- All-oral, 12-week treatment in UNITY-2 trial achieves 98%
cure rate in treatment-naïve and 93% in treatment-experienced
patients with cirrhosis when used with ribavirin and 93% and 87%
respectively without using ribavirin.
MONTREAL, Nov. 13, 2014 /CNW/ - Ten Canadian research sites
were among those that participated in a study whose results
announced this week show high cure rates for patients with genotype
1 hepatitis C, including those with cirrhosis, after a 12-week
regimen of the new Bristol-Myers Squibb all-oral daclatasvir (DCV)
TRIO regimen – a fixed-dose combination of daclatasvir with
asunaprevir (ASV) and beclabuvir (BCV) treatment
The UNITY-2 study showed sustained virologic response 12 weeks
after treatment (SVR12) among 98% of treatment-naïve and 93% of
treatment-experienced cirrhotic patients with ribavirin and 93% of
treatment-naïve and 87% of treatment-experienced cirrhotic patients
without ribavirin.
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 a very positive results, particularly as we see high
rates of viral eradication in patients with cirrhosis who are
normally very difficult to treat, even with treatment regimens
twice as long at 24 weeks," said Dr. Alnoor
Ramji, Clinical Associate Professor of Medicine in the
Division of Gastroenterology at the University
of British Columbia, and one of the Canadian investigators
who participated in the study. "The daclatasvir TRIO shows
tremendous promise in achieving a cure over a shorter period of
time, which should promote treatment adherence."
Study Design and Results
The Phase III UNITY clinical
trial program is an ongoing study investigating 12-week regimens of
the DCV-TRIO fixed-dose combination (daclatasvir 30 mg plus
asunaprevir 200mg plus beclabuvir 75 mg) in non-cirrhotic and
cirrhotic genotype 1 patients.
The open-label UNITY-1 study evaluated a 12-week regimen of the
DCV-TRIO without ribavirin in treatment-naïve and -experienced
non-cirrhotic patients. Non-cirrhotic treatment-naïve patients
(n=312) and treatment-experienced patients (n=103) received the
DCV-TRIO fixed-dose combination in one pill twice daily for 12
weeks, with 24 weeks of follow-up. The majority of the patients
(73%) were genotype 1a, and 91% of all patients achieved SVR12. 92%
of treatment-naive patients and 89% of treatment-experienced
patients achieved cure, without the use of ribavirin.
In the UNITY-2 study, both cirrhotic treatment-naïve and
treatment-experienced patients received the DCV-TRIO fixed-dose
combination, one arm without ribavirin (n=102) and one with
ribavirin (n=100). The study was double-blinded to ribavirin, and
the majority of the patients (74%) were genotype 1a. The study
showed 96% of all patients who received DCV-TRIO with ribavirin
achieved SVR12, and 90% of those who received DCV-TRIO without
ribavirin achieved SVR12.
In both UNITY-1 and UNITY-2 there were low rates of adverse
events (AEs) leading to discontinuation and of serious adverse
events (SAEs) overall. In UNITY-1 there were 7 SAEs, all considered
not related to study treatment and 3 AEs leading to treatment
discontinuation. The most common AEs were headache (25.8%) and
fatigue (16.6%). In UNITY-2, there were 3 SAEs related to treatment
and 4 AEs leading to discontinuation. The most common AEs
were headache and fatigue (both 19.8%).
Full abstracts for both presentations are 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 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