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Daclatasvir TRIO regimen has good cure rates for hepatitis C patients with or without cirrhosis
Liz Highleyman, 2014-11-11 12:40:00

A 12-week all-oral regimen of daclatasvir, asunaprevir and beclabuvir, with or without ribavirin, cured 86 to 90% of genotype 1 hepatitis C patients with cirrhosis in the phase 3 UNITY-2 trial, while the TRIO regimen without ribavirin demonstrated similar sustained response rates for people without cirrhosis in UNITY-1, according to two late-breaking reports presented yesterday at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting in Boston. Findings suggest that ribavirin is still useful for some people with harder-to-treat hepatitis C.

With the recent US approval of Harvoni (Gilead Sciences' sofosbuvir/ledipasvir) and the pending approval of AbbVie's 3D regimen (paritaprevir/ombitasvir/ritonavir + dasabuvir) – both of which are well-tolerated and cure well over 90% of genotype 1 patients – the bar has been raised for agents further back in the development pipeline. Although there is room for competition on price, any new regimen will have to be highly effective and easy to take with minimal side-effects.

Bristol-Myers Squibb's pan-genotypic (effective against multiple viral genotypes) NS5A inhibitor daclatasvir (Daklinza) was recently approved in the EU. An oral regimen of daclatasvir and the company's HCV NS3/4A protease inhibitor asunaprevir (Sunvepra) is approved in Japan, where most people with hepatitis C have easier-to-treat HCV genotype 1b.

Studies showed that this dual regimen did not work as well against harder-to-treat genotype 1a, but adding a third direct-acting antiviral improved response rates. BMS is now evaluating a twice-daily co-formulation containing daclatasvir (30mg), asunaprevir (200mg) and its non-nucleoside NS5B polymerase inhibitor BMS-791325, newly dubbed beclabuvir (75mg).