New study of ‘treatment with no treatment’ for chronic hepatitis B
New study of ‘treatment with no treatment’ for chronic hepatitis B opens at California Pacific Medical Center
Oct. 13, 2016
Many people with hepatitis B virus infection develop chronic disease that requires lifelong treatment with antiviral medications. The infection is a leading cause of cirrhosis and liver cancer deaths globally and in the San Francisco Bay Area, especially among Asian populations. Many adults with chronic hepatitis B have the ‘E-antigen negative’ form, which is treated indefinitely.
Studies suggest that even the best antiviral medications rarely clear the virus from the blood nor help the body’s immune system to generate defensive antibodies that fight the infection. But new evidence from independent clinical research groups in Germany and Greece suggests that a carefully planned approach to stopping antiviral therapy can be safe, avoid further liver damage for many, and—in an unprecedented number of cases—essentially cure the disease by decreasing or removing hepatitis B virus from the blood.
For the first time in the U.S., a new National Institutes of Health-funded study will attempt to validate findings from the European groups and determine if stopping antiviral therapy can be safe, prevent recurrent disease and achieve near cures in ethnically diverse people with E-antigen negative chronic hepatitis B.
Beginning this fall and expanding upon an initial pilot study at California Pacific Medical Center (CPMC), the BeNEG-DO study will test the effects of stopping antiviral treatment in 80 people with E-antigen negative chronic hepatitis B who have been treated successfully for at least 3.7 years (192 weeks). For comparison, 30 people in a control group will continue therapy.
“The European studies suggest that some patients who remain off antiviral therapy not only clear the virus from their blood and normalize their liver enzyme levels (meaning they have no liver injury), but a remarkable number develop protective immune responses, including surface antibodies, to combat the virus,” says Stewart Cooper MD, Chief of Hepatology, a clinician-scientist at CPMC and its Research Institute, and lead study investigator.
“None of the European patients who stopped therapy were harmed and the ones who restarted therapy because their disease recurred all responded. Our aim is to replicate these findings and learn how to select individuals with chronic hepatitis B who are most likely to experience long-term benefit from stopping treatment after appropriate times. Dr. Jody Baron at the University of California at San Francisco, myself and our expert co-investigator team are highly motivated by the potential implications of this study for millions of people with chronic hepatitis B, which could also alleviate the cost burden to healthcare systems nationally and globally.”
During the study, patients will be closely monitored for symptoms, liver injury, and blood levels of hepatitis B antigens and antibodies. Patients who show signs of disease recurrence will be promptly returned to their prior antiviral therapy. Over five years, Dr. Cooper and colleagues will evaluate the clinical outcomes, immune responses and genetic profiles of patients with E-antigen negative chronic hepatitis B who stop antiviral therapy.
For more information about the BeNEG-DO study, visit https://clinicaltrials.gov/ct2/show/NCT02845401?term=BeNEG&rank=1