- 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.
MONTREAL, Nov. 13, 2014 /CNW/ - 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.
SOURCE Bristol-Myers Squibb Canada