MSD Announces Results from its Pivotal Phase III C-EDGE Programme and C-SURFER Trial

MSD has announced the first presentation of data from the C-SURFER trial, the first to investigate an all-oral, once-daily, Ribavirin-Free Hepatitis C treatment regimen of grazoprevir (100 mg) and elbasvir (50 mg) in treatment-naïve and treatment-experienced patients infected with chronic hepatitis C virus (HCV) genotype 1 and advanced chronic kidney disease (CKD), demonstrating sustained virologic response (SVR) 12 rates of 99%.

In addition, results from the C-EDGE clinical trial programme were announced, including data sets evaluating treatment-naïve, treatment-experienced and HIV co-infected patients with chronic hepatitis C virus genotypes 1, 4 or 6 Infection, demonstrating SVR 12 rates of 92–97% These data were presented at The International Liver Congress 2015 – the 50th annual congress of the European Association for the Study of the Liver.

Dr Kosh Agarwal, Consultant Hepatologist and Transplant Physician at the Institute of Liver Studies, King's College Hospital, stated: “Data from the C-SURFER and C-EDGE trials are extremely encouraging given they provide well-tolerated treatment options for 'more difficult to treat patient populations', such as cirrhotics. Specifically, those patients with co-morbidities, such as CKD, demonstrate high efficacy and favourable tolerability within a well conducted trial design.”

The C-SURFER phase II/III clinical trial is evaluating patients infected with chronic HCV genotype 1 with advanced CKD stages 4 and 5 with or without liver cirrhosis, including treatment-naïve patients and patients who failed prior pegylated interferon HCV therapy. Following 12 weeks of immediate treatment with grazoprevir and elbasvir, in the modified full analysis set‡, 99% of patients receiving grazoprevir plus elbasvir achieved a sustained virologic response 12 weeks after completion of treatment (SVR12).

Dr Kosh Agarwal continued: “At present, there is limited treatment options for patients with advanced CKD including those on haemodialysis. The initial C-SURFER data demonstrates high cure rates without the need for ribavirin and interferon and favourable tolerability. This combination could improve patient care and access to renal transplantation.”

Data sets from the ongoing C-EDGE Phase III clinical trial programme include treatment-naïve, treatment-experienced and HIV co-infected patients with chronic hepatitis C virus genotypes 1, 4 or 6 Infection. Patients in both the HCV infected treatment-naïve (C-EDGE TN) and HIV/HCV co-infected treatment-naïve (C-EDGE CO-INFXN) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95%. In addition, HCV infected treatment-experienced patients (C-EDGE TE) treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94% and 92%, respectively, and those treated for 16 weeks achieved SVR12 rates of 97% and 92%, respectively.

Further, patients with cirrhosis in C-EDGE TN and C-EDGE CO-INFXN trials treated for 12 weeks achieved SVR12 rates of 97 percent and 100 percent respectively.2,3 In addition, HCV infected treatment-experienced patients (C-EDGE TE) with cirrhosis treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 89%, respectively, and those treated for 16 weeks achieved SVR12 rates of 92& and 100%, respectively.

Dr Mark Toms, Medical Director, MSD UK, commented: “The data from the C-SURFER trial and C-EDGE programme show that we are progressing towards being able to achieve our ultimate goal: helping to eliminate hepatitis C. Having demonstrated consistently high rates of SVR12 in a diverse population of patients infected with chronic HCV, including the more difficult to treat patients with co-morbidities such as advanced chronic kidney disease, physicians could hopefully soon have another treatment option in their armamentarium. This is great news for the estimated 214,000 people in the UK living with hepatitis C, many of which remain undiagnosed.”