Washington DC, March 22, 2019 – The Forum for Collaborative Research announced the publication of a manuscript, "Challenges, Considerations, and Principles to Guide Trials of Combination Therapies for Chronic Hepatitis B Virus" in the February 2019 volume of the peer-reviewed journal Gastroenterology.

"The Treatment Combinations Working Group of the HBV Forum has created a conceptual framework for clinical trials that provides adequate safeguards for trial participants while allowing rapid testing and innovation of new treatments," said Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research.

The paper addresses trials with two or more investigational drugs as well as those where novel therapeutics are combined with previously approved treatment options.

"Achieving the goal of finite therapy for chronic HBV infection will most likely require combination of two or more therapeutic strategies, " said Bruce Given, Chief Operating Officer of Arrowhead Pharmaceuticals. "We need to be smart as we proceed - what combinations are most likely to take us to the goal and how do we get the answers we need as safely and expeditiously as possible."

The development of this manuscript included input and contributions from key opinion leaders in the field of HBV, and was led by Seng Gee Lim of the National University of Singapore, Poonam Mishra and Eric Donaldson from the US Food and Drug Administration, Filip Josephson of the Swedish Medical Products Agency, and Bruce Given.

"Our aim with this manuscript was to facilitate the advancement of regulatory science by finding a consensus among a diverse group of experts for guiding combination drug development," said Ryan Anderson, MS, MPH, first author and Senior Research Associate with the Forum for Collaborative Research.

The article is available online at: https://doi.org/10.1053/j.gastro.2018.11.062.

The HBV Forum, a project of the Forum for Collaborative Research, is a platform for ongoing multi-stakeholder dialogue and collaboration to identify barriers, prioritize research, identify solutions to accelerate therapeutic development for chronic HBV infection.

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About the Forum for Collaborative Research
Founded in 1997, The Forum for Collaborative Research at the UC Berkeley School of Public Health is a public/private partnership with a mission to catalyze clinical development and improve global health by facilitating research, informing policy, and advancing regulatory science. The Forum's three-pronged approach (practice, research, education) accelerates safe drug development by increasing clarity, cooperation and innovation, while maintaining standards of evidence. Forum members work in clinical practice, research, academia, industry, regulatory authorities, and patient advocacy. Using proven models for stakeholder engagement they enhance clinical trial efficiency, support fair participation, and expand access programs. Current projects focus on cytomegalovirus (CMV), viral hepatitis B (HBV), human immunodeficiency virus (HIV), nonalcoholic fatty liver disease (NAFLD)/ nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and rare diseases.

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