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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