GENERAL PRINCIPLES

  • The country has adopted community-based TB care. It is recommended that all TB medicines are taken under direct
    observation by a treatment supporter (DOT) .
  • Anti-TB drugs are given in fixed dose combination (FDC) regimens according to the patient’s TB classification
  • Treatment is divided into 2 phases: an initial (intensive) phase of 2 months and a continuation phase of 4 months
    (longer in MDR-TB and severe forms of TB particularly TB meningitis and osteoarticular TB )
  • TB treatment regimens are expressed in a standard format, e.g. 2RHZE/4RH where:
    • Letters represent abbreviated drug names
    • Numbers show the duration in months
    • / shows the division between treatment phases
  • Anti-TB drugs have side effects and they should be managed appropriately (see next section)
  • TB treatment monitoring should be done by clinical, sputum and where possible radiological
  • A conclusion of ”treatment outcome” status should be done for every patient treated for TB

First line anti-TB medication

DRUG ADULT
DOSE
CHILDREN
DOSE
CONTRAINDICATIONS
(C) / INTERACTIONS (I)
Isoniazid
(H) oral
5 mg/kg
(max 300
mg)
10 mg/
kg (range
7–15 mg/
kg)
C: Liver
disease, known
hypersensitivity
I: carbamazepine,
phenytoin
Rifampicin
(R) oral
10 mg/kg
(max 600
mg)
15 mg/
kg (range
10–20
mg/kg)
C: Liver
disease, known
hypersensitivity
I: Oral
contraceptives,
nevirapine,
warfarin, phenytoin,
glibenclamide
Pyrazinamide
(Z) oral
30-40
mg/kg
(max
2500 mg)
35 mg/
kg (range
30–40
mg/kg)
C: Liver
disease, known
hypersensitivity
Ethambutol
(E)
oral
15 mg/kg 20 mg/
kg (range
15–25
mg/kg)
C: Pre existing optic
neuritis, established
kidney failure
Streptomycin
(S)*
IM
15 mg/kg Not recommended C: Impaired hearing,
hypersensitivity,
kidney failure
I: other nephrotoxic
drugs

*Streptomycin is being phased out and will be no longer used for treating susceptible TB. All previously treated TB
patients requiring re-treatment should have a geneXpert test done to rule out rifampicin resistance.

Note
  • Rifampicin interacts with oestrogen-containing contraceptives and reduces the protective efficacy of the
    contraceptives. Use high dose contraceptive or use an additional barrier method.

Important: The choice of regimen now depends on rifampicin sensitivity and not on the previous history of
treatment:

  • All patients without rifampicin resistance (either new or re-treatments) are treated with 1st line regimen.
  • Patients with rifampicin resistance (either new or retreatments) are treated with second line medication in a
    designated MDR-TB treatment facility.

Susceptible TB: 1st line treatment regimens

For patients without rifampicin resistance at gene Xpert (both new and re-treatment cases).

New cases not belonging to priority (risk) groups and in which diagnosis was done by sputum examination will also
be treated with this regimen.

TYPE OF TB DISEASE REGIMEN FOR
SUSCEPTIBLE TB
INTENSIVE
PHASE
CONTINUATION
PHASE
All forms of TB in
adults and children but
excluding TB meningitis
and Bone TB)
2RHZE 4RH
TB meningitis Bone
(Osteoarticular) TB
2RHZE 10RH

Retreatment cases

WHAT TO DO RESULT
Patients
previously
treated for TB
(Retreatment
cases e.g.
relapse, lost
to follow up,
treatment
failure)
Do
GeneXpert
to screen for
Rifampicin
resistance
If GeneXpert reveals
Rifampicin sensitivity
treat as susceptible (see
table above)

If GeneXpert reveals
Rifampicin resistance,
refer to MDR treatment
site

If unable to obtain a
sample or GeneXpert is
negative refer to District
or Regional Hospital for
further evaluation

Rifampicin-resistant TB

Patients with rifampicin-resistant TB should undergo culture and Drug Sensitivity testing, and be treated with
second line regimens according to national guidelines.
Notify the relevant TB focal persons and organise referral to MDR-TB specialised centers for appropriate management.

Adjunctive treatment

  • Vitamin B6 (pyridoxine): 25 mg per day; given concomitantly with isoniazid for the duration of
    therapy, to prevent peripheral neuropathy
  • Prednisolone in TB patients in whom complications of fibrosis are anticipated because
    of severe inflammation such as TB meningitis.

    • Prednisolone is given in a dose of 1-2 mg/kg body weight (not more than 60 mg/day) as a single dose
      for 4 weeks, and then tapered off over 2 weeks

Monitoring of susceptible TB

LABORATORY MONITORING (FOR PULMONARY TB)

At the end of the initial 2 months:

  • Sputum smear-negative; start continuation phase
  • Sputum smear-positive; do GeneXpert
  • If Rifampicin-resistant, refer for MDR-TB treatment
    and
  • If Rifampicin-sensitive, continue with first-line treatment, explore adherence issues but repeat smear at
    3 months
  • If positive, do DST
  • If smear negative continue with first-line treatment

At the beginning of 5 months:

  • Sputum smear-negative, continue with continuation treatment
  • Sputum smear-positive, diagnose Treatment Failure
  • Take sputum for GeneXpert to rule out Rifampicin Resistance
  • If Rifampicin Resistant, refer for DR treatment
  • If TB detected but not Rifampicin Resistant, restart first
    line regimen but explore adherence issues

During the 6th month:

  • Sputum smear-negative, complete treatment and declare cured or treatment completed
  • Sputum smear-positive, diagnose treatment failure
  • Take sputum for GeneXpert to rule out rifampicin resistance
  • If Rifampicin-resistant, refer for MDR-TB treatment
  • If Rifampicin-sensitive, restart first-line treatment, explore adherence issues

CLINICAL MONITORING (FOR ALL TB CASES)

  • Monitor well-being and weight gain
  • Assess and reinfornce treatment adherence
  • Assess and manage side effects
Note
  • Radiological monitoring– this method should not be used as the sole monitoring tool

Management of treatment interruptions Refer to NTLP TB treatment manual

Treatment outcomes

A conclusion should be made regarding treatment outcome of EVERY TB patient who has been started on anti-TB
treatment.

OUTCOME DESCRIPTION
Cure A pulmonary TB patient with
bacteriologically confirmed TB at the
beginning of treatment who was smearor
culture-negative in the last month of
treatment and on at least one previous
occasion
Treatment
completed
A TB patient who completed treatment
without evidence of failure BUT with
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
Lost to followup A TB patient who did not start
treatment, or completed more than
1 month of treatment and whose
treatment was interrupted for 2 or more
consecutive months
Died A TB patient who dies for any reason
before starting or during the course of
treatment
Treatment
failure
A TB patient whose sputum smear or
culture is positive at month 5 or later
during treatment
Not evaluated A patient for whom no treatment
outcome is assigned. This includes cases
“transferred out” to another treatment
unit as well as cases for whom the
treatment outcome is unknown to the
reporting unit
Treatment
success
The sum of cured and treatment
completed