Advances in clinical trial design for development of new TB treatments—Translating international tuberculosis treatment guidelines into national strategic plans: Experiences from Belarus, South Africa, and Vietnam

English version

Autoři: Grania Brigden ^aff001; Nguyen Viet Nhung ^aff002; Alena Skrahina ^aff003; Norbert Ndjeka ^aff004; Dennis Falzon ^aff005; Matteo Zignol ^aff005
Působiště autorů: Department of Tuberculosis, The International Union Against TB and Lung Disease, Geneva, Switzerland ^aff001; National Lung Hospital, Vietnam NTP, Vietnam ^aff002; Republican Scientific and Practical Centre for Pulmonology and TB, Minsk, Belarus ^aff003; Drug-Resistant TB, TB and HIV directorate, National Department of Health, Pretoria, South Africa ^aff004; Global Tuberculosis Programme, World Health Organization, Geneva, Switzerland ^aff005
Vyšlo v časopise: Advances in clinical trial design for development of new TB treatments—Translating international tuberculosis treatment guidelines into national strategic plans: Experiences from Belarus, South Africa, and Vietnam. PLoS Med 16(10): e32767. doi:10.1371/journal.pmed.1002896
Kategorie: Collection Review
doi: https://doi.org/10.1371/journal.pmed.1002896

Zdroje

1. WHO handbook for guideline development. 2nd ed. Geneva: World Health Organization; 2014. Available from: http://www.who.int/publications/guidelines/handbook_2nd_ed.pdf. [cited 2019 Jul 22]

2. Nasser SMU, Cooke G, Kranzer K, Norris SL, Olliaro P, Ford N. Strength of recommendations in WHO guidelines using GRADE was associated with uptake in national policy. J Clin Epidemiol. 2015 Jun;68(6):703–7. doi: 10.1016/j.jclinepi.2014.11.006 25578218

3. WHO 13th General Programme of Work 2019–2023. Geneva: World Health Organization; 2018. Available from: http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71_4-en.pdf. [cited 2019 Jul 22]

4. Lienhardt C, Vernon AN, Cavaleri M, Nambiar S, Nahid P. Development of new TB regimens: How to harmonize trial design, product registration requirements and public health guidance? PLoS Med. 2019;16(9): e1002915. doi: 10.1371/journal.pmed.1002915 31490921

5. Norris SL, Ford N. Improving the quality of WHO guidelines over the last decade: progress and challenges. Lancet Global Health. 2017 Sep;5(9):e855–6. doi: 10.1016/S2214-109X(17)30253-X 28807174

6. WHO handbook for guidelines development. Geneva: World Health Organization; 2012. Available from: https://apps.who.int/iris/bitstream/handle/10665/75146/9789241548441_eng.pdf;jsessionid=F3A28BE1E67C1D01B1DCA55DC994589A?sequence=1. [cited 2019 Jul 22]

7. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008 Apr 26;336(7650):924–6. doi: 10.1136/bmj.39489.470347.AD 18436948

8. Burdaa BU, Chambers AR, Johnson JC. Appraisal of guidelines developed by the World Health Organization. Public Health. 2014 May;128(5):444–74. doi: 10.1016/j.puhe.2014.01.002 24856197

9. Advances in Clinical Trial Design for Development of New Treatments for Tuberculosis. PLoS Medicine Special Collection. Available from: https://collections.plos.org/novel-tb-treatments. [cited 2019 Jul22]

10. The WHO Compendium of WHO Guidelines. 2nd ed. Geneva: World Health Organization; 2018. Available from: http://apps.who.int/iris/bitstream/handle/10665/272644/9789241514101-eng.pdf. [cited 2019 Jul 22]

11. The Use of Bedaquiline in the Treatment of Multidrug-Resistant Tuberculosis. Interim Policy Guidance (WHO/HTM/TB/2013.6). Geneva: World Health Organization; 2013. Available from: http://apps.who.int/iris/bitstream/10665/84879/1/9789241505482_eng.pdf. [cited 2019 Jul 22]

12. The Use of Delamanid in the Treatment of Multidrug-Resistant Tuberculosis in Children and Adolescents: Interim Policy Guidance (WHO/HTM/TB/2016.14). Geneva: World Health Organization; 2016. Available from: http://apps.who.int/iris/bitstream/10665/250614/1/9789241549899-eng.pdf. [cited 2019 Jul 22]

13. The Use of Delamanid in the Treatment of Multidrug-Resistant Tuberculosis. Interim Policy Guidance (WHO/HTM/TB/2014.23). Geneva: World Health Organization; 2014. Available from: http://apps.who.int/iris/bitstream/10665/137334/1/WHO_HTM_TB_2014.23_eng.pdf. [cited 2019 Jul 22]

14. WHO Treatment Guidelines for Drug-Resistant Tuberculosis, 2016 Update (WHO/HTM/TB/2016.4). Geneva: World Health Organization; 2016. Available from: http://apps.who.int/iris/bitstream/10665/250125/1/9789241549639-eng.pdf. [cited 2019 Jul 22]

15. WHO Treatment Guidelines for Isoniazid-Resistant Tuberculosis. Supplement to the WHO Treatment Guidelines for Drug-Resistant Tuberculosis (WHO/CDS/TB/2018.7). Geneva: World Health Organization; 2018. Available from: http://apps.who.int/iris/bitstream/handle/10665/260494/9789241550079-eng.pdf. [cited 2019 Jul 22]

16. Position statement on the continued use of the shorter MDR-TB regimen following an expedited review of the STREAM Stage 1 preliminary results. Geneva: World Health Organization; 2018. Available from: http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/WHOPositionStatementShorterRegimensSTREAMStage1.pdf. [cited 2019 Jul 22]

17. WHO Position Statement on the Use of Delamanid for Multidrug-Resistant Tuberculosis (WHO/CDS/TB/2018.1). Geneva: World Health Organization; 2018. Available from: http://www.who.int/tb/publications/2018/WHOPositionStatementDelamanidUse.pdf. [cited 2019 Jul 22]

18. Global tuberculosis report 2018 (WHO/HTM/TB/2018.20). Geneva: World Health Organization; 2018. Available from: http://apps.who.int/iris/bitstream/handle/10665/274453/9789241565646-eng.pdf. [cited 2019 Jul 22]

19. Out of Step TB policies in 29 countries. 3rd ed. 2017. Available from: https://msfaccess.org/sites/default/files/MSF_assets/TB/Docs/TB_Report_OutOfStep_3rdEd_ENG_2017.pdf. [cited 2019 Jul 22]

20. Global Update October 2017. DRTB STAT. Available from: http://drtb-stat.org/country-updates/. [cited 2019 Jul 22]

21. Chakkalakal RJ, Cherlin E, Thompson J, Lindfield T, Lawson R, Bradley EH. Implementing clinical guidelines in low-income settings: a review of literature. Glob Public Health. 2013;8(7):784–95. doi: 10.1080/17441692.2013.815794 23914758

22. A practical handbook on the pharmacovigilance of medicines used in the treatment of tuberculosis: enhancing the safety of the TB patient [Internet]. Geneva: World Health Organization; 2012. Available from: www.who.int/medicines/publications/Pharmaco_TB_web_v3.pdf [cited 2019 Jul 22]

23. Setkina S, Dotsenko M, Bondar S, Charnysh I, Kuchko A, Kaznacheeva A, et al. Safety and Effectiveness of Highly Active Antiretroviral Therapy in Treatment-Naïve HIV Patients: Preliminary Findings of a Cohort Event Monitoring Study in Belarus. Drug Saf. 2015 Mar 26;1–8. doi: 10.1007/s40264-014-0249-5

24. Skrahina A, Hurevich H, Falzon D, Zhylevich L, Rusovich V, Dara M, et al. Active pharmacovigilance for multidrug-resistant tuberculosis patients treated with Linezolid, Belarus– 2014–2015. European Respiratory Journal. 2015;46(suppl 59):PA2704

25. Public call for individual patient data on treatment of rifampicin and multidrug-resistant (MDR/RRTB) tuberculosis [Internet]. Geneva: World Health Organization; 2018 [cited 2019 Jul 22]. Available from: http://www.who.int/tb/features_archive/public_call_treatment_RR_MDR_TB/en/

26. Rapid communication: key changes to treatment of multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) (WHO/CDS/TB/2018.18) [Internet]. Geneva: World Health Organization; 2018. Available from: http://apps.who.int/iris/bitstream/handle/10665/275383/WHO-CDS-TB-2018.18-eng.pdf. [cited 2019 Jul 22]

27. Active tuberculosis drug-safety monitoring and management (aDSM). Framework for implementation (WHO/HTM/TB/2015.28) [Internet]. Geneva: World Health Organization; 2015. Available from: http://apps.who.int/iris/bitstream/10665/204465/1/WHO_HTM_TB_2015.28_eng.pdf. [cited 2019 Jul 22]

28. Active TB drug-safety monitoring and management (aDSM) [Internet]. Geneva: World Health Organization. Available from: http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/pharmacovigilance/en/. [cited 2019 Jul 22]

29. Review of the National Tuberculosis Programme in Belarus, 8–18 December 2015 [Internet]. Copenhagen: World Health Organization Regional Office for Europe; 2015. Available from: http://www.euro.who.int/__data/assets/pdf_file/0006/325959/Belarus-NTP-review-2015.pdf. [cited 2019 Jul 22]

30. Skrahina A, Setkina S, Hurevich H, Solodovnikova V, Viatushka D, Klimuk D, Dara M. Bedaquiline containing regimens in the treatment of multi- and extensively drug-resistant tuberculosis at the programmatic level: prospective cohort study. Int J Tuberc Lung Dis2018;22(11) sup 2OA 18-308-26, S263

31. Factsheet: Why Bedaquiline (TMC207) should be prioritised for drug-resistant TB patients in South Africa. MSF Access Campaign; 2012. Available from: https://msfaccess.org/sites/default/files/MSF_assets/TB/Docs/TB_FactSheet_TMC207CU_SouthAfrica_ENG_2012.pdf. [cited 2019 Jul 22]

32. Guglielmetti L, Hewison C, Avaliani Z, Hughes J, Kiria N, Lomtadze N,et al. Examples of bedaquiline introduction for the management of multidrug-resistant tuberculosis in five countries. Int J Tuberc Lung Dis 2017;21(2):167–174. doi: 10.5588/ijtld.16.0493 28234080

33. Directorate Drug-Resistant TB, TB & HIV. Introduction of new drugs, drug regimens and management for drug-resistant TB in South Africa: Policy framework. 1.1. Pretoria: National Department of Health; 2015.

34. Interim Clinical Guidance for the Implementation of Injectable-Free Regimens Rifampicin-Resistant Tuberculosis in Adults, Adolescents and Children. Pretoria: South African Department of Health; 2018. Available from: http://www.tbonline.info/media/uploads/documents/dr_tb_clinical_guidelines_for_rsa_september_2018.pdf [cited 2019 Jul 22]

35. Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children. Policy Update. Geneva: World Health Organization; 2014 Available from: http://apps.who.int/iris/bitstream/handle/10665/112472/9789241506335_eng.pdf;jsessionid=A573FF63E853397F801959730C1D6EFF?sequence=1. [cited 2019 Jul 22]

36. Xpert MTB/RIF assay for the diagnosis of TB Meeting Report. Geneva: World Health Organization; 2016. Available from: http://apps.who.int/iris/bitstream/handle/10665/250383/9789241511452-eng.pdf?sequence=1&isAllowed=y. [cited 2019 Jul 22]

37. Chest radiography in Tuberculosis detection. Summary of current WHO recommendations and guidance on programmatic approaches. Geneva: World Health Organization; 2016. Available from: http://apps.who.int/iris/bitstream/handle/10665/252424/9789241511506-eng.pdf?sequence=1 [cited 2019 Jul 22]

38. Nguyen VN, Nguyen TMP, Quelapio MI, Gebhard A, Nguyen VH, Le TNA, et al. Right diagnosis and right treatment through the patient triage approach: challenges and lessons from pilot to expansion in Vietnam Short Oral Abstract session [SOA11-1116-26]. Int J Tuberc Lung Dis. 2018;11(Supplement 2):S265–S286

39. WHO consolidated guidelines on drug-resistant tuberculosis treatment. Geneva: World Health Organization; 2019. Available from: https://apps.who.int/iris/bitstream/handle/10665/311389/9789241550529-eng.pdf?ua=1 [cited 2019 Jul 22]

40. Squire SB, Ramsay AR, van den Hof S, Millington KA, Langley I, Bello G et al. Making innovations accessible to the poor through implementation research. Int J Tuberc Lung Dis 2011 Jul;15(7):862–70 doi: 10.5588/ijtld.11.0161 21682960

41. World Leaders Reaffirm Commitment to End Tuberculosis by 2030, as General Assembly Adopts Declaration Outlining Actions for Increased Financing, Treatment Access. United Nations; 2018 Sep 26. Available from: https://www.un.org/press/en/2018/ga12067.doc.htm. [cited 2019 Jul 22]