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Hepatitis B Clinical Research Network Starts
Department of Health and Human Services and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) are starting the Hepatitis B Clinical Research Network, and have distributed Requests For Applications (RFA). The total amount to be awarded is approximately $3 MM during FY 2008 (year 1 of the Network) and up to approximately $7 MM per year in years 2 to 7 of the Network. NIDDK anticipates that funding will be available for up to 10 clinical center site awards complemented with two basic/translational research labs (virology and immunology). One single data coordinating center will be funded as well.
"A central challenge to the Hepatitis B Clinical Research Network will be to establish a randomized, controlled trial of long-term mono- versus combination therapy for chronic hepatitis B. The Network steering committee will formulate and design this trial which will be aimed at assessing the long-term (4-5 year) efficacy of monotherapy versus combination therapy of chronic hepatitis B. The Network will solicit industry partners to help support this trial. Possible agents to be studied would include (but not be limited to):
1. Entecavir vs tenofovir vs. the combination of both
2. Tenofovir & emtricitabine vs. tenofovir alone vs emtricitabine alone
3. Peginterferon vs entecavir vs. the combination of both
4. Peginterferon & tenofovir vs. tenofovir alone vs. tenofovir & emtricitabine.
All projects must be completed within the 7-year duration of this research program."
"Research Scope: The objective of this RFA is to establish a Hepatitis B Clinical Research Network that will accelerate advances in the understanding and clinical management of this liver disease."
"The Network would accelerate clinical research and progress in understanding the immunopathogenesis of chronic hepatitis B and treatment strategies with the currently available therapeutic agents."
"The Network would be charged with developing a large database of patients with chronic hepatitis B and with the design of a treatment protocol that would permit the development of testable hypotheses that will address the most important clinical research challenges that should be resolved in the next 5 to 10 years as delineated in the Management of Chronic HBV: 2006 summary."
Key Dates
Release Date: October 11, 2007
Letters of Intent Receipt Date: January 30, 2008
Application Receipt Date: February 27, 2008
Peer Review Date(s): June-July 2008
Council Review Date:October 2008
Earliest Anticipated Start Date: November 1, 2008
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: February 28, 2008
(There are 5 million in the USA with HCV). !!!!
"Chronic hepatitis B affects approximately 350 million persons throughout the world, a significant proportion of which are at risk for developing cirrhosis, liver failure, and liver cancer. In the United States, approximately 1.5 million Americans, or ∼ 0.5% of the population have acquired the disease. Chronic hepatitis B is uncommon in the "general" population, but affects certain groups at a much higher rate. Thus, the prevalence of chronic hepatitis B is estimated to be 3 to 5% among men who have sex with men, injection drug users, renal dialysis patients and persons with hemophilia. Importantly, chronic hepatitis B in the United States affects 10 to 15% of foreign born and first generation Asian Americans and is also common among recent immigrants from the Middle East, Africa and Eastern Europe. Approximately 5% of children adopted from Asia, Russia and Eastern Europe have chronic hepatitis B.
Therapy has recently advanced considerably with the availability of 6 different agents to treat chronic hepatitis B (interferon alpha, peginterferon, lamivudine, adefovir dipivoxil, telbuvidine and entecavir) and several more likely to be approved in the near future (tenofovir and emtricitabine). Each of these agents is effective; however, they do not cure hepatitis B but rather lead to potent suppression of viral replication. The majority of patients respond to treatment with improvements in liver histology and serum aminotransferase levels, but almost all patients relapse when therapy is stopped. Importantly, there are no reliable guidelines for how these agents should be used: which agent? in which patient? alone or in combination? for a defined period (1 yr, 2 yr) or indefinitely? using what markers to measure success or failure? Many patients are placed on an oral anti-HBV agent indefinitely, although the long-term efficacy and safety of most of these agents is unproven.
A major shortcoming of current therapies is the development of antiviral resistance.
Scientific knowledge to be achieved: Several research challenges remain regarding chronic hepatitis B despite the more than 40 years of investigation. Basic questions regarding the immunologic factors that interplay between the host and the hepatitis B virus in the progression of acute to chronic hepatitis B or in the evasion of immune clearance; the components of the host and virologic interactions that influence hepatocellular injury; the determinants of liver disease progression versus quiescence; determining which patients should be treated with which agent(s) for how long and when to stop therapy on the basis of which criteria.
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