CLINICAL PROFILE AND TREATMENT RESULTS OF PATIENTS RECEIVING BPALM REGIMEN FOR DRUG-RESISTANT TUBERCULOSIS AT A TERTIARY CARE TEACHING HOSPITAL: A PROSPECTIVE OBSERVATIONAL STUDY

Abstract

Background: Resistant TB is linked to long treatment duration, toxicity, poor adherence and poor outcomes. The six-month all-oral BPaLM regimen (bedaquiline, pretomanid, linezolid, moxifloxacin) is a paradigm shift in the treatment of rifampicin-resistant tuberculosis (RR-TB), however, real world data from tertiary hospitals are limited. Methods: This study characterizes clinical profile, microbiological response, safety, and treatment outcomes of BPaLM in people with drug-resistant pulmonary TB. Methods: The study was a prospective observational study of 72 eligible patients with rifampicin resistant or multidrug resistant (MDR) pulmonary tuberculosis (PTB) started on BPaLM in a tertiary care teaching hospital. Demographic, clinical, radiological, microbiological and comorbidity data were collected as a baseline. Patients were monitored for 26 weeks of treatment and early follow-up. Sputum smear and culture conversion, weight gain, symptom improvement, treatment success, adverse events and factors associated with unfavourable outcome were the outcomes. Results: Mean age was 36.8 +/- 12.7 years; 46 (63.9%) were male. Diabetes was present in 13 (18.1%), HIV infection in 4 (5.6%), and cavitary disease in 39 (54.2%). Culture conversion occurred in 53 (73.6%) by 8 weeks and 65 (90.3%) by 12 weeks. There was an overall success in treatment of 64/72 (88.9%) including 54 cured and 10 treatment completed. The adverse events were death (3, 4.2%), treatment failure (2, 2.8%) and loss to follow-up (3, 4.2%). Anaemia occurred in 22 (30.6%), peripheral neuropathy in 13 (18.1%), QTc prolongation above 500 ms in 3 (4.2%), and linezolid dose modification in 16 (22.2%). Conclusions: BPaLM had high early culture conversion rate and satisfactory treatment outcomes with low toxicity in a hospital environment of tertiary teaching center.