MSD’s once-daily, single pill, fixed-combination therapy elbasvir/grazoprevir is causing a stir after an analysis of trial data showed that it was able to cure the vast majority of hepatitis C patients who also had compensated liver cirrhosis, a traditionally difficult-to-treat population.
The data, harvested from six Phase II and III clinical trials, show that treatment-naive patients who received elbasvir/grazoprevir with or without ribavirin (RBV) achieved virologic cure at rates of 90 percent (28/31) and 98 percent (135/138), respectively.
Treatment-experienced patients who receiving the pill with or without RBV for 12 weeks achieved virologic cure rates of 91 percent (74/81) and 89 percent (48/54), respectively, while those in the 16 or 18 weeks treatment groups showed cure rates of 100 percent (49/49) and 94 percent (46/49), respectively.
“Patients whose chronic hepatitis C virus infection is complicated by cirrhosis are at a more advanced stage of the disease, and have historically been harder to treat because they are less responsive to antiviral therapy”, explained Graham Foster, Professor of Hepatology at Queen Mary University of London.
With current levels of treatment the number of patients with HCV-related cirrhosis in England is expected to increase by 20% over the next decade, he warned, but noted that the new data “show that we can achieve virologic cure in nine out of ten patients, offering the potential to offer a wider group of patients the opportunity for cure”.
Chronic HCV affects around 214,000 people in the UK and, in England alone, it is estimated that 10,470 individuals are living with HCV-related cirrhosis.
MSD has filed its therapy for approval in Europe, and expects a decision within the first half of next year, and it is also under a priority review in the US, with an action date of January 28.