Community engagement meeting in Kigoma DC discussing the feasibility of an integrated delivery model for arpraziquantel in the United Republic of Tanzania.
Photo: NIMR/Kazyoba
The National Institute for Medical Research in the United Republic of Tanzania is working together with TDR, the World Health Organization (WHO), the Pediatric Praziquantel Consortium, and other key national and international stakeholders and Access and Delivery Partnership (ADP) partners to address gaps and challenges towards the roll-out of an exciting new paediatric schistosomiasis treatment, arpraziquantel.
Schistosomiasis, also known as bilharziasis, is a neglected tropical disease (NTD) caused by parasitic worms. It is prevalent in warm climes and affects over 250 million people globally, especially poor communities with limited safe drinking water or inadequate sanitation. About 20% of those infected are children aged 5 years or under.
In November 2021 the Pediatric Praziquantel Consortium announced positive findings from a phase III trial for arpraziquantel to treat schistosomiasis (trial identifier: NCT03845140). Derived from praziquantel, which is the current standard treatment for schoolchildren, arpraziquantel was shown to be effective in leading to the clinical cure of affected children under 6 years of age in Kenya and the Ivory Coast.
Arpraziquantel (which was developed by Astellas Pharma Inc. in Japan, optimized by Merck in Germany and transferred for clinical manufacturing to Farmanguinhos in Brazil) is formulated as a small tablet that dissolves in the mouth and can be taken with or without water; additionally, its formulation withstands hot and humid tropical climate challenges. As such, arpraziquantel offers great potential as a new tool for tackling schistosomiasis in preschool-aged children in schistosomiasis-endemic regions.
In early 2022, the World Health Organization (WHO) launched new guidelines for the control and elimination of human schistosomiasis, stipulating the expansion of preventive chemotherapy to all in need, including adults and preschool-aged children. With the clinical development phase for arpraziquantel having been successfully completed, efforts are now underway to seek regulatory approval of this treatment; at the same time, preparations are being made to make it available on a not-for-profit basis in low-resource settings.
The Pediatric Praziquantel Consortium, in collaboration with the WHO and external experts, is now working towards timely registration, accessibility, and affordability of this new treatment for children less than 5 years old. Endemic countries in Africa as well as Brazil are the first countries where, once approved, the product will be made available. Local production capacities for endemic African countries will also be considered.
Meanwhile in the United Republic of Tanzania, a project entitled “Strengthening capacity for delivery and uptake of paediatric praziquantel formulation for schistosomiasis in the United Republic of Tanzania (STEPPS)“, led by the National Institute for Medical Research (NIMR), has been conducted with support from the ADP and TDR. This project aimed to improve institutional capacities to introduce the new treatment formulation for children aged less than 5 years old and to raise awareness and knowledge at both national and community level.
Based on the findings, the team subsequently developed guidelines and a training manual for integrated delivery of the new paediatric arpraziquantel formulation in the United Republic of Tanzania. The team further prepared a protocol to evaluate the implementation via different delivery models alongside a strategy for community-based engagement. Specifically, planned research for 2023–2024 will aim to test the feasibility of rolling out arpraziquantel treatment with standard vitamin A supplementation in postnatal clinics as compared to delivery through community-based mass drug administration efforts.
Dr Paul Erasto Kazyoba from NIMR says: “It is essential to evaluate real environment contexts so that any challenge or bottleneck encountered can be tackled early, before upscaling the delivery of arpraziquantel treatment to all schistosomiasis-endemic or priority areas. It is further important to engage the community so that any myth and sociocultural barriers to the access and/or uptake of arpraziquantel can be addressed timely, before a large-scale deployment of this treatment.”
TDR has also supported the Ministry of Health in The Gambia (another country in which schistosomiasis is endemic) in capacity building activities offered through TDR’s Massive Open Online Course (MOOC) on implementation research to inform the development of community engagement activities to increase awareness of schistosomiasis, improve health-seeking behaviours and increase the uptake of existing treatments.
For more information, please contact:
Dr Corinne Merle, TDR
Dr Branwen Hennig, TDR
This article was originally published on the https://tdr.who.int