Efficacy and Adverse Event Profile in Patients Receiving “Shorter Oral Bedaquiline-containing Multidrug-resistant/Rifampicin-resistant Tuberculosis Regimen” in a Tertiary Care Hospital in Eastern India
Introduction: Multidrug resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) is a leading cause of death in India. To combat this, National TB Elimination Programme, erstwhile RNTCP) has launched “shorter oral bedaquiline (Bdq)-containing MDR/RR-TB regimen” from March 2021 replacing the injectabl...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2025-07-01
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| Series: | Journal of Advanced Lung Health |
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| Online Access: | https://journals.lww.com/10.4103/jalh.jalh_64_24 |
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| author | Hindol Mondal Manasi Basu Banerjee Abheek Das Somnath Maity |
| author_facet | Hindol Mondal Manasi Basu Banerjee Abheek Das Somnath Maity |
| author_sort | Hindol Mondal |
| collection | DOAJ |
| description | Introduction:
Multidrug resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) is a leading cause of death in India. To combat this, National TB Elimination Programme, erstwhile RNTCP) has launched “shorter oral bedaquiline (Bdq)-containing MDR/RR-TB regimen” from March 2021 replacing the injectable containing MDR/RR-TB regimen in a phased manner.
Objective:
We want to measure the outcome and safety profile of this newly introduced shorter oral Bdq-containing MDR/RR-TB regimen.”
Materials and Methods:
A prospective observational study was conducted to evaluate the effectiveness and adverse drug reaction (ADR) profile of “Shorter oral Bdq-containing regimen.” After getting approval from the ethics committee, all MDR/RR-TB subjects receiving the regimen from MDR-TB clinic of Malda Medical College were included in the study and followed up. Sociodemographic data and treatment outcome details were evaluated. ADRs were evaluated for causality, severity assessment, and management aspects.
Result:
Of the total, 96 patients were assessed for eligibility. Sixty-three patients were enrolled (n = 63), followed up and analyzed. 19 (30%) patients were cured while 33 (52.4%) patients more had completed treatment. 6 (9.5%) patients declared as treatment failure. One subject died during treatment. Four patients were lost to follow-up (6.4%). In total, 189 ADRs were reported. Commonly observed ADRs were anorexia (60%), nausea (51%), and weakness (46%). Majority were “possible” category by causality assessment and “mild” in severity assessment. Hepatitis was only severe ADR observed.
Conclusion:
Success rate and adherence observed with this regimen were encouraging. ADRs were mostly mild and managed symptomatically with regular monitoring in some cases. |
| format | Article |
| id | doaj-art-18100cf27f2f475fbb40597d87d6df7c |
| institution | DOAJ |
| issn | 2772-7165 2772-7173 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Advanced Lung Health |
| spelling | doaj-art-18100cf27f2f475fbb40597d87d6df7c2025-08-20T02:44:22ZengWolters Kluwer Medknow PublicationsJournal of Advanced Lung Health2772-71652772-71732025-07-015313514010.4103/jalh.jalh_64_24Efficacy and Adverse Event Profile in Patients Receiving “Shorter Oral Bedaquiline-containing Multidrug-resistant/Rifampicin-resistant Tuberculosis Regimen” in a Tertiary Care Hospital in Eastern IndiaHindol MondalManasi Basu BanerjeeAbheek DasSomnath MaityIntroduction: Multidrug resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) is a leading cause of death in India. To combat this, National TB Elimination Programme, erstwhile RNTCP) has launched “shorter oral bedaquiline (Bdq)-containing MDR/RR-TB regimen” from March 2021 replacing the injectable containing MDR/RR-TB regimen in a phased manner. Objective: We want to measure the outcome and safety profile of this newly introduced shorter oral Bdq-containing MDR/RR-TB regimen.” Materials and Methods: A prospective observational study was conducted to evaluate the effectiveness and adverse drug reaction (ADR) profile of “Shorter oral Bdq-containing regimen.” After getting approval from the ethics committee, all MDR/RR-TB subjects receiving the regimen from MDR-TB clinic of Malda Medical College were included in the study and followed up. Sociodemographic data and treatment outcome details were evaluated. ADRs were evaluated for causality, severity assessment, and management aspects. Result: Of the total, 96 patients were assessed for eligibility. Sixty-three patients were enrolled (n = 63), followed up and analyzed. 19 (30%) patients were cured while 33 (52.4%) patients more had completed treatment. 6 (9.5%) patients declared as treatment failure. One subject died during treatment. Four patients were lost to follow-up (6.4%). In total, 189 ADRs were reported. Commonly observed ADRs were anorexia (60%), nausea (51%), and weakness (46%). Majority were “possible” category by causality assessment and “mild” in severity assessment. Hepatitis was only severe ADR observed. Conclusion: Success rate and adherence observed with this regimen were encouraging. ADRs were mostly mild and managed symptomatically with regular monitoring in some cases.https://journals.lww.com/10.4103/jalh.jalh_64_24adverse eventsbedaquilinemultidrug-resistant/rifampicin-resistant tuberculosis |
| spellingShingle | Hindol Mondal Manasi Basu Banerjee Abheek Das Somnath Maity Efficacy and Adverse Event Profile in Patients Receiving “Shorter Oral Bedaquiline-containing Multidrug-resistant/Rifampicin-resistant Tuberculosis Regimen” in a Tertiary Care Hospital in Eastern India Journal of Advanced Lung Health adverse events bedaquiline multidrug-resistant/rifampicin-resistant tuberculosis |
| title | Efficacy and Adverse Event Profile in Patients Receiving “Shorter Oral Bedaquiline-containing Multidrug-resistant/Rifampicin-resistant Tuberculosis Regimen” in a Tertiary Care Hospital in Eastern India |
| title_full | Efficacy and Adverse Event Profile in Patients Receiving “Shorter Oral Bedaquiline-containing Multidrug-resistant/Rifampicin-resistant Tuberculosis Regimen” in a Tertiary Care Hospital in Eastern India |
| title_fullStr | Efficacy and Adverse Event Profile in Patients Receiving “Shorter Oral Bedaquiline-containing Multidrug-resistant/Rifampicin-resistant Tuberculosis Regimen” in a Tertiary Care Hospital in Eastern India |
| title_full_unstemmed | Efficacy and Adverse Event Profile in Patients Receiving “Shorter Oral Bedaquiline-containing Multidrug-resistant/Rifampicin-resistant Tuberculosis Regimen” in a Tertiary Care Hospital in Eastern India |
| title_short | Efficacy and Adverse Event Profile in Patients Receiving “Shorter Oral Bedaquiline-containing Multidrug-resistant/Rifampicin-resistant Tuberculosis Regimen” in a Tertiary Care Hospital in Eastern India |
| title_sort | efficacy and adverse event profile in patients receiving shorter oral bedaquiline containing multidrug resistant rifampicin resistant tuberculosis regimen in a tertiary care hospital in eastern india |
| topic | adverse events bedaquiline multidrug-resistant/rifampicin-resistant tuberculosis |
| url | https://journals.lww.com/10.4103/jalh.jalh_64_24 |
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