Abstract

Among patients with kidney transplant receiving rifampicin-based anti-tuberculosis treatment regimen, the need for increased dose of immunosuppressants along with frequent drug level monitoring, imposes significant financial and economic burden in this disadvantaged population, more so in the middle- or low-income countries. However, as yet there are no prospective randomised studies comparing the efficacy of levofloxacin-based anti-tuberculosis treatment with rifampicin-based anti-tuberculosis treatment in kidney transplant recipients. The present study was designed to study the efficacy, safety and effect on allograft function in levofloxacin- versus rifampicin-based anti-tuberculosis treatment regimen. We conducted a prospective randomized study at the Post Graduate Institute of Medical Education and Research, Chandigarh between the period January 2020 to June 2021. The study included 20 kidney transplant recipients who developed TB post-kidney transplant and were randomized to receive 12 months of anti-tuberculosis treatment with either a rifampicin-based anti- tuberculosis treatment or levofloxacin-based anti-tuberculosis treatment regimen and were followed up for the duration of their treatment. All patients were on a calcineurin inhibitor based maintenance immunosuppression regimen, with 90% receiving tacrolimus and 10% on cyclosporine. Out of total 20 patients,40% had pulmonary TB, 50% had extra-pulmonary TB and 10% had pulmonary and extra-pulmonary TB. Tuberculosis was diagnosed by histopathology in 15%, microbiological in 40% and clinical-radiological in 45%. Anti-tuberculosis treatment was commenced within 4 weeks of onset of symptoms in 55% of the patients and, within 6 weeks in all patients. In the rifampicin-based anti-tuberculosis treatment group, 40% had to discontinue treatment and switch to levofloxacin-based anti-tuberculosis treatment, in view of drug related adverse effects or difficulty in maintaining immunosuppressant levels. All patients in the levofloxacin-based anti-tuberculosis treatment group remained on levofloxacin for the duration of treatment. All patients responded to anti- tuberculosis treatment and there was no mortality observed in the cohort during the period of follow- up. In our study levofloxacin-based anti-tuberculosis treatment had similar allograft outcomes as rifampicin-based anti-tuberculosis treatment and appeared to be associated with less adverse drug effects, lesser chance of discontinuation of drug therapy and more stable calcineurin inhibitor drug levels. Given these attributes, the study findings lend support to the use of Levofloxacin-based anti-tuberculosis treatment as the first line therapy regimen for kidney transplant recipients with TB who are on calcineurin inhibitor based maintenance immunosuppression regimen. The findings of this study serve as pilot towards future larger randomized trial to prospectively compare the two treatment regimens.

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