9.4 Follow-up for patients treated with first-line regimens


Patients should be followed for the entire duration of treatment. Follow-up includes, in particular, assessing the treatment results, adjusting the treatment if necessary, and detecting and managing adverse effects and adherence problems.

9.4.1 Clinical visits

Frequency of visits will depend on the patient’s clinical condition and evolution. On average, for an outpatient who is not having any particular problem, the recommendation is weekly visits during the first month, a visit every other week during the second month and once a month thereafter.

The patient should be weighed at each visit and the doses should be adjusted, if necessary.

The occurrence of adverse effects should be asked at each visit.

Visits should coincide with bacteriological testing, when done. In EPTB, the clinical evolution is essential to assess the treatment response. The resolution of the symptoms and weight gain are important elements for monitoring response to treatment.

9.4.2 Bacteriological examinations

For EPTB, sputum smears are only performed if the patient develops pulmonary signs.

Patients with PTB should have their sputum examined as follows:

Smears at the end of intensive phase

All PTB (smear-positive and smear-negative) should have sputum smear performed at the end of Month 2 (new patients) or end of Month 3 (retreatment patients).

If the smear is negative, start the continuation phase.

If the smear is positive:

Xpert available

Evaluate for resistance to rifampicin:

Xpert RIF−: start continuation phase with first-line anti-TB drugs for one month then repeat smear.

Xpert RIF+: switch to empiric MDR regimen (Chapter 10), perform culture and DST and adapt treatment accordingly.


Xpert
not available

Initially smear-positive patients:
Start continuation phase, repeat smear one month later. In most patients, sputum will test negative a month later (patients who started out with high bacillary loads may still have dead bacilli in their sputum at the end of the intensive phase but this is less likely a month later).
A patient with positive smear at Month 3 (new patients) and Month 4 (retreatment patients) should have a culture and DST performed. If clinically deteriorating, consider switching to empiric MDR treatment while waiting for DST.
If the results show a DR-TB, adapt treatment accordingly.

Initially smear-negative patients:
Suspect a treatment failure; perform culture and DST. If clinically deteriorating, consider switching to empiric MDR treatment while waiting for DST.
If the results show a DR-TB, adapt treatment accordingly.

Smears in middle of continuation phase

If smear is negative at the end of Month 4 (new patients) or at the end of Month 5 (retreatment patients), continue treatment until the end.

A positive smear at the end of Month 4 (end of Month 5 for retreatment patients) meets the standard definition of “treatment failure”.

Be careful when defining failure on the basis of microscopy alone; a positive smear might be due to the presence of dead bacilli, especially in patients who started out with a high bacillary load.

Always try to confirm the failure:
– By rapid culture;
– By clinical evaluation of the patient (if culture is not available, clinical evaluation can be sufficient).

If the culture is negative, and clinical evolution is good: a positive smear alone at Month 4 or Month 5 may not automatically indicate treatment failure. If the patient is considered highly likely not to be a failure despite the positive smear, then continue the present treatment and monitor every two weeks with clinical visits, smears and cultures, until it is determined with certainty the patient has been cured.

Xpert MTB/RIF (or other molecular methods) should not be used to monitor therapy. However it can be useful to show that a positive smear during the follow-up has rifampicin resistance, making it likely that the current therapy is not working.

End of treatment sputum examination

The sputum smear performed at the end of Month 6 (new patients) or Month 8 (retreatment patients) helps establish the final outcome of the treatment. Outcome definitions are discussed in Chapter 17.

9.4.3 Patient information and adherence interviews

The clinician who makes the diagnosis and prescribes treatment should inform the patient about his disease and its treatment. Nevertheless, this initial interview alone is not sufficient to ensure that all the information has been given and taken in.

Interviews are recommended:
– At the start of treatment: two interviews devoted to informing the patient (one for informing him/her, the second for making sure the information has been absorbed);
– At the end of the intensive phase: an interview to explain the treatment changes that accompany the change in treatment phase;
– Throughout the treatment at all consultations: an interview to help assess and encourage adherence should be performed.

See Chapter 13 for more information on adherence and patient’s support.

When there are a large number of patients, interviews devoted to treatment adherence with specially trained personnel may be justified.

9.4.4 Follow-up schedules

See reference 1

New patients on 6 month first-line regimen

Month

0

1

2

3

4

5

6

Clinical visitsa

* * *

* *

*

*

*

*

*

Bacteriological monitoringd

*


*


*b,c


*

Adherence

* * *

* *

*

*

*

*


a. If the patient’s clinical condition is not improving or deteriorating, a DST or a molecular test for resistance should be performed.
b. Smear-positivity or culture-positivity at Month 4 or later is defined as “treatment failure” and necessitates re-registration as “previously treated patient” and a change of treatment as described in Section 9.1.2.
c. It is not necessary to perform smear microscopy after Month 2 if patient was not bacteriologically confirmed at the start of treatment, smear was negative at Month 2, and patient is clinically improving.
d. Bacteriological monitoring is not needed for EPTB, except if lung involvement is suspected.

Patients on retreatment 8 month first-line regimen

Month

0

1

2

3

4

5

6

7

8

Clinical visitsa

* * *

* *

*

*

*

*

*

*

*

Bacteriological monitoringd

*



*b


*c



*

Adherence

* * *

* *

*

*

*

*

*

*

*

a. If the patient’s clinical condition is not improving or deteriorating at any time a DST or a molecular test for resistance should be performed.
b. If a positive smear microscopy is found at Month 3, a DST or a molecular test should be performed.
c. Smear- or culture-positivity at Month 5 or later is defined as treatment failure and necessitates reregistration and a change of treatment as described in Section 9.1.2.
d. Bacteriological monitoring is not needed for EPTB, except if lung involvement is suspected.