AbbVie has released late-stage clinical data showing high cure rates for its experimental ribavirin-free hepatitis C therapy glecaprevir/pibrentasvir (G/P) across the majority of patients infected with the virus.
G/P is a once-daily regimen that combines two distinct antiviral agents – the NS3/4A protease inhibitor glecaprevir (300mg) and NS5A inhibitor pibrentasvir (120mg) – dosed once-daily as three oral tablets.
In the EXPEDITION-1 study, 99 percent (n=145/146) of chronic hepatitis C virus (HCV) infected patients with genotypes 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) taking the regimen achieved sustained virologic response at 12 weeks (SVR12) post-treatment.
Also of note, these high SVR12 rates were seen following 12 weeks of G/P treatment without ribavirin, while patients those virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study.
On the safety side, the majority of adverse events were mild and no patients discontinued treatment due to an AE, while the most common AEs (≥10 percent) were found to be fatigue and headache.
"We have already seen great progress in the treatment of HCV patients with compensated cirrhosis. However, treatment challenges remain related to the use of ribavirin," commented Xavier Forns, head of hepatitis unit, Hospital Clinic de Barcelona, Spain. "The positive findings from the EXPEDITION-1 study, along with previously reported data, show that G/P has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes."
Marketing applications for G/P are currently under review by regulatory authorities across the globe. The treatment has been granted accelerated assessment by the European Medicines Agency (EMA), and priority review designations by the USa Food and Drug Administration (FDA) and Japanese Ministry of Health, Labour and Welfare (MHLW).
According to the firm, the G/P regimen could provide a shorter, eight week, once-daily, ribavirin-free treatment option for the majority of HCV patients without cirrhosis, as well as an additional treatment option to patients with compensated cirrhosis (Child-Pugh A).