From left to right: Philip Kwame Yeboah (Hepatitis B Foundation Community Advisory Board), Peter Ramge (Roche Diagnostics), Wendy Spearman (University of Cape Town), John Ward (Coalition for Global Hepatitis Elimination), Philippa Easterbrook (World Health Organization), Danjuma Adda (World Hepatitis Alliance), Veronica Miller (Forum for Collaborative Research), Nicaise Ndembi (Africa CDC), Mitchell Leus (Forum for Collaborative Research), Edith Okeke (University of Jos)
Forum for Collaborative Research facilitates dialogue on bringing hepatitis B clinical trials to Africa
The Forum attended the 2023 African Hepatitis Summit and hosted a session that facilitated a discussion on the urgent need to bring hepatitis B clinical research to the African continent. Held in Abuja, Nigeria from October 24 – 26, 2023, the Summit convened civil society organizations, policy makers, global funders, medical professionals, and advocacy organizations to strengthen political will for putting Africa on track towards viral hepatitis elimination.
Hepatitis B is a viral infection of the liver, caused by the hepatitis B virus (HBV), that can cause both acute and chronic liver disease. Chronic hepatitis B (CHB), frequently leading to cirrhosis and liver cancer, affects nearly 300 million people globally, with around 70% of worldwide HBV infections occurring in Africa. The HBV vaccine—which requires that the first dose be administered within 24 hours of a newborn’s birth—is safe and effective, but implementation across Africa is low. In 2021, only 14 of 47 African countries had introduced routine HBV vaccination, and only 17% of African newborns received a timely vaccination. Diagnosis and linkage to care across Africa are alarmingly low. In 2021, only 2% of persons infected with hepatitis B were diagnosed, and only 0.1% received antiviral treatment that suppresses virus replication to prevent cirrhosis and cancer.
Despite the continent’s high burden of disease, clinical trials for hepatitis B are generally not conducted in Africa. According to Dr. Nicaise Ndembi, Chief Science and Senior Advisor to the Africa Centres for Disease Control and Prevention Director General, only 5 hepatitis B clinical trials were conducted in Africa from 2016 – 2021, and these were Phase IV trials focused on post-marketing surveillance for already-approved therapies. The dearth of hepatitis B clinical trials in Africa can partially be attributed to suboptimal research and development (R&D) investment, with Dr. John Ward, Director at the Coalition for Global Hepatitis Elimination of the Task Force for Global Health, stating that hepatitis B received $16 million in R& investment for new products and technologies in 2021, about 1% of R&D investment for HIV in the same year. Through the Forum’s model of multi-stakeholder discussion and deliberation, panelists from the World Health Organization, Roche Diagnostics, World Hepatitis Alliance, and the Hepatitis B Foundation Community Advisory Board provided an array of perspectives including capacity-building, health equity, and patient-centered clinical research.
Inclusion of African patients in hepatitis B clinical trials is important for promoting global health equity and ensuring that these communities are engaged in efforts to develop new treatments for hepatitis B. There are clear benefits to participation in clinical research. At the individual-level, patients have access to screening and potentially beneficial treatments, which may improve psychosocial and clinical outcomes associated with hepatitis B. At the community-level, clinical research may increase community-level knowledge and awareness of the disease, which could be important for addressing stigma and discrimination associated with hepatitis B.
“We feel strongly that clinical research is so important for communities,” said Dr. Veronica Miller, Director of the Forum and Adjunct Professor in the Division of Infectious Diseases and Vaccinology. Presentations at the Summit focused on implementation of hepatitis B vaccination, screening, and linkage to care; Dr. Miller emphasized that “we need to go back one step and bring the clinical research infrastructure to this continent, because clinical research is a stepping stone that is so important for implementation.”
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 transplantation associated virus infections (TAVI), viral hepatitis B (HBV), human immunodeficiency virus (HIV), metabolic dysfunction-associated steatotic liver disease (MASLD)/ metabolic dysfunction-associated steatohepatitis (MASH), primary sclerosing cholangitis (PSC), ocular diseases, and rare diseases.
