Prevalence and Determinants of Hearing Loss in Multidrug-Resistant Tuberculosis Patients: A Prospective Observational Cohort Study in Kinshasa, Democratic Republic of the Congo.

Purpose. The occurrence of the hearing loss (HL) is a challenge during the treatment of multidrug-resistant tuberculosis (MDR-TB). Aminoglycoside-based regimen, to a lesser extent based on bedaquiline (BDQ), induce ototoxic HL. Identifying associated risk factors is crucial in a resource-limited setting. This study assessed the determinants of the HL in patients with MDR-TB. Methodology. This prospective observational multicenter cohort study included patients with MDR-TB. It was performed in Kinshasa (Democratic Republic of the Congo) between February 15, 2020 and February 14, 2021. Sociodemographic, clinical, biological, therapeutic, and audiometric data were exported and analyzed using Stata 17 and MedCalc. The fixed-effect linear regression panel model was used to assess the degree of the HL over time according to the following covariates: therapeutic regimen (aminoglycosides, bedaquiline, or alternate), chronic kidney disease (CKD), age at inclusion, body mass index, serum albumin level, HIV status, alcohol intake, hypertension, and hemoglobin level. The Hausman test was used to select between fixed- and random-effect estimators. The threshold for statistical significance was set at p < 0.05.Findings. Of the 337 patients included, 236 (70%) received an aminoglycoside-based regimen, 61 (18%) received a bedaquiline-based regimen, and 40 (12%) received an aminoglycosides (AG) relayed by BDQ. The frequency of the HL increased from 62% to 96.3% within six months for all therapeutic regimens. The HL worsened, with moderate (72.4%) and profound (16%) deafness being predominant. An exposure to the treatment for more than one month (β coeff: 27.695, Se: 0.793, p< 0.001), aminoglycoside-based regimen, age ≥ 40 years (β coeff: 6.102, Se: 1.779, p< 0.001), hypoalbuminemia (β coeff: 5.610, Se: 1.682, p= 0.001), and the estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (β coeff: 6.730, Se: 2.70, p= 0.013) were the independent risk factors associated with the HL in MDR-TB patients. Unique contributor to theory, policy and practice: The hearing loss is more prevalent and worsens during the treatment of the patients with MDR-TB. A systematic audiometric evaluation and monitoring plan are needed for the management of these patients. It should focus on the elderly patients, and those who have an exposure for more than one month, an aminoglycoside-based regimen, a hypoalbuminemia, and have an impaired kidney function. However, further prospective interventional cohort studies are required to assess the incidence of the HL during the MDR-TB treatment.