Asian Journal of Pharmaceutical Research

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Utilization of Bedaquiline Among Drug Resistant-Tuberculosis Patients


Affiliations
1 G. Pulla Reddy College of Pharmacy, Hyderabad, India
2 Assistant Professor, Department of Pharmacy Practice, G. Pulla Reddy College of Pharmacy, Hyderabad, India
3 Associate Professor, Department of Pulmonary Medicine, Govt. Chest Hospital, Hyderabad
     

   Subscribe/Renew Journal


Background: India has one of the highest burdens of drug-resistant tuberculosis (DR-TB) globally. The persistent spread of DR-TB is one of the most daunting problems the world is witnessing. Current regimens for DR-TB are complicated, lengthy, and expensive compared to those used to treat drug-susceptible TB, leaving patients with much less effective treatment options. Bedaquiline (BDQ) is a novel drug that has strong bactericidal and sterilizing activities against Mycobacterium tuberculosis. The WHO recommends BDQ for the treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). The objective of the study is to evaluate the utilization of BDQ among drug-resistant tuberculosis patients in a tertiary care hospital. Materials and Methods: A hospital-based retrospective observational study was conducted at the Government General and Chest Hospital in Erragadda, Hyderabad, Telangana, where suspected Tuberculosis cases are referred. All patients who were prescribed bedaquiline regimen were included in the study. Results: 23 Patients were prescribed BDQ during the study duration. The mean age of the patients was 41&#177 14.24 years and most of them were in the age group of 21-40 years. 15 patients (65.21%) were Males. Diabetes mellitus was the most common co-morbid condition. Two patients (8.70%) successfully completed the treatment, 3 patients (13.04%) died during treatment and 18 patients (78.26%) were still receiving the treatment during the study period. Adverse effects were documented in 12 patients and the most common adverse events were related to gastrointestinal tract. Conclusion: Bedaquiline containing regimen was well tolerated with less number of manageable adverse effects.


Keywords

Mycobacterium tuberculosis, Multidrug-resistant tuberculosis, extensively drug-resistant tuberculosis, Bedaquiline, Adverse effects
Subscription Login to verify subscription
User
Notifications
Font Size


  • Sagavkar Sandhyarani R, Devkar Swati R. Tuberculosis: A Review. Asian J. Pharm. Res. 2018; 8(3): 191-194. doi: 10.5958/2231-5691.2018.00033.3

  • Definitions and reporting framework for tuberculosis – 2013 revision (updated December 2014). Geneva: World Health Organization; 2014. Available at https://apps.who.int/iris/bitstream/handle/10665/79199/978924150 5345_eng.pdf?sequence=1

  • Centres for Disease Control and Prevention (CDC): Drug Resistant TB – Fact Sheets. Available at https://www.cdc.gov/tb/publications/factsheets/drtb/MDRTB.pdf.

  • Jain A, Dixit P, Prasad R. Pre-XDR and XDR in MDR and ofloxacin and kanamycin resistance in non-MDR M. tuberculosis isolates. Tuberculosis. 2012; 92:404–6. doi: 10.1016/j.tube.2012.05.010

  • Prajakta Patil, Shital Patil, S.R. Kumbhoje, S. S. Patil. Review on Current Practices of DOTS for TB Treatment in Rural India. Asian J. Res. Pharm. Sci. 5(2): 2015; 111-114. doi: 10.5958/2231- 5659.2015.00018.1

  • Lalit Kumar, Rajan, Vivek Sharma. Tuberculosis: A Brief Overview. Asian J. Pharm. Res. 2(2): April-June 2012; Page 59- 62.

  • Annabel B, et al. Global tuberculosis report 2019. Geneva: World Health Organization. 2019. Available at https://www.who.int/teams/global-tuberculosis-programme/tb- reports/global-report-2019

  • Johnston JC, et al. Treatment outcomes of multidrug-resistant tuberculosis: a systematic review and meta-analysis. PLoS One. 2009 Sep 9;4(9): e6914. doi: 10.1371/journal.pone.0006914.

  • Migliori GB, et al. Drug resistance beyond extensively drug- resistant tuberculosis: individual patient data meta-analysis. Eur Respir J. 2013;42(1):169-179. doi:10.1183/09031936.00136312.

  • Falzon D, et al. World Health Organization treatment guidelines for drug-resistant tuberculosis, 2016 update. European Respiratory Journal. 2017 Mar 1;49(3). doi: 10.1183/13993003.02308-2016.

  • Mbuagbaw L, et al. Outcomes of Bedaquiline Treatment in Patients with Multidrug-Resistant Tuberculosis. Emerging Infectious Diseases. 2019;25(5):936-943. doi:10.3201/eid2505.181823.

  • Borisov SE, et al. Effectiveness and safety of bedaquiline- containing regimens in the treatment of MDR- and XDR-TB: a multicentre study. Eur Respir J. 2017 May 21;49(5):1700387. doi: 10.1183/13993003.00387-2017. PMID: 28529205.

  • Periadurachi Kumar, Dr. K.R. John. Impact of need-based training of healthcare workers on their knowledge and practice regarding case finding under RNTCP at selected tuberculosis unit’s of primary health centres, Bangalore. Asian J. Nursing Education and Research. 2020; 10(2):145-153. doi: 10.5958/2349- 2996.2020.00032.4 14. Nisha P Nair, Vinay Kumar G, Mahadevprasad V.S, Sheela Williams. A study to assess the Knowledge regarding Tuberculosis among the adults in selected rural areas of, Mysore with a view to develop an information pamphlet. Asian J. Nursing Education and Research. 2015; 5(1):15-7.

  • Soha Patel. A Study to assess the effectiveness of structured teaching programme on knowledge regarding prevention of Tuberculosis among the adult people in selected rural area at Gothava. Asian J. Nursing Education and Research. 2020; 10(3): 339-342. doi: 10.5958/2349-2996.2020.00072.5

  • Akoijam Sangita Devi. Knowledge and Attitude of Patients Regarding Pulmonary Tuberculosis. Int. J. Nur. Edu. and Research 3(2): April-June, 2015; Page 201-208

  • Sandip Zine, Shweta A. Patankar, Sushmita S. Raopati. Rise of Antibiotic Resistance in Tuberculosis. Research J. Pharm. and Tech 2018; 11(7): 3201-3204. doi: 10.5958/0974- 360X.2018.00588.7

  • Satheesh Kumar. G, Noorjahan, G. Sadhna Reddy, Sted Khundmeer Mujahid, T.Ashwini, V.Mahender Chary. Extraction, Phytochemical Studies and In–Vitro Screening of the Leaves and Flowers of Crossandra infundibuliformis against Mycobacterium tuberculosis. Asian J. Res. Pharm. Sci. 2018; 8(4):247-252. doi: 10.5958/2231-5659.2018.00041.3

  • Mahajan R. Bedaquiline: First FDA-approved tuberculosis drug in 40 years. Int J Appl Basic Med Res. 2013 Jan;3(1):1-2. doi: 10.4103/2229-516X.112228. PMID: 23776831; PMCID: PMC3678673.

  • Lu X, Smare C et al. Health outcomes of bedaquiline in the treatment of multidrug-resistant tuberculosis in selected high burden countries. BMC Health Serv Res. 2017 Jan 26;17(1):87. doi: 10.1186/s12913-016-1931-3. PMID: 28122562; PMCID: PMC5267460.

  • Guidelines on Programmatic Management of Drug-Resistant Tuberculosis in India 2017Central TB Division, Ministry of Health and Family Welfare, Govt. of India. Available at https://tbcindia.gov.in/index1.php?lang=1andlevel=2andsublinkid =4780andlid=3306

  • Diacon AH, et al. Randomized dose-ranging study of the 14-day early bactericidal activity of bedaquiline (TMC207) in patients with sputum microscopy smear-positive pulmonary tuberculosis. Antimicrob Agents Chemother. 2013 May;57(5):2199-203. doi: 10.1128/AAC.02243-12. Epub 2013 Mar 4. PMID: 23459487; PMCID: PMC3632959.

  • Diacon AH, et al. TMC207-C208 Study Group. Multidrug- resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med. 2014 Aug 21;371(8):723-32. doi: 10.1056/NEJMoa1313865. PMID: 25140958.

  • World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis: interim policy guidance. World Health Organization; 2013. Available at https://apps.who.int/iris/handle/10665/84879

  • Worley MV, Estrada SJ. Bedaquiline: a novel antitubercular agent for the treatment of multidrug-resistant tuberculosis. Pharmacotherapy. 2014 Nov;34(11):1187-97. doi: 10.1002/phar.1482. Epub 2014 Sep 9. PMID: 25203970.

  • Udwadia ZF, Ganatra S, Mullerpattan JB. Compassionate use of bedaquiline in highly drug-resistant tuberculosis patients in Mumbai, India. Eur Respir J 2017; 49: 1601699 [https://doi.org/10.1183/13993003.01699-2016].

  • Mase S, Chorba T, Parks S, Belanger A, Dworkin F, Seaworth B, Warkentin J, Barry P, Shah N. Bedaquiline for the Treatment of Multidrug-resistant Tuberculosis in the United States. Clin Infect Dis. 2020 Aug 14;71(4):1010-1016. doi: 10.1093/cid/ciz914.

  • Salhotra VS, et al. Effectiveness and safety of bedaquiline under conditional access program for treatment of drug-resistant tuberculosis in India: An interim analysis. Indian J Tuberc. 2020 Jan;67(1):29-37. doi: 10.1016/j.ijtb.2019.10.002.

  • Gao, et al. Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China: focus on the safety. Infect Dis Poverty 10, 32 (2021). https://doi.org/10.1186/s40249-021-00819-2.


Abstract Views: 62

PDF Views: 0




  • Utilization of Bedaquiline Among Drug Resistant-Tuberculosis Patients

Abstract Views: 62  |  PDF Views: 0

Authors

Mohammed Musa Saaduddin
G. Pulla Reddy College of Pharmacy, Hyderabad, India
G. Sultana
Assistant Professor, Department of Pharmacy Practice, G. Pulla Reddy College of Pharmacy, Hyderabad, India
Dhanalakshmi
Associate Professor, Department of Pulmonary Medicine, Govt. Chest Hospital, Hyderabad

Abstract


Background: India has one of the highest burdens of drug-resistant tuberculosis (DR-TB) globally. The persistent spread of DR-TB is one of the most daunting problems the world is witnessing. Current regimens for DR-TB are complicated, lengthy, and expensive compared to those used to treat drug-susceptible TB, leaving patients with much less effective treatment options. Bedaquiline (BDQ) is a novel drug that has strong bactericidal and sterilizing activities against Mycobacterium tuberculosis. The WHO recommends BDQ for the treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). The objective of the study is to evaluate the utilization of BDQ among drug-resistant tuberculosis patients in a tertiary care hospital. Materials and Methods: A hospital-based retrospective observational study was conducted at the Government General and Chest Hospital in Erragadda, Hyderabad, Telangana, where suspected Tuberculosis cases are referred. All patients who were prescribed bedaquiline regimen were included in the study. Results: 23 Patients were prescribed BDQ during the study duration. The mean age of the patients was 41&#177 14.24 years and most of them were in the age group of 21-40 years. 15 patients (65.21%) were Males. Diabetes mellitus was the most common co-morbid condition. Two patients (8.70%) successfully completed the treatment, 3 patients (13.04%) died during treatment and 18 patients (78.26%) were still receiving the treatment during the study period. Adverse effects were documented in 12 patients and the most common adverse events were related to gastrointestinal tract. Conclusion: Bedaquiline containing regimen was well tolerated with less number of manageable adverse effects.


Keywords


Mycobacterium tuberculosis, Multidrug-resistant tuberculosis, extensively drug-resistant tuberculosis, Bedaquiline, Adverse effects

References