Late Breaking News
New Drugs Hold Promise for Veterans with HCV
- Categorized in: December 2010, Department of Veterans Affairs (VA), FDA, HHS and USPHS, News, Research
WASHINGTON, DC—The hepatitis C (HCV) treatment program in VA marks its 10-year anniversary this year on a note of hopeful expectation. For years the only treatment for HCV has been combination pegylated interferon and ribavirin—a treatment with harsh side effects and a cure rate between 20% and 25% among VA patients. But several new drugs currently in development promise to almost double that success rate, which is good news for VA’s 150,000 HCV patients.
“They’re still investigational, but there’s a lot of hope,” declared David Ross, MD, PhD, director of VA’s Office of Clinical Public Health Programs. “We’re preparing the system for the possibility that they’ll be available.”
Currently, the interferon and ribavirin combination must be taken for at least a year—the interferon by injection, the ribavirin orally—and the treatment has a list of side effects, including depression in as many as 20% of individuals taking the drugs. The length of treatment, the side effects, and the relatively low success rate has a negative impact on treatment adherence.
The two investigational drugs farthest in development (telaprevir, manufactured by Vertex, and boceprevir, manufactured by Merck) are both oral medications that would be given in conjunction with the standard therapy. The new medications would be taken for the first three months of therapy, and then discontinued while the standard therapy continued for three to nine months longer.
In clinical trials that have yet to be FDA-verified, the add-on drugs increased the response rate significantly—from 44% to 75% in the study enrollees. VA patients, who are generally older and sicker than the average US population—and far sicker than the carefully selected clinical trial patients—could still expect to see a proportional increase in the success rate, Ross explained. “In the real world, the cure rates go down dramatically. A lot of times you treat patients with problems who would never have gotten into the clinical trial.”
The trials also suggest that patients who have been treated before with no success might find success with the new drug combination. At least two VA hospitals have enrolled patients in these drug trials.
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