Treatment with a telaprevir-based combination regimen for hepatitis C - heretofore a chronic, destructive and difficult to manage disease - effectively can be shortened to six months in about two-thirds of patients, finds a new study published Thursday in the New England Journal of Medicine.
Telaprevir, a drug approved for use against hepatitis C in May, inhibits replication of virus. This anti-viral drug and a similar medication called boceprevir have nearly doubled the number of patients with sustained response. Among patients treated with teleprevir, pegylated interferon and ribavirin in the new study, 72 percent were cured of their hepatitis C.
This study shows that two-thirds of patients can be cured in half the time: Patients who are clear of the virus within the first four to 12 weeks of therapy effectively can cut their treatment time from 48 weeks to six months. Besides the considerable benefits to patients of shorter treatment, these findings also show that response-guided therapy is a successful strategy.
"This means that rather than a one-size-fits-all approach, we can individualize treatment for patients based on their specific response to the drugs," said Fred Poordad, MD, chief of Hepatology and Liver Transplantation at Cedars-Sinai and a senior author on the study. "Once you're cured by these anti-viral drugs, you're cured of hepatitis C completely. That's a little known fact among the public - and even among physicians who don't regularly treat liver disease.
Cedars-Sinai is one of the major research sites investigating new treatments for hepatitis C; the medical center is involved in developing most of these new compounds. Earlier this year, Dr. Poordad was the lead author of a study published in the New England Journal of Medicine on the anti-viral drug boceprevir, also an oral protease inhibitor. In that study, 1,097 patients with hepatitis C who had never been treated for the virus received standard treatment - pegylated interferon and ribavirin - for four weeks. Then, a third of the patients continued only on those drugs, while two other groups also received different durations of boceprevir. The boceprevir patients responded well, with 63 percent and 66 percent achieving sustained virus suppression - compared to 38 percent among patients taking only pegylated interferon and ribavirin.
According to the Centers for Disease Control, an estimated 3.2 million people in the United States have chronic hepatitis C virus infections. The disease is spread through virally infected blood, often by sharing of syringes or other equipment to inject drugs; prior to 1990, some infections can be attributed to blood transfusions. Some rare infections can be traced to medical procedures. Chronic hepatitis C is the leading cause of liver cancer and cirrhosis and is the chief reason for the need for liver transplants in the U.S. The disease is linked to as many as 10,000 deaths each year.
In the new telaprevir study, funded by Vertex Pharmaceuticals in Cambridge, Mass., a total of 540 patients were enrolled. They took a 12-week course of 750 milligrams of telaprevir three times a day in addition to therapy with pegylated interferon and ribavirin. Patients eligible for shortened treatment - meaning the virus was not detectable in the first month of treatment - were randomized to receive either 24 weeks or 48 weeks of treatment. The high cure rates among both groups showed that there was no benefit to additional treatment for early responders.
For patients, the shorter course of treatment means decreased costs, fewer side effects and less disruption to their daily lives, as this therapy requires intensive monitoring and laboratory visits.
Dr. Poordad has received research grants and served as an adviser and consultant for Vertex Pharmaceuticals, which makes telaprevir, and Merck, which makes boceprevir.
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