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TB treatment in India – New patients & previously treated

The “Standards for TB care in India” sets out how TB treatment should be provided in India. It was published in 2014 and details the TB treatment that should be provided for all patients with TB including those in special categories, such as those with TB and HIV co-infection. It does not however explain exactly how the TB treatment should be provided, as this information is given in guidelines from the Government of India (GoI)1National Strategic Plan (2012-2017) for Tuberculosis – Directorate of Health Services, Central TB Division, Ministry of Health & Family Welfare (MoHFW) Government of India, New Delhi, www.tbcindia.nic.in.

Categories of Patients

Until 2010 there were three categories of patient requiring treatment for TB.

Then in 2010, with the launch of the DOTS-Plus Guidelines (in future known as the Programmatic Management of Drug Resistant TB) TB treatment for patients with drug resistant TB started to be provided.

The categories were reorganised and in future the categories were to be:

Category 1 for the treatment of new patients
Category 2 for previously treated patients
Category 4 for patients requiring treatment for MDR TB
Category 5 for patients requiring treatment for XDR TB.

There was in future to be no treatment category 3. This page describes the TB treatment for new and previously treated patients without drug resistance (that is categories 1 & 2). There is separately more about the treatment of drug resistant TB in India (that is treatment for categories 4 & 5).

Treatment for new TB patients

All new TB patients in India should receive an internationally accepted first line treatment regimen (a regimen is the prescribed course of treatment, in this case the TB drugs) for new patients. The initial phase should consist of 2 months of the drugs Isoniazid (H), Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E). The continuation phase should consist of the three drugs Isoniazid, Rifampicin and Ethambutol given for at least four months. This is alternatively written as 2HREZ/4-6HRE.

A child watches as her mother takes her TB medications (DOTS) &#169 WHO/TBP/Gary Hampton

A child watches as her mother takes her TB medications (DOTS) © WHO/TBP/Gary Hampton

In special situations the continuation phase may be extended by three to six months. The drug dosages should be given according to the body weight of the patient.

All patients should receive their daily TB drugs under direct observation (DOTS). However, the standards say that the country program may consider intermittent (usually three times a week) dosing acceptable depending on available resources. All paediatric TB patients and all patients with HIV associated TB should be given a daily regimen under direct observation by a DOTS provider. Under DOTS (Directly Observed Therapy Short Term) the patient has to take the TB medication in front of a DOTS agent. The DOTS agent is usually a volunteer from the patient’s community, and may be a family member. DOTS does not say which drugs should be taken. DOTS applies when any TB drugs are taken with the patient being observed by a DOTS volunteer.

Fixed dose combinations

Fixed dose combinations are desirable as they simplify drug procurement and logistics and the delivery of DOTS. They may also increase adherence. Individual drug dosing should be reserved for patients with toxicities or contraindications to one or more components of the FDC. It is recommended that the treatment regimes used will consist of fixed dose combinations of four drugs (Isoniazid, Rifampicin, Pyrazinamide and Ethambutol), three drugs (Isoniazid, Rifampicin and Ethambutol) and two drugs (Isoniazid and Rifampicin).

Previously treated patients

With previously treated patients, MDR-TB or R resistance must firstly be ruled out by a quality assured test. Then if the TB patient is:
a) Returning after being lost to follow up;
b) Relapsing from their first treatment course;`
or c) They are new TB patients failing with their first treatment course,

RNTCP patient wise boxes for adult TB treatment in India

RNTCP patient wise boxes for adult TB treatment in India

they may then receive the retreatment regime 2HREZS/1HREZ/5HRE containing first line drugs, in a similar way to new TB patients but with the main difference being the addition of streptomycin to the intensive phase. This recommendation seems rather surprising, but is apparently currently under review, as the addition of a single drug to a failing regime, is usually something that should never be done with TB therapy. If a drug sensitivity test is available, then this is likely to give a better guide to what a retreatment regimen should consist of.

Patient wise boxes

The TB drugs for RNTCP patients are supplied in an individual patient wise box which contains the entire course of treatment for the patient. In each patient wise box there are two pouches. One is for the intensive phase and the other is for the continuation phase.

RNTCP patient wise child boxes for TB treatment of children in India

RNTCP patient wise child boxes for TB treatment of children in India

The patient wise boxes are colour coded. Red boxes are for new patients, sometimes referred to as category 1. Blue boxes are for previously treated patients and are sometimes referred to as category 2. For paediatric TB patients separate patient wise boxes have been developed.

Monitoring treatment response

The response to therapy in patients with pulmonary TB, both new and retreatment patients, should be monitored by follow-up sputum microscopy/culture (one specimen) at the time of completion of the intensive phase of treatment and at the end of treatment.

Major Sources for TB treatment in India

Draft 2015 report on Indian Revised National TB Control Programme from Joint Monitoring Mission www.tbonline.info/media/uploads/documents/jmmdraft2015.pdf

Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India  www.tbcindia.nic.in

Revised National Tuberculosis Control Programme Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India www.tbcindia.nic.in

Revised National Tuberculosis Control Programme National Strategic Plan 2012-2017

Standards for TB Care in India www.tbcindia.nic.in

TB India 2015 Revised National TB Control Programme Annual Status Report, New Delhi, 2015 www.tbcindia.nic.in

References

 

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1. National Strategic Plan (2012-2017) for Tuberculosis – Directorate of Health Services, Central TB Division, Ministry of Health & Family Welfare (MoHFW) Government of India, New Delhi, www.tbcindia.nic.in