3

Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

May
27, 2024
DEPARTMENT CIRCULAR
No. 2024- 02(\

FOR

: ALL _UNDERSECRETARIES AND ASSISTANT SECRETARIES OF

HEALTH; MINISTER OF HEALTH - BANGSAMORO AUTONOMOUS
REGION IN MUSLIM MINDANAO; DIRECTORS OF BUREAUS.
SERVICES, AND CENTERS FOR HEALTH DEVELOPMENT (CHD):
CHIEFS OF DEPARTMENT OF HEALTH MEDICAL CENTERS,
HOSPITALS; AND OTHERS CONCERNED

SUBJECT : Supplemental Guidelines to the Omnibus Health Guidelines _on the

Implementation of 2HRZE/2HR Treatment Regimen for months 1 to

years of age with Non-severe Drug-susceptible Tuberculosis (DS-TB)

Attached for your information and guidance is a copy of the supplemental guidelines on
the implementation of 2HRZE/2HR for 3 months to 16 years of age with non-severe
drug-susceptible TB.

The guidelines specify the standard operating procedures, and the roles and
responsibilities of various DOH units, such as the Centers for Health Development (CHDs),
other healthcare facilities that provide TB services both public and private, the Local
Government Units (LGUs) and others concerned.

Dissemination of the information to all is requested.

C!S
By Authority of the Secretary of Health
“
EW
GL G. BAGGAO, 5 >
MSN, FPSMS, FPCHA
Undersecretary of Health
Public Health Services Cluster

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila # Trunk Line 651-7800 local 1113,1108, 1135
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: dohosec(@doh zov.ph
 BACKGROUND

Tuberculosis (TB) remains significant public health concern and serious threat
for children and young adolescents. Children and young adolescents account for
approximately 12% of all TB patients globally, with an estimated 1.1 million children and
young adolescents aged under 15 years falling ill with TB each year; of the global TB
deaths among HIV-negative people, 14% were in children (aged <15 years), of the global
TB deaths among HIV positive people, 11% were in children; and treatment success rate
for children aged 0-14 years was 88% in 2020 which is the same level as of 2019.' To
support the countries in responding to the challenges of TB, the World Health
Organization (WHO) has developed guidance on prevention, diagnosis, treatment, and
care for people with TB including for children and adolescents. In August 2021, the
WHO released a rapid communication on updated guidance on the management of TB in

children and adolescents to address critical gaps in diagnostic approaches for TB in

children, the optimal duration of treatment for children with non-severe TB, as well as
optimal models of care for the delivery of child and adolescent TB services.

In March 2022, the WHO issued the “WHO Operational Guidelines on

Tuberculosis Module 5: Management of Tuberculosis in Children and Adolescents”,
which included the recommendations for treatment shortening in children and
adolescents with non-severe DS-TB based on the SHINE trial.2 The SHINE trial
concluded that the 4-month shorter treatment regimen is effective and non-inferior to 6
months of treatment in children with drug-susceptible, nonsevere, smear-negative TB?
and can result in lower costs to health services, less toxicity, lower risks of drug-drug
interactions in children and adolescents living with HIV (CALHIV), and fewer problems
with adherence.”

This guideline includes updated and detailed recommendations using

2HRZE/2HR as the primary standard treatment regimen for eligible children and
adolescents between 3 months and 16 years of age with non-severe DS-TB. This order
shall provide detailed instructions to the Centers for Health Development (CHDs),
Provincial/Municipal/City Health Offices (PHO/MHO/CHO), and healthcare providers
both in public and private in the delivery of TB services.

II. OBJECTIVE

This guideline is issued to provide standards and guidance for the implementation
of the new 2HRZE/2HR treatment regimen for 3 months to 16 years of age with
non-severe DS-TB.

World Health Organization. (2022). Global Tuberculosis Report 2022. World Health Organization: Geneva,
Switzerland
?
World Health Organization. (2022). WHO Operational Handbook on Tuberculosis Module 5: Management of
Tuberculosis in Children and Adolescents. World Health Organization: Geneva, Switzerland
3
in
Chabala, C., Turkova, A. et al., SHINE trial team (2018). Shorter treatment for minimal tuberculosis (TB)
children (SHINE):a study protocol for a randomized controlled trial. Trials, 19(1), 237
IY. SCOPE OF APPLICATION

This guideline shall apply to the Department of Health (DOH) TB facilities

providing services and other government and private health facilities managing TB cases.
In the case of the Bangsamoro Autonomous Region in Muslim Mindanao (BARMM), the
adoption of these guidelines shall be in accordance with Republic Act (RA) 11054
(Bangsamoro Organic Act) and the subsequent laws and issuances to be issued by the
Bangsamoro government.

IV. DEFINITION OF TERMS

For the purpose of this guideline, the following are the definitions of terms:

A. Children - defined as those between 3 months and 9 years of age.

B. Adolescent
- defined as those in the age group of 10-16 years.

-
Bacteriologically-confirmed TB (BC-TB) refers to a person from whom biological
specimen either sputum or non-sputum sample is positive for Mycobacterium |
tuberculosis using rapid diagnostic tests (RDTs).

Clinically-diagnosed TB (CD-TB) - refers to a patient for which the criterion for

bacteriological confirmation is not fulfilled but diagnosis is made by the attending
physicians on the basis of clinical findings, X-ray abnormalities, suggestive histology,
and/or other biochemistry or imaging tests.

Mild symptoms are defined as follows:

1. Do not require hospitalization
2. Absence of the danger or high-priority signs of severe illness or health problems
for aged under 10 years aslisted in Annex A,
3. No asymmetrical and persistent wheezing
4. No signs of extrapulmonary TB (EPTB) other than peripheral lymph node TB
5. Absence of the following: severe acute malnutrition (SAM), respiratory distress,
high fever over 39°C, severe pallor, seizures, restlessness, irritability, or lethargy

Severe acute malnutrition - defined by a very low weight for height (below -3 Z
score), by visible severe wasting, or by presence of nutritional edema. In children
aged 6-59 months, an arm circumference less than 110 mm
acute malnutrition.‘ - is
also indicative of severe

. Non-severe tuberculosis - defined as peripheral lymph node (in isolation); or

pulmonary TB confined to less than one lobe of the lung with no cavities;
intrathoracic lymph node TB without radiologically visible or clinically significant

4
World Health Organization. (2013), Pocket book of hospital care for children: guidelines for the management of
common childhood illnesses, 2nd edition.Geneva: World Health Organization; (https://apps.who.int/iris/bitstream
/handte/10665/8 1170/97894 1548373_eng.pdf)
 airway obstruction; uncomplicated TB pleural effusion or paucibacillary, non-cavitary
disease confined to one lobe of the lungs and without a miliary pattern.

H. Severe TB - includes TB meningitis, abdominal TB, congenital TB, pericarditis,

renal, spinal, disseminated or osteoarticular TB, and those suspected of having
MDR/RR-TB (in contact with a person with confirmed or suspected MDR/RR-TB, or
children and adolescents diagnosed with TB who
treatment.*
are
not responding to first-line TB

I. Presumptive DR-TB cases

-individuals with previous history of TB treatment, close
contacts of a known DR-TB case or
a non-converter of DS-TB regimen.‘

J. Rapid diagnostic tests - refers to WHO-approved rapid diagnostic tests that employ
molecular or biomarker-based techniques for the diagnosis of TB. :

K. TB Healthcare Provider - refers to a physician who has received DOH-approved

training for implementing the 2HRZE/2HR treatment regimen.

L. Supervised treatment - refers to helping patients to take their TB medications

regularly and to complete TB treatment.
and able detect
It is also meant to ensure that the providers
treatment
give proper care are to interruption.

M. Treatment supporter - a person nominated by the patient and/or health-care provider

to supervise the treatment of the patient at home, in the community, or facility-based
treatment settings, including facilitating follow-up laboratory diagnostic monitoring
and the provision of counseling and motivational support for adherence and who may
use digital adherence tools such as but not limited to video-based treatment, 99
DOTS, or artificial intelligence to aide self-administered treatment.*

N. Lack of clinical improvement - refers to assessment made by an attending physician

when
a patient has no resolution or progression of baseline TB signs or symptoms or
development of new TB-related symptoms, no weight gain or no improvement in
nutritional status.

O. Treatment outcomes for the 2HRZE/2HR treatment regimen*

1. Cured - a patient with bacteriologically-confirmed TB at the beginning of
treatment and who was smear-negative in the last month of treatment.
2. Treatment completed - a patient who completes treatment without evidence of
failure but with no sputum smear-negative results in the last month of treatment,
either because the tests were not done or because results are unavailable. This
group alsoincludes clinically-diagnosed patients.
3. Treatment failed - a patient whose follow-up sputum smear
second month of treatment, has no symptom resolution,
is has
positive at the
worsening
symptoms, or shows continued weight loss.

5
World Health Organization. (2022). WHO Operational Handbook on Tuberculosis Module 4: Management of
Treatment - Drug-susceptible Tuberculosis Treatment. World Health Organization: Geneva, Switzerland
 4. Died - a patient who dies for any reason before start or during the course of
treatment
5. Lost to follow-up - a patient whose treatment was interrupted for at least two
consecutive months
6. Not evaluated - a patient for whom no treatment outcome is assigned. This
includes patients transferred to another facility for continuation of treatment, but
the final outcome was not determined.

GENERAL GUIDELINES

A. Children and adolescents aged 3 months to 16 years with non-severe DS-TB shall be
evaluated for eligibility for the 2HRZE/2HR treatment regimen before initiation of
treatment.

All children and adolescents aged 3 months to 16 years of age diagnosed with
non-severe DS-TB who fulfill the clinical indications based on the physician's clinical
assessment and judgment shall be promptly initiated on the ZHRZE/2HR treatment
regimen.

MTB-positive tests using RDTs capable of producing semi-quantitative scales, such

as but not limited to Xpert MTB/RIF or Xpert Ultra must be reported such that the
corresponding semiquantitative results (e.g., trace, very low, low, medium, high) are
reflected in laboratory results.

Current weight shall be used to calculate the drug dosage upon initiation of treatment
and during follow-up.

All DS-TB patients under the 2HRZE/2HR treatment regimen shall have a treatment
supporter for supervision.

Treatment adherence shall be ensured through patient-centered approaches. Treatment

support shall be provided by healthcare workers, community volunteers, or family
members.

DS-TB patients receiving the 2HRZE/2HR treatment regimen shall be registered in

the TB registry of the Integrated TB Information System (ITIS).

The new treatment regimen for non-severe DS-TB must be

rolled out using a standard
training design approved by the Department of Health.

VI. SPECIFIC GUIDELINES

A. Diagnosis of TB in children and adolescents

 The approach to diagnosing TB among children and adolescents should be consistent
with the National Tuberculosis Control Program (NTP) Manual of Procedures
(MOP), 6th edition, and the Omnibus Health Guidelines (OHG).

B. Clinical indications for the 2HRZE/2HR DS-TB treatment regimen

Special Consideration - among CALHIV, the 4-month regimen may be considered, in

consultation with an Infectious Disease specialist, depending on the degree of
immunosuppression, ART status, and presence of other opportunistic infections

1. In children and adolescents who have undergone bacteriological testing

and/or CXR, a 4-month treatment regimen should be started for those who
meet ALL of the following criteria.
a. Baseline CXR findings consistent with non-severe TB
i. Intrathoracic lymph node TB without significant airway
obstruction; OR —
ii. B.1.1.2 Pulmonary TB confined to one lobe with no cavities and
no miliary pattern; OR “
iii B.1.1.3 Uncomplicated pleural effusion (without pneumothorax or
empyema) “
b. Respiratory or gastrointestinal specimen with MTB-negative, trace, very
low, or low results by RDT capable of producing semiquantitative scales,
or negative result using smear microscopy or other RDTs
c. The child or adolescent has mild symptoms

2. In settings without access to CXR, a 4-month treatment regimen may be

considered in children and adolescents with mild symptoms AND meeting
either of the following criteria.
a. B.2.1 Respiratory or gastrointestinal specimen that is MTB-negative,
trace, very low or low results by RDT capable of producing
semiquantitative scales, or negative result using smear microscopy or
other RDTs
b. B.2.2 Isolated extrathoracic (peripheral) lymph node TB, without
confirmed or suspected involvement of other extrapulmonary sites of
disease (histological, biochemical, and other tests and imaging modalities
are not suggestive of extrapulmonary TB

3. In settings without access to CXR and bacteriological testing, a 4-month

treatment regimen should not be started unless in consultation with a trained TB
specialist. Instead, the standard 6-month regimen is recommended. CXR
critical tool for evaluating the severity of intrathoracic disease in
isis
children and
a

crucial in making a decision on the treatment regimen and duration of treatment.

C. Exclusion Criteria for the 2HRZE/2HR treatment regimen

 A child or adolescent who satisfies any of the following should NOT be
initiated on
the 2HRZE/2HR treatment regimen:
1. Severe Acute Malnutrition (SAM) and/or severely
2. Smear-positive respiratory sample
ill
3. MTB-positive by RDT with moderate or high result
4. Infants aged under 3 months and/or weighing < 3kg
5. More than 16 years of age
6. Presumed or confirmed DR-TB (retreatment, contact of DR-TB, non-converter
of DS-TB regimen with Xpert result of MTB detected with rifampicin
resistance)
7. Exposure to a confirmed DR-TB case
8. Pregnancy

D. Treatment

1. The 2HRZE/2HR treatment regimen should be initiated in children and young

adolescents who are found to be eligible for the shorter 4-month treatment
regimen. Daily dosing is recommended using fixed-dose dispersible
formulations or single-dose tablet formulations. In the absence of such supplies,
a 6-month regimen should be used.

2. Weight-based dosing with fixed-dose combinations is recommended. a patientIf

gains weight while on TB treatment, the drug dosage should be adjusted
accordingly. Refer to Annex B1-B4.

3. A treatment supporter shall be identified for patients who will be started on

2HRZE/2HR treatment regimen for supervision.

4. Perform monthly clinical assessment during follow up visits. Refer to Annex C.

5. Ask patient to follow-up at the health facility two weeks after initiation of
treatment and then at least monthly thereafter.’

6. All Adverse events (AEs) regardless of severity and seriousness shall be

managed promptly and appropriately, and shall be reported to the national
authorities following Administrative Order No. 2020-0025, “Policy and
Guidelines on the Implementation of Active Drug Safety Monitoring and
Management of
the National Tuberculosis Control Program.”

7. If treatment interruption occurs, the following steps are recommended:

Any interruptions in treatment should be discussed with the patient and

treatment supporter, and interventions to address problems in adherence should
be instituted.>
a. If the interruption is <14 consecutive days during the intensive phase,
continue treatment and complete all intensive phase doses
 b. If the interruption is >14 consecutive days during the intensive phase,
restart intensive phase
c. If the interruption occurred during the continuation phase, and completed
>45 doses within 2 months, further treatment is no longer necessary
d. If the interruption occurred in the continuation phase, and the cumulative
interruption is <l month and completed <22 doses, complete the
remaining doses of treatment
e. If the interruption occurred in the continuation phase, and the cumulative
interruption is >] month and completed <22 doses, restart treatment from
beginning of intensive phase
f. If the interruption is at feast two months, declare lost to follow up. Exert
all efforts to trace the patient, perform Xpert MTB/RIF or Ultra, TB
culture, and DST of Xpert MTB/XDR on respiratory or gastrointestinal
specimen. The patient no longer qualifies for the 2HRZE/2HR treatment
regimen.

Intensive Phase Continuation Phase

(2 months of 2HRZE) (2 months of 2HR)

Interruption Continue treatment and complete

all intensive phase doses
Completed > 45 doses Further treatment is no
< 14 days longer necessary

Interruption Restart intensive phase Cumulative interruption is Complete the remaining

> 14 days <1 month and completed doses of treatment
22 doses

Cumulative interruption is Restart treatment from the

> | month and completed < beginning of the intensive
22 doses phase

For bacteriologically-confirmed patients, and able to provide sputum or provide

gastric aspirate specimen, examination should be done at the 2nd month (end of
the intensive phase), and at the completion of treatment at 4 months

For clinically-diagnosed patients, follow-up smear microscopy may not be

needed
if
clinically improving.

10. For patients with poor treatment response, such as persistent symptoms, lack of
weight gain, and/or a positive follow-up smear at the 2nd month of treatment,
shall be assessed for possible treatment failure and should complete additional
investigation to assess for drug resistance (e.g., RDT with drug resistance
detection, genotypic DST, phenotypic TB culture and DST). Refer to Annex D.

11. Treatment outcomes shall be determined at the end of the 4-month treatment
regimen, and reported following the treatment outcome definitions.

12. Patients on the 2HRZE/2HR treatment regimen should be followed up every 6

months for 1 year after successful completion of the TB treatment. Follow-up
 procedures should include clinical evaluation of TB signs and symptoms and
chest X-ray.

E. Provision of Commodities

The Department of Health shall ensure adequate commodities for the provision of this
shorter regimen in accordance with Administrative Order No. 2022-0010,
“Guidelines on Tuberculosis-Human Immunodeficiency Virus Services Integration
for Universal Health Care Implementation” under the section of commodities.

Recording and Reporting

Existing DOH-prescribed TB recording and reporting forms or those specified in the

NTP Manual of Procedures 6th edition shall be used to document patient assessment,
laboratory results, including semiquantitative RDT results (Refer to Annex E), and
to monitor patient management and progress. The notification form, DS-TB treatment
in
card, and ITIS shall be updated accordingly. Report Form 4a.1 will also be used
interim for the treatment decision of 2HRZE/2HR. Refer to Annex F. ITIS will
the

remain the official electronic TB information system.*

. Capacity Building

All TB focals, CHD coordinators, healthcare providers both in public and private
facilities providing TB services shall be trained on the use of the 2HRZE/2HR
treatment regimen.

VII. MONITORING AND EVALUATION

A. Standard indicators shall be used to monitor the implementation of this shorter

DS-TB treatmentregimen:
1. No. of TB patients initiated under the 2HRZE/2HR treatment regimen
2. Treatment outcome of patients under 2HRZE/2HR treatment regimen

B. Other TB and HIV indicators shall continue to be monitored.

VIII. ROLES AND RESPONSIBILITIES

A. The Disease Prevention and Control Bureau (DPCB) shall:

1. Develop a plan for the implementation of the shorter treatment regimen
2. Ensure adequate commodities
3. Develop and approve capacity-building tools
4,
5.
Provide technical assistance to CHDs inthe implementation of this guideline
Monitor and evaluate implementation of the shorter treatment regimen
6. Update guidelines as necessary
The Epidemiology Bureau (EB) shall:
 1. Maintain and update surveillance systems to capture the data required for the
indicators
Collect and validate data reported by healthcare facilities
YN Ensure patients’ data privacy and security
Monitor compliance of healthcare facilities to reporting guidelines and facilitate
enforcement of compliance as necessary

C. The Knowledge Management and Information Technology Service (KMITS)

shall:
1. Update and maintain the ITIS and ensure availability for reporting to its end users

D. The Centers for Health Development and Ministry of Health Bangsamoro

Autonomous Region in Muslim Mindanao shall:
1. Lead capacity building of LGU health facilities
2. Coordinate with LGUs for the allocation and distribution of drugs and
commodities
3. Provide technical assistance to LGUs and facilities, both public and private in the
implementation of
this guideline.
4. Work and coordinate with the DPCB to monitor and evaluate the implementation
of this guideline
5. Provide feedback and quarterly reports to the DPCB to guide policy updates or
revisions
6. Actively monitor adequacy of drugs and commodities

E. The Local Government Units (Provincial, City, and Municipal Levels) shall:
1, Co-lead the capacity building activities related to the implementation of this
guideline
Implement shorter treatment regimen guidelines
wPwn
Implement policy advocacy at the local level
Ensure adequate supply of commodities, and provide augmentation as necessary
Provide feedback and quarterly reports to CHDs and participate in monitoring and
review of the implementation

F. The healthcare facilities shall:

1. Implement shorter treatment regimen guidelines
2. Ensure that protocols and standards are followed accordingly

G. The National TB Reference Laboratory:

1. Instruct all TB laboratories to indicate the semiquantitative results in the
laboratory forms used.

H. The rapid TB diagnostic laboratories shall:

1.Perform testing based on prescribed protocols and standards
2. Ensure that semiquantitative scales are indicated in the result forms if the RDT
used is capable of producing such scales.

10
Annex A. Danger and priority signs of severe illness or health problems in children aged under
10 years

Aged 5-9 years All children aged <10 years |

Danger signs (MCT) Danger signs (ETAT) Priority signs

Gastrointestinal/circulatory: Gastrointestinal/circulatory: e Any sick child aged <2

@ Unable to drink e Diarrhea with any two
e Vomiting up everything signs of severe
e Signs of severe dehydration (lethargy,
dehydration (sunken eyes, unconsciousness, sunken
skin pinch returns very eyes, very slow return of
slowly) skin after pinching)
e@
Severe palmar pallor e Signs of shock (cold
extremities with capillary
refill time >3 seconds,
weak and fast pulse)
months
e High fever (>39°C)
@ Severe pallor
© Restless, continuously
irritable, lethargic
e Severe Acute
Malnutrition

Respiratory: Respiratory:
e Stridor e Obstructed or absent
© Oxygen saturation <90% breathing
e Severe respiratory distress
e Central cyanosis

Neurological: Neurological:
@ Seizures @ Coma (or seriously
e Profound lethargic, reduced level of
unconscious consciousness)
e Neck stiffness or bulging e Seizures
fontanelle

-
-
*IMCI Integrated Management of Childhood Hiness
*ETAT Emergency triage, assessment and treatment
__
Annex B1: Dosing recommendations for children weighing <25 kg using the Single-dose liquid
formulations

Body Weight Isoniazid Rifampicin Pyrazinamide Ethambutol

(kgs) (200 mg/Sml) (200 mg/Sml) (250 mg/Smi) (100 or 400 mg/tab)
10 mg/kg 15 mg/kg 30 mg/kg 20 mg/kg

ml ml ml tablet
3 0.75 1 1.75 50 mg
4 ] 1.5 2.5
5 1.25 2 3
100 mg
6 1.50 2.25 3.5
7 1.75 2.5 4.25
8 2 3 4.75
9 2.25 3.5 5.5
10 2.5 3.75 6 200 mg
ll 2.75 4 6.5
12 3 4.5 7.25
13 3.25 5 7.75
14 3.5 5.25 8.5
15 3.75 5.5 9
300 mg
16 4 6 9.5
17 4.25 6.5 10.25
18 4.5 6.75 10.75
19 4.75 7 11.5

20 5 75 12

21 5.25 8 12.5
400 mg
22 5.5 8.25 13.25
23 5.75 8.5 13.75

24 6 9 14.5
Annex B2: Dosing recommendations for children weighing <25 kg using the dispersible
pediatric fixed-dose combinations

8)
Weight band Number of tablets

Intensive phase: RHZ Intensive phase: Etham Continuation phase: RH

75/50/150 mg Etham 100 mg/tab 75/50 mg

4-7 J 1 1

8-11 2 2 2

12-15 3 3 3

16 - 24 4 4 4

25+ kg Adult dosage recommended

H- Isoniazid; R - Rifampicin; Z - Pyrazinamide; E/Etham - Ethambutol

Annex B3: Dosing recommendations for children and adolescents weighing over 25 kg using
the adult fixed-dose combinations

Weight band Number of tablets

(8)
os Intensive phase: 2 RHZE Continuation phase: 2 RH
150/75/400/275 mg 150/75 mg

25 - 29 2 2

30 - 34 3 3

35 - 49 4 4

50 - 64 4 4

65 +kg 5 5

HT - Isoniazid; R - Rifampicin; Z - Pyrazinamide; E/Etham - Ethambutol

13
Annex B4: Dosing recommendations for children weighing >25 kg using the Single-dose
formulations

oo Number of tablets
Wetec pnd Isoniazid Rifampicin Pyrazinamide Ethambutol
300 mg/tab 300 mg/tab 500 mg/tab 400. mg/tab
“
4-6 mg/kg 8-12 mg/kg 20-30 mg/kg 15-25 mg/kg

25 - 29 kg 0.5 ] 1.5 1.5

30 - 34 kg 1 1.5 2.5 2

35 - 49 kg I 2 3 3

50 - 64 kg 1 2 3 3

65 +kg 1.25 2.5 4 4

Annex C: Recommended Monthly Clinical Assessments

All children and adolescents initiated on TB treatment should undergo a monitoring assessment
as follows:

1. Ask a patient to follow-up at the health facility 2 weeks and 4 weeks after the start of
treatment, then at least monthly thereafter until completion of 4-month treatment, and
should be followed up every 6 months for 1 year after successful completion of the TB
treatment

Update Form 4b. DS-TB Treatment Card during every visit. If with missed doses, discuss
with the patient and treatment supporter the interventions to improve treatment
adherence. Wherever the agreed location of treatment and whoever the treatment
supporter is, ensure that the health worker or trained volunteer regularly communicates
with the patient at least every two weeksaspart of psychosocial support

Perform clinical assessment during follow-up visits

a. Get the weight monthly and adjust dosage accordingly. Get additional tablets from
stocks if adjustment upward is needed.
b. Ask about the resolution of TB signs and symptoms
c. Manage any adverse drug reactions (ADRs) or refer if needed (refer to Table 12.
Management of adverse drug reactions (first-line TB drugs) and Table 13.
Reintroduction of anti-TB drugs following drug reaction of the NTP MOP 6th
edition.’
d. Continue management of comorbid conditions, and refer if necessary

Follow-up sputum samples for smear microscopy 2 months after the start of treatment
at
and treatment completion may be collected from any child who was Xpert MTB/RIF or
Ultra positive, smear-positive, or culture-positive at diagnosis if the treatment site has
capacity to perform the test
a. If a follow-up smear is positive, the patient should complete additional
investigations to assess for drug-resistance (Xpert MTB/RIF or Ultra, TB culture
and DST or molecular test for drug resistance) and other causes of poor treatment
response
b. In children who cannot expectorate, a repeat specimen at the end of treatment is
not necessary if the specimen collected at 2 months
collection months children
is
with
negative
c. Repeat sample at 2 in clinically-diagnosed TB is
not indicated unless there is an inadequate clinical response without symptomatic
and nutritional improvement

Follow-up CXR is not needed if the child is responding well to TB treatment. Children
commonly have a slow radiographic response to treatment and may have persistent
radiographic abnormalities at treatment completion, but this does not mean they are not
responding to treatment.

45
. Explain the results of any baseline or follow-up test conducted. For any positive sputum
follow-up results, review the treatment adherence and discuss with the patient and
treatment supporters on how to improve adherence, if necessary.

if
Inform the patient already cleared for school/work based on non-infectiousness.
a. After one week of uninterrupted treatment for clinically-diagnosed TB cases
b. After a negative follow-up smear microscopy bacteriologically-confirmed TB
cases. If the patient wishes to return to work sooner, smear microscopy may be
repeated (outside of the regular schedule) at least two weeks after treatment
initiation.

. Record the visit, drug intake, and all findings in Form 4b. DS-TB Treatment Card.

16
Annex D: Algorithm for Patient Treatment Response

Treatment Response
|

Good response but with positive Poor response either presenting as:
SM result ¢ Persistent symptoms/no clinical improvement
« Poor weight gain
« Positive follow-up smear at 2nd month of treatment
Complete treatment for 6
months
Yes No

for treatment failure:

Assess Complete treatment
« Determine other risk factors or co-morbidities (i.e. tegimen
diabetes, HIV, mainutrition),A and appropriate
management
e Check for adherence/compliance
« Severe uncontrolled ADR

De
the following to rule out DR-TB:
e Xpert MTB/RIF
o ©Xpert MTB/XDR

o TB culture
o =6DST

If DR-TB positive lf DR-TB negative

Start DR-TB treatment regimen Close follow-up
Or
Refer to a health facility capable of
providing DR-TB treatment
Annex E: Notation of semiquantitative RDT results

MTB semi quantification MTB DETECTED MTB DETECTED

RIF Resistance NOT RIF Resistance
Detected DETECTED

Very Low Ty RRyt

Low TL RR,
Medium Tm RRy

High Ty RRy

Notation for other results (N, TT, TI, I) shall remain the same

18
Annex F: Form 4a.1 Screening for 2HRZE/2HR Treatment Decision

FORM 4A.1 SCREENING FOR 2HRZE/2HR TREATMENT DECISION

Yes
1. Age less
than 3 months or more than 16
years oO}0

2. Infants aged under 3 months and/or weighing <3kg

3. Pregnant
jojoojooojojs

4, MTB-positive by RDT with moderate or high result

5. Smear-positive respiratory sample Oooo

6, Presumed or confirmed DR-TB

7. Exposure to a confirmed DR-TB case
8. Chest x-ray findings
a. Intrathoracic lymph node TB with significant airway obstruction
b. Pulmonary TB confined to
more than one lobe with cavities and miliary pattern joo) jojo)

c. Complicated pleural effusion (with pneumothorax or empyema)

9. Symptoms
a. Requires hospitalization
ao) ao}
b. Presence of danger signs requiring urgent medical care for age under 10 years (Refer to
Annex A of the Guidelines)
c. With signs of EPTB other than peripheral lymph node T8 jo) jo}

d. Presence of the following:

j. severe acute malnutrition and/or severely ill
ii. respiratory distress
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ili, high fever over 39°c

iv. severe pallor
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v. seizure
vi. restlessness
oOo

vii. irritability
viii. lethargy
OIANY YES from list, DO treat with 2HRZE/2HR
the NOT treatment.
O ALLNO from list, initiate 2HRZE/2HR treatment
the