The Peak Plasma Concentration (Cmax)/Minimum Inhibitory Concentration (MIC) of bedaquiline and levofloxacin with special attention to the sputum conversion in the treatment of multidrug-resistant tuberculosis in Indonesia
Abstract
Background Tuberculosis in Indonesia remains a serious public health concern, as the country has the third-largest number of multidrug-resistant tuberculosis (MDR-TB) patients in the world. Bedaquiline and levofloxacin are the primary drug regimen for MDR-TB treatment in Indonesia. This study aimed to investigate whether the Cmax/MIC of bedaquiline and levofloxacin differs between patients with sputum conversion and those without sputum conversion during the first four months of MDR-TB treatment in Indonesia. Methods A cohort study was performed in adult patients (18–65 years old) treated with the 18–24-month oral regimen. Patients were excluded if they were pregnant or HIV positive, with uncontrolled diabetes, or had any of the following severe conditions: cancer, digestive, cardiovascular system disorders, hepatic, or renal problems. Two blood samples were collected to measure the plasma concentrations of bedaquiline and levofloxacin using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Mycobacterium tuberculosis (Mtb) isolates from patients’ sputum were used to determine the MIC of individual drugs using liquid growth media (MGIT). Results Among the 74 patients enrolled, 16 dropped out during the four-month follow-up period. Blood samples were successfully obtained 1–2 hours after drug administration from 48 patients and 4–6 hours after drug administration from 32 patients, which were used for pharmacokinetic analysis. Sputum conversion was detected in 84.5% of…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 74 participants or records.
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