TB Guidelines 2010

|

Treatment of Tuberculosis - Guidelines by

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1.1 Chapter objectives
1.2 Purpose of the guidelines
1.3 Target audience
1.4 Scope
1.5 Why a new edition?
1.6 Methodology
1.7 International Standards for Tuberculosis Care
1.8 Expiry date

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± Chapter ± This chapter defines the purpose,
objectives target audience, scope and
development of this fourth edition of
the guidelines

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± Purpose ± The principal purpose of these
of the guidelines is to help national TB
guidelines control programmes (NTPs) in setting
TB treatment policy to optimize
patient cure: curing patients will

in the community

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± Target ± The primary target audience for the
audience guidelines is the managers and staff
of NTPs, together with other TB
service providers

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± Scope ± These guidelines address the

± They exclude diagnosis, laboratory
standards for smear microscopy, protocols
for use of rapid drug susceptibility tests,
paediatric TB, drug procurement and
supply management, infection control,
intensified case-finding in persons living
with HIV, and isoniazid preventive therapy

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± Why a ± Major progress in global TB control
new followed the widespread
edition? implementation of the Î

(DOTS is the internationally agreed
strategy for TB control)
(DOT is directly observed treatment)
± The
, launched in
2006, builds upon and enhances the
achievements of DOTS
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± Why a ± Historically, the greatest emphasis of
new TB control activities has been on the
edition? most infectious patients.
± This changed with the

.

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± Why a ± This fourth edition of the guidelines
new has therefore |

edition? , which were used to prioritize
patients for treatment. According to
this prior categorization, smear-
negative TB patients were assigned
third priority and MDR-TB patients
fourth priority.
± Aor treatment decisions

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± Why a ± To replace Categories IʹIV, this fourth
new edition groups patients (and
edition? standard regimens recommended for
each group) according to the

.
± Why?
Because Drug resistance is a critical
determinant of

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± Methodology ± The recommendations are based
on the quality of the evidence,
values, and costs, as well as
judgements about trade-offs
between benefits and harm
± The quality of the evidence was

assessed according to the GRADE
methodology

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± Methodology ± A
means
that the desirable effects of
adherence to the
recommendation clearly outweigh
the undesirable effects.
± Strong recommendations use the
words ͞should͟ or ͞should not͟.
± No alternatives are listed

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± Methodology ± A means
that the desirable effects of adherence
to the recommendation probably
outweigh the undesirable effects, but
the trade-offs are uncertain.
± Reasons for lack of certainty include:
Ͷ high-quality evidence to support the
recommendation is lacking
Ͷ benefits of implementing the
recommendation are small
Ͷ benefits may not justify the costs

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± Methodology ± A means that
there is insufficient evidence; the
recommendation is therefore based on
field application and expert opinion

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± International ± The International Standards for
Standards for Tuberculosis Care (ISTC) describe a
Tuberculosis widely accepted level of TB care
Care that all practitioners should seek
to achieve

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± Expiry
date
± The WHO Stop TB Department will

review and update these guidelines
or when
new evidence, treatment regimens
or diagnostic tests become available
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|
Chapter objectives
Purposes of defining a TB case
Case definitions
Anatomical site of TB disease
Bacteriological results
History of previous treatment: patient
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registration group
|
± Chapter ± This chapter describes
objectives Ͷ the purpose of having case definitions
for tuberculosis;
Ͷ the definition of a case of TB, as well as
of suspected and confirmed cases;
Ͷ additional features of TB cases
important for the treatment of individual
patients, as well as for evaluating TB
programmes and monitoring the epidemic

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± Purposes of ± Uniform criteria to define a TB case are needed
for:
defining a Ͷ proper patient registration and case notification
TB case Ͷ selecting appropriate standard treatment
regimens
Ͷ standardizing the process of data collection for
TB control
Ͷ evaluating the proportion of cases according to
site, bacteriology and treatment history
Ͷ cohort analysis of treatment outcomes
Ͷ accurate monitoring of trends and evaluation of
the effectiveness of TB programmes within and
across districts, countries and global regions
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± Case ± The TB case definitions below are
definitions based on 2 things:
the level of certainty of the diagnosis
whether or not laboratory

confirmation is available.

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± Case ± : Any person who
definitions presents with symptoms or signs
suggestive of TB.
± The most common symptom of
pulmonary TB is a productive cough for
more than 2 weeks
(which may be accompanied by other
respiratory symptoms (shortness of
breath, chest pains, haemoptysis) and/or
constitutional symptoms (loss of appetite,
weight loss, fever, night sweats, and
fatigue).
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± Case ± | A definite case of TB
definitions (defined below) or one in which a health
worker (clinician or other medical
practitioner) has diagnosed TB and has
decided to treat the patient with a full
course of TB treatment.
± D


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± Case ± Î . A patient
definitions with v

±

v

!

"#

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± Case ± Cases of TB are also classified according to
definitions the:
Ͷ anatomical site of disease
Ͷ bacteriological results (including drug
resistance)
Ͷ history of previous treatment
Ͷ HIV status of the patient

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± Bacterio- ± Bacteriology refers to the smear
logical status of pulmonary cases and the
results identification of M. tuberculosis for
any case by culture or newer
methods.

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± Bacterio- ± |: Case of
logical pulmonary TB if one or more
results sputum smear specimens at the
start of treatment are positive for
AAB (provided that there is a
functional EQA system with blind
rechecking)
O

O

a

O
a

v


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± Bacterio- ±
þ

$
logical A. have sputum that is

results for v

%&
± B. meet the following diagnostic criteria:
decision by a clinician to treat with a full
course of anti-TB therapy; and
radiographic abnormalities consistent
with active pulmonary TB and
± Evidence of HIV
± No improvement on broad spectrum
antibitics ( excluding AQs and
Aminoglycosides) 30
|
± History of ± It is important to identify previously
previous treated patients because they are at
treatment: increased risk of drug resistance,
patient including MDR-TB
registration ± At the start of therapy, specimens
group should be obtained for culture and
DST from all previously treated
patients

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± HIV status ± Determining and recording the
patient͛s HIV status is critical for
treatment as well as for monitoring
trends and assessing programme
performance.

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!

3.2 Aims of treatment
3.3 Essential anti-TB drugs
3.4 Standard regimens for defined patient groups
3.5 New patients
3.6 Previously treated patients and multidrug
resistance
3.7 Standard regimens for previously treated
patients
3.8 Overall considerations in selecting a country͛s
standard regimens
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!

± Chapter ± This chapter describes:
objectives Ͷ the aims of treatment;
Ͷ the recommended doses of first-line
anti-TB drugs for adults;
Ͷ regimens for new and previously
treated patients;
Ͷ considerations in selecting regimens
for defined patient groups;
Ͷ evidence base for the selected
regimens in defined patient groups

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!

± Aims of 1. To cure the patient and restore
treatment quality of life and productivity
2. To prevent death from active TB or
its late effects
3. To prevent relapse of TB
4. To reduce transmission of TB to
others
5. To prevent the development and
transmission of drug resistance

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!

± Essential ± Isoniazid
anti-TB ± Rifampicin
drugs ± Pyrazinamide
± Ethambutol
± Streptomycin

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!

± '
± WHO continues to recommend the use of
ADCs (Aixed Dose Combinations)
(

± ADCs are thought to:

prevent acquisition of drug resistance due to

monotherapy
Prescription errors are likely to be less
frequent because dosage recommendations
are more straightforward
adjustment of dosage according to patient
weight is easier
the number of tablets to ingest is smaller
and may thus encourage patient adherence

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!

± '
± Using ADCs does not obviate the
(
need for separate drugs for
patients who develop:

drug toxicity
Intolerance
or who have contraindications to
specific component drugs

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!

± Patient Kits ± A TB patient kit contains the full course of
treatment for a single patient
± This helps limit confusion and wastage, and
makes it easier to monitor the regularity of
treatment
± The patient may feel a sense of ͞ownership͟
of the patient kit and enhanced motivation
to complete the full course of treatment
± It should be noted that the TB patient kit
does not eliminate the need for directly
observed treatment (DOT)

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!

± Standard ± Standardized treatment means that all
regimens for patients in a defined group receive the
same treatment regimen.
defined
± Standard regimens have the following
patient
advantages over individualized
groups prescription of drugs:
Ͷ errors in prescription, and thus the risk
of development of drug resistance,
are reduced
Ͷ costs are reduced
Ͷ outcome evaluation is convenient and
results are comparable
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!

± New ± D are defined as those
patients who have no history of prior TB
treatment or who received less than 1
month of anti-TB drugs (regardless of
whether their smear or culture results
are positive or not)

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!

± New ± New patients are presumed to have
patients drug-susceptible TB with =" :
Where there is a high prevalence of
isoniazid resistance in new patients

If they have developed active TB after
known contact with a patient
documented to have drug-resistant TB;
they are likely to have a similar drug
resistance pattern to the source case

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± New ! #$#
patients ± D

%
= !&'() !
(Strong/High grade of evidence)

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± New ! #$=
patients ± = !&'(% '


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± New ! =$#
patients ± ë


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± New ! =$#*
patients ± D

+= !&'(), !-.

(Conditional/High or moderate grade
of evidence)

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± New ! =$#
patients ±

+=, !&'-(), !-.
! =$#

D

(Conditional/High or moderate grade

of Treatment
evidence) of Tuberculosis - Guidelines by
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± New ! =$=
patients ± D

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± New ± !
patients

/

!'

!
(Weak/Insufficient evidence, expert
opinion)

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± Previously ± Previous TB treatment is a strong
treated determinant of

patients and
multidrug ± MDR (rather than any drug
resistance resistance) is used to describe the
retreatment patient groups

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!

± Previously ± At the global level, 15% of
treated previously treated patients have
patients and MDR, which is five times higher
multidrug than the global average of 3% in
resistance new patients

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!

± Previously
treated
patients and
multidrug
resistance
Ä


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!

± Standard ± Previously treated TB cases are
regimens for classified now in 3 categories:
previously
treated 1. Relapsers
patients
2. Aailures
3. Defaulters

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regimens for *+./

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treated ')
patients *+./

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regimens for ±

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patients
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± Standard ±
regimens for
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previously (With line probe assays, MDR can
treated be essentially confirmed1 or
patients excluded within 1ʹ2 days)
! 0$=
±

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± Standard ±
regimens for
Î
previously (Conventional DST include Solid or
treated Liquid culture and sensitivity)
patients

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± Overall ± National TB control programmes
considerations will need three standard regimens:
in selecting a ' oD !
1: the
country͛s regimen containing 6 months of
standard rifampicin: 2HRZE/4HR(E)
regimens
' o! !

2 Î
1:
2HRZES/1HRZE/5HRE
' o Î!!
1
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± Overall ± Ideally, DST is done for all patients
considerations at the start of treatment, so that
in selecting a the most appropriate therapy for
country͛s each individual can be determined
standard
regimens

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Î

4.2 Monitoring the patient
4.3 Assessing treatment response in new and previously
treated pulmonary TB patients, and acting on the results
4.4 Extrapulmonary TB
4.5 Recording standardized treatment outcomes
4.6 Cohort analysis of treatment outcomes
4.7 Management of treatment interruption
4.8 Prevention of adverse effects of drugs
4.9 Monitoring and recording adverse effects
4.10 Symptom-based approach to managing side-effects of
anti-TB Treatment of Tuberculosis - Guidelines by
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M
Î

± Chapter ± This chapter describes how to:
objectives Ͷ monitor and record the response
to treatment, and decide on
actions to take in response to
monitoring results;
Ͷ use cohort analysis to evaluate
treatment outcomes;
Ͷ manage treatment interruption;
Ͷ detect and manage drug-
induced toxicity
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M
Î

± Monitoring ± All patients should be instructed to
the patient report the persistence or
reappearance of symptoms of TB
(including weight loss), symptoms of
adverse drug reactions, or treatment
interruptions.
±

, and dosages should be
adjusted if weight changes

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Î

± Assessing ! $#
treatment ± 2
response in
new and

previously
treated
pulmonary TB
patients, and (Conditional/High or moderate
acting on the grade of evidence)
results
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± Assessing ! $=
treatment ±
response in
new and , =-
previously
treated
pulmonary TB
patients, and (Strong/High grade of evidence)
acting on the
results
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± Assessing ! $
treatment ±
response in
new and
previously

treated ,Î-
pulmonary TB
patients, and
acting on the (Strong/High grade of evidence)
results
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Î

± Assessing ± The main purpose of obtaining
treatment cultures at this stage is to detect
response in drug resistance without waiting
new and until the fifth month to change to
previously appropriate therapy
treated ± Note: The treatment is declared a
pulmonary TB failure if a patient is found to
patients, and harbour MDR-TB at any point in
acting on the time during treatment
results
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M
Î

± Assessing ± at the end of the intensive
treatment phase is a of which new
patients will relapse.
response in
± However, the proportion of smear-
new and
positive patients with sputum smear
previously conversion at the end of the intensive
treated phase is also an indicator of TB
pulmonary TB programme performance
patients, and ±
acting on the
results
$

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Î

A positive sputum smear at the end of the
± Assessing intensive phase may indicate any of the
following:
treatment
± the initial phase of therapy was poorly
response in supervised and patient adherence was poor;
new and ± poor quality of anti-TB drugs;
previously ± doses of anti-TB drugs are below the
recommended range;
treated
± resolution is slow because the patient had
pulmonary TB extensive cavitation and a heavy initial bacillary
patients, and load;
acting on the ± the patient may have drug-resistant v

results 1
± non-viable bacteria remain visible by microscopy
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M
Î

± Extra- ± As in pulmonary smear-negative
pulmonary disease, the
of the patient is
TB a useful indicator.

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Î

± Recording ± At the of the treatment course
standardized for each individual patient, the
treatment District TB Officer records the
outcomes treatment outcome in the Î
!
$

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± Cohort ± The district/local TB officer should
analysis of perform cohort analysis of
treatment treatment outcome every quarter-
outcomes year and at the end of every year
± A typical cohort consists of all TB

patients registered during a quarter

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Î

± Management ± The NTP should ensure that the
of treatment patient is contacted within a day
interruption after missing treatment during the
initial phase, and within a week
during the continuation phase

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Î

± Management ± Most serious interruptions are if:
The patient is found to be smear- or culture-
of treatment positive upon returning from default.
interruption Interruption occurs in the intensive, rather
than the continuation, phase.
Interruption occurs early (rather than later) in
the continuation phase.
The interruption is of long duration.
The patient is immunocompromised (living
with HIV or another condition).
The patient had poor response to treatment
before the interruption.
Drug-resistant disease is known or suspected

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Î

± Management ± Culture and DST should be
of treatment performed upon return of patients
interruption who meet the definition for
,
= ).
± If laboratory capacity permits,
specimens for culture and DST
should also be obtained from other
patients returning after treatment
interruption.
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Î

± Prevention ± Health personnel can some
of adverse drug-induced side-effects, for
effects of example isoniazid-induced
drugs peripheral neuropathy ( with
Pyridoxine 10 mg/day or 25
mg/day)

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Î

± Monitoring ± Adverse reactions to drugs should
and be recorded on the
recording | under ͞Observations͟
adverse
effects

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Î

± Symptom- ± The most common adverse effects
based are classified as 3 or .
approach to
managing
side-effects
of ATT

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Î

± Symptom- ± Î

based Of the first-line anti-TB drugs,
approach to isoniazid, pyrazinamide and rifampicin
managing can all cause liver damage
side-effects Rifampicin can cause asymptomatic
of ATT jaundice without evidence of hepatitis
It is important to try to rule out other
possible causes before deciding that
the hepatitis is induced by the TB
regimen

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Î

± Symptom- ± Î

based If it is thought that the liver disease is
approach to caused by the anti-TB drugs, all drugs
managing should be stopped.
side-effects If the patient is severely ill with TB and
of ATT it is considered unsafe to stop TB
treatment, a non-hepatotoxic regimen
consisting of streptomycin,
ethambutol and a fluoroquinolone
should be started (or continued) for a
total of 18ʹ24 months

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Î

± Symptom- ± Î

based If TB treatment has been stopped, it is
approach to necessary to wait for liver function
managing tests to revert to normal and clinical
symptoms (nausea, abdominal pain)
side-effects
to resolve before reintroducing the
of ATT anti-TB drugs.
If it is not possible to perform liver
function tests, it is advisable to wait
an extra 2 weeks after resolution of
jaundice and upper abdominal
tenderness before restarting TB
treatment
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Î

± Symptom- ± Î

based Once drug-induced hepatitis has
approach to resolved, the drugs are reintroduced
managing one at a time.
side-effects If symptoms recur or liver function
of ATT tests become abnormal as the drugs
are reintroduced, the last drug added
should be stopped. Some advise
starting with rifampicin because it is
less likely than isoniazid or
pyrazinamide to cause hepatotoxicity
and is the most effective agent
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Î

± Symptom- ± Î

based
approach to After 3ʹ7 days, isoniazid may be
managing reintroduced. In patients who have
side-effects experienced jaundice but tolerate the
of ATT reintroduction of rifampicin and
isoniazid, it is advisable to avoid
pyrazinamide

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Î

± Symptom- ± Î

based
approach to If rifampicin is implicated, a suggested
managing regimen without rifampicin is 2
side-effects months of isoniazid, ethambutol and
of ATT streptomycin followed by 10 months
of isoniazid and ethambutol.

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Î

± Symptom- ± Î

based If isoniazid cannot be used, 6ʹ9
approach to months of rifampicin, pyrazinamide
managing and ethambutol can be considered.
side-effects
of ATT If pyrazinamide is discontinued before
the patient has completed the
intensive phase, the total duration of
isoniazid and rifampicin therapy may
be extended to 9 months

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Î

± Symptom- ± * 4Î
based ,f Serum ALT > 3 ULN)
approach to ± "
(rather than the
managing three in the standard regimen):
side-effects 9HRE
of ATT 2HRES/6HR
9 RZE
± "
2HES/ 10 HE
± D "

18 -24 SEAQ
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*
Î
5.2 HIV testing and counselling for

5.3 HIV prevention in TB patients
5.4 TB treatment in people living with HIV
5.5 Co-trimoxazole preventive therapy
5.6 Antiretroviral therapy
5.7 Drug susceptibility testing
5.8 Patient monitoring during TB treatment
5.9 Considerations when TB is diagnosed in people living with HIV who
are already receiving antiretroviral therapy
5.10 HIV-related prevention, treatment, care and support

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*
Î
± Chapter ± This chapter describes WHO recommendations
for:
objectives Ͷ HIV testing and counselling of all patients
known or suspected to have TB;
Ͷ HIV prevention for TB patients;
Ͷ treatment of TB in people living with HIV;
Ͷ providing co-trimoxazole preventive therapy
to all HIV-positive TB patients;
Ͷ when to start antiretroviral therapy (ART) and
what antiretroviral agents to use;
Ͷ drug susceptibility testing and patient
monitoring;
Ͷ ensuring comprehensive HIV care and
support services
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103
|
*
Î
± HIV testing ± WHO recommends HIV testing for
and patients of all ages who present with
signs or symptoms that suggest
counselling
tuberculosis, whether TB is suspected or
for already confirmed

± TB is often the first clinical indication
that a person has underlying HIV

infection, and TB services can be an
extremely important entry point to HIV
prevention, care and treatmenT

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*
Î
± HIV ± Harm-reduction measures for TB
prevention in patients who are injecting drug
TB patients users should be provided

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*
Î
± TB treatment ± Case-fatality is higher in people living
in people with HIV with smear-negative
pulmonary and extrapulmonary TB, as
living with
these patients are generally more
HIV immunosuppressed than those with
smear-positive TB
± The case-fatality rate is reduced in

patients who receive concurrent ART

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*
Î
± TB treatment ! )$#
in people ±
living with
HIV

#


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*
Î
± TB treatment ! )$=
in people ± 2
living with

HIV

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*
Î
± TB treatment ! )$)
in people ±
living with

HIV


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*
Î
± Co- ± In HIV-positive TB patients, co-
trimoxazole trimoxazole preventive therapy
preventive should be initiated as soon as
therapy possible and given throughout TB
treatment

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*
Î
± Antiretroviral ± Antiretroviral therapy reduces TB
therapy rates by:
up to 90% at an individual level
by 60% at a population level and
TB recurrence rates by 50%

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*
Î
± Drug ± WHO recommends that NTPs
susceptibility undertake DST at the start of TB
testing therapy in all HIV-positive TB
patients
( especially those with CD4 counts
less than 200 cells/mm3)

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*
Î
± Patient ± Overlapping toxicities between
monitoring ART, TB therapy and co-
during TB trimoxazole include rash (and,
treatment more rarely, hepatic dysfunction)

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*
Î
± Considerations ± Monitoring of drug interactions
when TB is
diagnosed in ± Monitoring of side-effects
people living
with HIV who
are already ± Monitoring of individual disease
receiving activity
antiretroviral
therapy

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*
Î
± HIV-related ± Reducing the burden of TB via
prevention, intensified TB case-finding, infection
control, and isoniazid preventive
treatment,
therapy;
care and
± Psychosocial counselling and support;
support
± Disclosure of HIV status, partner
notification and testing and counselling;
± Co-trimoxazole prophylaxis;
± Preventing fungal infections;
± Preventing sexually transmitted and
other reproductive tract infections;
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*
Î
± HIV-related ± Preventing malaria;
prevention, ± Providing selected vaccines (hepatitis B,
treatment, pneumococcal, influenza, and yellow
fever);
care and
support ± Nnutrition;
± Aamily planning;
± Preventing mother-to-child transmission
of HIV;
± Needle/syringe programmes and opioid
substitution therapy; and water,
sanitation and hygiene
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6.2 Roles of the patient, TB programme staff,
the community and other providers
6.3 Supervised treatment
6.4 Using a patient-centred approach to care
and treatment delivery
6.5 Prevention of treatment interruption

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objectives Ͷ the role of the patient, the TB
programme, other providers, and the
community in the cure of TB;
Ͷ treatment supervision and directly
observed therapy;
Ͷ patient-centred care;
Ͷ measures to prevent interruption of
treatment

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± Roles of the ± patients are not
patient, TB passive recipients of services but active
partners
programme
staff, the
community
and other
providers

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± Roles of the ± !

patients ± Patients have the right to care,
dignity, information, privacy,
food supplements and/or other
types of support and incentives,
if needed

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± Roles of the ± !
patients
Patients have the responsibility of
sharing information with the health
provider, following treatment,
contributing to community health,
and showing solidarity by passing
expertise gained during treatment to
others in the community.

122
WHO: 2010

± Roles of the ± Involvement in stigma-
patients reduction activities in the
community

123
WHO: 2010

± Roles of the ± ! D
patient, TB It is a responsibility of the health staff
programme and of the NTP to:
staff, the facilitate patient adherence
community establish and maintain systems that
and other maximize patient access to care
providers train and supervise health workers to
provide patient-centred care
engage other care providers and
involving communities

124
WHO: 2010

± Roles of the ± '

patient, TB

Any practitioner treating a patient for TB must be
programme capable of$
staff, the Ͷ discussing the condition and the treatment
community being given to the patient
and other Ͷ recognizing and managing adverse effects of
providers medications
Ͷ assessing the patient͛s adherence
Ͷ completing the appropriate documentation
Ͷ collaborating with the local health services
Ͷ ensuring that the patient accepts the
proposed care
125
WHO: 2010

± Roles of the ± |
patient, TB Another component of the Stop TB
programme Strategy is to empower communities
staff, the
community Social mobilization can create
and other demand for quality-assured TB
providers services

126
WHO: 2010

± Supervised ± Directly observed therapy (DOT), a
treatment recommended method of
supervision, should be seen as a
part of a
that
addresses patients͛ needs ( rather
than just ͚supervised swallowing͛)

127
WHO: 2010

± Using a ± In addition to supervised treatment (or
patient- DOT), measures to support patient
adherence to regular and complete
centred
treatment include:
approach to
A regular supply of drugs (free,
care and accessible, and patient kits)
treatment Accessible, high-quality, continuous
delivery ambulatory TB care (if treatment is
health facility-based)
Positive action to remove barriers to
treatment and care
Availability of hospitalization
128
WHO: 2010

± Prevention ± Default includes patients:
of who have interrupted treatment
treatment who have died or transferred out
interruption whose outcomes are unknown to the
NTP treatment staff
± Supervised treatment can help

prevent interruptions

129
WHO: 2010
Î

7.2 Green Light Committee Initiative
7.3 Groups of drugs to treat MDR-TB
7.4 General principles in designing an MDR-TB treatment regimen
7.5 Programmatic strategies for treatment of MDR-TB
7.6 Selection of the country͛s standard MDR-TB treatment regimen
7.7 Selection of individualized MDR-TB regimens
7.8 Monitoring the MDR-TB patient
7.9 Duration of treatment for MDR-TB
7.10 Treating TB with resistance patterns other than MDR
7.11 Recording and reporting drug-resistant TB cases, evaluation of
outcomes

130
WHO: 2010
Î

± Chapter ± the Green Light Committee
± groups of drugs used to treat MDR-TB, and the
objectives principles for constructing an MDR-TB regimen
± programmatic strategies for MDR-TB treatment
± how to monitor MDR-TB patients, determine
when to stop the injectable agent, and decide
when treatment is completed
± how to treat TB with resistance patterns other
than MDR
± recording and reporting of drug-resistant TB
cases

131
WHO: 2010
Î

± Green Light ± The GLC (Green Light Committee )
Committee is a subgroup of the MDR-TB
Initiative Working Group of the Stop TB
Partnership, and an advisory body
of WHO that promotes access to
(and monitors the use of) quality-
assured, life-saving MDR-TB
treatment.

132
WHO: 2010
Î

± Groups of ± Group 1
drugs to treat ± Group 2
MDR-TB ± Group 3
± Group 4
± Group 5

133
WHO: 2010
134
WHO: 2010
Î

± General ± Treatment regimens should consist of at
principles in least four drugs with either certain, or
almost certain, effectiveness
designing an
± Susceptibility testing for isoniazid,
MDR-TB
rifampicin, the fluoroquinolones, and
treatment the injectable agents is fairly reliable
regimen and should be done
± Each dose in an MDR regimen is given as
DOT throughout the treatment

135
WHO: 2010
Î

± Programmatic ± Once MDR-TB is confirmed (by
strategies for either type of laboratory method),
treatment of patients can be treated with:
MDR-TB
a Î!

(standardized approach)
or
an
,
based on DST of additional drugs.

136
WHO: 2010
137
WHO: 2010
138
WHO: 2010
Î

± Selection of ± Selection of MDR regimen consists
the country͛s of 2 things:
standard ' Î!
: based on
MDR-TB country͛s own specific resistance
treatment data
regimen | Î!
: based on
DST testing, preferably newer
Molecular or Line Probe tests

139
WHO: 2010
Î

± Selection of ± Best done by Experts in treating
individualized MDR-TB
MDR-TB
regimens

140
WHO: 2010
Î

± Monitoring ± To assess treatment response,
the MDR-TB and
patient should be performed monthly
until smear and culture
conversion.
± | is defined as two
consecutive negative smears and
cultures taken 30 days apart
± Each patient͛s weight should be
monitored monthly
141
WHO: 2010
Î

± Duration of ± In MDR-TB treatment, the
treatment for intensive phase is defined by the
MDR-TB is =) duration of treatment with the
injectable agent.
" ± The injectable agent should be
continued for a minimum of 6
months, and for at least 4 months
after the patient first becomes and
remains smear- or culture-
negative
142
WHO: 2010
Î

± Duration of ± See the following link:
treatment for
MDR-TB

$
*++2 3 4
% 5 *++2
34%64v66*++27+*!

143
WHO: 2010
Î

± Recording ± See the following link:
and reporting
drug-

resistant TB

cases,

$
evaluation of *++2 3 4
outcomes % 5 *++2
34%64v66*++27+*!

144
WHO: 2010
'"

8.2 Treatment of extrapulmonary TB
8.3 Important drug interactions
8.4 Treatment regimens in special situations

145
WHO: 2010
'"

objectives the treatment of extrapulmonary TB
important drug interactions
the treatment of TB in pregnancy and
breastfeeding
the treatment of patients with pre-
existing liver disease, renal failure or
renal insufficiency

146
WHO: 2010
'"

± Treatment of ± Of specific forms of EPTB,
extra- lymphatic, pleural, and bone or
pulmonary joint disease are the most
TB common, while pericardial,
meningeal and disseminated
(miliary) forms are more likely to
result in a fatal outcome.

147
WHO: 2010
'"

± Treatment of ± Tuberculous Meningitis (TBM)
extra- Duration: 9 ʹ 12 months
pulmonary With Steroids
TB Ethambutol should be replaced by
streptomycin
Surgical intervention for
Hydrocephalus

148
WHO: 2010
'"

± Treatment of ± Pleural TB
extra- Duration: 6 months
pulmonary Indications for surgical intervention:
TB ± Empyema
± Hydropneumothorax

149
WHO: 2010
'"

± Treatment of ± TB of bones and joints
extra- Duration: 9 months
pulmonary Same Regimen as for PTB
TB

150
WHO: 2010
'"

± Important ± The most important interactions
drug with anti-TB drugs are due to
interactions !
± Rifampicin induces pathways that

metabolize other drugs, thereby
reducing the concentration and
effect of those drugs.

151
WHO: 2010
'"

! substantially the concentration
± Important ±
and effect of the following drugs:
drug anti-infectives (including azole antifungal agents,
interactions clarithromycin, erythromycin, doxycycline)
hormone therapy, including OCPs, SERMs, T4
Warfarin
Corticosteroids
anticonvulsants (including phenytoin)
cardiovascular agents including digoxin (among
patients with renal insufficiency, verapamil,
nifedipine, diltiazem, propranolol, metoprorol,
enalapril, losartan)
theophylline
sulfonylurea hypoglycaemics
Benzodiazepines
152
WHO: 2010
'"

± Treatment ±

regimens in Streptomycin is ototoxic to the fetus
special and should not be used during
situations pregnancy
A breastfeeding woman who has TB
should receive a full course of TB
treatment
Pyridoxine supplementation is
recommended for all pregnant or
breastfeeding women taking isoniazid

153
WHO: 2010
'"

± Treatment ± !
regimens in
special Regimen: 2HR(ZE)3 / 4 HR
situations Isoniazid and rifampicin are
eliminated by biliary excretion, so no
change in dosing is necessary.
There is significant renal excretion of
ethambutol and metabolites of
pyrazinamide, and doses should
therefore be adjusted as thrice
weekly administration
Streptomycin should be avoided
154
WHO: 2010
'"

± Treatment ± 4Î
regimens in
special (Already discussed)
situations

155
WHO: 2010
Thank You
156
WHO: 2010

TB Guidelines 2010

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