosbuvir, ribavirin and interferon (a ratio consistent among US and EU5 respondents), Gilead's product could significantly over-perform versus revenue expectations in 2014.

In May, the NEJM published results from a US Centers for Disease Control and Prevention analysis of the estimated prevalence of hepatitis C in the US, which is likely to become the new gold standard reference source for market forecasts, noted Sanford C. Bernstein analyst Geoffrey Porges. These data point to between 250,000 and 290,000 patients who have been diagnosed but not treated with antiviral therapy, and between a further 50,000 and 150,000 who have been treated with antiviral therapy that has not been successful. Analysts at Bloomberg Industries estimate that the US warehoused population could stand at around 460,000 patients.

FirstWord Pharma PLUS subscribers can click here to gain access to the full data and analysis from this poll, which also gauged physician opinion on usage of sofosbuvir in newly diagnosed genotype 1 patients, newly diagnosed and warehoused genotype 2/3 patients and potential usage of sofosbuvir in combination with Johnson & Johnson's simeprevir – also soon expected to gain FDA approval.

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