Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries

Authors

Lario Viljoen, Stellenbosch University, Faculty of Medicine and Health Sciences
H. R. Draper, Stellenbosch University, Faculty of Medicine and Health Sciences
N. T. Castillo-Carandang, University of the Philippines College of Medicine
N. Suryavanshi, National Institutes of Health, University of the Philippines Manila
A. Marthinus, Stellenbosch University, Faculty of Medicine and Health Sciences
A. M.A. Cheong, De La Salle Medical and Health Sciences Institute
J. D.D. Ocampo, National Institutes of Health, University of the Philippines Manila
G. Dhumal, Byramjee Jeejeebhoy Government Medical College-Johns Hopkins Clinical Research Site
S. Bagchi, Byramjee Jeejeebhoy Government Medical College-Johns Hopkins Clinical Research Site
D. T. Wademan, Stellenbosch University, Faculty of Medicine and Health Sciences
A. Kinikar, Byramjee Jeejeebhoy Government Medical College
M. Paradkar, Byramjee Jeejeebhoy Government Medical College-Johns Hopkins Clinical Research Site
M. V.G. Frias, De La Salle Medical and Health Sciences Institute
D. J.O. Casalme, De La Salle Medical and Health Sciences Institute
A. C. Hesseling, Stellenbosch University, Faculty of Medicine and Health Sciences
A. J. Garcia-Prats, Stellenbosch University, Faculty of Medicine and Health Sciences
M. Palmer, Stellenbosch University, Faculty of Medicine and Health Sciences
G. Hoddinott, Stellenbosch University, Faculty of Medicine and Health Sciences

Publication Date

8-13-2025

Document Type

Article

Publication Title

Ijtld Open

Abstract

BACKGROUND: Rifampicin-resistant TB (RR-TB) in children is frequently treated with clofazimine (CFZ), widely available as a 100mg gel capsule. This formulation is challenging to administer and is poorly acceptable to children and caregivers. Poor acceptability may negatively impact adherence and treatment outcomes. We describe the acceptability of a novel 50mg CFZ tablet formulation among children in South Africa, India, and the Philippines. METHODS: Mixed methods assessments were completed in a moxifloxacin and CFZ safety and pharmacokinetics trial in children with RR-TB. Quantitative data were collected from 36 participants at 4 timepoints. A subsample of 26 child/caregiver dyads participated in ~4 qualitative interviews. Descriptive statistics and thematic analysis were employed. FINDINGS: The median age of n¼36 participants (South Africa n¼20; India n¼6; the Philippines n¼10) was 4.9 years. The majority (29/36) received a CFZ gel capsule prior to switching to the tablet formulation. The 50mg tablet had better acceptability scores for taste (p¼0.035), smell (p¼0.035), and ease of swallowing (p¼0.02) compared to gel capsules. Participants described the tablet formulation as easier to administer/take without a lingering smell or taste. Limited concerns were noted on staining. CONCLUSION: The novel 50mg CFZ tablet has better acceptability and should be prioritised for children wherever possible.

First Page

478

Last Page

485

APA Citation

Viljoen, L., Draper, H., Castillo-Carandang, N., Suryavanshi, N., Marthinus, A., Cheong, A., Ocampo, J., Dhumal, G., Bagchi, S., Wademan, D., Kinikar, A., Paradkar, M., Frias, M., Casalme, D., Hesseling, A., Garcia-Prats, A., Palmer, M., & Hoddinott, G. (8-13-2025). Acceptability of a clofazimine tablet in children with rifampicin-resistant TB in three high-burden countries. Faculty Research and Scholarly Works.
DOI:10.5588/ijtldopen.25.0309