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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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