Treatment

A. Guidelines to determine the type of patient
New
A TB patient who has never had treatment for tuberculosis or has taken anti-tuberculosis drugs for less than one month.
Relapse
A TB patient who was declared cured or treatment completed by a physician, but who reports back to the health service and is now found to be sputum smear-positive.
Transferred in
A TB patient who has been received for treatment in a Tuberculosis Unit, after starting treatment in another unit where s/he has been registered.
Treatment after default
A TB patient who received anti-tuberculosis treatment for one month or more from any source and returns to treatment after having defaulted, i.e., not taken anti-TB drugs consecutively for two months or more, and is found to be sputum smear-positive.
Failure
Any TB patient who is smear-positive at 5 months or more after starting treatment. Failure also includes a patient who was treated with Category III regimen but who becomes smear-positive during treatment.
Chronic
A TB patient who remains smear-positive after completing a re-treatment regimen.
Others
TB patients who do not fit into the above mentioned types. Reasons for putting a patient in this type must be specified.

B. Record history of previous anti TB treatment
Prior to treatment categorization it is essential to elicit history of previous treatment with duration and record it in the space provided on treatment card.

C. Determine the category of treatment
Treatment is given according to categories. The information needed for categorization of a TB patient includes: disease classification; results of sputum smear examination; history of previous treatment; type of case; and severity of illness. These categories must be strictly adhered to.

Basis for the regimens in each category
Category I: This category is generally prescribed to new sputum smear-positive patients. They have a high bacillary population with higher chances of having naturally occurring drug resistant mutants. Therefore, four drugs are prescribed during the intensive phase.

Category II: These are cases who have had previous anti-tuberculosis treatment. Therefore, the chances of harboring resistant bacilli are higher. Hence, a 5 drug regimen is prescribed in the intensive phase, and the total duration of treatment is 8 months.

Category III: These are sputum smear-negative cases with a low bacillary population. There is a lower chance for drug-resistant mutants. Therefore, a 3 drug regimen is prescribed.

It is very important to elicit history of previous anti-tuberculosis treatment to help define a case; to identify patients with increased risk of acquired drug resistance; to prescribe appropriate treatment; and for epidemiological monitoring.

Severity of TB disease
The severity of the disease depends on the bacillary load, the extent of the disease, and the anatomical site of the disease. The involvement of an anatomical site helps in classifying if the disease is severe, depending on whether it is life threatening or has high risk of developing subsequent severe handicap or both. The following forms of extra-pulmonary TB are classified as “seriously ill”:

• Meningitis
• Pericarditis
• Peritonitis
• Bilateral or extensive pleural effusion
• Spinal TB with neurological involvement
• Intestinal
• Genitourinary
• Co-infection with HIV

All forms of pediatric extra-pulmonary TB other than lymph node TB and unilateral pleural effusion are considered to be seriously ill.
The following forms of smear-negative pulmonary TB are classified as seriously ill:

• Miliary TB
• Extensive parenchymal infiltration
• Co-infection with HIV
• Cavitary disease
• All forms of pediatric sputum smear negative pulmonary TB except primary complex

Any patient, pulmonary or extra-pulmonary, who is known to be HIV positive, is considered as seriously ill. As per the intensified TB-HIV package, all TB patients on DOTS are now screened for HIV status and if found positive are linked to HIV care and support along with DOTS therapy.

Under RNTCP, intermittent treatment (3 days in a week) for short duration (6 to 8 months) is used. Following are the treatment categories and drugs used

:

* The number before the letters refers to the number of months of treatment. The subscript after the letters refers to the number of doses per week. The dosage strengths are as follows: H: Isoniazid (600 mg), R: Rifampicin (450 mg), Z:Pyrazinamide (1500 mg), E: Ethambutol (1200 mg), S: Streptomycin (750 mg).
Patients who weigh 60 kg or more receive additional Rifampicin 150 mg. Patients who are more than 50 years old receive Streptomycin 500 mg. Patients who weigh less than 30 kg, receive drugs as per body weight (pediatric PWB). Patients in Categories I and II who have a positive sputum smear at the end of the initial intensive phase receive an additional month of intensive phase treatment.

** In rare and exceptional cases, patients who are sputum smear-negative or who have extra-pulmonary disease can have Relapse or Failure. This diagnosis in all such cases should always be made by an MO and should be supported by culture or histological evidence of current, active TB. In these cases, the patient should be categorized as ‘Others’ and given Category II treatment.

2. Treatment of Pediatric TB
DOTS is the recommended strategy for treatment of TB in all Pediatric TB patients. Intermittent short course chemotherapy given under direct observation, as advocated in the RNTCP, should be used in children. To assist in calculating required dosages and administration of anti-TB drugs for children, the medication are made available under RNTCP in the form of combi-packs in patient wise-boxes linked to the child’s weight.
The RNTCP regimens for pediatric TB management are the same as those used in adults.
Use of Ethambutol: As per the consensus statement for management of pediatric TB issued by the central TB division in collaboration with IAP and other professional bodies recommends the use of Ethambutol in pediatric TB management since-

• Ethambutol toxicity is generally dose related (safe in dose of 15mg/day)
• There is no confirmed report of ethambutol toxicity in children, except in some treated cases of TB meningitis (in TBM it may be replaced by SM)

Drug Doses in pediatric PWB under RNTCP: intermittent thrice weekly doses:

• Isoniazid=10–15 mg/kg
• Rifampicin=10 mg/kg
• Pyrazinamide=35 g/kg
• Streptomycin=15 mg/kg
• Ethambutol =30 mg/kg

Weight bands:

• 6 –10 kg
• 11 – 17 kg
• 18 – 25 kg
• 26 – 30 kg
• Children below 6 Kg would be treated as per drugs recommended by pediatricians.
• Children falling in between the weight bands would be treated with the lower weight band boxes

PWB Formulations:

• For the first time in the world PWBs are introduced for management of Pediatric TB
• Rifampicin is made available in tablet form
• Pediatric Patients are grouped in 4 weight bands
• Only two generic boxes developed for use across four weight bands for logistic difficulties.