BRISTOL-MYERS SQUIBB ANNOUNCES HIGH CURE RATES FOR GENOTYPE 3 HEPATITIS C USING COMBINATION OF DACLATASVIR AND SOFOSBUVIR IN ALLY-3 TRIAL
• Sustained virologic response after 12 weeks achieved in 90% of treatment-naïve and 86% of treatment-experienced patients in first all-oral, ribavirin-free treatment regimen in difficult-to-treat genotype 3.
Results of the landmark ALLY-3 trial announced this week show sustained virologic response after 12 weeks of treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced patients with genotype 3 hepatitis C (HCV) who received the investigational Bristol-Myers Squibb treatment daclatasvir in combination with sofosbuvir.
The combination is the first all-oral, ribavirin-free treatment regimen for genotype 3 in HCV. This is the second most common genotype of the disease worldwide and has emerged as one of the most difficult to treat. The results were presented at The Liver Meeting® 2014, the Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, Massachusetts.
“These are very encouraging results from this new combination therapy, particularly given the challenges we have in treating patients with this genotype of hepatitis C that can progress very rapidly,” said Dr. Samuel Lee, hepatologist at the University of Calgary. “The availability of an effective all-oral treatment regimen with the possibility to cure is very promising because these are some of the most difficult patients to treat.”
“Canadians with hepatitis C are very pleased to see positive results from studies of new treatments that are revolutionizing the management of this disease and hold promise of a cure for many patients,” said Daryl Luster, President and Chair of Pacific Hepatitis C Network in Vancouver. “We hope these much-needed new treatments become available to Canadian patients soon. The complexity of this disease makes it important for patients to have different treatment options.”
In the ALLY-3 study, the daclatasvir and sofosbuvir combination regimen was well tolerated, with no deaths, treatment-related serious adverse events, or discontinuations due to adverse events. The most frequent side effects (≥5%) were headache (19.7%), fatigue (19.1%), nausea (11.8%), diarrhea (8.6%), insomnia (5.9%), abdominal pain and arthralgia (both 5.3%). Additionally, there were 17 (11.2%) treatment failures, with 16 relapses post-treatment and 1 rebound at the end of treatment. There were no viral breakthroughs in this ribavirin-free regimen.
About ALLY-3: Study Design
This Phase III open label clinical trial enrolled 152 genotype 3 HCV patients; 101 treatment-naïve patients and 51 treatment-experienced patients in 2 cohorts each received daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks, with 24 weeks of follow-up. The primary endpoint was SVR12 rates, defined as HCV RNA < LLOQ target detected or not detected at follow-up week 12 in treatment-naïve and treatment-experienced patients. The full abstract for the presentation is available at The Liver Meeting website.
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 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 percent may progress to liver cancer.
About Genotype 3
Genotype 3 is estimated to affect 54 million people and is the second most common worldwide behind genotype 1 (83 million). It is now potentially the most difficult-to-treat genotype, and the more aggressive nature of genotype 3 lies in the damage it causes to the liver, as it is associated with progressive disease, increased rates of steatosis and a disproportionately increased risk of hepatocellular carcinoma.
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.