Tuberculosis future or investigational therapies: Difference between revisions

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__NOTOC__
__NOTOC__
{{Tuberculosis}}
{{Tuberculosis}}
{{CMG}} ; {{AE}} {{Ammu}}
{{CMG}} ; {{AE}} {{Mashal Awais}}; {{Ammu}} ; {{marjan}}
==Overview==
==Overview==
Since new drug resistant tuberculosis have been emerging, the role of future therapies is vital in curbing outbreaks. The new drugs should be more effective than the current regimen and a few drugs in clinical trials have been showing good results.
With emergence of new drug-resistant tuberculosis, the role of future therapies is crucial in curbing outbreaks. The new drugs should be more effective than the current regimen and a few drugs in clinical trials have been showing promising results.


==Future investigations==
==Future investigations==


===Principles of future investigations===
===Principles of future investigations===
Any future regimen should satisfy the following principles. <ref name=Cost>{{cite web | title = Future therapy purposed by WHO| url = http://www.who.int/bulletin/volumes/92/1/13-122028/en/}}</ref>
Any future regimen must fulfill the following recommendations: <ref name="Cost">{{cite web | title = Future therapy purposed by WHO| url = http://www.who.int/bulletin/volumes/92/1/13-122028/en/}}</ref>


* It should not have more than a maximum duration of 6 months
*It should not have more than a maximum duration of 6 months
* The dosing schedule must be simple
*The dosing schedule must be simple
* The number of drugs in it should be ideally not more than 3-5 drug each from a different class
*The ideal number of drugs should not exceed 3-5 drug from a different class
* It should have minimum side effect profile so that we could have minimum monitoring
*It should have a minimum side effect profile so that we could have minimum monitoring
* It should be effective against [[MDR]], [[XDR]] and [[XXDR]] strains
*It should be effective against [[MDR]], [[XDR]], and [[XXDR]] strains
* It should be administered per orally
*It should be administered orally
* It should have minimum interaction with anti retroviral drugs.
*It should have minimum interaction with antiretroviral drugs.
* It should have atleast one new class of drug
*It should have at least one new class of drug


===New drugs involved in clinical trial for treatment of tuberculosis===
===New drugs involved in a clinical trial for the treatment of tuberculosis===


{| style="border: 0px; font-size: 90%; margin: 3px;" align=center
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! style="background: #4479BA; width: 200px;" | {{fontcolor|#FFF|Drug}}
! style="background: #4479BA; width: 200px;" |{{fontcolor|#FFF|Drug}}
! style="background: #4479BA; width: 200px;" | {{fontcolor|#FFF|Phase}}
! style="background: #4479BA; width: 200px;" |{{fontcolor|#FFF|Phase}}
! style="background: #4479BA; width: 200px;" | {{fontcolor|#FFF|Class}}
! style="background: #4479BA; width: 200px;" |{{fontcolor|#FFF|Class}}
|-
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| style="padding: 5px 5px; background: #DCDCDC; font-weight: bold" |[[Moxifloxacin]]
| style="padding: 5px 5px; background: #DCDCDC; font-weight: bold" |[[Moxifloxacin]]
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| style="padding: 5px 5px; background: #F5F5F5;" |[[Diarylquinoline]]
| style="padding: 5px 5px; background: #F5F5F5;" |[[Diarylquinoline]]
|-
|-
| style="padding: 5px 5px; background: #F5F5F5;" colspan="3"|Data provided by WHO<ref name=CDC>{{cite web | title = Tuberculosis (TB) Future drugs| url = http://www.who.int/bulletin/volumes/92/1/BLT-13-122028-table-T1.html }}</ref>
| colspan="3" style="padding: 5px 5px; background: #F5F5F5;" |Data provided by WHO<ref name="CDC">{{cite web | title = Tuberculosis (TB) Future drugs| url = http://www.who.int/bulletin/volumes/92/1/BLT-13-122028-table-T1.html }}</ref>
|}
|}


==Tuberculosis vaccine development==
==Tuberculosis vaccine development==
*Neonatal BCG vaccination is partially effective at protecting infants and children, particularly from the most severe consequences of TB disease.
*BCG is poorly protective against pulmonary disease in adults, and therefore at reducing Mycobactarium tuberculosis transmission.
*A new novel vaccine is warranted in decreasing the incidence and mortality of Tuberculosis; a  vaccine that is effective in adult individuals who have not yet been infected with Mycobactarium tuberculosis, as well as in those with latent Mycobacterium tuberculosis infection.
*This new novel vaccines will also offer the best chance to contain the accelerating spread of multi-drug resistant tuberculosis.
*To this date this new vaccine has not been develop but many TB vaccine candidate are in pipeline.
*Potential vaccines are either whole cell vaccines, adjuvanted proteins, and vectored subunit vaccines.
*Up till now, there was no communicated consensus as to the preferred product characteristics (PPC) that would adequately support favorable policy recommendations for implementation where needed.


*[[Infant|Neonatal]] [[BCG]] [[vaccination]] is partially effective at protecting infants and children, especially from the most severe [[complications]] of [[Tuberculosis|TB]] disease.<ref name="urlWHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT">{{cite web |url=https://www.who.int/immunization/research/development/tuberculosis/en/ |title=WHO &#124; Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref>
*[[BCG]] is poorly effective at protecting against [[pulmonary disease]] in adults, and hence at decreasing [[Mycobacterium tuberculosis]] [[Transmission (medicine)|transmission]].<ref name="urlWHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT">{{cite web |url=https://www.who.int/immunization/research/development/tuberculosis/en/ |title=WHO &#124; Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref>
*A new novel vaccine is needed to reduce the [[Incidence (epidemiology)|incidence]] and [[Mortality rate|mortality]] of [[tuberculosis]]; a vaccine that is effective in adult individuals who have not yet been infected with [[mycobacterium tuberculosis]], in addition to in those with latent [[mycobacterium tuberculosis]] infection.<ref name="urlWHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT">{{cite web |url=https://www.who.int/immunization/research/development/tuberculosis/en/ |title=WHO &#124; Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref>
*This new novel [[vaccine]] will also provide the best way to counteract accelerating spread of [[Multi-drug-resistant tuberculosis|multi-drug resistant tuberculosis]].<ref name="urlWHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT">{{cite web |url=https://www.who.int/immunization/research/development/tuberculosis/en/ |title=WHO &#124; Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref>
*To this date, this new vaccine has not been developed but many [[Tuberculosis|TB]] [[vaccine]] candidates are in pipeline.<ref name="urlWHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT">{{cite web |url=https://www.who.int/immunization/research/development/tuberculosis/en/ |title=WHO &#124; Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref>
*Potential vaccines are either whole-cell vaccines, adjuvanted proteins, and vectored subunit vaccines.<ref name="urlWHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT">{{cite web |url=https://www.who.int/immunization/research/development/tuberculosis/en/ |title=WHO &#124; Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref>
*A document highlighting [[World Health Organization|WHO]] preferred Product Characteristics (PPC) for new TB vaccines has been devised based on a high unmet medical need and technical feasibility assessment.<ref name="urlWHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT">{{cite web |url=https://www.who.int/immunization/research/development/tuberculosis/en/ |title=WHO &#124; Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref>
*The vaccine PPCs are built through a large consensus building process and originate from interactions with different stakeholders.<ref name="urlWHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT">{{cite web |url=https://www.who.int/immunization/research/development/tuberculosis/en/ |title=WHO &#124; Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref>
*The new vaccine, made by GSK and now known as M72/AS01E, was tested in about 3,300 adults in Kenya, South Africa, and Zambia.
*All of them already had latent [[tuberculosis]], Of those who got two doses of the GSK vaccine, only 13 developed active [[tuberculosis]] during three years of follow-up, according to the new study which was published in The New England Journal of Medicine. On the other hand, 26 of those who received a [[placebo]] progressed to active tuberculosis.
<br />
==References==
==References==
{{Reflist|2}}
{{Reflist|2}}
{{WH}}
{{WS}}


[[Category:Disease]]
[[Category:Disease]]
 
[[Category: Pulmonology]]
[[Category:Pulmonology]]
[[Category:Primary care]]
[[Category:Bacterial diseases]]
[[Category:Bacterial diseases]]
{{WH}}
{{WS}}

Latest revision as of 05:47, 27 March 2021

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] ; Associate Editor(s)-in-Chief: Mashal Awais, M.D.[2]; Ammu Susheela, M.D. [3] ; Marjan Khan M.B.B.S.[4]

Overview

With emergence of new drug-resistant tuberculosis, the role of future therapies is crucial in curbing outbreaks. The new drugs should be more effective than the current regimen and a few drugs in clinical trials have been showing promising results.

Future investigations

Principles of future investigations

Any future regimen must fulfill the following recommendations: [1]

  • It should not have more than a maximum duration of 6 months
  • The dosing schedule must be simple
  • The ideal number of drugs should not exceed 3-5 drug from a different class
  • It should have a minimum side effect profile so that we could have minimum monitoring
  • It should be effective against MDR, XDR, and XXDR strains
  • It should be administered orally
  • It should have minimum interaction with antiretroviral drugs.
  • It should have at least one new class of drug

New drugs involved in a clinical trial for the treatment of tuberculosis

Drug Phase Class
Moxifloxacin Phase III Fluoroquinolone
Linezolid Phase II Oxazolidinone
AZD-5847 Phase II Oxazolidinone
Sutezolid Phase II Oxazolidinone
Clofazimine Phase II Riminophenazine
SQ-109 Phase II Ethylenediamine
PA-824 Phase IIb Nitroimidazole
Delamanid Phase III Nitroimidazole
Bedaquiline Phase III Diarylquinoline
Data provided by WHO[2]

Tuberculosis vaccine development

  • Neonatal BCG vaccination is partially effective at protecting infants and children, especially from the most severe complications of TB disease.[3]
  • BCG is poorly effective at protecting against pulmonary disease in adults, and hence at decreasing Mycobacterium tuberculosis transmission.[3]
  • A new novel vaccine is needed to reduce the incidence and mortality of tuberculosis; a vaccine that is effective in adult individuals who have not yet been infected with mycobacterium tuberculosis, in addition to in those with latent mycobacterium tuberculosis infection.[3]
  • This new novel vaccine will also provide the best way to counteract accelerating spread of multi-drug resistant tuberculosis.[3]
  • To this date, this new vaccine has not been developed but many TB vaccine candidates are in pipeline.[3]
  • Potential vaccines are either whole-cell vaccines, adjuvanted proteins, and vectored subunit vaccines.[3]
  • A document highlighting WHO preferred Product Characteristics (PPC) for new TB vaccines has been devised based on a high unmet medical need and technical feasibility assessment.[3]
  • The vaccine PPCs are built through a large consensus building process and originate from interactions with different stakeholders.[3]
  • The new vaccine, made by GSK and now known as M72/AS01E, was tested in about 3,300 adults in Kenya, South Africa, and Zambia.
  • All of them already had latent tuberculosis, Of those who got two doses of the GSK vaccine, only 13 developed active tuberculosis during three years of follow-up, according to the new study which was published in The New England Journal of Medicine. On the other hand, 26 of those who received a placebo progressed to active tuberculosis.


References

  1. "Future therapy purposed by WHO".
  2. "Tuberculosis (TB) Future drugs".
  3. 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 "WHO | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT".

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