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Hepatitis B Foundation releases report on first-ever Externally Led Patient-Focused Drug Development meeting for hepatitis B

Doylestown, Pa., Oct. 27, 2020 – In cooperation with the U.S. Food and Drug Administration (FDA), the Hepatitis B Foundation hosted an Externally Led Patient-Focused Drug Development (PFDD) meeting focused on hepatitis B in June. Today, the Foundation released its comprehensive report on the information-gathering event.

The Foundation has posted the 55-page report, along with a complete transcript of the meeting, the more than 300 email comments that were submitted and a link to the official video recording on its website. The FDA has reviewed and posted the report on its External Resources and Information Related to Patients’ Experience page.

The Foundation was given approval by the FDA to organize and conduct this meeting, which was an online-only event due to COVID-19, making it the first PFDD to be conducted exclusively as a webcast since the agency began holding PFDD meetings in 2012.

Held on June 9, the four-hour meeting allowed health care providers, FDA officials and drug developers to hear directly from patients and family members, specifically regarding their experiences living with chronic hepatitis B, to better inform these and other key stakeholders about the patient perspective. By incorporating personal anecdotes and firsthand experiences, the FDA can enhance its decision-making in terms of drug development and clinical trial design with relation to hepatitis B.

The PFDD meeting focused on two formal topics: 1) living with chronic hepatitis B: symptoms and disease impacts, and 2) perspectives on current and future approaches to treatment. A panel of four individuals for each topic shared their opinions and experiences to begin the dialogue. An FDA facilitator led each discussion. Audience members who were viewing the webcast also were able to participate in the discussion by sending in comments on the Foundation website or by calling in. Additionally, participants online who are living with hepatitis B, or family members of someone living with HBV, were encouraged to participate in live polling with a series of questions and to submit comments and their own questions.

More than 650 people joined the online PFDD meeting from around the globe. Chari Cohen, DrPH, MPH, who is the foundation’s senior vice president, organized the meeting.

“Overall, the discussion documented the significant physical and emotional impact for people living with hepatitis B, which leads to reduced quality of life and affects family and social relationships, as well as education and careers for many people,” Dr. Cohen said. “We heard directly from the people who joined us about their experiences with fatigue, shame and isolation, stigma and discrimination, and their fear of dying prematurely from liver cancer.”

Participants discussed major challenges with current treatment including finding a knowledgeable clinician to manage their hepatitis B, cost of medication, and the burden of taking a daily pill for many years. 

PFDD participants stressed a strong desire for future treatments that will result in loss of hepatitis B surface antigen (HBsAg, the blood marker of infection) and reduced risk of liver cancer over a finite treatment period. There was strong interest in participating in future clinical trials that might lead to a functional cure, as long as trials would not be too disruptive of daily lives and participants would receive adequate safety information on experimental treatments.

In addition to conducting the PFDD meeting, the Foundation collected patient experiences through an online survey and in-depth phone interviews. More than 2,100 people from 102 countries responded to the survey, and 24 people participated in the phone interviews. Results coincide what the Foundation team learned from the PFDD meeting and also highlighted the different experiences and challenges faced by people living in other countries. For example, outside the U.S., more people documented experiencing stigma and discrimination, and had difficulty finding affordable care and treatment for their hepatitis B.

Along with prominently posting the complete report from the June 9 PFDD on www.hepb.org, the Hepatitis B Foundation will be announcing its availability through its newsletters and social media plus professional publications and meetings. All of the experiences collected from the PFDD meeting, the survey and the interviews will be used by the Foundation to help advocate for the needs of people living with hepatitis B, and ensure that drug and clinical trial development take the needs and concerns of patients into account.

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