ViewPoints: New Hep C data validates Gilead's solo approach

 ViewPoints: New Hep C data validates Gilead's solo approach 

(Ref: ViewPoints Desk)
May 5th, 2013

New data from Gilead Sciences' LONESTAR study has not only strengthened the company's position in the race to develop an oral, interferon-sparing treatment for hepatitis C, but reinforced the strategic rationale for not pursuing a co-developed product with Bristol-Myers Squibb last year.

Insight, Analysis & Opinion

Gilead may have attracted a raft of criticism for the decision not to develop its nucleotide NS5B inhibitor sofosbuvir with Bristol-Myers Squibb's NS5A inhibitor daclastasvir (see Spotlight On: Bristol-Myers Squibb and Gilead Sciences deliver stellar HCV results, decide to go separate ways?), but its rationale for not doing so has proven correct.

Just days after that combination delivered a second set of highly impressive data, Gilead's own combination – of sofosbuvir and ledipasvir – has demonstrated comparable efficacy in a Phase II study. Furthermore, this combination advances Gilead's opportunity to deliver the 'holy grail' of next-generation hepatitis C therapies – a single fixed dose, once-daily tablet.

In genotype 1 treatment-naive patients, the sofosbuvir/ledipasvir combination demonstrated an impressive SVR 8 rates of 95 percent (which increased to 100 percent when ribavirin was added to the regimen) after 8 weeks of treatment. In the same patient group the combination achieved an SVR 4 rate of 100 percent without ribavirin after 12 weeks of therapy. Both analysts at Lazard Capital and International Strategy & Investment suggested that the data will further enhance Gilead's leadership within the hepatitis C development space.

Perhaps most impressively – commented analysts at Barclays – was a 12 week SVR 4 rate of 95 percent in treatment-experienced genotype 1 patients, of whom half were cirrhotic. Barclays analyst Anthony Butler described the data in this patient cohort as "remarkable."

Such had been the clear best-in-class combination properties of sofosbuvir and daclastasvir, there has been considerable speculation that physicians may prescribe the two product off-label. While there is likely to be an element of this, noted key opinion leaders interviewed by FirstWord, cost – and the availability of cheaper fixed dose combinations – is a likely deterrent. Data from the LONESTAR study would appear to significantly enhance this point of view.

See ViewPoints: Cost will limit uptake of off-label Gilead/Bristol-Myers Squibb Hep C combo, despite best-in-class data.

http://www.firstwordpharma.com/node/1081565?tsid=28&region_id=2