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Consensus forecasts indicate that Gilead Sciences will dominate the market for all oral, interferon-sparing hepatitis C therapies, with this success expected to be centred on its combination sofosbuvir plus ledipasvir franchise. Final Phase III data for this combination therapy are expected to emerge in early 2014, with potential approval secured towards the end of next year.
However, impressive Phase III data released earlier this week from the first of six late-stage studies for AbbVie’s ‘3D’ regimen - which puts the company on a similar regulatory timescale to Gilead – suggest that the US biotech will not be competing completely on its own terms. Similarly, analysts have recently pointed out that Merck & Co. could also emerge as a viable competitor in the genotype 1 space.
A number of analysts noted that data from the SAPPHIRE study confirm AbbVie’s competitive position among the first generation of interferon-free therapies for genotype 1 patients, given the efficacy and safety of its regimen.
A consensus appears to be emerging that AbbVie could secure a 10 percent to 15 percent share of the market, despite its regimen being more complex to dose – a multi-tablet (six) therapy dosed twice-daily (versus Gilead’s once-daily fixed-dose combination) – and including ritonavir – which can increase drug-drug interactions.
Analysts at Goldman Sachs argue that Merck’s Victrelis previously achieved a 20 percent to 30 percent share of the hepatitis C market, despite being a "worse regimen" relative to Vertex’s Incivek than AbbVie’s ‘3D’ regimen is to sofosbuvir + ledipasvir. Possibly reflecting a pharma to biotech disconnect, they also point to 2015 forecast hepatitis C sales for Gilead being 10 times those currently anticipated for AbbVie.
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To gain a better perspective on how physicians expect to use interferon-free regimens, FirstWord is polling gastroenterologists/hepatologists and infectious disease specialists based in the US and EU5. Specifically the poll will ask them:
• What percentage of diagnosed but untreated genotype 1 hepatitis C patients they expect to warehouse until interferon-free therapies are made available – anticipated in late 2014/early 2015?
• Assuming cure rates are comparable, to what percentage of genotype 1 patients they would prescribe an interferon-sparing, once-daily, single-tablet therapy rather than an interferon-sparing multi-tablet therapy dosed five-times daily?
• What their level of concern is regarding ritonavir-boosting in future interferon-sparing regimens?
• Whether prescribing Gilead’s sofosbuvir during 2014 will positively influence their subsequent prescribing habits for an interferon-free sofosbuvir-based regimen in genotype 1 patients?
• To what percentage of genotype 1 patients they expect to prescribe Gilead’s sofosbuvir + ledipasvir fixed-dose combination?
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