WHITEHOUSE STATION, N.J.--
Hepatitis C sufferers might have a new light going on at theend of the proverbial tunnel. Boceprevir, Merck & Co.'s experimental drugfor the liver disease, cures more patients than do current therapies and worksbetter than current drugs alone in clinical trials, says U.S. Food and DrugAdministration (FDA) staff in a preliminary review. Regulators will consider whetherto clear the drug, the first treatment for hepatitis C in over a decade, and externaladvisers to the FDA will be meeting April 27 to evaluate Merck's findings.
FDA staff noted in a preliminary report that "in general, weagreed with the applicant's analysis of the primary efficacy endpoint" ofboceprevir in patients had experienced failure with prior treatments. Merck'sdrug candidate was also effective in treatment-naïve patients as well.
In a self-funded study of the drug, Merck found that nearlyhalf of the patients taking boceprevir were able to shorten the duration oftheir treatment by 12 to 20 weeks, the company reported in a statement March30. The study also showed that in combination with standard therapy, boceprevircured 64 percent of chronic hepatitis-C patients for whom previous treatmentshad failed, compared to 21 percent of patients who took peginterferon andribavirin without boceprevir. For the study participants who were new totreatment, 65 percent of those taking boceprevir were cured, compared with 38percent of those strictly taking the standard therapy.
The current standard therapy combines ribavirin, anantiviral drug, with peginterferon, an immune-boosting protein sold by Merck asPegIntron and Roche Holding AG as Pegasys, which received FDA approval in 2001and 2002 respectively. The current therapy calls for nearly a year of treatmentand cures less than half of patients, according to Donald Jensen, director ofthe Center for Liver Diseases at the University of Chicago Medical Center.
Hepatitis C is a blood-borne disease that can lead to livercirrhosis and cancer. According to the Centers for Disease Control andPrevention, nearly 170 million people worldwide have hepatitis C, and novaccine exists for the disease.
Recently, though, companies like Merck have begun exploringthe development of hepatitis C drugs that are more effective and demonstratefewer side effects than the current method. Vertex Pharmaceuticals Inc. hastheir own drug candidate for treating hepatitis C, and FDA advisers will bemeeting April 28 to review the drug, known as telaprevir. Separate trials haveshown that both drugs, known as protease inhibitors, succeed in curing morepatients and shortening the treatment period when combined with standardtherapy. Both drugs are likely to secure FDA approval, and Geoffrey Porges, ananalyst at Sanford C. Bernstein & Co. in New York, says that the drugs mayhit the mark by May or June. Jensen notes that the two drugs "clearly have theability to revolutionize the therapy for hepatitis C." Six analysts surveyed byBloomberg estimated that sales of boceprevir might surpass $604 million in2013.
According to the FDA staff report, side effects ofboceprevir include increased frequency and severity of anemia. The agency isasking the advisory panel to carefully weigh boceprevir's benefits against therisks.