Chemotherapy Options in New Patients with Drug Susceptible Tuberculosis and Concurrent HIV Infection

Abstract

The objective: to compare effectiveness and safety of isonicotinoylhydrazine-O,N' iron (II) sulfate dihydrate with the drug of isonicotinic acid hydrazide group in the complex therapy of patients with drug susceptible tuberculosis and HIV infection.

Subjects and Methods. In 2020-2021, 40 patients with HIV infection and drug susceptible respiratory tuberculosis with a positive sputum test were examined in Moscow Regional Clinical TB Dispensary as a part of the post-registration observational study. The subjects were randomized into two groups – Main Group (MG) and Comparison Group (CG). Isonicotinoylhydrazine-O,N' iron (II) sulfate dihydrate was administered to the patients from MG as a part of regimen 1 of chemotherapy (instead of isoniazid). The effectiveness and safety of the investigational drug and comparator were evaluated. The primary effectiveness criteria included resolution of clinical symptoms of intoxication and sputum conversion. The secondary effectiveness criterion was positive X-ray changes. The safety criterion was the absence of adverse reactions.

Results. During the study period, no adverse reactions were registered when isonicotinoylhydrazine-O,N' iron (II) sulfate dehydrate was used, as well as isoniazid. Good tolerability was noted as well as high compliance to treatment by patients. Thus, both in terms of effectiveness and safety, isonicotinoylhydrazine-O,N' iron (II) sulfate dihydrate is comparable to isoniazid as part of anti-tuberculosis chemotherapy for patients with drug susceptible tuberculosis and concurrent HIV infection.