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Shortened MDR-TB Regimens:Union-Supported Research
I.D. Rusen, MD MSc, The UnionJune 21, 21!
"#S $e%inar &or Journa'ists
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Outline
MDR-TB burden and shortcomings of current treatment
Union involvement in shortened MDR-TB regimens
Bangladesh MDR-TB treatment pilot project
West Africa observational study
TR!AM clinical trial
"ther treatment-shortening research
#onclusions
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Outline
W$" estimates% appro&imately '()*))) ne+ MDR-TB cases
globally in ,)'
"nly a .uarter of these estimated cases are detected and
treated
"f reported MDR-TB patients treated / only 0)1 are treated
successfully
#urrently recommended treatments are lengthy and oftendifficult to tolerate
% World $ealth "rgani2ation3s 4lobal Tuberculosis Report ,)0
MDR-TB / burden and treatment limitations
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Outline
Union believed5believes strongly that a more accessible
and tolerable treatment for MDR-TB +as5is urgentlyneeded
!&perience from a Damien 6oundation pilot programme
utili2ing a nine-month treatment regimen in Bangladesh
demonstrated impressive results
Union 7nvolvement in hortened
MDR-TB Regimens
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8Bangladesh3 Regimen
Daily treatment for 9 months
Months**
Drug
9anamycin% -'7sonia2id :$; -'
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Results from Bangladesh
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Outline6urther !valuation of hortened Regimens
A
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Outline6urther !valuation of hortened Regimens
A
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Outline
"bservational cohort study of ))) patients on a modifiedBangladesh regimen
Cine countries of francophone Africa are participating Benin* Bur?ina 6aso* Burundi* #ameroon* #entral African
Republic* #te dE7voire* DR #ongo* Ciger* R+anda
7nterim analysis of ')( patients demonstrated (,F1
treatment success%
%9uaban et alF Gate brea?er sessionF '@ thUnion World #onference on Gung $ealth* #ape To+nF
West African #ohort tudy
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Outline6urther !valuation of hortened Regimens
A
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Outline
STR4M is a randomised contro''ed tria' o& non-in&eriorit5 design
In STR4M Stage 1 the Bang'adesh regimen iscompared to the 'oca''5 used $6 recommendedregimen in the participating countries
TR!AM Trial Design
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TR!AM tage Trial ites
Vietnam(Ho Chi Minh)
Ethiopia (AddisAbaba)
South Africa (Sizwe, Durban,Pietermaritzbur)
Mongolia :Ulan Bataar;
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TR!AM tage Timelines
ctua' 7'anned
irst patient randomised: 2/thJu'5 212
4nro''ed 2
"omp'etion o& recruitment: Ju'5 21)
ina' patient &o''o8-up isit: 9 21/
Resu'ts epected: 91 21(
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TR!AM tage ,
After e&tensive discussions bet+een the study team* the
local investigators and other e&perts it +as agreed that
additional regimens to be evaluated of primary interest to
patients and programmes +ould be
/ a fully oral =-month regimen
/ a @-month simplified regimen
Both of these regimens include beda.uiline as part of a
broader agreement for support +ith Hanssen
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TR!AM tage , Timelines
ctua' 7'anned
irst patient enro''ed: March 21!
4nro''ed 1 11))
"omp'etion o& recruitment: 9+ 21(
ina' patient &o''o8-up isit: 91 221
Initia' end point resu'tsepected:
9+ 22
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ther MDR-TB Research
#umerous other c'inica' research studies p'anned orunder8a5 ; isit 888.resistt%.org
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#onclusions
The Union supports further evaluation of shortened MDR-TB
regimens to find the optimal regimens for patients and
programmes
As ne+ medicines become available their potential impact on
treatment shortening must be evaluated in programme settings
#apacity of programmes to evaluate regimens in both
observational and R#T studies must be strengthened
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Ac?no+ledgements
TR!AM Trial Management 4roup* TR!AM trial site staff
and patients
West Africa "bservational tudy staff and patients
Research funders UA7D* D67D5MR#* A6D* Hanssen
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