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TB CPG 2016 UPDATE:

Harmonized Evidence-Based Care

LALAINE L. MORTERA, MD, FPCP, FPCCP, FCCP


Over-all Chair, TB CPG Task Force 2016

Venue, Date
DISCLOSURE:
The End TB Strategy: 2015-2035
Vision A world-free of TB
(zero deaths, disease, suffering due to TB)
Goal End the Global TB Epidemic
Milestones Targets
Indicators
2020 2025 2030 End 2035
Reduction in
TB deaths 35% 75% 90% 95%
(vs 2015)
Reduction in
TB incidence
20% 50% 80% 90%
(vs 2015) (<85/100,000) (<55/100,000) (<20/100,000) (<10/100,000)
TB QUICK FACTS:

• 288/100,000 incidence
• 417/100,000 prevalence
• 10/100,000 mortality

Philippines 2014:
8/22 High TB Burden
7/27 High MDR Burden
Philippines 2013 Data: 0/41 High TB-HIV Burden
8/22 High TB Burden
7/27 High MDR Burden
0/41 High TB-HIV Burden Philippine Health Statistics 2011
• #6 morbidity & mortality
MDR-TB QUICK FACTS:
Globally,
• New 480T MDR cases
• 25% are detected/treated
• 50% treated successfully
• Regimens are lengthy, difficult to
tolerate

Philippines:
2003-
Philippines 2013 Data: Drug Resistance Survey 2004 2012
8/22 High TB Burden Among new cases 4% 2%
7/27 High MDR Burden
Among re-treatment 21% 21%
0/41 High TB-HIV Burden
WHO Estimates: 11,000 MDR-TB cases in 2014 based on
the notified TB cases
Much Has Happened Since 2006!
• ISTC 2006, 2009, 2014
• WHO Policies 2006-2015
• WHO Global TB Report 2006-2015
• NTP Manual of Procedures 2013
• Growing concern for MDR and HIV
• Novel Rapid TB Diagnostics
• Studies available (foreign, local)
• WHO Case Definitions & Reporting Framework 2013
• WHO Treatment Guidelines 2010
[REPUBLIC ACT NO. 10767]

AN ACT ESTABLISHING A COMPREHENSIVE PHILIPPINE PLAN OF ACTION TO ELIMINATE


TUBERCULOSIS AS A PUBLIC HEALTH PROBLEM AND APPROPRIATING FUND THEREFOR

SECTION 1. Title – This Act shall be known as the “Comprehensive Tuberculosis Elimination Plan Act”.
SEC. 2. Declaration of Policy. – The State is mandated to adopt an integrated and comprehensive approach to health
development. Towards this end, the State shall support and expand efforts to eliminate tuberculosis as a public health
problem by increasing investments for its prevention, treatment and control, and adopting a multi-sector approach in
responding to the disease.

SEC. 8. Education Programs. – The Secretary of Health, in coordination with the CHED, shall encourage the faculty
of schools of medicine, nursing or medical technology and allied health institutions, to intensify information and
education programs, including the development of curricula, to significantly increase the opportunities for students
and for practicing providers to learn the principles and practices of preventing, detecting, managing, and controlling
tuberculosis.

SEC. 11. Regulation on Sale and Use of TB Drugs. – The FDA shall strengthen its implementation of the “No
prescription, No anti-TB drugs” to regulate the sale, use and quality of anti-TB drugs in the market.

SEC. 12. Notification on TB Cases. – All public and private health centers, hospitals and facilities shall observe the
national protocol on TB management arid shall notify the DOH of all TB cases as prescribed under the Manual of
Procedures of the National TB Program and the Philippine Plan of Action on Tuberculosis Control.
Session Objectives
• To present highlights of the “unified” recommendations on TB
(NTP Manual of Procedures 5th Ed, ISTC 2014, WHO policies)
relevant to clinicians
• To present medical evidence to support current policies of the
NTP Manual of Procedures as applicable to various clinical
settings
• To increase awareness and possibly compliance to the
standardized TB care for all healthcare providers
2016 Update
Participating Organizations & Agencies

Other Contributing Organizations: With Support From:


Hepatology Society of the Philippines (HSP) USAID/Philippines
Philippine Obstetrical and Gynecological Society (POGS) WHO/Philippines
Philippine Rheumatology Association (PRA) All Participating Societies
Philippine Society of Endocrine and Metabolism (PSEM)
Philippine Society of Medical Oncology (PSMO)
Philippine Society of Nephrology (PSN)
Philippine Society of Allergy, Asthma and Immunology (PSAAI)
The TB CPG Complements the NTP MOP 5th Ed…
NTP Manual of Clinical Practice
Procedures (MOP) Guidelines (CPG)
Target audience TB care providers Clinicians as TB care providers
Program managers Training institutions
Policy makers Academe
Advocates, Donors Professional Societies
Perspective “Programmatic” “Clinical“
“Programmatic”
Content Procedures Clinical questions
“Operationalize” Review of evidence in the
context of the MOP
Setting “Resource limited” “May go beyond”
Organization of the Task Force
Endorsements Technical and
Oversight Steering Committee
PHILCAT* Function PHILCAT, PSMID, PCCP, DOH
PSMID*
Advisory Group
PCCP* Secretariat

DOH*
Chest-PH
Diagnosis Treatment DR-TB
PCP
PCR
PAFP High Risk Prevention
PCOM Clinical Groups and Control
PCPGTB 2015
Milestones:
Second
Consensus PHILCAT
Meeting Soft Launch
Final Writeshop July 2015
with Advisers Aug 2015
Presented at June 2015
the PCCP
Convention
First March 2015
Consensus
Meeting
Training Feb 2015
Workshop
Sept 2013

Creation of Dissemination using standard modules


Task Force
October 2012
to members of participating societies by
a pool of trained speakers
Workshop on Guidelines SUMMARY OF RECOMMENDATIONS:
for Developing CPGs
September 27, 2013, Heritage Hotel Recommendations on: NO.
Diagnosis 24
Grades of Treatment 29
Recommendation Drug-Resistant TB 4
Assessment, TB-HIV and other High 17
Development and Risk Groups
Prevention and Control 10
Evaluation
A=Accept completely;
B=Accept with some reservations;
C=Accept with major reservations;
Consensus Panel D= Reject with some reservations; and
E= Reject completely.
Meetings & Write shops Consensus: 80% voted A or B
2014-2015 Rejected: if at least 1 voted D or E
Quality of Evidence (GRADE Approach)
Quality of Evidence Study Design Lower if: Higher if:
High Further research is very RCTs Study quality: Strong
unlikely to change our Poor quality of RCT association:
confidence in the implementation Large magnitude
Inconsistency of of effect, no
estimate of effect results plausible
Moderate Further research is Downgraded confounders
likely to have impact RCT; upgraded Indirectness:
on our confidence observational Different population, Very large
studies intervention, magnitude of
Low Further research is very Observational outcomes
effect, no major
likely to have an studies threats to validity
important impact on Imprecise results
our confidence Dose response
Very Low Any estimate of effect Case series or High probability gradient
is very uncertain expert opinion of reporting bias
Grading the strength of recommendations
Strong Weak
• Benefit > Harm • Best available evidence is
very low to low quality
• Cost, Access • Uncertain magnitude of
• NO major benefits or risks
variability • Benefits and harms
• “We recommend” closely balanced
• Benefits may not warrant
• “..should” cost or resources in all
• “…must” settings
• “We suggest”,
• “….may be done”
Implications of CPG Recommendations
Recommendation To Patients To Clinicians Policy Makers
Most would want the Most patients should The
recommended course receive the recommendation
Strong of action, only very
few would not;
recommended course
of action
can be adopted as a
policy in most
request discussion if situations
not offered

Most would want the Different choices Policy making will


recommended course appropriate for require substantial
Weak of action, but many different patients; debate and
would not decision based on involvement of many
individual values or stakeholders
preferences
RECOMMENDATIONS:

Diagnosis
Treatment
Drug-Resistant TB
TB-HIV & Other High Risk Groups
Prevention & Control
2013 WHO Case Definitions:
Adult – person at least 15 years old and older

Presumptive TB – A patient with symptoms or signs (radiologic


findings) suggestive of TB, replaces TB suspect or TB symptomatic.

Bacteriologically confirmed case of TB – A patient with biological


specimen positive by smear microscopy, culture or WHO-approved
rapid diagnostic test (Xpert® MTB/RIF)

Clinically diagnosed case of TB – A patient who does not fulfill the


criteria for bacteriologically confirmed TB, and decided by a clinician
for full treatment for TB
2013 WHO Case Definitions:
Case of pulmonary TB – TB case involving the lungs and the
tracheobronchial tree (bacteriologically/clinically diagnosed).

Case of extra-pulmonary TB – TB case involving organs other than


lungs, e.g. abdomen, genitourinary tract, joints/bones, lymph nodes,
meninges, pleura, skin, etc. (bacteriologically/clinically diagnosed)

A patient with both pulmonary and extra-pulmonary TB should be


classified as a case of pulmonary TB.
Q1: How is a PRESUMPTIVE PTB identified?

 Cough of at least 2 weeks duration (Strong R, low QE)

 Unexplained cough of any duration in a close contact (Strong R, low QE)

 Chest x-ray findings suggestive of PTB, +/- symptoms (Strong R, low QE)

 ANY of the following: cough of any duration, significant unintentional


weight loss, fever, bloody sputum or hemoptysis, chest pains not
referable to any musculoskeletal disorders, easy fatigability or malaise,
night sweats, shortness of breath or difficulty of breathing
(Weak R, low QE)
Q2: What exams should be performed to
bacteriologically confirm PTB?
A Bacteriologically Confirmed TB case is one from whom a
biological specimen is positive by:

• Smear microscopy
• Culture or
• WHO-approved rapid (WRD) diagnostic test - Xpert MTB/Rif
Q3: How should sputum specimens
be collected for DSSM?

Sputum for DSSM should be collected through spontaneous


expectoration. (Strong R, moderate QE)

NTP MOP requires at least 1 teaspoonful (5-10mL) for DSSM.


Q4: How many sputum specimens should be
collected? Timing?

For the diagnostic evaluation of PTB, 2 sputum specimens should


be obtained for DSSM. (Strong R, moderate QE)

Same day (spot-spot) strategy using 2 consecutive specimens


collected 1-hour apart is recommended for direct Ziehl-Neelsen
microscopy (Strong R, moderate QE)
Q5: What is the preferred type of microscopy
for DSSM?

If available, light-emitting diode (LED) microscopy is the preferred


diagnostic microscopy method for DSSM replacing conventional ZN
microscopy (Strong R, moderate QE)
Q6: How are results of DSSM interpreted?

A case of PTB is already considered bacteriologically confirmed if at


least one (1) sputum smear is positive for acid-fast bacilli
(Strong R, moderate QE).
Interpretation of DSSM Results by ZN/FM
Fluorescence Microscopy (FM)
What to Conventional
200x magnification 400x magnification
Report Light Microscopy
1 length = 30 fields 1 length = 40 fields
0 No AFB seen in 300 OIF No AFB observed/ 1 length No AFB observed/ 1 length
Confirmation
required*
1-4 AFB/1 length 1-2 AFB/1 length

+n 1-9 AFB seen in 100 OIF 5-49 AFB/1 length 3-24 AFB/1 length

1+ 10 – 99 AFB seen in 100 OIF 3-24 AFB/1 field 1-6 AFB/1 field

2+ 1-10AFB/OIF, at least 50 fields 25-250/1 field 7-60/1 field

3+ >10 AFB/OIF, at least 20 fields >250/1 field >60/1 field

Reference: Laboratory Diagnosis of Tuberculosis by Sputum Microscopy: The Handbook, Global Edition (as adopted by
the NTP Manual of Procedures 5th edition)
Q7: When should TB culture be requested?

TB culture remains the gold standard for TB diagnosis. If available,


sputum TB culture can be requested in the diagnostic work-up of
TB, specifically in ruling out NTM. The long turnaround time of
results, limited access and cost of test, limits its routine use.

If culture-positive for Mycobacterium tuberculosis (MTB), case is


bacteriologically-confirmed PTB.
TB Culture Facilities - Luzon
Region Public Private
NCR Lung Center of the Philippines PTSI - Quezon Institute
San Lazaro Hospital
UP PGH Medical Research Lab
National TB Reference Laboratory
CAR Baguio General Hospital &
Medical Center
1 Region I Medical Center
2 DOH-Region II TB Laboratory
3 DOH- Region III TB Laboratory
4-A Batangas Medical Center De La Salle Health Sciences Inst.
5 Bicol TB Regional Laboratory Sorsogon MMG Hospital and
Health Services Cooperative
TB Culture Facilities – VisMin
Region Public Private
6 Western Visayas Medical Center Dr. Pablo O. Torre Memorial
Visayas
7 Cebu TB Reference Laboratory
9 Zamboanga City Medical Center
10 Northern Mindanao TB Ref Lab CDO Polymedic Medical Plaza
11 Davao TB Reference Laboratory
Mindanao
Davao Regional Hospital
12 Dr. Arturo Pingoy Medical Center
13 RO XIII TB Culture Laboratory
Q8: What are the indications for performing
sputum TB culture with DST?
Sputum TB culture with DST should be performed for the ff:
• Retreatment cases (Strong R, high QE)
• Treatment failure (Strong R, high QE)
• Contacts of known DR-TB cases (Strong R, moderate QE)

DST should not be routinely performed among new cases of PTB.


(Strong R, high QE)
Q9: When should Xpert®MTB/Rif be requested?
How accurate in confirming PTB? (1)
If available, sputum XpertMTB/Rif can be requested in the
following clinical situations:

• As initial diagnostic test for presumptive TB (Weak R, high QE)


Pooled sensitivity 89%, specificity 99% (Strong R, high QE)

• As follow-on test to smear- (+) CXR findings (Weak R, high QE)


Pooled sensitivity 67%, specificity of 99% (Strong R, high QE)
Q9: When should Xpert®MTB/Rif be requested?
How accurate in confirming PTB? (2)
• As initial diagnostic test for presumptive DR-TB (Strong R, high QE)
Pooled sensitivity 95%, specificity 99% for RR-TB (Strong R, high QE)

• Increased TB detection among culture-confirmed cases by 23% compared


to DSSM (Strong R, high QE)

• For smear-positive, culture-positive TB, Xpert ® MTB/Rif pooled


sensitivity was 98% (Strong R, high QE).
Q10: What are the requirements for
sputum specimens for Xpert®?
At least 1 mL of sputum specimens or 2mL of fresh sputum for test and
retest is needed for Xpert® MTB/Rif. If available, bronchial washings
may be alternate specimens for sputum.

The DOH National TB Program (NTP) has designated DOTS centers


nationwide with capacity to process specimens for free Xpert
MTB/Rif testing for the following priority cases:
• presumptive DR-TB,
• presumptive HIV-associated TB,
• follow-on test for smear negative with CXR (+) new presumptive TB
Xpert MTB/RIF Test

• Fully automated rapid test that detects MTB and rifampicin resistance
• Needs minimum laboratory expertise
• Less than 2h turnaround time
• Biosafety requirements are similar to sputum smear microscopy
Read-out, Interpretation of Xpert TB Results
Xpert® MTB/Rif Report*
Interpretation
Readout (Suggested Minimal Language)
MTB DETECTED; MTB target is detected within sample. MTBC detected.
RIF Resistance A mutation in the rpoB gene has been rpoB mutation detected; likely rifampin
DETECTED detected. A full first and second line drug resistance; Confirmatory testing in progress
panel should be conducted. OR isolate has been forwarded to a reference
laboratory for confirmatory testing.
MTB DETECTED; MTB target is detected within sample. MTBC detected.
RIF Resistance NOT A mutation in the rpoB gene has not been No rpoB mutation detected; likely rifampin
DETECTED detected. susceptible.
MTB DETECTED; MTB target is detected within sample. MTBC detected.
RIF Resistance A mutation in the rpoB gene could not be Insufficient MTB in the sample to allow
INDETERMINATE determined due to insufficient signal determination of rpoB mutation result.
detection.
MTB Not Detected MTB target is not detected within the MTBC not detected
sample.
Q11: How are results of Xpert® interpreted?

Xpert MTB/Rif assay should be interpreted along with


clinical, radiographic, and/or other laboratory findings
(Strong R, high QE)

If positive, case is considered bacteriologically-confirmed PTB


Xpert Facilities in Region 8

Eastern Samar Eastern Samar Provincial Hospital


Leyte Carigara District Hospital
Leyte Ormoc City Health Office
Leyte RO VIII TB Culture Laboratory
Leyte Eastern Visayas Medical Center
Northern Samar Northern Samar Provincial Hospital
Western Samar Calbayog City Health Office
Western Samar Samar Provincial Hospital
Southern Leyte Southern Leyte Provincial Hospital
Q12: What should be done for presumptive PTB
who cannot expectorate sputum?
Sputum induction (15-20 min nebulization with 15mL 2.5-5% hypertonic
saline) for individuals unable to expectorate, provided it is done by trained
staff in well-equipped facilities, with special caution for patients with
history of asthma. (Strong R, low QE)

The Revised NTP Program Manual of Procedures 5th Edition recognizes the
following conditions where patients are classified as “Sputum Not Done” or
unable to produce sputum (UPS):
• Mentally incapacitated as decided by a medical institution
• Debilitated or bedridden
• Patients unable to produce sputum despite sputum induction
Q13: What additional work-up should be
performed among smear negative?
If not yet done, chest x-ray should be performed for all smear-
negative presumptive PTB. (Strong R, moderate QE)

If available, Xpert® MTB/Rif should be requested among


smear-negative presumptive TB cases with radiologic findings
suggestive of PTB with no risk for drug-resistant TB or HIV-
associated TB. (Strong R, high QE)
MOP Procedures (Decision on Diagnosis based on Lab Results)
PRESUMPTIVE TB:
• Cough of at least 2 weeks in an adult (age >15 y/o)
• A child (<15 y/o) w/ any 3 out of 6 criteria for TB Signs/Symptoms No or not Decision of MD or TBDC?
• Chest X-ray suggestive of tuberculosis done
DSSM Age For ages <15 y/o, decide based on the
• Cough of any duration in a high risk individual or a close contact of
positive? <15 y/o? following diagnostic criteria (3/5):
an active TB case (adult/adolescent) No
Yes • Clinical signs and symptoms (3/6) -
No or
Yes Chest x-ray Yes – Coughing/wheezing of > 2 weeks,
With access UPS* esp. if unexplained
findings
Bacteriologically No History of to Xpert – Unexplained fever of > 2 weeks after
Bacteriologically- suggestive
confirmed PTB, previous MTB/Rif? common causes such as malaria or
confirmed PTB of TB?
New treatment? pneumonia have been excluded
Yes No Yes – Loss of weight/failure to gain
Bacteriologically Not TB or investigate weight/weight faltering/loss of
confirmed PTB, further/refer to specialist appetite
MTB positive, Not TB or
– Failure to respond to 2 weeks of
Retreatment investigate
Rif-sensitive MTB negative appropriate antibiotic therapy for
further/refer to LRTI
Refer to PMDT MTB positive, specialist – Failure to regain previous state of
services for
Rif-resistant Xpert health 2 weeks after a viral infection
evaluation
MTB/Rif or exanthema (e.g., measles)
Clinically diagnosed TB, result? – Fatigue, reduced playfulness, or
Retreatment Yes Clinically lethargy (child has lost his/her
Category II Treatment (PTB if CXR+ or with cough) History of normal energy)
diagnosed TB
(for Rif-sensitive) previous
Clinically diagnosed TB, (PTB if CXR+ or • Exposure to an active TB case
Category I Treatment New No treatment? (adult/adolescent)
with cough)
(PTB if CXR+ or with cough) • Positive Tuberculin Skin Test
• Chest X-ray suggestive of TB
COLOR LEGEND Question Xpert Result Disposition • Other laboratory findings
Diagnostic Test Classification Diagnosis Treatment
Notes:
*Unable to produce sputum
Decision Making for TB PRESUMPTIVE TB
Diagnosis Among Smear- NO Bacteriologically
Negative Presumptive TB SMEAR-NEGATIVE Confirmed TB
Adults (modified from NTP YES
NO
MOP 5th Ed) Is CXR Suggestive of PTB? PTB Unlikely, Consider Other
YES Diagnosis or Refer to Specialist
Request for Xpert® MTB/Rif

MTB DETECTED MTB DETECTED MTB NOT NOT Done or


RIF-Sensitive RIF-Resistant DETECTED NO Access to Test
YES YES YES YES
There is decision by clinician to treat as TB and
Bacteriologically will give FULL treatment of anti-TB meds
Confirmed TB NO
YES
Clinically
Diagnosed TB
Q14: What is the role of chest x-ray
in the diagnosis of PTB?
• Although a good screening test to identify presumptive PTB, a single
film cannot accurately confirm active PTB by this modality alone
(Strong R, high QE)

• No CXR findings considered specific for active TB. Clinical correlation,


together with bacteriologic confirmation, is required BEFORE initiation
of appropriate treatment (Strong R, high QE)

• A good quality CXR film is needed to initially guide the clinician in the
identification of presumptive PTB for further bacteriologic
confirmation (Strong R, moderate QE)
Q15: What is an acceptable CXR film? How should
CXR be interpreted?
The quality of the chest x-ray film cannot be overemphasized.
A standard chest examination should be an erect PA and left
lateral projection performed during full inspiration, and should
include both lung apices and costophrenic sulci.

Radiographic interpretation remains unchanged since 2006


recommendations.
Q16: What is the role of digital imaging in TB
diagnosis? Acceptable specifications?
If available, digital imaging can be used in the diagnostic work-up
of PTB similar to a chest film if the appropriate standards are
followed. (Strong R, moderate QE)

For digitized radiographic films, the recommended minimum


specifications are 2.5 lp/mm spatial resolution with an 8-bit pixel
depth.
Q17: What is the role of chest CT scan
in the diagnosis of PTB?
The routine use of chest CT scan in the diagnosis of active
pulmonary tuberculosis cannot be recommended, unless other
co-existing disease conditions are highly considered to explain
the patient’s presentation, or to evaluate possible
complications or sequelae of PTB. Clinical correlation and
bacteriologic confirmation should still be done.
(Strong R, moderate QE)
Q18: What are the recommended
diagnostic work-up for extra-PTB?
• Includes direct microscopy, TB culture and Xpert® MTB/Rif.

• Xpert® MTB/Rif should be preferred over conventional


microscopy and culture as initial diagnostic test for CSF
specimens from presumptive TB meningitis. (Strong R due to
urgency for rapid diagnosis, very low QE)

• Xpert® MTB/Rif may replace usual practice (conventional


microscopy, culture or histopathology) for testing lymph node
and other selected tissues from presumptive extra-pulmonary
TB. (Weak R, very low QE)
Meta-Analysis of Xpert in Diagnosing EPTB
Specimen Comparison Median (%) Pooled Median (%) Pooled
Type (no. of studies, no. of samples Sensitivity (95% Crl) Specificity (95% Crl)
Lymph Xpert® MTB/Rif compared against culture (14 84.9 (72-92) 92.5 (80-97)
node tissue studies, 849 samples)
and Xpert® MTB/Rif compared against a composite 83.7 (74-90) 99.2 (88-100)
aspirate reference standard (5 studies, 1 unpublished)
CSF Xpert® MTB/Rif compared against culture (16 79.5 (62-90) 98.6 (96-100)
studies, 709 samples)
Xpert® MTB/Rif compared against a composite 55.5 (51-81) 98.8 (95-100)
reference standard (6 studies, 512 samples)
Pleural fluid Xpert® MTB/Rif compaed against culture (17 43.7 (25-65) 98.1 (95-99)
studies, 1385 samples)
Xpert® MTB/Rif compared against a composite 17 (8-34) 99.9 (94-100)
reference standard (7 studies, 698 samples)
Gastric Xpert® MTB/Rif compared against culture (12 83.8 (66-93) 98.1 (92-100)
lavage studies, 1258 samples)
Other tissue Xpert® MTB/Rif compared against culture (12 81.2 (68-90) 98.1 (87-100)
samples studies, 699 samples)
Q19-24: What is the role of the following tests?

NAAT (other than Xpert® MTB/Rif) not recommended as stand-alone test


for TB (Strong R, high QE).

NAATs (other than Xpert® MTB/Rif) can be a more sensitive and specific
adjunct to diagnose PTB which requires clinical and radiographic
correlation (Weak R, moderate QE).

Commercial NAATs preferred over in-house (home brew) assays since


they are more sensitive and specific (Strong R, high QE).
Q19-24: What is the role of the following tests?

• TST cannot be used to diagnose active PTB (Strong R, high QE).


• QFT-GIT cannot be used to diagnose active PTB (Strong R, low QE).
• EliSpot cannot be used to diagnose active PTB (Strong R, low QE).
• IGRA not recommended to diagnose active TB (Strong R, high QE).

• MODS and LAM not recommended to diagnose TB disease. These


tests are not readily available in the country. In areas where they
are available, they are mainly used for research purposes
RECOMMENDATIONS:

Diagnosis
Treatment
Drug-Resistant TB
TB-HIV & Other High Risk Groups
Prevention & Control
2013 WHO Case Definitions:
New Case – never been treated for TB or has taken TB drugs < 1 month.

Retreatment Case – received at least 1 month of TB drugs in the past


• Relapse – previously treated, now diagnosed with a recurrent episode of TB
• Treatment after failure – previously treated and recently declared treatment failed
• Treatment after lost to follow-up (TALF) – who interrupted treatment for 2
consecutive months
• Previous Treatment Outcome Unknown (PTOU) – previously been treated for TB
but most recent treatment outcome unknown or undocumented
• Other - do not fit into any of the categories listed above
Q1: What pre-treatment evaluation should be done
for patients with TB disease?
• Thorough history and PE should be done on ALL patients with TB
- previous TB treatment, risk factors for hepatic, renal, ocular
toxicity, sexual history, personal/social history, occupation
(Strong R, moderate QE).

• Liver risk factors - chronic alcohol consumption, viral hepatitis,


pre-existing liver diseases, exposure to hepatotoxic agents, prior
abnormal ALT/AST/bilirubin, HIV (Strong R, moderate QE).

• Baseline visual acuity (Strong R, low QE)


Q2: What baseline labs should routinely be
requested before starting TB meds?
• Baseline ALT, creatinine, at least, for >60y/o, (+) risk factors for liver or
kidney disease (Strong R, low moderate QE).
• All TB patients with history of high-risk behavior for HIV and coming
from areas with high HIV prevalence should be offered PICT for HIV.
(Strong R, moderate QE).
• Screening for DM using FBS, RBS or 75g OGTT for all TB patients.
Proper management of glucose levels essential in TB treatment
(Strong R, high QE).
• Serum uric acid testing NOT recommended before starting TB meds.
Finding of asymptomatic hyperuricemia not indication to avoid PZA.
(Strong R, moderate QE).
Priority Areas for HIV Intervention in the PHL
Greater Metro Manila: Metro Cebu:
Caloocan City Quezon City Cebu City
Las Piñas City San Juan City Danao City
Makati City Taguig City Lapu-Lapu City
Malabon City Valenzuela City Manadaue City
Mandaluyong City San Jose Del Monte City, Naga City
Manila City Bulacan Talisay City
Marikina City Antipolo City, Rizal
Muntinlupa City Cainta, Rizal Other High Prevalence
Navotas City Bacoor City, Cavite Areas:
Parañaque City Imus City, Cavite Angeles City
Pasay City Dasmarinas City, Cavite Bacolod City
Pasig City Sta. Rosa City, Laguna Cagayan De Oro City
Pateros Davao City
Iloilo City
Zamboanga City
Q3: What is the effective treatment regimen
for new TB cases?
Effective treatment regimen for new PTB cases (without risk
factors for drug resistance):

Category I (2HRZE/4HR) regardless of bacteriologic


status. (Strong R, high QE).
Q4: What is the effective treatment regimen
for retreatment TB cases?
Category II regimen (2HRZES/1HRZE/5HRE) should only be
given among confirmed Rifampicin-sensitive retreatment cases or in
circumstances where XpertMTB/Rif services cannot be performed
(Strong R, moderate QE).

• Should immediately be referred to the nearest XpertMTB/Rif


facility for rifampicin susceptibility testing . (Strong R, high QE).

• RR-TB cases should immediately be referred to a PMDT facility for


further management
Q5: How should PTB patients who have interrupted
treatment be managed?
• Patients who fail to follow-up as scheduled should be immediately
traced through: telephone call, text message or home/workplace visit.

Length of Do DSSM if >1 month How long was


Interruption interruption treatment?
Disposition
< 1 month Continue treatment, prolong to compensate
Negative DSSM Continue treatment, prolong to compensate
> 1 month but
<5 months Continue tx, prolong to compensate
< 2 months Positive DSSM
>5 months Classify as “Treatment failed”
> 2 months Classify as “Lost to follow up”, repeat DSSM
Q6: What is the effective treatment regimen
for miliary TB?
In the absence of meningitis or bone and joint involvement,
the effective treatment regimen for new miliary TB cases is
Category I (2HRZE/4HR).

Dissemination to other organs such as the CNS, joints/bones,


lungs, heart, gastrointestinal tract, and genitourinary tracts are
to be treated according to the recommendations for treatment
of EPTB.
(Strong R, low QE)
Q7: What are the effective regimens and duration
for new extra-PTB?

Site Regimen Recommendation/ Level of Evidence


CNS 2HRZE/10HR Strong recommendation, high quality evidence
Bone, Joints 2HRZE/10HR Strong recommendation, mod quality evidence
Lymph node 2HRZE/4 HR Strong recommendation, mod quality evidence
Pericardium 2HRZE/4 HR Strong recommendation, low quality evidence
Pleura 2HRZE/4 HR Strong recommendation, mod quality evidence
Liver 2HRZE/4 HR Strong recommendation, mod quality evidence
GI, Peritoneum 2HRZE/4 HR Strong recommendation, mod quality evidence
Kidney, GUTB 2HRZE/4 HR Strong recommendation, low quality evidence
Treatment
Indication Regimen
Category
Category I New Pulmonary TB, miliary TB 2HRZE/4HR
New EPTB (except CNS/bones/joints)
Category Ia New TB CNS/bones/joints 2HRZE/10HR
Category II Retreatment of Rif susceptible PTB 2HRZES/
and EPTB (except CNS/bones/joints) 1HRZE/5HRE
Category Retreatment of Rif susceptible TB 2HRZES/
IIa CNS, bones or joints 1HRZE/9HRE
Q8: How effective are corticosteroids
for the treatment of extra-PTB?
As adjunct therapy recommended ONLY for patients with TB meningitis
and/or TB pericarditis.

In TB meningitis, the recommended regimen is dexamethasone 0.4


mg/kg/24H with a reducing course over 6-8 weeks (Strong R, high QE).

In TB pericarditis, the recommended regimen is prednisolone 60 mg for


the first 4 weeks, 30 mg for weeks 5-8, 15 mg for weeks 9-10 and 5 mg
for week 11 (Strong R, moderate QE).
Q9: What is the role of surgery in the
management of extra-PTB?
CNS - Hydrocephalus, tuberculous cerebral abscess, and vertebral TB with paraparesis are
indications for neurosurgical referral for early VP shunting (Strong R, moderate QE).

Spine -Surgery for those who develop progressive kyphosis; spinal cord compression
(Strong R, moderate QE).

LN - therapeutic excision not recommended (Strong R, moderate QE).

Pericardium - Open surgical drainage under GA for pericardial effusion. (Weak R, low QE).

Pleura – pigtail drainage and decortication may be needed in symptomatic patients due to
pleural loculation and thickening. (Weak R, low QE).
Q10: How should anti-TB meds administered?
Patient-centered DOT should be offered to all patients who will undergo
TB treatment in health facilities with DOTS programs
• Patient given opportunity to choose where to be treated, who will be
treatment partner (healthcare worker or family member)

Outcomes are better with patient-centered DOT in terms of completion of


treatment, smear conversion and default rates compared to daily health
facility based treatment and is less expensive in a programmatic setting.
(Strong R, high QE).
Q11: What are the effective ways of
tracking patients and monitor adherence?
The healthcare provider should educate the patient and treatment
partner along with the following strategies to track and monitor
adherence to treatment:

• Remind patients of appointments, by phone calls and SMS


• Default reminder letter/SMS or home visits for those who miss visits
• Give incentives and enablers such as nutritious, culturally appropriate
daily meals and food packages
• Coordinate with DOTS centers and support groups
(Strong R, moderate QE).
Q12: How effective are FDCs compared to single
drug formulations?
FDCs are convenient in terms of acceptability, side effects and adherence
and preferred in programmatic setting; similar to single-drug formulations
(SDF) in preventing treatment failure or relapse when given under DOT.
(Strong R, moderate QE).

Single-drug formulations useful for the following situations:


• Adverse reactions or at risk for adverse reactions (elderly, liver disease)
• Co-morbid conditions requiring dose adjustments (liver or kidney
disease) or expected to have significant drug interactions (HIV, DM)
Q13: How effective is daily vs intermittent regimen
for TB treatment?
• Daily regimen recommended particularly if FDC is used
• Intermittent regimens <3x/week not preferred
• 3x weekly intermittent regimens offered in special
situations where daily regimen is not feasible
(Strong R, moderate QE).
Q14: How should we monitor treatment response?

• Rapid diagnostic tests (IGRA, Xpert, Antiphopholipid Ab tests)


NOT recommended for monitoring treatment response
pending further studies. (Strong R, low QE).

• CXR NOT a substitute for microbiological monitoring. It may


be used in monitoring complications, identifying co-existing
conditions. (Strong R, low QE).
Monitoring Treatment Response
CATEGORY I (Bacteriologically confirmed)

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6


X X X
Sm+ “FAILED” Sm+ “FAILED”
X X X X
Sm+ Sm+ Sm+ Sm+
Culture, DST “FAILED” “FAILED”
Strong Recommendation, Low Quality Evidence
CATEGORY I (Clinically Diagnosed)
Month 1 Month 2 Month 3 Month 4 Month 5 Month 6
X
Strong Recommendation, Low Quality Evidence
Monitoring Treatment Response
CATEGORY 2

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8


X X X
Sm+ Sm+ Sm+
culture, “FAILED” “FAILED”
DST
Q15: How should we classify treatment outcomes?

Outcome Definition
Cured Bacteriologically-confirmed TB who was smear- or culture-
negative in the last month of treatment and on at least one
previous occasion in the continuation phase.
Treatment Completes treatment without evidence of failure but with
Completed no record to show that sputum smear or culture results in
the last month of treatment and on at least one previous
occasion were negative, either because tests were not
done or because results are unavailable.
Q15: How should we classify treatment outcomes?

Outcome Definition
Treatment Smear or culture (+) at five (5) months or later during
Failed treatment; Clinically-diagnosed patient w/o clinical
improvement anytime during treatment
Died Dies for any reason during the course of treatment.
Lost to Treatment was interrupted for 2 consecutive months or
Follow-up more
Not No treatment outcome is assigned; including those
evaluated transferred to another DOTS facility, outcome unknown.
Q16: When is patient on TB treatment
considered non-infectious?

Bacteriologically-confirmed (no risk factors for DR-TB) considered


non-infectious – at least 14 daily doses of treatment, (+) sputum
conversion, (+) clinical improvement. (Strong R, high QE).

Clinically diagnosed (no risk factors for DR-TB) considered non-


infectious – at least 5 daily doses of treatment, (+) clinical
improvement. (Strong R, high QE).
Q17: What is paradoxical treatment response
and how should it be managed?

Paradoxical Response (PR) is the unusual expansion or new


formation of a tuberculous lesion (PTB, EPTB) during TB
treatment in the absence of evidence of disease relapse or
presence of another diagnosis.

Non-severe form does not require specific treatment and anti-


TB treatment should be continued. Severe forms require
symptomatic treatment. (Strong R, low QE).
Q18: What are common adverse reactions
to anti-TB drugs?
Minor adverse reactions
Gastrointestinal intolerance
Mild or localized skin reactions
Orange/red-colored urine
Pain at the injection site
Burning sensation in the feet due to peripheral neuropathy
Arthralgia due to hyperuricemia
Flu-like symptoms (fever, muscle pains, inflammation of the respiratory tract)

Major adverse reactions


Severe skin rash due to hypersensitivity
Jaundice due to hepatitis
Impairment of visual acuity and color vision due to optic neuritis
Hearing impairment, ringing of the ears, dizziness due to damage of the eighth cranial nerve
Oliguria or albuminuria due to renal disorder
Psychosis and convulsion
Thrombocytopenia, anemia, shock
Q19: How should common AEs due to anti-TB drugs
(HRZES) be monitored/managed?
General principles in the management of adverse reactions
due to anti-TB drugs are as follows:

• Minor adverse reactions - symptomatic therapy, first-line


drugs should not be stopped without adequate justification
• Major adverse reactions - all drugs must be discontinued,
switching to single drug formulations may be needed,
referral to specialist warranted.
Q20: How should drug-induced hepatotoxicity
be monitored and managed? (1)
• Routine liver function monitoring NOT needed among
asymptomatic patients with no liver risk factors.
(Strong R, moderate QE)

• Serum ALT (SGPT) requested for:


(1) symptoms of hepatotoxicity (jaundice, anorexia, nausea,
vomiting, abdominal pain);
(2) baseline risk factors for hepatotoxicity or abnormal LFTs
2-4 weeks after start of anti-TB meds.
(Strong R, moderate QE)
Q20: How should drug-induced hepatotoxicity
be monitored and managed? (2)
• Hepatotoxicity - serum ALT >3x ULN (symptomatic) or >5x ULN
(asymptomatic)

• ALL medications stopped immediately, evaluated promptly


(Strong R, moderate QE).

• When ALT normalizes <2x ULN AND symptoms resolve, re-introduce


Rifampicin, followed by INH after 3 to 7 days

• PZA permanently discontinued in prolonged/severe hepatotoxicity.


(Strong R, low QE).
Q21: How should GI reactions be managed?

• Mild GI symptoms – reassure and continue TB medications


(Strong R, low QE).

• Persistent GI symptoms - antacids


(Strong R, moderate QE).

• Food intake not recommended as first-line management


(Strong R, low QE).
Q22: How should peripheral neuropathy
be managed?
• Monitor for burning, numbness or tingling sensation in hands, feet

• No laboratory tests needed

• Risk factors: alcoholism, malnutrition, diabetes, co-infection with HIV,


slow acetylator phenotype, pregnancy, breastfeeding, renal failure
(Strong R, moderate QE).

• Treatment: Vitamin B6 50-100mg OD (Strong R, moderate QE).

• Prophylaxis: Vitamin B6 10mg OD (Strong R, low QE).


Q23: How should visual impairment be monitored?

• Manifestations: progressive painless blurring of vision, decreased


color perception, loss of central vision, optic atrophy.

• Testing of visual acuity and color perception for individuals who


develop signs and symptoms of ocular toxicity while on anti-TB
treatment. (Strong R, low QE).

• Ethambutol should be discontinued if visual impairment develops.


Referral to an ophthalmologist is warranted. (Strong R, low QE).
Q24: How should patients presenting with
symptoms of ototoxicity be managed?
• Patients on streptomycin who develop symptoms of ototoxicity
(decreased hearing, vertigo, nausea, vomiting, nystagmus, or ataxia),
should be advised to stop streptomycin and referred to an ENT
specialist for appropriate management.
(Strong recommendation, low quality evidence)
Q25: How should patients with hyperuricemia
be monitored?
• Patients on PZA should be monitored for symptoms of gouty
arthritis. Serum uric acid should ONLY be requested for
patients who develop symptoms of gouty arthritis.
(Strong R, low QE).

• For patients who develop gouty arthritis, discontinue the


PZA, administer standard treatment for hyperuricemia/
gout. Referral to a rheumatologist if symptoms persist.
(Weak R, low QE).
Q26: How should cutaneous reactions
be monitored?
• If minor rashes (limited area) - antihistamines, cont. drugs

• If generalized, associated with fever and/or mucus membrane


involvement, stop all drugs immediately. Referral to a specialist
(Strong R, low QE).

• When cutaneous reaction improve, medications can be


restarted at full dose or reintroduced one by one at intervals of
3-7 days. (Weak R, low QE).
Q27: How should nephrotoxicity be monitored?

• Routine monitoring of renal function not needed if


asymptomatic and without risk factors for nephrotoxicity.

• Serum BUN, creatinine, urinalysis should be requested for


patients who have signs and symptoms of nephrotoxicity such
as oliguria and edema.

• Among individuals who develop nephrotoxicity, Streptomycin


should be discontinued. Referral to a nephrologist is
warranted. (Strong R, low QE).
Q28: Should immuno-modulators be
given as adjunct therapy?
• Immunomodulators NOT recommended as adjunctive
therapy (Strong R, low QE).
Q29: Should vitamin and micronutrient
supplementation be routinely given?
• Vitamin and micronutrient supplementation should NOT be
routinely given as adjunctive therapy for TB (except for
vitamin B6 or if the patient has pre-existing nutritional
deficiency). (Strong R, low QE).
RECOMMENDATIONS:

Diagnosis
Treatment
Drug-Resistant TB
TB-HIV & Other High Risk Groups
Prevention & Control
Q1: When is DR-TB suspected?

• All retreatment cases – relapse, treatment failure, treatment


after lost to follow-up (TALF), PTOU
• New cases who are:
1. Non-converter of Category I
2. Contacts of confirmed DR-TB cases
3. PLHIV with signs and symptoms of TB -
(Strong R, high QE).

Assessment of likelihood of drug resistance should be done


(Strong R, high QE).
Q2: How is DR-TB diagnosed?
• Conventional (phenotypic) Drug Susceptibility Testing (DST) on
culture isolates.
• Genotypic DST (Xpert MTB/Rif, LPA) (Strong R, high QE).
• XpertMTB/Rif as initial test in presumptive DR-TB
(Strong R, high QE).

All presumptive DR-TB referred to nearest DOTS facility with


PMDT services or to an XpertMTB/Rif facility (Strong R, high QE).
Q3: How should DR-TB be managed?

• All DR-TB patients should be managed under programmatic


setting. Management outside the proper framework will only
lead to further drug resistance. (Strong R, high QE).

• Immediate referral to the nearest PMDT Treatment Center or


Satellite Treatment Center is mandatory. (Strong R, high QE).
Q4: What is the role of surgery in
management of DR-TB?
• Surgery for DR-TB: localized cavitary forms with continuous
Mtb excretion (DSSM/DST), after 4-6 months of DOT
(Strong R, moderate QE).

• Surgery should be considered integral component of MDR-TB


programs, as long as adequate surgical expertise/facilities
present. (Strong R, moderate QE).

• Multidisciplinary approach (surgeons, anesthesiologists,


specialists) (Strong R, moderate QE).
RECOMMENDATIONS:

Diagnosis
Treatment
Drug-Resistant TB
TB-HIV & Other High Risk Groups
Prevention & Control
Q1: Should routine screening for active TB
be done among PLHIV?
• All newly diagnosed PLHIV should be screened for active TB.
(Strong recommendation, high quality evidence)
Q2: How does one reliably diagnose PTB in HIV?
• Based on symptomatic screening (cough any duration, fever, night
sweats, weight loss), CXR and Xpert® MTB/Rif

• XpertMTB/Rif as initial test in presumed HIV-TB. (Strong R, high QE).

• Should be referred to nearest DOTS facility with PMDT services or to


an XpertMTB/Rif facility for screening and testing before initiating
any form of TB treatment. (Strong R, high QE).

• If Xpert® MTB/Rif is negative, diagnosis for PTB will be based on a high


index of clinical suspicion. (Strong R, high QE).
Q3: What is the recommended treatment regimen
for PTB among PLHIV?
• Same as the general population.

• Co-trimoxazole prophylaxis (800/160) should also be given


to prevent Pneumocystis jirovecii pneumonia among PLHIV
regardless of CD4 count. (Strong R, high QE).
Q4: When is the optimal time to start ART?

• ART should be initiated after the second week of TB


treatment regardless of CD4 count.

• For patients with TB meningitis, antiretroviral therapy should


be initiated after the intensive phase of TB treatment.

• Efavirenz the preferred NNRTI for HIV patients on TB


treatment. Avoid the use of nevirapine because of drug-drug
interactions.
(Strong recommendation, high quality evidence)
Q5: What is the management of PLHIV with
presumed DR-TB?
• Refer to PMDT treatment facilities immediately
(Strong recommendation, high quality evidence)
Q6: Should routine screening be done among
patients with DM?
• Screening for TB in people with DM may be considered due
to the high TB prevalence in the Philippines.
(Weak recommendation, low to moderate quality evidence)
Q7: What is the recommended treatment regimen
for TB among patients with DM?
• Same as the general population (Strong R, high QE).

• Glucose control for diabetic individuals with TB should be


optimal

• In difficult to control diabetes mellitus, referral to a


diabetes specialist is recommended to achieve optimal
glucose control. (Strong R, moderate QE).
Q8: What is the recommended work-up? Most
suitable treatment among SOT and HSCT?
Same as general population.

For kidney and liver transplant candidates, will need dose


adjustments based on drug and disease severity. (Strong R,
moderate QE)

For those without risk factor for DR-TB, 12-18HE


(Weak R, moderate QE)

For severe TB (disseminated, cavitary, bacteriologically-positive),


2HRZE/4-9HR (Weak R, moderate QE)
Q9: What is the appropriate treatment regimen
for TB among CKD patients?
• First line drugs with dose modifications where appropriate.

• CKD on second-line drugs - adjusted based on renal


function. (Strong recommendation, high quality evidence)
Q10: When is the best time to administer anti-TB
medication among CKD patients?

• For patients on hemodialysis, anti-TB medications should be


administered immediately after hemodialysis session.

• For patients on peritoneal dialysis, anti-TB medications may


be administered regardless of PD schedule.
Strong recommendation, low quality evidence
Reference dose Dose Adjustment and Timing
Drug (normal renal GFR> GFR<
HD PD
function) 30mL/min 30mL/min
Isoniazid+ 5 (4-6) mg/kg, None None AD None
400 mg daily
Rifampicin 10 (8-12) mg/kg, None None AD None
600 mg daily
Pyrazinamide 25 (20-30) mg/kg, None 25-35 mg/kg, 25-35 25-35
2 g daily 3x/week mg/kg, mg/kg,
3x/week, 3x/week
AD
Ethambutol 15 (15-20) mg/kg, GFR > 70 mL/min: 15-25 mg/kg, 15-25 15-25
1.6 g daily None 3x/week mg/kg, mg/kg,
GFR < 70 mL/min: 3x/week, 3x/week
15-25 mg/kg, AD
3x/week
Q11: What is the appropriate treatment regimen
for TB among CLD patients?

• Compensated liver cirrhosis, 2HRSE/6HR; 2HSE/10HE or 9HRE

• Decompensated liver cirrhosis, referral to specialized centers is


warranted because of the possible use of second line TB drugs.
(Strong recommendation, low quality evidence)
Q12: What is the appropriate treatment regimen
for pregnant and lactating women?
• Same as general population. Streptomycin, however, is
contraindicated in pregnant and lactating women.

• Supplementation with pyridoxine 10-25 mg/day to


pregnant and lactating women recommended to prevent
peripheral neuropathy. (Strong recommendation, moderate
quality evidence)
Q13: Is CXR considered safe during pregnancy?

• Chest radiography with abdominal shield, if indicated, is


considered to be relatively safe during pregnancy. An
informed consent is necessary. Pregnancy should neither
deter nor delay the diagnosis and management of PTB.
(Strong recommendation, low quality evidence)
Q14: Who should be screened for LTBI?

• PLHIV (treated for presumed LTBI if active disease ruled out)


(Strong R, moderate QE).
• Solid organ, hematologic transplant recipients (Strong R,lowQE).
• RA patients on biologicals (Strong R, low QE).
• Patients on chronic dialysis (Strong R, low QE).
• DM who are Type 1, Type 2 on insulin with poor control,
contacts, or smokers (Weak R, moderate QE).
• Pregnant patients who are contacts, injection drug users, or
immunocompromised. (Strong R, low QE).
• Pregnant women with HIV (same as non-HIV)
Q15-16: What is the recommended screening and
treatment for LTBI among high risk clinical groups?
TST skin test (TST) is the preferred screening test for LTBI in
resource-limited setting like the Philippines
(Strong R, low QE)

Isoniazid 300mg daily for 6 months under DOT


(Strong R, mod-high QE)

Pyridoxine at a dose of 25 mg/day recommended to prevent


peripheral neuropathy. (Strong R, low QE)
Q17: How often should LTBI screening be for
patients on biologicals?
Annual LTBI screening using either TST or IGRA is recommended
for all rheumatoid arthritis patients receiving biologic therapy.
(Strong R, low QE)
RECOMMENDATIONS:

Diagnosis
Treatment
Drug-Resistant TB
TB-HIV & Other High Risk Groups
Prevention & Control
Q1: Will the observance of proper cough etiquette
help minimize transmission of PTB?
Covering one’s mouth when coughing minimizes the spread of
potentially infectious aerosols, including those laden with MTB.
(Strong R, low QE)
Q2: Will the use of face masks decrease
TB transmission?
• Surgical face masks, NOT face-piece respirator masks, among
presumptive or diagnosed PTB deemed infectious
(Strong R, low QE)
• No evidence of additional protection for 2 or more surgical
face masks in layers (Strong R, moderate QE)
• Filtering face-piece respirator masks, NOT surgical masks,
among exposed health care workers (ex N95) during
procedures with high risk of aerosolization
• Regular fit-testing to ensure proper use of filtering face-piece
respirator masks. (Strong R, high QE)
Q3: Why and how should household contacts of
active TB be screened?
• Household contacts of active TB cases at increased risk of
infection and disease

• Should be screened for disease activity; at least by CXR,


especially if the index case is bacteriologically confirmed,
cavitary disease, with frequent coughs and has yet to receive
or in the early stages of the recommended treatment regimen
(Strong R, high QE)
Q4: What factors increase the risk of contracting TB
infection and promote progression to disease?
• Smokers, alcoholics (i.e., > 40g/day), underweight (BMI<20)
have increased risk of TB infection vs general population.

• Risk for TB disease significant among recent TB infection (i.e.,


<2years), upper lobe fibro-nodular disease on CXR

• Periodic monitoring for symptoms, repeat CXR 4-6 months to


establish radiographic stability to detect TB disease early

(Strong R, moderate QE)


RISK FACTOR RELATIVE STUDIES
RISK
HIGH RISK
Recent TB infection (<2years) 15 SutherlandI, ‘76, ‘66
Upper lobe, fibronodular 6-19 Nolan ‘88; Grzybowski ‘71, ‘66
SLIGHTLY INCREASED RISK
Underweight BMI<20 2-3 Comstock 1975
Smoking (1 pack/day) 2-3 Maruya ‘02, Gajalakshmi ‘03
BMI <18.5 and smoker 4.95 (F); 2.34 (M) Bates 2007, Batista 2008
BMI <18.5 and DM 10 (F); 6.43(M) Patra 2014
Alcohol >40g/day 2.94 Lonnroth 2008
Granuloma, CXR 2 Grzybowski ‘71, Horwitz ‘69
RISK FACTOR RELATIVE STUDIES
RISK
LOW RISK
Infected person, no known 1 Comstock 1974
risk factor, normal CXR
VERY LOW RISK
+ 2-step booster, no known 0.5 Comstock 1974, Ferebee 1970
risk factor, normal CXR
Q5: Do we need to treat LTBI in the general
population?
• Treatment of latent TB infection in the general population not
recommended (Strong R, moderate QE)
Q6: What is the role of BCG re-vaccination among
adults to prevent TB infection?
• B CG re-vaccination NOT recommended to prevent TB
infection (Strong R, moderate QE)
Q7: When should isolation be recommended?

• Bacteriologically confirmed PTB cases not started or in early


stages of TB treatment
• Presumptive DR-TB or known MDR/XDR-TB
• Documented or presumptive HIV (Strong R, moderate QE)
Q8: What infection control measures must be
observed in healthcare facilities?
• Administrative control – triage for symptomatic patients,
separation from infectious cases, minimize exposure in health
care facilities, cough etiquette
• Surveillance of TB disease among HCW for TB transmission
• Environmental control – good ventilation
• Use of PPE for HCW at high risk
(Strong R, low QE)
Q9: What infection control measures must be
observed when handling TB biological specimens?
• Hand hygiene
• Use of PPE
• Filtering respirator face-masks not required during smearing
• Biological safety cabinets not mandatory during DSSM
• Disinfection with sodium hypochlorite, phenol, ethanol
• Disposal of infectious wastes
(Strong R, low QE)
Q10: How should job applicants/students be
managed if pre-employment screening suggest TB?
• Workup for presumptive TB
• For TB activity not entirely ruled out – periodic monitoring,
repeat CXR 4-6 months
• Policies of host countries prevail
(Strong R, low QE)