Association of baseline HALP and PIV/AISI with 2-month sputum culture conversion in newly diagnosed culture-positive pulmonary tuberculosis: a prospective single-center cohort study
Year: 2026
Type: article
Study design: Observational Study
Abstract: Baseline blood composites that summarize nutritional reserve and systemic inflammation may help identify pulmonary tuberculosis patients less likely to achieve early microbiologic response, but prospective evidence remains limited. We conducted a prospective single-center cohort study enrolling adults with newly diagnosed, culture-positive, rifampicin-susceptible pulmonary tuberculosis who started first-line treatment between January 2023 and October 2025. Pretreatment HALP and PIV/AISI were calculated from the closest complete blood count plus albumin sample within 72 h before the first dose. The primary endpoint was 2-month sputum culture conversion in the day 42–70 window. Separate multivariable logistic models evaluated the independent association of ln-transformed, standardized HALP and PIV/AISI, with secondary assessment of incremental model performance. A post hoc end-of-treatment cure analysis used Firth penalized logistic regression. Among 317 analyzed participants, 249 achieved 2-month culture conversion and 68 did not. Higher HALP independently predicted conversion (adjusted OR 1.58, 95% CI 1.15–2.17; p =0.004), whereas higher PIV/AISI predicted lower odds of conversion (adjusted OR 0.64, 95% CI 0.46–0.90; p =0.010). HALP improved the apparent C-statistic from 0.739 to 0.813 and the optimism-corrected C-statistic from 0.723 to 0.809. Findings remained directionally consistent in prespecified sensitivity/supportive analyses, including the stricter culture-conversion endpoint and an exploratory day-90 time-to-conversion analysis. In the post hoc end-of-treatment analysis, 278 of 317 participants met the WHO definition of cure; associations remained directionally consistent for HALP (Firth-adjusted OR 1.42, 95% CI 1.05–1.92) and PIV/AISI (Firth-adjusted OR 0.72, 95% CI 0.53–0.98). In this prospective single-center cohort, higher baseline HALP and lower baseline PIV/AISI were independently associated with sputum culture conversion during intensive-phase treatment, with HALP showing slightly better incremental model performance. These low-cost biomarkers may complement baseline risk stratification, but external validation is required before routine implementation.
Authors: Yuwei Cai, Junhua Li, Qiaoqiao Xie, Zhongtie Lin
Institution: Wenzhou Central Hospital
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,190
OpenAlex ID: W7204069550
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