TREATMENT OF

DRUG-RESISTANT
TUBERCULOSIS
CASEHOLDING 2
OBJECTIVE
To achieve treatment success rate of
>85%
 Learning Outcomes
1. Familiarize with the latest WHO groupings of DR-TB drugs and
abbreviations
2. Assign the appropriate standard regimen basing on exclusion criteria
(SSOR, SLOR Fq-S, SLOR Fq-R)
3. Design an ITR regimen following the steps provided
4. Determine indications for off-label use of Bdq and Dlm and provide
consent form
5. Use the WHO weight based dosing
6. Do baseline tests and scheduled bacteriology, blood chemistries and
other diagnostic tests
7. Determine when to shift to continuation phase in SSOR and ITR with
SLI.
8. Determine modifications for SSOR and ITR
9. Assign appropriate treatment outcome
10. Assign post treatment outcome
 POLICIES

1. Treatment shall be started within 7 days from

diagnosis.

2. Standard treatment regimens shall be given based on

patient eligibility and exclusion criteria.
Individualized treatment shall be given to patients not
eligible to any of the standard regimens.
 POLICIES

3. First and second-line LPA test shall be done prior

to treatment.

▪ Results should be available within 2 weeks

from submission
▪ Prompt adaptation of treatment shall be done
if with resistance to fluoroquinolone, or both
high dose Isoniazid and Prothionamide.
 POLICIES
4. Regular adherence counselling
▪ Before treatment
▪ Two weeks after treatment
▪ Monthly throughout treatment

 Establish a responsive treatment adherence

mechanism that allows for prompt follow-up of
patients who interrupt treatment

5. Patients shall be provided with support to enhance

treatment adherence (e.g. Community-based care,
transportation allowance and conditional cash
transfers)
 POLICIES

6. Each patient shall be assigned a Treatment supporter

• Health worker
• Trained lay volunteer
• Family member

Who shall ensure daily intake

• Home
• Designated community area
• Workplace
• Health facility
 POLICIES
Use of digital adherence technologies may be
applied reinforced with proper and regular
adherence counselling and support

7. Treatment monitoring shall be undertaken by clinical,

microbiological (smear microscopy and culture) and
laboratory investigation according to recommended
schedules and as needed
 POLICIES

8. Prompt management of adverse events shall be done

▪ Modification of treatment in case of
intolerance to drugs
▪ Prompt referral shall be made for patients who
need hospital care for severe adverse events or
other co-morbidities
 POLICIES

9. All serious adverse event (SAE) and adverse event

of special interest (AESI) shall be recorded and
reported through:

• Pharmacovigilance Monitoring System (PVIMS)

• Paper based form using FDA Suspected Adverse
Reaction form
 POLICIES

10.Treatment education including infection prevention

education shall be given to patients and family
members prior to and during treatment.

11.Prompt discussion of the cases with TB MAC shall

be done for patients whenever indicated.
 PROCEDURES
A. Education, Counselling and Support to Patients and Family
Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management (aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
 PROCEDURES
A. Education, Counselling and Support to Patients
and Family Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management (aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
A. Education, Counselling, and Support to
Patients and Family Members Prior to Treatment
1. Inform patients that they have MDR/RR-TB
disease.

2. Educate patients and their families.

Key messages:
▪ Basic information about TB disease
▪ Duration of treatment
▪ Schedule of treatment monitoring
▪ Potential adverse events and how to address
them
▪ Contact investigation
▪ Tracing mechanism
▪ Availability of free of charge services
A. Education, Counselling, and Support to
Patients and Family Members Prior to Treatment

3. Discuss with patients their social and financial needs

and offer possible sources of support to enable
adherence to treatment.
 PROCEDURES
A. Education, Counselling and Support to Patients and
Family Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management
(aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
B. Pre-Treatment Evaluation
1. Determine other co-morbidities and other health
issues and manage them accordingly. Refer to
specialist, if needed.

2. Do pre-treatment evaluation
 Clinical examination including body weight and
height
 Smear Microscopy
 TB culture (and DST)
 First and second-line LPA test
 Chest x-ray
 Electrocardiogram (ECG)
B. Pre-Treatment Evaluation
 Visual Acuity and Color Vision tests
 K, BUN, Creatinine, AST, ALT, FBS
 CBC
 HIV Rapid Antibody test (with written consent)
 Pregnancy test
 TSH
 Mental health screening
 Brief Peripheral Neuropathy Screening (BPNS)
 Baseline tests required for specific regimens:
• Albumin, if regimen contains Delamanid (SLOR
FQ-R, ITR)
• Audiometry, if regimen will contain Amikacin
or Streptomycin (ITR)
 B. Pre-Treatment Evaluation
Line Probe Assay (LPA)
1. First-Line LPA – use to detect resistance to rifampicin,
high dose isoniazid and low dose isoniazid (which also
confers resistance to Prothionamide)

2. Second-Line LPA - use to detect resistance to

fluoroquinolones (FQ) and second-line injectables (SLI)
B. Pre-Treatment Evaluation

Line Probe Assay (LPA)

▪ Initial test for patients with confirmed RR-TB
or MDR-TB
▪ Can be used for pulmonary and
extrapulmonary TB irrespective of smear
status
▪ Can be used for diagnosis of XDR-TB
 PROCEDURES
A. Education, Counselling and Support to Patients and
Family Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment
Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management (aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
C. Assigning an Appropriate DR-TB Treatment
Regimen

▪ Standardized Treatment
• Defined group or category of patients receive the
same regimen.
• Drug Resistance Surveillance data used as basis for
designing the treatment regimen

▪ Individualized Treatment Regimen (ITR)

• Composed for individual patient based on previous
TB treatment history, individual DST results and
history of contact with DR-TB patients
Medicine Abbreviation
Levofloxacin Lfx
Moxifloxacin Mfx
Bedaquiline Bdq
Linezolid Lzd
Clofazimine Cfz
Cycloserine Cs
Ethambutol E
Delamanid Dlm
Pyrazinamide Z
Imipenem-cilastatin Imp-cln
Meropenem Mpm
Amikacin Am
Streptomycin S
Prothionamide Pto
p-aminosalicylic acid PAS
Isoniazid high dose Hhd
C. Assigning an Appropriate DR-TB Treatment
Regimen
MDR/RR-TB Regimens for Adults
Regimen Name* Regimen**
4-6 months of Lfx-Bdq(6)-Cfz-
Regimen 3:
Pto-Z-E-Hhd
Standard Short All Oral
5 months of Lfx-Cfz-Z-E
Regimen (SSOR)

Regimen 4:
Standard Long All Oral 6 months of Lfx-Bdq-Lzd-Cfz
Regimen for FQ Susceptible 12-14 months of Lfx-Lzd-Cfz
(SLOR FQ-S)
C. Assigning an Appropriate DR-TB Treatment
Regimen
MDR/RR-TB Regimens for Adults
Regimen Name* Regimen**
Regimen 5: 6 months of Bdq-Lzd-Cfz-Cs-
Standard Long All Oral Dlm
Regimen for FQ Resistant 12-14 months of Lzd-Cfz-Cs
(SLOR FQ-R)
Individualized Treatment Construct to have at least 4-5
Regimen (ITR) likely effective drugs
C. Assigning an Appropriate DR-TB Treatment
Regimen
1. Evaluate children with RR/MDR-TB for eligibility to
standard all oral regimens recommended for children

2. Offer standard treatment regimens only if all of the

drugs in the regimen are available and accessible.

Refer patients who are pregnant, or contacts of

patient who failed on MDR-TB treatment to TB
MAC for design of an ITR
C. Assigning an Appropriate DR-TB Treatment
Regimen

3. Check exclusion criteria to SSOR for patients who are

adults, not pregnant, and not a contact of a patient
who failed MDR-TB treatment
 Checking Eligibility for Different MDR/RR-TB Regimens
Exclusion Criteria for SSOR (If YES to any of the following exclusion criteria, DO NOT GIVE SSOR)

1. Disseminated/extensive TB or severe/intractable EPTB

2. Confirmed resistance to FQ (Mfx/Lfx)
3. Exposure to Mfx/Lfx, Bdq, Cfz, Pto for >1 month
4. Risk of toxicity or intolerance to any drugs in SSOR as
manifested by:
 History of heart disease (heart failure, myocardial
infarction, cardiac conduction abnormality, arrythmia)
 QTcF >500 ms
 History of chronic active hepatitis (AST/ALT >5 times
elevated)
 History of chronic renal insufficiency (Creatinine Clearance
<20 ml/min)

First check eligibility to SSOR – if eligible, give SSOR. If not, check eligibility to SLOR
C. Assigning an Appropriate DR-TB Treatment
Regimen

4. Start treatment with SSOR If ALL of the exclusion

criteria are ABSENT

5. If NOT eligible to SSOR, check eligibility to SLOR FQ-S

 Checking Eligibility for Different MDR/RR-TB Regimens

Exclusion Criteria for SLOR FQ-S (If YES to any of the following exclusion criteria, DO NOT GIVE SLOR FQ-S)

1. Confirmed resistance to FQ (Mfx/Lfx)

2. Exposure to Mfx/Lfx, Bdq, Lzd or Cfz for >1 month
3. Risk of toxicity or intolerance to any drugs in SLOR FQ-S as
manifested by:
 History of heart disease (heart failure, myocardial
infarction, cardiac conduction abnormality, arrythmia)
 QTcF >500 ms
 History of chronic active hepatitis (AST/ALT > 5 times
elevated)
 History of chronic renal insufficiency (CrCl <20 ml/min)
 Severe anemia (Hgb <8g/dl)

Check eligibility to SLOR FQ-S – if eligible, give SLOR FQ-S. If not, check eligibility to SLOR FQ-R.
C. Assigning an Appropriate DR-TB Treatment
Regimen

6. Start treatment with SLOR FQ-S If ALL of the

exclusion criteria are ABSENT

7. If NOT eligible to SLOR FQ-S, check eligibility

SLOR FQ-R
 Checking Eligibility for Different MDR/RR-TB Regimens

Exclusion Criteria for SLOR FQ-R (If YES to any of the following exclusion criteria, DO NOT GIVE SLOR FQ-R)

1. Exposure to Bdq, Lzd, Cs, Cfz or Dlm for >1 month

2. Risk of toxicity or intolerance to any drugs in SLOR FQ-R as
manifested by:
 History of heart disease (heart failure, myocardial
infarction, cardiac conduction abnormality, arrythmia)
 QTcF >500 ms
 History of chronic active hepatitis (AST/ALT > 5 times
elevated)
 History of chronic renal insufficiency (CrCl <20 ml/min)
 Severe anemia (Hgb <8 g/dl)

Check eligibility to SLOR FQ-R – if eligible, give SLOR FQ-R. If not, refer to TB MAC for ITR.
C. Assigning an Appropriate DR-TB Treatment
Regimen

8. Start treatment with SLOR FQ-R If ALL of the exclusion

criteria are ABSENT

9. If NOT eligible to SLOR FQ-R, refer to TB MAC for

composition of ITR.

Bedaquiline-Pretomanid-Linezolid (BPaL) regimen may

be considered as a last resort
 Grouping of Medicines Recommended for Use in
Individualized Treatment Regimen (ITR)
Group Medicine Abbreviation
New Grouping of MDR/RR Medications by Hierarchical
Levofloxacin OR Lfx
Priority
Group A
Moxifloxacin Mfx
(Include all three medicines
Bedaquiline2,3 Bdq
unless they cannot be used) Linezolid4 Lzd
Group B Clofazimine Cfz
(Add both medicines unless Cycloserine OR Cs
they cannot be used) Terizidone Trd

Ethambutol E
Delamanid3,5 Dlm
Pyrazinamide6 Z
Group C
Imipenem-cilastatin OR Ipm-cln
(Add to complete the Meropenem7 Mpm
regimen and when medicines
Amikacin Am
from Groups A and B cannot (OR Streptomycin)8 (S)
be used)
 Ethionamide OR Eto
Prothionamide9 Pto
p-aminosalicylic acid9 PAS 

Based on efficacy and safety of individual drug.

The regimen should include at least 4 “likely effective drugs”.
Source: WHO Consolidate Guidelines for Drug Resistant Tuberculosis Treatment, Mar 2019
37
 Principles of Designing an ITR

1. The regimen should include at least 4 “likely effective

drugs”. A drug is considered “LED” when
a. Not been used in a regimen that failed to cure the
individual patient
b. DST showing susceptibility to the drug
c. No known resistance to drugs known to have high
cross-resistance (FQs, SLIs, INH & Pto)
d. No known close contacts with resistance to the drug
e. In the absence of DST/unreliable DST results, results
of drug resistance survey that showed for a patient
group with similar TB history
Principles of designing an MDR/RRT-TB treatment regimen

2. After stopping Bdq, at least 3 likely effective

drugs should remain for the rest of
treatment duration.
 STEPS for Designing an Individualized
Treatment Regimen (ITR)

Main aim:
To design a treatment regimen containing 4 likely effective drugs
(>4 may be needed if in doubt of the effectiveness of any of the first 4 drugs)
 Steps for Designing an ITR
Step 1
Use all Group A drugs if possible
(Lfx/Mfx, Bdq, Lzd)

Step 2
Use Group B drugs to make up 4 likely effective drugs
(Cfz, Cs)

Step 3
Add Group C drugs if 4 likely effective drugs cannot
be made from Groups A and B
 Assignment of DR-TB Regimens

Collect 3 Sputum
Specimens for LPA, SM,
TBC and DST

Start SLOR FQ-S

C. Assigning an Appropriate DR-TB Treatment
Regimen
10. Follow recommended regimen from TB MAC

11. Perform the following for off-label use of anti-TB drug

a. Present any situation that requires the off-label use
of an anti-TB drug to TB MAC
 Use of Bdq and Dlm in combination
 Extended use of Bdq and/or Dlm for more than
6 months
 Use of Bdq and/or Dlm in EPTB
 Use of Bdq in children <6 years old and
pregnant patients
 Use of Dlm in children <3 years old and
pregnant patients
C. Assigning an Appropriate DR-TB Treatment
Regimen

b. Once approved by TB MAC, explain to the patient

and/or significant others the benefits and risks
involved with off-label use

c. Once a patient agrees to the use of anti-TB drugs

off-label, ask patient to sign the informed consent
form
Patient Information Sheet and Consent Form for “Off
Label Use” of Bdq and Dlm
Patient Information Sheet and Consent Form for “Off
Label Use” of Bdq and Dlm
Patient Information Sheet and Consent Form for “Off
Label Use” of Bdq and Dlm
Department of Health – National TB Control Program
C. Assigning an Appropriate DR-TB Treatment
Regimen

12. After determining treatment regimen, follow the

recommended dosing for adults and children
 DOSING OF MEDICINE USED IN SECOND-LINE MDR/RR-
TB REGIMENS BY WEIGHT BANDS FOR PATIENTS
OLDER THAN 14 YEARS OLD
WEIGHT
WEIGHT BANDS FOR PATIENTS OLDER THAN 14 YEARS
GROUP MEDICINE BASED DAILY FORMULATION USUAL UPPER DAILY DOSE COMMENTS
DOSE OLD
        30-35 kg 36-45kg 46-55kg 56-70kg >70kg    
             

A
Fluoroquinolones 250 mg tab 3 3 4 4 4
     
Levofloxacin 500 mg tab 1.5 1.5 2 2 2 1.5 g
Standard dose 400 mg tab 1 1 1 1 1 400 mg As used in the standardized
Moxifloxacin                 shorter MDR-TB Regimen
High dose 400 mg tab 1 or 1.5 1.5 1.5 or 2 2 2 800 mg
Bedaquiline   100 mg tab 4 tabs OD for 2 weeks; then 2 tabs OD M/W/F for 22 weeks 400 mg  
Linezolid   600 mg tab (<15 y) (<15 y) 1 1 1 1.2 g  

B
50 mg cap 2 2 2 2 2 100 mg
Clofazimine                  
100 mg cap 1 1 1 1 1 100 mg
Cycloserine or
10-15 mg/kg 250 mg cap 2 2 3 3 3 1g  
Terizidone
Ethambutol 15-25 mg/kg 400 mg tab 2 2 3 3 3    
Delamanid   50 mg tab 2 BID 2 BID 2 BID 2 BID 2 BID 200 mg  
Pyrazinamide 20-30 mg/kg 500 mg tab 2 3 3 3 4    

C
Imipenem-   0.5 g + 0.5 g 2 vials (1g + 1g) BID   To be used with clavulanic
Cilastatin vial acid
1g vial To be used with clavulanic
Meropenem   (20ml) 1 vials 3x/day or 2 vials BID   acid
500 mg/2ml 3 to 4
Amikacin 15-20 mg/kg vial 2.5 ml 3ml ml 4ml 4ml 1g  
Streptomycin 12-18 mg/kg 1 gm vial Calculate according to the dilution used 1g  

Once daily dose advised but

Ethionamide or can start with 2 divided
15-20 mg/kg 250 mg tab 2 2 3 3 4 1g
Prothionamide doses until tolerance
improves (2 weeks)

8-12 g/day in 2
p-amino salicylic PAS Acid (4gm)
acid to 3 divided sachet 1 BID 1 BID 1 BID 1 BID 1 to 1.5 BID 12 g  
doses

100 mg isoniazid tablet can

Standard dose: 300 mg tab 2/3 1 1 1 1 facilitate the administration of
4-6 mg/kg             certain dosages
Isoniazid                 Pyridoxine is given with
High dose:10-             isoniazid in patients at risk
15 mg/kg 300 mg tab 1.5 1.5 2 2 2 (such as dose with HIV and
OTHERS malnutrition)

To be used only with

carbapenems (such as
Clavulanic acid   125 mg tab 1 BID 1 BID 1 BID 1 BID 1 BID   imipenem
and Meropenem)
 DOSING OF MEDICINE USED IN SECOND-LINE MDR/RR-
TB REGIMENS BY WEIGHT BAND AMONT PATIENTS
UNDER 15 YEARS OLD
WEIGHT BANDS AMONG PATIENTS NOT YET 15 YEARS OLD
WEIGHT-
GROUP MEDICINE BASED
FORMULATI USUAL UPPER DAILY COMMENTS
ON 10-15 16-23 31-34 DOSE
DAILY DOSE 5-6 kg 7-9 kg 24-30 kg >34 kg
kg kg kg
100 mg
Fluoroquinolo dispersible 1 1.5 2 or 3 3 or 4 (>14 y) (>14 y) (>14 y) 1.5 g
nes 15-20 tablet  
mg/kg
Levofloxacin
 250 mg tab 0.5 0.5 1 to 1.5 1.5 to 2 2 3 (>14 y) 1.5 g

Moxifloxacin 10 – 15 400 mg tab 2ml 3ml 5ml 0.5 or 1 (>14 y) (>14 y) 400 mg Use 10 mg/kg in <6months
 

A
mg/kg 0.75
2 tabs OD for 2 4 tabs OD for 2 weeks; Only in patients >5 years old
weeks; then 1 tab
Bedaquiline   100 mg tab   then2 tabs OD M/W/F for   (lower dose from 15-29 kg;
OD M/W/F for 22
22 weeks higher dose from >29 kg)
weeks

10 mg/kg
OD in < 16
kg
Linezolid   600 mg tab 0.25 0.25 0.25 0.5 0.5 0.5 0.75d 600 mg  
10-12mg/
kg OD in
>15 kg

B
1 alt 1 alt
50 mg cap days 1 alt days 1 2 2 (>14 y) 100 mg
 
    days            
 
Clofazimine 2-5 mg/kg                 Give on alternate days if dose
 
                in mg/kg/day is too high
1 alt
100 mg cap M/ M/W/F 1 alt 1 (>14 y) (>14 y) 100 mg
days
W/F days
4 to 5 5 to 6 7 to 10
250 mg cap mlC mlC mlC 2 2 2 (>14 y) 1g  
Cycloserine or 15-20
Terizidone mg/kg 125 mg mini
capsule (CS) 1 1 2 3 4 (>14 y) (>14 y) 1g Dissolve in 10mL of Water
15-25
Ethambutol 400 mg tabC 3mlC 4mlC 6mlC 1 1 or 1.5 2 (>14 y)    
mg/kg
Only in patients >2 years old

C
  Delamanid   50 mg tab - - - - 1 BID 1 BID 2 BID 200 mg
(25 mg BID in 3-5 years; 50
mg BID in 6-11 years 100 mg
in 12- 17 years

Pyrazinamide 30-40 500 mg tab 0.5 0.5 0.75 or 1.5 2 2.5 (>14 y) -  
mg/kg 1
Imipenem-   0.5 g + 0.5 g - - - - - - - - Cannot be used in patients
Cilastatin vial <15 years (use Meropenem)

20-40mg/ 1g vial To be used with clavulanic

Meropenem kg IV q 8 2ml 4ml 6ml 8-9ml 11ml (>14 y) (>14 y)  
hours (20ml) acid
 DOSING OF MEDICINE USED IN SECOND-LINE MDR/RR-
TB REGIMENS BY WEIGHT BAND IN PATIENTS UNDER
15 YEARS OLD
Amikacin 15-20 500 0.4 ml 0.6 ml 0.8 – 1.2 - 2.0 (>14 y) (>14 y) 1g  
mg/kg mg/2ml 1.0 1.5 ml
vial ml ml
Streptomycin 20-40 1 gm vial Calculate according to dilution used (>14 y) (>14 y) 1g  

C
mg/kg
Ethionamide 15-20 250 mg 0.5 0.5 1 2 2 2 (>14 y) 1g  
or mg/kg tab
Prothionamide
p-amino 200-300 PAS Acid 0.5 to 0.75 1-2 g 2-3 g 3 to (>14 y) (>14 y)  
salicylic acid mg/kg (4gm) 0.75 g to 1 g BID BID 3.5
in 2 sachet BID BID g Full dose can be given daily if
divided BID tolerated
doses

  Isoniazid 15-20 100 mg 1 1.5 2 3 4 4 (>14 y)   300 mg isoniazid tablet be used in

  mg/kg tab patients > 20 kg. Pyridoxine is always
  (high given with high dose isoniazid in
OTHERS dose) children (12.5 mg OD in < 5yrs old and
25 mg OD in >4 years old

Clavulanic acid   250mg 2ml 3 ml 5 ml 8 ml 10 (>14 y) (>14 y)   Only to be used with carbapenems
Amx/62.5 BID BID BID BID ml
mg Clv 5 BID
ml susp
C. Assigning an Appropriate DR-TB Treatment
Regimen

 For SSOR and ITR containing Pto, start Pto in

two divided dosage (morning and evening) for
the first two weeks of treatment if total daily
dose is >250mg

 Advise patients to take Pto after light meals

 Once tolerance has improved, change Pto

dosing to once daily after 2 weeks
C. Assigning an Appropriate DR-TB Treatment
Regimen

13. Upon receipt of 1st and 2nd line DST results of LPA and
phenotypic DST, revise the regimen accordingly

▪ Check the result of LPA and take appropriate action

Guide on Deciding Appropriate Treatment Regimen Based on LPA
Results
Baseline LPA Result
Initial FQ High Dose H Pto Clinical and Programmatic
Regimen Resistance (Hhd) Resistance Resistance Action
Detected Detected Detected
- - - Continue SSOR.
- + - Continue SSOR.
- - + Continue SSOR.
Shift to SLOR FQ-S. Continue
dose count if shifting
SSOR - + + happened within 1 month
from treatment initiation.
Shift to SLOR FQ-R.
+ +/- +/- Restart dose count.
- +/- +/- Continue SLOR FQ-S.
SLOR FQ-S Shift to SLOR FQ-R.
+ +/- +/- Restart dose count.
SLOR FQ-R +/- +/- +/- Continue SLOR FQ-R.
Review initial regimen and
ITR +/- +/- +/- revise if needed in
consultation with TB MAC.
 Assignment of DR-TB Regimens

Collect 3 Sputum
Specimens for LPA, SM,
TBC and DST

Start SLOR FQ-S

C. Assigning an Appropriate DR-TB Treatment
Regimen
Clinical and Programmatic Action
Other LPA Before treatment or Treatment >2
Results within 2 weeks from weeks
treatment initiation
MTB Not Recollect sputum Continue initial
Detected specimen if result is regimen and
received before wait for the
Invalid treatment or within phenotypic
two weeks from start DST result
of treatment; Continue
Indeterminate initial regimen and
wait for the repeat LPA
result
C. Assigning an Appropriate DR-TB Treatment
Regimen

LPA Result Delayed >2 Clinical and

months or Not Available Programmatic Action
With culture conversion and Continue initial regimen
clinical improvement
No culture conversion at Repeat DST (both LPA and
month 4 of treatment phenotypic); Consult the
No clinical improvement case with TB MAC
With recurrence of TB signs
and symptoms
With culture reversion
C. Assigning an Appropriate DR-TB Treatment
Regimen

▪ Follow the same procedures upon receipt of

phenotypic DST results

In case of discordant result between LPA and

phenotypic DST, follow the worst result and
consult the case with TB MAC for regimen
revision, if needed
 PROCEDURES

A. Education, Counselling and Support to Patients and

Family Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management (aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
 PROCEDURES
A. Education, Counselling and Support to Patients and
Family Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management
(aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
F. Initiation of Treatment

1. Accomplish Form 4c. DR-TB Treatment Card and Form

5. TB and TP Treatment Patient Card and assign case
number.

2. Record patient details in Form 6b. DR-TB Register

(ITIS).
F. Initiation of Treatment

3. Discuss and finalize appropriate treatment adherence

mechanism with patient

● Location: Can be at home, community, workplace

or health facility
● Treatment Supporter: Can be family member,
trained lay volunteer, health worker
 
F. Initiation of Treatment
4. Provide initially a one week supply to the treatment
supporter and adjust later to a maximum of
monthly dispensing depending on the situation

Ensure that health workers or trained volunteers

regularly communicate with patient at least
every 2 weeks

Other modes of treatment supervision such as

self-administered treatment assisted by
technology may also be done
 PROCEDURES

A. Education, Counselling and Support to Patients and

Family Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management (aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
G. Treatment Monitoring

1. Record successful intake of daily dose in Form 4c.

DR-TB Treatment Card and Form 5. TB and TP
Treatment Patient Card by affixing the initial of the
health staff or treatment supporter
 G. Treatment Monitoring

2. Conduct treatment monitoring clinically,

microbiologically and by laboratory investigation as per
schedule

● General well-being, weight and height in children,

resolution of symptoms
● Promptly identify adverse events and provide
prompt and appropriate management
● Remind patient to submit sputum specimen and
undergo other laboratory examinations
 Schedule of Baseline and Follow-up Clinical, Laboratory and
Bacteriologic Examination for Patients on SSOR
Intensive Phase: 4 Continuation Phase: 5 months Post-
months, may be Treatment
extended up to 6 Follow-up
months
Test/Examination BL M1 M2 M3 M4 M5 M6 M7 M8 M9 6 12
m m
Clinical Evaluation by the
PMDT Physician including
/ / / / / / / / / / / /
weight for all and height
for children
Mycobacteriological Tests
Smear Microscopy / / / / / / / / / / / /
TB Culture (TBC) / / / / / / / / / / / /
Drug Susceptibility Testing /       If culture remains positive at month 4 of
(DST) treatment, in case of culture reversion or
    culture positive during post-treatment
First-line and Second-line /
follow-up
Line Probe Assay (LPA)
 Schedule of Baseline and Follow-up Clinical, Laboratory and
Bacteriologic Examination for Patients on SSOR
Intensive Phase: 4
Post-
months, may be
Continuation Phase: 5 months Treatment
extended up to 6
Follow-up
months
Test/Examination BL M1 M2 M3 M4 M5 M6 M7 M8 M9 6 12
m m
Diagnostic Tests
Chest X-ray (CXR) / / / /
Electrocardiogram (ECG) / / / / / / / / / /
Visual Acuity and Color / / / / / / / / / /
Vision
Brief Peripheral
Neuropathy Screening / / / / /
(BPNS)
Mental health screening Monthly if regimen contains Cycloserine (Patient
/ Health Questionnaire-9 or short screening tool    
may be used)
 SCHEDULE OF BASELINE AND FOLLOW-UP CLINICAL,
LABORATORY AND BACTERIOLOGIC EXAMINATION
FOR PATIENTS ON SSOR
Intensive Phase: 4
Post-
months, may be
Continuation Phase: 5 months Treatment
extended up to 6
Follow-up
months
Test/Examination BL M1 M2 M3 M4 M5 M6 M7 M8 M9 6 12
m m
Blood Chemistry/Hematology/Immunological Tests
Alanine and Aspartate / / / / / / / / / /
Transaminase (ALT/AST)*    

Complete Blood Count /

(CBC) Monthly if regimen contains Linezolid    

Urea Nitrogen, Creatinine, /

Fasting Blood Sugar (FBS),                      
Potassium (K),

Thyroid Stimulating / /
Hormone (TSH)                    

HIV Rapid Antibody Test /                      

Pregnancy Test /                      
*
If ALT and/or AST are higher than upper limit of normal value, consider doing total bilirubin test.
 Schedule of Baseline and Follow-up Clinical, Laboratory and
Bacteriologic Examinations for Patients on 18-20 months SLOR/ITR
  Post-
  Treatment
Intensive Phase: 6 months Continuation Phase: 12-14 months
Follow-
up
Test/ B M M M M M M M M M M M M M M M M M M M M 6 12
Examination L 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 m m
Clinical / / / / / / / / / / / / / / / / / / / / / / /
Evaluation
Mycobacteriological Tests
Smear / / / / / / / / / / / / / / / / / / / / / / /
Microscopy
TB Culture / / / / / / / / / / / / / / / /
(TBC)
DST /       If culture remains positive at month 4 of treatment, in case of culture reversion or culture positive during
LPA /       post-treatment follow-up
Diagnostic Tests
CXR /           /           /           /     / /
ECG# / Monthly if regimen contains Bedaquiline, Delamanid, Clofazimine and/or Moxifloxacin
Visual Acuity
and Color / Monthly if regimen contains Linezolid and/or Ethambutol    
Vision  
BPNS / Monthly if regimen contains Linezolid, Cycloserine and/or High Dose Isoniazid    
Audiometry Baseline and Monthly if regimen contains Amikacin or Streptomycin    
Mental health Baseline and Monthly if regimen contains Cycloserine (Patient Health Questionnaire-9 or short screening tool may be
   
screening used)
 SCHEDULE OF BASELINE AND FOLLOW-UP CLINICAL,
LABORATORY AND BACTERIOLOGIC EXAMINATIONS FOR
PATIENTS ON 18-20 MONTHS SLOR/ITR
  Post-
  Treatment
Intensive Phase: 6 months Continuation Phase: 12-14 months
Follow-
up
Test/ B M M M M M M M M M M M M M M M M M M M M 6 12
Examination L 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 m m
Blood Chemistry/Hematology/Immunological Tests
ALT/AST* / Monthly if regimen contains Bedaquiline and/or Pyrazinamide    
CBC / Monthly if regimen contains Linezolid    
FBS, /                                            
Urea
Nitrogen, / Monthly if regimen contains Amikacin or Streptomycin    
Creatinine, K
TSH Every 6 months if regimen contains Prothionamide or Para-aminosalicylic Acid (PAS)
/    
Every 3 months if regimen contains both Protionamide and Para-aminosalicylic Acid (PAS)
Albumin Baseline if regimen contains Delamanid    
HIV Rapid
Antibody /                                            
Test
Pregnancy /
                                           
Test

*If AST and/or ALT above normal levels, consider requesting for Total Bilirubin.
#If regimen contain Bdq+Dlm and/or Mfx+Cfz, more frequent ECG monitoring, every other week for initial 3 months is
recommended.
 EXAMINATION RESULTS CONSIDERED
AS RED FLAGS

Examination Result (RED FLAG)

Chest x-ray Increasing size of lesion, new lesions,
pleural effusion, etc.
12 L ECG Check QTcF: >500 ms or > 60 ms from
baseline
Color vision/visual acuity Check for color blindness, progressive
blurring of vision despite correction of
Error of Refraction
AST, ALT, Bilirubin 5x the upper limit of normal or 3x ULN
with clinical manifestation or with
bilirubin ≥1.5 x ULN
EXAMINATION RESULTS CONSIDERED AS RED FLAGS

Examination Result (RED FLAG)

Potassium <3 mmol/liter ( Serum Ca and Mg needs to be
corrected)
CBC Hgb: <8.0 g/dL; <4.9 mmol/L
Platelet: <50,000 - 25,000/mm3; <50.0 -25.0 x
10e9/L
WBC: <2000- 1000/mm3; <2.0-1.0 x10e9/L
Absolute Neutrophil Count: <1000 mm3
(% Neutrophils + % bands) x WBC/100
Creatinine <30 mL/min
Clearance
(Creatinine,
BUN)
 G. Treatment Monitoring

3. Weigh the patient monthly and adjust dosage

accordingly

4. Give positive feedback on the patient’s treatment Record

the interaction in the individual treatment record or
patient’s chart

5. Manage any adverse events appropriately

Report SAE or AESI thru PVIMS or using FDA Suspected
Adverse Reaction form
 G. Treatment Monitoring

6. Consider modification of treatment in case of

intolerance or toxicity to any of the drugs in the
regimen

Discuss the case with TB MAC if it is necessary

to replace more than one drug

7. Revise the regimens based on 1st and 2nd LPA and

phenotypic DST results
 
G. Treatment Monitoring

8. Decide whether to shift to continuation phase

for patients on SSOR based on smear
microscopy result
Transition from Intensive to Continuation phase for
Patients on SSOR
Smear result at Month 4 Negative Discontinue Hhd and Pto;
Proceed to Continuation Phase
Positive
Extend intensive phase by
one month

Negative Discontinue Hhd and Pto;

Smear result at Month 5
Proceed to Continuation Phase
Positive
Extend intensive phase by
one month

Negative Discontinue Hhd and Pto;

Smear result at Month 6
Proceed to Continuation Phase
Positive

Discuss the case with TB Discontinue Bdq

MAC
G. Treatment Monitoring

9. Collect one (1) sputum sample from patients or

use isolate from the latest positive culture if
there is no culture conversion (for all
regimens) at month 4 of treatment or if there
is culture reversion
G. Treatment Monitoring

10. Do adherence counseling regularly

• Assess compliance to treatment
• Explore potential issues or constraints related to
treatment
• Provide psychological support and refer to
psychologist or psychiatrist, if necessary
• Refer to any relevant department for social
support needed
G. Treatment Monitoring
11. Immediately make a phone call upon missing 1
dose and do follow-up in person if a patient missed
3 doses

12. Congratulate the patient once treatment is finished

and instruct to follow-up every 6 months for the
next year

13. Record and update necessary forms during every

follow-up visit – Form 4c. DR-TB TB Card and Form
5. TB and TB Treatment Patient Card
 PROCEDURES

A. Education, Counselling and Support to Patients and Family

Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management
(aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
 PROCEDURES

A. Education, Counselling and Support to Patients and Family

Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management (aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
 Recommended Replacement of Anti-TB Drug in Case of
Toxicity or Intolerance for SSOR
Anti-TB Recommended Remarks
Drug Replacement
Bdq Not recommended Consult with R-TB MAC. May need to shift
to replace to ITR.
Lfx Not recommended Consult with R-TB MAC. May need to shift
to replace to ITR.
Cfz Cycloserine as first Give Cs or Lzd for the entire treatment
option. duration.
Linezolid as second If it happens after intensive phase, Bdq
option. may be continued for entire duration
without replacement with Cs or Lzd. If
patient has underlying seizure or mental
health condition, Lzd is preferred over Cs.
If underlying condition of psychosis or
depression or seizure is uncontrolled,
avoid Cs and use Lzd instead.
 Recommended Replacement of Anti-TB Drug in Case of
Toxicity or Intolerance for SSOR
Anti-TB Recommended Remarks
Drug Replacement
Pto Cycloserine as first Quickly shift Pto to Cs or Lzd if splitting
option. the dose for two weeks did not prevent
Linezolid as second vomiting, or tolerance to Pto did not
option. improve. Give Cs or Lzd for 4-6 months
(intensive phase). If patient has
underlying seizure or mental health
condition, Lzd is preferred over Cs. If
underlying condition of psychosis or
depression or seizure is uncontrolled,
avoid Cs and use Lzd.
Z None No need to replace.
E None No need to replace.
Hhd None No need to replace.
 RECOMMENDED REPLACEMENT OF ANTI-TB
DRUG IN CASE OF TOXICITY OR INTOLERANCE
FOR SSOR

If modification requires replacement or

premature discontinuation of >2 drugs, or
complete discontinuation of SSOR, shift to ITR in
consultation with TB MAC.
 Recommended Replacement of Anti-TB Drug in Case
of Toxicity or Intolerance for SLOR
Anti-TB Recommended Remarks
Drug Replacement
Lfx Dlm as 1st option If there is a need to stop Lzd when Bdq
Bdq has alredy been stopped, replace Lzd
Lzd with Cs except in peripheral
neuropathy
Cfz Cs as 1st option If Cs has never been used before;
PAS, Pto, E, Z as 2nd If PAS or Pto has never been used
option before; Use E or Z if susceptible by
Imp-Cln or Am or S DST; Use Am or S if susceptible by DST
as last resort
Cs PAS, Pto, E, Z as last If the oral anti-TB drugs cannot be
option used, consider Ipm-Cln or Am (or S) if
susceptible to Am/S by DST
 PROCEDURES
A. Education, Counselling and Support to Patients and
Family Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management
(aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes
K. Post-treatment follow-up
J. Defining Treatment Outcome

1. Assign the appropriate treatment outcomes for DR-

TB patients based on definitions for SSOR, and for
SLOR and ITR
Treatment Outcome Definitions for SSOR
Outcome Definition
Cured A patient with bacteriologically confirmed
RR/MDRTB who has completed treatment as
recommended by the national policy, without
evidence of failure and with three or more
consecutive cultures taken at least 30 days
apart negative after the intensive phase.
Treatment Treatment completed as recommended by the
completed national policy without evidence of failure BUT
no record that the three or more consecutive
cultures taken at least 30 days apart are
negative after the intensive phase.
 SSOR Cured
Month SM TBC
B 2+ / 1+ MTB/MTB
1 0 0
2 0 0
3 0 0
4 0 0 Shift to Continuation Phase

5 0 0 1
6 0 0 2
7 0 0 3
8 0
9 0
 SSOR Treatment Completed
Month SM TBC
B 2+ / 1+ MTB/MTB
1 0 0
2 0 0
3 0 0
4 0 0 Shift to Continuation Phase

5 0 0 1
6 ND ND
7 0 0 2
8 0
9 0
Treatment Outcome Definitions for SSOR
Failed Any one of the following:
- Treatment terminated or need for permanent regimen
change
- Lack of evidence of at least two consecutive negative
cultures (not followed by a positive culture) by the end of
an extended intensive phase (6 months) of the shorter
regimen
- Positive sputum smear (confirmed by two consecutive
samples) after > 6 months of treatment
- Culture reversion* in the continuation phase after
conversion to negative
- Evidence of additional acquired resistance to FQ or SLI
- Adverse drug reaction resulting to switching to a new
regimen
 SSOR Treatment Failed by
Lack of Smear Conversion at the end of extended IP

Month SM TBC
B 2+ / 1+ MTB/MTB
1 1+ 0
2 2+ MTB
3 1+ MTB
4 2+ MTB
5
2+
6 3+
7
8
9
 SSOR Treatment Failed by
(+) SM after > 6 months of treatment

Month SM TBC
B 2+ / 1+ MTB/MTB
1 0 0
2 0 0
3 0 0
4 0 0
5 0 0
6 0 pending

7 1+ 0 pending Recollect SM if (+)

8 1+ 1+ Declare Treatment Failed

9
 SSOR Treatment Failed by
Culture Reversion

Month SM TBC
B 2+ / 1+ MTB/MTB
1 0 0
2 0 0
3 0 0
4 0 0 Shift to Continuation Phase

5 0 MTB
6 0 Declare Treatment
0
Failed
7 0 MTB
8 0 Recommended by
RTBMAC and clinical
9 0 correlation
 SSOR Treatment Failed by
Culture Reversion

Month SM TBC
B 2+ / 1+ MTB/MTB
1 0 0
2 0 0
3 0 0
4 0 0 Shift to Continuation Phase

5 0 0
6 0 MTB Declare Treatment
7 0 MTB Failed

8 0 Recommended by
RTBMAC and clinical
9 0 correlation
 SSOR Treatment Failed by
Evidence of additional acquired resistance to a FQ or SLI

Month SM TBC
Baseline LPA Result:
B 2+ / 1+ MTB/MTB FQ Resistance NOT Detected
SLI Resistance NOT Detected
1 0 0
2 0 0
3 0 0
4 0 0 Shift to Continuation Phase

5 0 MTB Request for LPA and DST

6 0
7 0 5th Month LPA Result:
FQ Resistance Detected
SLI Resistance NOT Detected

Declare Treatment Failed

Treatment Outcome Definitions for SSOR

Died A patient who dies for any reason during

the course of treatment
Lost to follow- A patient whose treatment was
up** interrupted for >2 consecutive months
Not evaluated A patient for whom no treatment
outcomes is assigned. (This includes cases
“transferred out” to another treatment
unit and whose treatment outcome is
unknown).
 Treatment Outcome Definitions for SLOR and ITR

Treatment Definition
outcome
Cured Treatment completed as recommended by the
national policy without evidence of failure AND
three or more consecutive cultures take at least 30
days apart are negative after 8 months of treatment
(for SLOR) or after the intensive phase (for ITR with
SLI).

Treatment Treatment completed as recommended by the

completed national policy without evidence of failure BUT no
record that three or more consecutive cultures
taken at least 30 days apart are negative after 8
months of treatment (for SLOR) or after the
intensive phase (for ITR with SLI).
 SLOR Cured
Month SM TBC Month SM TBC
B 2+ / 1+ MTB/MTB 11 0 ND
1 0 12
0 0 0 2
2 13
0 0 0 ND
3 14
0 0 0 0 3
4
0 0 15 ND
5 0
16 0 0 4
6 0 0
0 17 Phase 0
7 0 Shift to Continuation

0 18 0
8 ND
9 0 0
10 0 ND Three or more consecutive cultures taken at
0 0 1 least 30 days apart are negative.
• SLOR = After 8 months of treatment
• ITR with SLI = After the Intensive Phase
 ITR with SLI Cured
Month SM TBC Month SM TBC
B 2+ / 1+ MTB/MTB 11 0 ND
1 0 12
0 0 0 3
2 13
0 0 0 ND
3 14
0 0 0 0 4
4
0 0 15 ND
5 0
16 0 0 5
6 0 0
0 17 Phase 0
7 0 Shift to Continuation

0 18 0
8 ND
9 0 0 1
10 0 ND Three or more consecutive cultures taken at
0 0 2 least 30 days apart are negative.
• SLOR = After 8 months of treatment
• ITR with SLI = After the Intensive Phase
 SLOR Treatment Completed
Month SM TBC Month SM TBC
B 2+ / 1+ MTB/MTB 11 0 ND
1 0 12
0 ND ND
2 13
0 0 0 ND
3 14
0 0 ND ND
4
0 0 15 ND
5 0
16 0 0
6 0 0 2
0 17
Shift to Continuation Phase
0 ND
7 0
0 18 ND ND
8 ND
9 19 ND
0 0 ND
10 ND 20 ND ND
0
0 0 1
ITR with SLI Treatment Completed
Month SM TBC Month SM TBC
B 2+ / 1+ MTB/MTB 11 0 ND
1 0 12
0 ND ND
2 13
0 0 0 ND
3 14
0 0 ND ND
4
0 0 15 ND
5 0
16 0 0
6 0 0 2
0 17
Shift to Continuation Phase
0 ND
7 0
0 18 ND ND
8 ND
9 1 19 ND
0 0 ND
10 ND 20 ND ND
0
ND ND
 Treatment Outcome Definitions for SLOR and ITR

Failed Treatment terminated or need for permanent

regimen change of at least two anti-TB drugs
because of:
● Lack of conversion by the end of 8 month from
the start of treatment
● Bacteriological reversion after the conversion to
negative in the initial 8 months of treatment
● Evidence of additional acquired resistance to FQ
or other second-line drugs in the regimen
● Adverse drug reaction that needed to completely
stop MDR/RR-TB treatment
 SLOR/ITR Treatment Failed by
Culture Reversion
Month SM TBC Month SM TBC
B 2+ / 1+ MTB/MTB 11 0 ND
1 0 12
0 Request for LPA &0
DST MTB 1
2 13
0 0 0 ND
3 14
0 0 0 0
4
0 0 15 ND
5 0
16 for LPA &0DST MTB 2
6 0 0 Request

0 17
Shift to Continuation Phase
0
7 0
0 18 0
8 ND
9 19
0 0
10 ND 20
0
0 0
 SLOR/ITR Treatment Failed by
Culture Reversion
Month SM TBC Month SM TBC
B 2+ / 1+ MTB/MTB 11 0 ND
1 0 12
0 Request for LPA &0
DST MTB 1
2 13
0 0 0 ND
3 14 for LPA &0DST
0 0 Request MTB 2
4
0 0 15
5 0
16 0
6 0 0
0 17
7 0
0 18
8 ND
9 19
0 0
10 ND 20
0
0 0
Treatment Outcome Definitions for SLOR and ITR

Died A patient who dies for any reason during

the course of treatment.
Lost to A patient whose treatment was
follow-up interrupted for two consecutive months
or more.
Not A patient for whom no treatment
evaluated outcome is assigned (this includes cases
‘transferred out' to another treatment
unit and whose treatment outcome is
unknown)
J. Defining Treatment Outcome

2. Record the treatment outcome in the Form 4c. DR-

TB Treatment Card and update Form 6c. TB Register
for DR-TB Treatment (ITS)

3. Issue a certificate of treatment completion and

advise patient on post-treatment follow-up
 PROCEDURES

A. Education, Counselling and Support to Patients and Family

Members Prior to Treatment
B. Pre-Treatment Evaluation
C. Assigning an Appropriate DR-TB Treatment Regimen
D. MDR/RR-TB Treatment in HIV Co-Infected
E. MDR/RR-TB Treatment in Children
F. Initiation of Treatment
G. Treatment Monitoring
H. Active Drug Safety Monitoring and Management (aDSM)
I. Modification of Treatment Regimen
J. Defining Treatment Outcomes at Completion of Treatment
K. Post-treatment follow-up
K. Post-treatment Follow-up

1. Do post-treatment follow-up at month 6 and 12

after successful completion of treatment (cure or
completed). Follow-up procedures include:
• Clinical evaluation of TB signs and symptoms
• CXR
• SM and culture
 J. Defining Treatment Outcome
 
2. Define the outcomes of post-treatment follow-up below:
● Non-relapsing Cure: a successfully treated individual
who remains culture-negative within 6-12 months post-
treatment

● Relapse: recurrent TB disease in a successfully treated

individual who becomes culture-positive within 6-12
months after cure or treatment completion
 J. Defining Treatment Outcome
 
3. Define the outcomes of post-treatment follow-up below:
Died: A patient who dies for any reason during the 12
months post- treatment
Lost to follow-up after treatment completion: individuals
who had an outcome recorded but cannot be traced in the
12 months following treatment outcome

4. Record the outcome of post-treatment follow-up in Form

4c. DR-TB Treatment Card
 Exercise 3:
Assigning appropriate treatment
regimen (DR-TB CASES)