Spirometry, DLCO, lung volumes and PET/CT findings after completion of tuberculosis treatment - preliminary findings of the StatinTB trial

Mortality rates after tuberculosis (TB) treatment remain elevated. Persistent lung inflammation (PLI) has been associated with TB relapse. The ongoing StatinTB trial (NCT04147286), evaluates safety and efficacy of 40 mg atorvastatin to reduce PLI after TB treatment in HIV-/HIV+ adults measured by ¹⁸F-FDG-PET/CT. We report findings at time of enrollment into StatinTB of the first 53 participants. Participants with clinical response to TB treatment and a negative sputum culture for <i>M. tuberculosis</i> at 16 weeks, were screened after completing 24-weeks of treatment for drug-sensitive TB. Pulmonary function and PLI were measured using EasyOne Pro® Lab and PET/CT. PLI was defined as total lung glycolysis (TLG) ≥50SUV*mL. StatinTB trial is conducted according to ICH-GCP. Of the 53 participants (34% women) aged 36.4±12.6 years who underwent PET/CT, 20.8% were HIV+, 52.8% smokers, 22.6% had previous TB; 17.0% reported ongoing cough, 7.6% chest pain and 7.6% shortness of breath. PLI was present in 43.4% of participants (mean TLG of 299±233 SUV*mL.) Diffusing capacity of the lung for carbon monoxide (DLCO) was consistently reduced in participants with PLI (DLCO %Pred 74.8% vs. 90.0%; p=0.002) as was FVC %Pred (78.0% vs. 92.3%; p=0.01); FEV1 %Pred was 75.9% vs 87.6%, p=0.06. After adjusting for other variables, DLCO %Pred was inversely associated with TLG (OR, 0.89, 95%CI 0.82-0.97, p=0.01) as well as positive HIV status (OR 16.9, 95%CI 1.52-189.10, p=0.02). Chronic lung disease is present in at least half of participants. Impaired DLCO is associated with PLI in young adults with excellent adherence to a 24-week treatment regimen for drug-sensitive TB.