Evaluating the risk of dapsone hypersensitivity syndrome in Nepalese Leprosy Patients via HLA-B* 13:01 screening using real-time PCR and comparative meta-analysis of international data
PLOS Neglected Tropical Diseases·
- DOI
- 10.1371/journal.pntd.0014568
- PMID
- 42594150
- PMCID
- —
- OpenAlex
- W7202363485
- Study type
- Meta-analysis
- Publisher
- Public Library of Science (PLoS)
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Routine pre-therapy genetic assessment might lower the burden of severe medication-related complications in endemic regions with limited laboratory infrastructure.
Structured evidence summary
Research question
Does the HLA-B*13:01 allele correlate with dapsone-induced hypersensitivity reactions in a Nepalese leprosy cohort, and can a rapid polymerase chain reaction assay reliably substitute for more complex sequencing methods?
Study design
The authors conducted a combined case-control evaluation utilizing both historical and newly identified patient samples, supplemented by a comprehensive meta-analysis of previously published international datasets.
Population and setting
The primary cohort comprised multi-ethnic leprosy patients undergoing standard multidrug therapy in Nepal, while the secondary analysis incorporated aggregated results from global investigations focusing on the same pharmacogenetic interaction.
Main findings
Statistical modeling revealed a pronounced correlation between the genetic variant and the adverse drug event within the local sample. The rapid molecular screening technique achieved near-perfect alignment with established sequencing protocols. Aggregated global metrics strengthened this association, and demographic breakdowns showed that genetically positive individuals experienced symptom onset considerably earlier than their counterparts.
Public-health relevance
Routine pre-therapy genetic assessment might lower the burden of severe medication-related complications in endemic regions with limited laboratory infrastructure.
Important limitations
Nearly a quarter of diagnosed reaction cases tested negative for the target allele, highlighting incomplete sensitivity. Furthermore, the screening tool demonstrated a modest positive predictive value, meaning many positive results would not correspond to actual clinical events.
GIDS interpretation
The article establishes a quantifiable biological marker linked to a documented treatment complication, offering a reference point for tracking diagnostic advancements and regional pharmacovigilance frameworks.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 9 auditable classifier relationships to diseases, places, topics, and study design.