DDW 2013 - New therapy for patients with hepatitis C examined

Pharmaceutical advances offer new options for health outcomes

Research presented at DDW® 2013 feature new drugs for IBS, hepatitis C

Orlando, FL (May 20, 2013) — Research presented at Digestive Disease Week® (DDW) explores pharmaceutical advances for treating irritable bowel syndrome with diarrhea (IBS-D) and hepatitis C.

An international study holds promising results for patients suffering from IBS-D. In the phase II study, researchers found that the drug ibodutant significantly improved symptoms in more than 50 percent of the individuals treated.

"While there's been a lot of progress in medicines for IBS with constipation, we haven't seen the same in IBS with diarrhea," said Jan Tack, MD, professor and director of the division of gastroenterology and internal medicine at Leuven University in Belgium. "Up to this point, we haven't been able to provide a pharmaceutical option for this patient group that successfully manages the pain associated with the condition."

IBS is an extremely common condition, affecting an estimated 10 percent of adults. Funded by Menarini, the double-blind, multinational study recruited 559 patients with IBS-D who were randomized and treated with 1, 3 or 10 mg of ibodutant or a placebo. Patients took an oral tablet once daily for eight consecutive weeks. Researchers found that 10 mg was the most effective dose and that it worked best for females.

"These are exciting findings that could bring a lot of relief to many patients," said Dr. Tack said. "We're looking forward to moving into phase III to confirm our findings with a much larger sample of patients."

New therapy for patients with hepatitis C examined

New research suggests that an investigational therapy for patients with hepatitis C can achieve high response rates in a wide range of patients, even those who respond poorly to current treatments. The study examined the safety and efficacy of interferon-free regimens, including three direct-acting antiviral drugs with and without ribavirin, for 12 or 24 weeks, in patients with chronic hepatitis C who were either treatment-naïve or had previously failed standard treatment with peginterferon and ribavirin.

In the phase II study, researchers found that the treatment regimens achieved high sustained virologic response (SVR) rates, an efficacy measure of a hepatitis C treatment, in non-cirrhotic patients with HCV genotype-1 (GT 1). SVR was achieved by 98.7 percent of treatment-naïve patients and 93.3 percent of prior nonresponders after 12 weeks of treatment with three direct-acting agents with ribavirin.

"Hepatitis C genotype 1 is the most common type of hepatitis in the U.S., and many of these patients are still quite difficult to treat with current interferon-based therapies," said Frederick Nunes, MD, clinical associate professor of medicine at Penn Medicine. "This includes specific populations such as African Americans and patients with high body mass or pre-diabetes. These results suggest that highly effective regimens like this one may overcome that difficulty, without the need for interferon."
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Assigning 247 patients to 12- or 24-week regimens, researchers found that four weeks after treatment, SVR rates were high regardless of patient characteristics previously associated with poorer response to interferon therapy. Funded by AbbVie (formerly Abbott), the study's results hold particular significance for patients who are older, black, Hispanic or have a higher body mass index.

Dr. Tack will present data from the study "Efficacy of ibodutant, a selective antagonist of neurokinin 2 receptors, in irritable bowel syndrome with diarrhoea (IBS-D): the results of a double-blind, randomised, placebo-controlled, parallel-group phase II study (The IRIS-2)," abstract 520, on Monday, May 20, at 8 a.m. ET in Room 300 of the Orange County Convention Center.

Dr. Nunes will present data from the study "Interferon-free Regimens of ABT-450/r, ABT-267, ABT-333, and Ribavirin Achieve High Sustained Virologic Response 4 Weeks Post-Treatment (SVR4 ) Rates in Patients With Chronic HCV Genotype 1 Regardless of Race, Ethnicity, or Other Baseline Characteristics" abstract 514, on Monday, May 20, at 8 a.m. ET in Room 203AB of the Orange County Convention Center.

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 to 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at http://www.ddw.org.