Tuberculosis future or investigational therapies: Difference between revisions
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{{CMG}} ; {{AE}} {{Mashal Awais}}; {{Ammu}} ; {{marjan}} | {{CMG}} ; {{AE}} {{Mashal Awais}}; {{Ammu}} ; {{marjan}} | ||
==Overview== | ==Overview== | ||
Since new drug-resistant tuberculosis has been emerging, the role of future therapies is vital in curbing outbreaks. The new drugs | Since new drug-resistant tuberculosis has been emerging, the role of future therapies is vital in curbing outbreaks. The new drugs are required to be more effective than the current regimen and a few drugs in clinical trials have been showing good 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 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> | ||
* 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 number of drugs in it should be ideally not more than 3-5 drug each from a different class | ||
* It should have a 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 orally | *It should be administered orally | ||
* It should have minimum interaction with antiretroviral drugs. | *It should have minimum interaction with antiretroviral drugs. | ||
* It should have at least one new class of drug | *It should have at least one new class of drug | ||
===New drugs involved in a clinical trial for the 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 | {| style="border: 0px; font-size: 90%; margin: 3px;" align="center" | ||
|valign=top| | | valign="top" | | ||
|+ | |+ | ||
! 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}} | ||
|- | |- | ||
| 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" 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.<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 | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref> | *Neonatal BCG vaccination is partially effective at protecting infants and children, particularly from the most severe consequences of 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 | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref> | ||
*BCG is poorly protective against pulmonary disease in adults, and therefore at reducing Mycobactarium tuberculosis 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 | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref> | *BCG is poorly protective against pulmonary disease in adults, and therefore at reducing Mycobactarium tuberculosis 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 | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref> | ||
| Line 79: | Line 80: | ||
*The preferred product characteristics (PPC) describe WHO preferences for parameters of vaccines, in particular their indications, target groups, possible immunization strategies, and features of clinical data desired related to safety and efficacy, supportive of policy decision making.<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 | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref> | *The preferred product characteristics (PPC) describe WHO preferences for parameters of vaccines, in particular their indications, target groups, possible immunization strategies, and features of clinical data desired related to safety and efficacy, supportive of policy decision making.<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 | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref> | ||
*The vaccine PPCs are built through a wide consensus building process and result from interactions with a variety of 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 | Tuberculosis vaccine development, SYSTEM DO NOT MOVE OR EDIT |format= |work= |accessdate=}}</ref> | *The vaccine PPCs are built through a wide consensus building process and result from interactions with a variety of 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 | 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. | *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 published in The New England Journal of Medicine. By contrast, 26 of those who got a placebo progressed to active tuberculosis. | *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 published in The New England Journal of Medicine. By contrast, 26 of those who got a placebo progressed to active tuberculosis. | ||
Revision as of 05:47, 29 January 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
Since new drug-resistant tuberculosis has been emerging, the role of future therapies is vital in curbing outbreaks. The new drugs are required to be more effective than the current regimen and a few drugs in clinical trials have been showing good results.
Future investigations
Principles of future investigations
Any future regimen should satisfy the following principles. [1]
- It should not have more than a maximum duration of 6 months
- 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
- 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, particularly from the most severe consequences of TB disease.[3]
- BCG is poorly protective against pulmonary disease in adults, and therefore at reducing Mycobactarium tuberculosis transmission.[3]
- 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 Mycobacterium tuberculosis, as well as in those with latent Mycobacterium tuberculosis infection.[3]
- This new novel vaccines will also offer the best chance to contain the accelerating spread of multi-drug resistant tuberculosis.[3]
- To this date this new vaccine has not been develop but many TB vaccine candidate are in pipeline.[3]
- Potential vaccines are either whole cell vaccines, adjuvanted proteins, and vectored subunit vaccines.[3]
- 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.[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 preferred product characteristics (PPC) describe WHO preferences for parameters of vaccines, in particular their indications, target groups, possible immunization strategies, and features of clinical data desired related to safety and efficacy, supportive of policy decision making.[3]
- The vaccine PPCs are built through a wide consensus building process and result from interactions with a variety of 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 published in The New England Journal of Medicine. By contrast, 26 of those who got a placebo progressed to active tuberculosis.