Addition of boceprevir significantly increased treatment success in more patients and in a significantly shorter time period compared to standard treatment
MONTREAL , March 30 /CNW/ -Two Phase III studies (HCV RESPOND-2 and HCV SPRINT-2) are published in the March 31 edition of the New England Journal of Medicine (NEJM) demonstrating that addition of the investigational oral medication boceprevir to standard treatment significantly improved sustained virologic response (SVR) - the goal of treatment - in a significantly greater number of adult patients who failed previous treatment (treatment-failure) and in those who were new to treatment (treatment-na?ve) for chronic hepatitis C virus (HCV) genotype 1, compared to standard therapy alone. Also, both studies investigated a new treatment strategy resulting in many patients being able to shorten the duration of therapy from the standard 48 weeks. 1
"These results signal a truly important change in the treatment of hepatitis C genotype 1 infection, one of the most prevalent genotypes in Canada ," said Dr. Marc Bilodeau , a Canadian investigator in the SPRINT-2 study and Associate Professor of Medicine at Universit? de Montr?al . "The addition of boceprevir not only substantially increased the success rates, but also by using response-guided therapy - which indicates how individuals are responding to treatment - many patients taking the drugs for the first time saw their treatment times cut almost in half."
"Being able to shorten the length of treatment is extremely important given that one of the most challenging aspects of treating HCV is managing the debilitating side effects. Because the side effects are so hard to take, unfortunately some patients stop their course of therapy," said Dr. Mark Levstik , an investigator in the SPRINT-2 NEJM-published study and Assistant Professor, Department of Medicine, Division of Gastroenterology, University of Western Ontario.
Boceprevir, an investigational agent not currently available in Canada , belongs to a novel class of direct-acting antiviral agents - called HCV protease inhibitors - that reduce the amount of virus in the blood through inhibition of the function of a viral protein called 'protease' that HCV needs to replicate. 2
An estimated 250,000 individuals in Canada are infected with HCV and there are 3,200 to 5,000 newly infected individuals each year. 3 HCV damages the liver and may lead to serious complications, including death, when left untreated. 4 It is the leading cause of liver transplants in Canada . 5
"The use of a protease inhibitor to treat hepatitis C infection is an important advance in the management of the disease," said Dr. Alnoor Ramji , an investigator in both the SPRINT-2 and the RESPOND-2 published studies and a Clinical Assistant Professor at the University of British Columbia. "As a Canadian investigator, I am encouraged that the studies have been published in this prestigious medical journal. It reinforces the importance of our results."
Karen Stacey lived with the virus for many years before experiencing any symptoms. Her diagnosis came slowly, and only after many tests and visits to multiple physicians.
"I remember constantly feeling dizzy and nauseous, and having a hard time with my memory," said Ms. Stacey . "When I was finally diagnosed with hepatitis C, I had this sinking feeling that people felt I deserved to get this disease. In the minds of many people, only drug addicts or alcoholics get this virus."
Past or current drug use accounts for more than 56 per cent of all hepatitis C infection in Canada . 6 In addition, the virus may be contracted via use of unscreened blood or blood products in medical procedures, body piercing, mother-child transmission and accidental needle-sticking in medical settings. In Karen's case, she contracted the virus following a blood transfusion, which she required during a failed pregnancy in the 1970s.
"To help eliminate the terrible stigma I suffered following my diagnosis, I'm dedicated to educating Canadians about the disease," said Ms. Stacey . "The most frightening thing about the stigma is that it creates an enormous barrier for people infected with hepatitis C to get diagnosed and receive treatment that could cure their disease."
Approximately one-in-three of those infected with HCV are not aware of their infection and it often goes undetected for many years until symptoms appear. 7 Symptoms can include fever, fatigue, reduced appetite, stomach pain, dark urine, jaundice (yellowing of skin or eyes), nausea and vomiting, aching muscles and joints, and poor concentration. 8 If left untreated, HCV may lead, in some patients, to liver fibrosis, cirrhosis, liver cancer and liver failure. 9
The two studies (HCV RESPOND-2 and HCV SPRINT-2) each evaluated two new treatment strategies with boceprevir administered in combination with peginterferon alfa-2b and ribavirin (PR) to assess the ability of boceprevir to improve SVR rates - the goal of treatment - and potentially shorten overall treatment duration compared to the use of PR alone for 48 weeks, which is the current standard duration of therapy.
The HCV RESPOND-2 study examined the use of boceprevir in adult patients who previously failed to eradicate the virus with current standard therapy, including patients who had either relapsed after initially clearing the virus or were non-responders to prior treatment with PR. The HCV SPRINT-2 study examined the use of boceprevir in adult patients who were treatment-na?ve (no prior treatment).
A total of 1,500 patients participated in the two studies, with nearly 10 per cent of patients (146) recruited at 15 Canadian investigation sites. In each study, patients were randomized to one of three treatment arms:
In the HCV RESPOND-2 study (treatment-failure patients), the addition of boceprevir in the RGT arm resulted in 59 per cent of patients eliminating the virus and 66 per cent in the 48-week treatment arm, compared to 21 per cent in the control group (p
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