Hepatitis C cure rate of 94% achieved in patients post-liver transplant and up to 94% in those with advanced cirrhosis (Child-Pugh Class A and B) following 12-week, oral treatment with combination daclatasvir and sofosbuvir once daily, plus ribavirin, in ALLY-1 trial

• Positive results seen in historically difficult-to-treat patients without changing other medications, including those post-transplant with genotypes 1 and 3

MONTREAL, April 29, 2015 /CNW/ - A 12-week treatment with the Bristol-Myers Squibb investigational therapy daclatasvir in combination with sofosbuvir, two once-daily, oral medications for chronic hepatitis C infection, as well as ribavirin, has been shown in new study results to cure 94% of those all trial patients with post-liver transplant hepatitis C recurrence and up to 94% of all participants with advanced cirrhosis (Child-Pugh Class A and B).

These patients historically have been challenging to treat, particularly due to drug-drug interactions for post-transplant patients. The new results from the ALLY-1 study announced last week show no need to alter patients' transplant-related therapies to treat their hepatitis C infection.

"The data from this new study confirm that the combination of daclatasvir and sofosbuvir is very effective in curing hepatitis C infection in various groups of patients who have historically been difficult to treat/cure," said Dr. Paul Marotta, head of the Liver Transplant Unit at London Health Sciences Centre and Associate Professor of Medicine at Western University, London, Ontario. "These new results are very encouraging for those dealing with advanced liver disease. Additionally, those patients who have received liver transplant now have the opportunity to keep their new liver healthy following transplant without needing to alter the dosing of other medications they need to take."

Hepatitis C infection and its resulting liver damage is the leading cause for liver transplantation worldwide. Without treatment, hepatitis C infection of the new liver after transplant is inevitable, and is associated with rapid progression to cirrhosis and death in up to 30% of patients within five years.

ALLY-1 study design and results
The ALLY-1 phase III open-label clinical trial enrolled treatment-naïve and treatment-experienced patients with HCV infection of any genotype in two cohorts: advanced cirrhosis (n=60) and post-liver transplant with recurrence of hepatitis C infection (n=53). All patients received daclatasvir 60 mg plus sofosbuvir 400 mg once-daily with ribavirin initially dosed at 600 mg/d (with potential for adjustment based on hemoglobin levels and creatinine clearance) for 12 weeks. Patients receiving a variety of immunosuppressive agents were permitted. In the cirrhosis cohort, patients transplanted during treatment could receive 12 weeks of extended treatment immediately post-transplant, regardless of treatment duration before transplant.

The study's primary endpoints were reached, with 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis achieving SVR12. Among all ALLY-1 patients, 94% of those with post-transplant HCV recurrence and 83% of all participants with advanced cirrhosis achieved cure (sustained virologic response 12 weeks after treatment; SVR12).

The Child-Pugh scoring system is commonly used to assess the severity and prognosis of chronic liver disease and cirrhosis, and uses an A through C classification (C being the most advanced). Patients with class C cirrhosis are decompensated, often with later-stage conditions such as ascites (the build-up of fluid in the abdomen), hepatic encephalopathy (confusion or altered level of consciousness due to the liver's inability to remove toxins from the blood), and abnormal liver function, which can complicate treatment. The ALLY-1 trial included 16 patients with decompensated cirrhosis Child-Pugh class C; nine (56%) achieved SVR12. Those with Child-Pugh class A and B cirrhosis achieved cure rates up to 94%.

Over the course of the study, four advanced cirrhotic patients received a liver transplant during treatment; three of four extended treatment post-transplant and all four achieved SVR12. There were no serious adverse events related to study medications throughout the treatment phase. 

About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90% of those infected with hepatitis C will not spontaneously clear the virus and become chronically infected. According to the World Health Organization, up to 20% of people with chronic hepatitis C will develop cirrhosis; of those, up to 20% may progress to liver cancer.

About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bmscanada.ca.

SOURCE Bristol-Myers Squibb Canada

Monica Flores, Public Affairs Lead, Bristol-Myers Squibb Canada, 514-333-3845, [email protected]