AbbVie’s Hepatitis C drug works in difficult to treat patients
New data on AbbVie’s three-pronged Hepatitis C treatment shows the combination helped patients whose infection had previously been difficult to treat.
AbbVie’s three way regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without RBV (weight-based), dosed twice daily.
The combination of three different mechanisms of action interrupts the Hepatitis C virus (HCV) replication process, with the aim of maximising the number of patients and groups of patients with different variants of the disease being cleared of the virus.
Hepatitis C is currently one of the most exciting areas of new medical developments, with a wave of new treatments promising to cure more patients of their condition.
AbbVie unveiled its Phase III pivotal study, SAPPHIRE-I at the International Liver Congress (ILC) 2014 in London today, following on yesterday’s results from the pivotal phase III study, SAPPHIRE-II.
In the SAPPHIRE-I (N=631) and SAPPHIRE-II (N=394) placebo-controlled studies, adult, non-cirrhotic patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection receiving the AbbVie regimen with ribavirin (RBV) for 12 weeks achieved sustained virologic response rates 12 weeks post-treatment (SVR) of 96.2% and 96.3% respectively.
In SAPPHIRE-II, treatment-experienced sub-populations randomised to the AbbVie regimen with RBV were prior null responders (49.2 percent), prior relapsers (29%) and prior partial responders (21.9%) to pegylated interferon and RBV.
“Patients with chronic hepatitis C who have not responded well to treatment in the past have historically been more difficult to treat,” said Stefan Zeuzem, M.D., lead clinical investigator on SAPPHIRE-II and Chief of the Department of Medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. “These data show very promising results in people who are infected with either subtype of the GT1 hepatitis C virus and who are either new to therapy or treatment-experienced.”
In SAPPHIRE-I, high response rates were seen across patients with certain variable characteristics, including gender, race, body mass index, fibrosis stage and baseline HCV viral load, as some of these patients have historically had a reduced response to treatment.
Other new competitors in the Hepatitis C field include Gilead’s Sovaldi (approved in the US and Europe) Janssen’s approved Olysio (approved in the US) and Merck’s two drug combination MK-5172 and 50 mg of MK-8742 (in phase III development) and Bristol Myer Squibb’s two drug combination of daclatasvir and asunepravir.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.