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AbbVie takes 'one-size-fits-all' HCV regimen into phase III

Comes shortly after Gilead wins priority FDA review for its 'pan-genotypic' treatment
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AbbVie has started enrolling patients into phase III trials of a new hepatitis C virus (HCV) therapy that aims to treat all genotypes of the virus with an all-oral, once-daily, ribavirin-free regimen.

The co-formulated drug - which combines NS3/4A protease inhibitor ABT-493 with NS5A inhibitor ABT-530 - will be tested in six phase III trials involving patients with HCV genotypes 1-6, which account for the vast majority of HCV infections worldwide. AbbVie's trial programme will look at treatment durations of eight and 12 weeks.

The announcement comes shortly after AbbVie's main rival in the HCV sector - Gilead Sciences - won a priority review from the FDA for its own 'pan-genotypic' treatment combining nucleotide analogue polymerase inhibitor Sovaldi (sofosbuvir) with velpatasvir, a new NS5A inhibitor.

If the FDA approves Gilead's drug - which has also been submitted for approval in Europe - it could be on the market as early as the middle of this year, well ahead of AbbVie's candidate.

Gilead leads the market for oral HCV therapies with Sovaldi and two-drug combination Harvoni (sofosbuvir and ledipasvir) - which brought in $3.7bn and $10.5bn in sales respectively in the first nine months of 2015.

AbbVie has however been building market share with its Viekirax/Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) drug which cleared $1bn in sales in the same period of 2015 following its launch in October 2014 and launch the following January.

However, initial expectations that this would quickly grow into a $3bn product have been held back somewhat by a label update last year requiring AbbVie to include information about serious liver injury adverse events, as well as a less convenient dosing regimen (twice-daily) compared to Harvoni.

AbbVie filed for approval of a once-daily version of Viekira Pak/Viekirax in the US last September, but has indicated it sees its current product as a "foothold" in the HCV marketplace. It believes the new two-drug regimen "is poised to deliver meaningful improvements relative to currently available therapies", according to chief executive Richard Gonzalez.

Article by
Phil Taylor

13th January 2016

From: Research



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