In a recent publication in The Lancet Gastroenterology and Hepatology, a study has brought to light the absence of Africa's representation in clinical trials focused on Hepatitis B (HBV) interventions. Despite Africa bearing the highest burden of new HBV infections globally, a mere 1.0% of HBV clinical trials involve the WHO African region.

The research, which delved into global clinical trial registries, uncovered a total of 1,804 unique HBV clinical trials, showcasing a significant disparity in representation across regions. This stark discrepancy emphasizes the urgent necessity for increased HBV clinical trials in Africa to evaluate the effectiveness of new treatments.

Investigators have pointed out that the absence of HBV trials in Africa exacerbates existing health disparities and obstructs efforts to achieve global HBV elimination targets. The populations most in need of new interventions often encounter significant barriers to access, perpetuating the cycle of disease burden and morbidity.

Moreover, the study highlights a lack of improvement in the quantity of HBV clinical trials in Africa over time. Additionally, the range of new interventions and the level of industry sponsorship in the region remain minimal compared to trials for other endemic infectious diseases.

Researchers stress the significance of prioritizing phase 3 and 4 clinical trials in the WHO African region, given the high burden of HBV infection and associated morbidity. However, challenges such as diverse populations, healthcare systems, and regulatory frameworks complicate trial demographics and the inclusion of vulnerable groups like asylum seekers.

Addressing these issues necessitates collaborative efforts involving local stakeholders, clinical teams, community leaders, and individuals with lived experience of HBV infection. It also requires enhancements in clinical infrastructure, education, vaccine and treatment access, and increased investment in equitable healthcare.

The critical lack of investment in HBV clinical trials in Africa underscores the need for concerted action from governments, industry, donors, and community advocates. Such efforts are imperative not only for generating essential data to optimize treatments but also for ensuring the equitable distribution and utilization of new anti-HBV compounds to combat the high rates of morbidity and mortality associated with chronic HBV infection.

Article by Nyokabi Wanjiku

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