Abstract
Childhood tuberculosis (TB) has hitherto been treated through estimation of pediatric doses through the crushing of adult pills, but the bitter taste of the pills and the inaccuracy of this dosing method presents a challenge for both patients and healthcare providers, leading to poor treatment outcomes. The TB Alliance therefore launched the Speeding Treatments to End Pediatric-Tuberculosis (STEP-TB) project to incentivize the introduction of pediatric Fixed-Dose Combinations (FDCs) of TB drugs. This case study describes the elements of this project, evaluates its impact, and highlights future challenges for pediatric TB treatment. The impact assessment incorporates both market impact as well as projected public health impact, evaluating the availability, affordability, and quality of the FDCs, and lastly providing a projection of lives saved as a result of scale-up of the FDCs to near-universal availability and utilization, based on a publicly available pediatric TB-specific model. STEP-TB resulted in the development of two child-friendly FDCs that were successfully brought to market and made available in 20 of the project’s 22 high-burden countries. On the basis of a country-specific projection of pediatric TB mortality in Kenya, scale-up to near-universal availability and utilization of the new FDCs could reduce pediatric TB-associated mortality by 2660 cases over the next 5 years. Future challenges include maintaining affordable prices for the FDCs and considering mechanisms to incentivize their introduction among high-risk groups in low-burden countries.
Highlights
To assess the impact of the program, we utilize the goals set by Speeding Treatments to End PediatricTuberculosis (STEP-TB) itself as a framework for initial impact evaluation, and lastly, we employ a pediatric TB-specific model [7] to provide a projection of the impact of near-universal utilization of the new pediatric Fixed-Dose Combinations (FDCs) on lives saved in Kenya, the first country to have rolled out the regimens [3]
Owing to the lack of individual-level data regarding the efficacy of the regimens in terms of improved pediatric TB treatment outcomes, World Health Organization (WHO) prequalification of the FDCs is the quality indicator for the purpose of this impact evaluation
WHO prequalification of the FDCs was obtained in September 2017, attesting to the quality of the regimens, concrete measurements of quality are not possible at this time given the absence of data on patient outcomes with the new FDCs [3]
Summary
Tuberculosis (TB) is an infectious disease caused by the bacterium Mycobacterium tuberculosis. TB is responsible for a greater number of deaths than any other single infectious disease, and an estimated 80% of the global burden of TB morbidity is attributable to 22 high-burden countries (HBCs) [1], eight of which are in Africa [2] (Nigeria, Ethiopia, South Africa, Kenya, DR Congo, Tanzania, Uganda, and Mozambique). 10% of TB patients are children [3], and the World Health Organization (WHO) estimates that more than 1 million children under 15 years of age will fall ill with active TB disease each year [1]. At increased risk of progression to active TB disease, making accurate diagnosis and prompt treatment initiation crucial in this group [4]. TB treatment in children is considered critical to the attainment of the Sustainable Development Goal of ending preventable deaths in children by 2030
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