Explorative Analysis of Treatment Outcomes of Levofloxacin- and Moxifloxacin-Based Regimens and Outcome Predictors in Ethiopian MDR-TB Patients: A Prospective Observational Cohort Study

Abstract

Purpose/Background: Although Ethiopia is among the thirty high multi-drug resistant tuberculosis (MDR-TB) burden countries in the world, comparative therapeutic efficacy of moxifloxacin and levofloxacin has not been explored, particularly in MDR-TB patients. We therefore aimed to prospectively compare clinical outcomes and determine potential predictors of the outcomes among patients on moxifloxacin or levofloxacin-based MDR-TB drug regimens. Methods: We analyzed clinical parameters and laboratory data of eighty MDR-TB patients on moxifloxacin-or levofloxacin-based regimens. The clinical outcomes were compared using the Kaplan-Meier survival functions and the outcome definitions of the 2013 World Health Organization. Monthly sputum culture conversions and a molecular line probe assay results were also assessed. Observed outcomes and patient-related variables between the two groups were compared using chi-square, Wilcoxon Rank and Fisher exact tests. We also determined the potential predictors influencing treatment outcomes of moxifloxacin and levofloxacin using Cox proportional hazard model. Results:The levofloxacin-based treatment group had a lower failure rate and adverse drug events as well as better treatment success than the moxifloxacin-based group. Overall treatment success was 65%. Disaggregating the data revealed that 53.8% were cured, 11.2% completed treatment, 10.0% died, 11.2% failed, and 13.8% were lost-to-follow-up. The line probe assay result showed that 11.3% of the clinical isolates were resistant to fluoroquinolones and 3.8% were resistant to both fluoroquinolones and injectable anti-TB agents. Treatment regimen type, culture conversion rate, alcohol use, cavity lesion, serum levels of creatinine and alanine aminotransferase were independent predictors of treatment outcome. Conclusion:The levofloxacin-based regimen group has a better overall treatment success than the moxifloxacin-based group among MDR-TB patients. Clinical parameters and substance use history of the patients influenced treatment outcomes. We recommend further broader clinical studies to substantiate our findings as an input to review MDR-TB treatment guidelines.

Diagnosis and Treatment Pathway of MDR/RR-TB in Taizhou, Zhejiang Province, China

“…The treatment success rate was 62.1%, similar to the results in other countries [ 32 , 33 ]. Although several studies have concluded that treatment delays were associated with poor treatment outcomes [ 8 , 9 ], our research reached a different conclusion.…”

Population Pharmacokinetics of Levofloxacin and Moxifloxacin, and the Probability of Target Attainment in Ethiopian Patients with Multidrug-Resistant Tuberculosis

“…This is a follow-up of our previous prospective cohort study, 23 enrolling MDR-TB/RR-TB patients in four hospitals of Southern Ethiopia, namely, Butajira, Yirgalem, Arbaminch, and Nigist Eleni Mohammed Memorial teaching hospitals. These hospitals were among the first four hospitals identified by the Ministry of Health of Ethiopia as treatment initiative centers for MDR-TB treatment in Southern Ethiopia.…”

Clinical efficacy of chemotherapy regimen combined with Levofloxacin in patients with Pulmonary Tuberculosis complicated with Type-2 Diabetes

“…Patients in the experimental group were given the chemotherapy regimen combined with levofloxacin: 2HRZEL/6HRE, isoniazid 0.3g daily at a draught; rifampicin 0.45g daily at a draught; pyrazinamide 0.5g daily, tid; ethambutol 0.75 g daily at a draught; levofloxacin 0.8g daily, orally. 10 All patients underwent sputum culture + drug sensitivity test before treatment. After two months of treatment, patients were switched to the HRE regimen for six months, with the drug application method and dose as above.…”