Evaluation of health-related quality of life and adherence among pre-extensively drug-resistant tuberculosis patients receiving either Bedaquiline or Delamanid regimen at a teaching hospital in Eastern India.

BACKGROUND

The foremost concern and challenge in managing drug-resistant tuberculosis is ensuring a high health-related quality of life (HRQoL). The effectiveness of pre-extensively drug-resistant (Pre-XDR) tuberculosis management hinges on patients adhering to therapy, a crucial factor in averting the development of drug-resistant strains, ultimately enhancing HRQoL.

METHODOLOGY

This analytical longitudinal study spanned two years at a teaching hospital and involved collaboration between the Departments of Pharmacology and Pulmonary Medicine. A case record form was utilized to gather baseline data, encompassing patient demographics, medication details, WHO BREF HRQoL scores, and treatment adherence. Patients were classified as either adherent or nonadherent using three distinct criteria: the guidelines of the Revised National Tuberculosis Programme (RNTCP), the Morisky-Green-Levine Scale (MGLS), and the Batalla test. The sample size was determined based on 30% nonadherence rates from preliminary analysis of prior data, resulting in 86 patients included in the study. The association between the improvement of HRQoL score from the baseline with the predictor variables was assessed with a linear regression model. Comparison of nonadherence with the different predictors of the study population was assessed with binary logistic regression model.

RESULTS

Analysis of demographic data revealed no notable differences in age and BMI between the Bedaquiline and Delamanid groups. However, there was a gender-related difference in treatment distribution, with more men in the Bedaquiline group. Other factors, such as marital status, socioeconomic status, employment status, stigma/discrimination, comorbidity, and addiction, showed no significant differences between the groups. Comparing HRQoL scores at baseline and after six months showed substantial improvements in all domains, indicating a positive impact of the treatment. Linear regression analysis revealed a strong association between QoL improvement and adherence. Adherence patterns did not significantly differ between the two treatment groups, as assessed by various criteria. The patients with high stigma, newly diagnosed Pre-XDR cases, and the presence of adverse events had higher odds of nonadherence.

CONCLUSION

This study highlights the substantial impact of Bedaquiline and Delamanid treatment on the HRQoL of Pre-XDR TB patients in Eastern India. Adherence to treatment plays a crucial role in improving QoL, and factors like stigma, newly diagnosed Pre-XDR patients, and adverse drug reactions influence adherence adversely. The findings emphasize the importance of patient support and education to enhance treatment outcomes.