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Monitoring for Treatment Effectiveness
Patients who are smear positive initially should be
monitored by repeat sputum smears (Table 2). Young
children, smear-negative pulmonary TB patients, and
extrapulmonary TB patients can be followed clinically.
Repeat chest x-ray is not recommended for routine
follow-up and is considered a poor use of resources.
Chest x-ray should be repeated only for a patient with
new or progressive symptoms.
Table 2. Timing of Sputum Smears
When to
Monitor
Category I
(6-month regimen)
Category II
(8-month regimen)
At diagnosis 3 specimens 3 specimens
End of initial
phase
End of additional
month of
initial phase, if
needed*
In continuation
phase
During last
month of
treatment
1 spot specimen 1 spot specimen
1 spot specimen 1 spot specimen
1 spot specimen at
end of month 5
1 spot specimen
during month 6
1 spot specimen at end
of month 5
1 spot specimen during
month 8
Source: Harries A, Maher D, Graham S. TB/HIV: A Clinical Manual, second edition. 2004. World Health
Organization, Geneva. *See text.
Patients who were previously sputum smear-positive
with 2 subsequent negative sputum smears and
completion of 6-8 months of treatment are considered
cured. Previously sputum smear-negative patients, or
patients who cannot produce sputum, who respond
clinically (cessation of cough and fever, weight gain)
and complete 6-8 months of treatment are considered
“completers.” Successful treatment includes all cured
patients and “completers.”
Patients who are smear positive at the end of the initial
phase (2 months of Category I treatment or 3 months
of Category II treatment) should continue on the initial
phase for 1 additional month. Patients who are smear
positive after the additional month need 2 sputum
samples sent for culture and sensitivity (if available)
and progress to the continuation phase for the usual 4
months (Category I) or 6 months (Category II).
Patients who are smear positive at 5 months are
considered treatment failures; sputum is sent for culture
and sensitivity and they progress to the retreatment
regimen.
Those who have a gap in treatment are called
“interrupters,” and efforts must be made to get them
back into treatment. Those who have at least a 2-month
gap in treatment are “defaulters,” and must be reassessed
with new sputum smears.
Monitoring for Toxicity
(See Table 4 in chapter Mycobacterium tuberculosis:
Treatment in the United States and Other High-
Income Nations for information on adverse effects of
TB therapy.)
Standard guidelines for anti-TB therapy in resourcelimited
settings do not require baseline or follow-up
laboratory tests as a matter of routine. Rather, clinical
assessment should be performed at least monthly
and should include evaluation of symptoms or signs
such as gastrointestinal intolerance, minor and major
cutaneous drug reactions, joint pain, hepatitis (nausea,
vomiting, abdominal pain, jaundice), peripheral
neuropathy, changes in visual acuity, or development
of blind spots (Table 3). Where laboratory facilities
and financial resources allow, many clinicians prefer to
check baseline and periodic complete blood counts with
differential, alanine/aspartate aminotransferase (ALT/
AST) or bilirubin, and baseline creatinine. Laboratory
monitoring is more important in persons with
preexisting liver disease or those on concomitant ART
although TB treatment should not be withheld for lack
of access to hematology or chemistry laboratory testing.
Management of severe rash includes discontinuation
of TB therapy, supportive care, administration
of corticosteroids for severe or life-threatening
desquamation, and gradual reintroduction of escalating
dosages of medications after resolution. Drugs are
reintroduced in the reverse order of their likelihood of
causing severe rash: isoniazid, rifampin, pyrazinamide,
ethambutol, streptomycin. Avoid thiacetazone because
of high risk of severe cutaneous reactions. Seek expert
advice.
Management of liver toxicity includes cessation of
therapy until bilirubin and ALT return to normal levels.
If laboratory testing is not available, wait until 2 weeks
after the resolution of jaundice. Treat with ethambutol,
streptomycin, rifampin (if tolerated), and isoniazid
(if tolerated). See the discussion of hepatic disease,
above, for 2 possible treatment regimens. If the TB is
severe, treatment may have to be resumed early without
hepatotoxic drugs (ethambutol and streptomycin), until
additional drugs can be reintroduced to the regimen.
Seek expert advice.