Hepatitis C - Danoprevir shows potential in phase 2 trials

Related - Novel HCV therapy leads to rapid response

New hepatitis C drug shows potential in phase 2 trials

Bethesda, MD -- The addition of danoprevir to the current treatment regimen for patients with hepatitis C leads to high rates of remission, according to a new article in Gastroenterology, the official journal of the American Gastroenterological Association. The current standard of care for hepatitis C patients includes a combination of peginterferon and ribavirin.

"Despite recent advances, the current hepatitis C treatment regimen is burdensome on the patient and prone to adverse events," said Patrick Marcellin, lead study author from the Service d'Hépatologie and Inserm CRB3, Hôpital Beaujon, APHP University of Paris. "The promising results from this study offer hope that danoprevir can improve the quality of life for patients suffering from this disease."

Investigators conducted a phase 2, randomized, placebo-controlled study and found that, within just one week of treatment, the addition of danoprevir to the current treatment regimen (peginterferon alfa-2a/ribavirin) led to reductions in levels of hepatitis C virus in the blood. Overall, danoprevir was well tolerated and demonstrated an 85 percent sustained virologic response rate (or no detectable virus in the patient's blood after six months).

Importantly, 79 percent of patients who added danoprevir to their treatment regimen achieved an early virologic response and were eligible for a shortened treatment schedule.

Studies of lower doses of danoprevir on top of the current standard of care, to reduce overall danoprevir exposure while maintaining the drug's effectiveness, are underway. Interim effectiveness and safety data are promising.

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver. Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer. Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain. For more information on hepatitis, please read the AGA brochure "Understanding Hepatitis."

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This research was funded by F. Hoffmann-La Roche Ltd.

About the AGA Institute
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. http://www.gastro.org.

About Gastroenterology
Gastroenterology, the official journal of the AGA Institute, is the most prominent scientific journal in the specialty and is in the top 1 percent of indexed medical journals internationally. The journal publishes clinical and basic science studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. The journal is abstracted and indexed in Biological Abstracts, Current Awareness in Biological Sciences, Chemical Abstracts, Current Contents, Excerpta Medica, Index Medicus, Nutrition Abstracts and Science Citation Index. For more information, visit http://www.gastrojournal.org.
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