International Liver Congress 2016: Glecaprevir/pibrentasvir will pose the fiercest competition to Gilead in non-cirrhotic patients.
By Michael Haydock, Lead Analyst
28 April 2016
I am the Lead Analyst of the immunology and inflammation and infectious diseases and vaccines teams at Datamonitor Healt...
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Glecaprevir/pibrentasvir (ABT-493/ABT-530; AbbVie) is forecast to gain US approval in September 2017 and will pose a major threat to Gilead’s non-cirrhotic genotype 1/2/3 (GT-1/2/3) revenues because of its attractive eight-week duration and anticipated lower price. During the 2016 International Liver Congress, impressive efficacy data were presented from the Phase II SURVEYOR-1 and SURVEYOR-2 studies, which showed that glecaprevir/pibrentasvir produced competitive cure rates (97−98%) in non-cirrhotic GT-1/2/3 patients after just eight weeks of treatment. Glecaprevir/pibrentasvir is therefore likely to be considered interchangeable with Gilead’s sofosbuvir/velpatasvir/GS-9857 given its competitive efficacy and convenient once-daily dosing schedule.
Datamonitor Healthcare expects that glecaprevir/pibrentasvir will have a significant impact on Gilead’s GT-1/2/3 revenues, either by directly taking share from sofosbuvir/velpatasvir/GS-9857 or by forcing Gilead to offer further discounts to payers in order to retain patient share. However, glecaprevir/pibrentasvir will pose weaker competition in cirrhotic patients because it is currently being investigated in a longer 12-week duration in this segment, while Gilead is pursuing a more ambitious eight-week dosing schedule. The lack of a nucleotide NS5B inhibitor in AbbVie’s next-generation regimen may prevent the shortening of treatment duration beyond 12 weeks in patients with advanced disease, placing the company at a disadvantage to rivals in possession of nuc-containing triple regimens.
|SURVEYOR-1 and SURVEYOR-2 efficacy data in non-cirrhotic patients treated for eight weeks|
|Patient population||SVR12 rates|
|Non-cirrhotic GT-1 patients||97% (33/34)|
|Non-cirrhotic GT-2 patients||98% (53/54)|
|Non-cirrhotic GT-3 patients||97% (28/29)|
|Source: Datamonitor Healthcare’s hepatitis C pipeline, April 2016|
This is excerpted from Datamonitor Healthcare’s Hepatitis C: Pipeline, comparing the clinical and commercial attractiveness of early-phase and late-phase candidates, providing an assessment of future product positioning and competitiveness in the marketplace.
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