Physician Views: FDA throws up surprise labelling for Gilead Sciences' hepatitis C treatment Sovaldi – will it boost first year uptake?

Confirmed late on Friday, FDA approval of Gilead Sciences' hepatitis C therapy Sovaldi (sofosbuvir) has been highly anticipated.

Nevertheless, the company managed to spring a surprise on both investors and rivals by securing labelling for Sovaldi as an all-oral therapy – in combination with ribavirin – for the large genotype 1 patient population (estimated 75 percent of US patient pool), when dosed over 24 weeks among patients who are deemed to be ‘ineligible’ to interferon.

This outcome is particularly surprising, noted International Strategy & Investment analyst Mark Schoenebaum, as Gilead had provided no indication that data to support this particular labelling had been submitted to the FDA. Expectation instead was for sofosbuvir to only be approved in genotype 1 patients in combination with interferon and ribavirin.

Excluding interferon from the equation may theoretically boost the number of genotype 1 patients whom are treated with a sofosbuvir regimen in 2014, prior to the anticipated launch of all-oral therapies (such as Gilead's sofosbuvir + ledipasvir fixed-dose combination) at the end of next year. Particularly as a number of earlier FirstWord Physician Views polls had already suggested significant enthusiasm for the more unfavourable sofosbuvir+ interferon + ribavirin combination anyway.

Physician Views: Entering the post-interferon era – will Gilead Sciences dominate hepatitis C? and Physician Views: What opportunity for Gilead Sciences' hepatitis C therapy sofosbuvir before interferon-sparing regimens reach the market?

Nevertheless, there are a number of potential barriers to uptake for a genotype 1 sofosbuvir + ribavirin combination in 2014. Schoenebaum points out, for example, that quantifying the number of 'ineligible' interferon patients is difficult; will genotype 1 patients simply refuse interferon as they are aware that an interferon-sparing regimen is now technically available, or will physicians only use this regimen in patients who are known not to be able to tolerate interferon?

Furthermore, with a duration of 24 weeks, the sofosbuvir + ribavirin combination will be priced higher, at an estimated gross cost of around $168,000. This could cause an issue with payers, and Gilead is reportedly offering a patient support programme that will ensure that most commercially insured patients will have no more than a $5 co-pay, which will include patients who are charged larger co-insurance amounts.

In addition, approval for the sofosbuvir + ribavirin combination is supported by a relatively small clinical data set. Therefore, Schoenebaum argues that physicians may be reluctant to prescribe the combination, particularly as Gilead's fixed-dose product – which will be supported by more clinical data at launch and likely cost around $100,000 per patient – is probably some 12 months away.

To help provide some clarity on how this labelling for Sovaldi has been perceived by physicians and how it may influence their prescribing decisions in 2014, FirstWord is polling US-based gastroenterologists/hepatologists and infectious disease specialists on the following 5 questions...

How they perceive Sovaldi’s labelling (permitting combination use with ribavirin only, for a 24-week course of therapy in interferon-ineligible genotype 1 patients) to influence their use in genotype 1 patients during 2014

How they perceive this labelling to impact their treatment of warehoused genotype 1 patients in 2014

What factor would act as the main reason for them not using Sovaldi + ribavirin as a 24-week therapy in genotype 1 patients in 2014

Whether they believe that a genotype 1 patient saying that they did not want to be treated with interferon would constitute that patient to be 'interferon ineligible'

How much influence they expect payers to have on the eligibility of genotype 1 patients to receive the Sovaldi + ribavirin combination, particularly in light of the impending arrival of cheaper, fixed-dose combinations in late 2014/early 2015.

You will be able to read the results and analysis on Thursday.

Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings.

To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions.

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