Isoniazid treatment to prevent TB in kidney and pancreas transplant recipients based on an interferon-g-releasing assay: an exploratory randomized controlled trial.
Kim S-H, Lee S-O.Journal of Antimicrobial Chemotherapy. 2015 May; 70(5): 1567-72
Aims
To establish whether interferon-g-releasing assay (IGRA)-based isoniazid treatment can prevent tuberculosis in kidney transplant recipients.
Interventions
Isoniazid treatment or control group.
Participants
263 patients with positive IGRA and without clinical risk factors for latent tuberculosis were assigned to the treatment or control group.
Outcomes
Tuberculosis, rejection, adverse drug reactions.
Follow-up
6 months after transplantation and every 3 months thereafter.
CET Conclusions
In transplant recipients without risk factors for TB, but who were interferon-gamma-release assay positive, isoniazid did not significantly reduce TB incidence compared to no treatment. The observed rate of TB in the control group was considerably less than the authors had suspected (2% instead of 7% approximately) so the study may have been underpowered. If the study had been conducted on a larger scale, the observed reduction in TB occurrence may well have been very small and there were a number of patients (9%) who had adverse drug reactions to isoniazid. These included deranged liver function tests, gastro-intestinal disturbance and alopecia.
Data analysis
Per protocol analysis
Trial registration
Clinicaltrials.gov - NCT01087190.