The Standards for TB care in India sets out the TB treatment that 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.
Subsequently the Technical & Operational Guidelines for Tuberculosis Control in India 2016 was launched by the Health Minister. This document does not replace the Standards for TB Care in India. However it does update it as well as expand it. In particular it makes it clear that the Standards for TB Care in India applies to all patients including those in the private sector. This page is based on these documents.
There are two main ways to classify patients for TB treatment. The first is classifying them by the site of their disease. The second is classifying patients by their history of TB treatment.
Classification by the site of TB disease basically divides patients in two categories. This is Pulmonary TB which is TB in the lungs. There is also extra pulmonary TB which is TB involving any organ apart from the lungs.
There are three categories of patient based on their history of TB treatment. These are:
a) New TB patients – these are TB patients who have never had treatment for TB or they have taken anti TB drugs for less than one month
b) Previously treated patients – these are patients who have received one month or more of anti TB drugs in the past.
Recurrent TB cases are patients who have previously been considered as successfully treated (cured/treatment completed) and they have subsequently been micro biologically confirmed as a case of TB.
Treatment after failure patients are those who have previously been treated for TB and their treatment failed at the end of their most recent course of treatment.
Treatment after lost to follow-up is a TB patient who has previously received TB treatment for a month or more and they were declared lost to follow up in their most recent course of treatment. They have also subsequently been found to be a microbiologically confirmed TB case.
Other previously treated patients are patients who have previously been treated but whose outcome after their most recent course of treatment is unknown or undocumented.
c) Transferred in – is a TB patient who is received for treatment in a TB unit, after being registered for treatment in another TB unit.
A micro biologically confirmed TB case refers to a patient who is presumed to have TB and who has a biological specimen positive for acid fast bacilli. It is also a patient positive for TB through a quality assured Rapid Diagnostic Molecular test.
Patients can also be classified according to their drug resistance.
There is separately more about drug resistant TB in India.
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 intensive phase should consist of eight weeks 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 another sixteen weeks. This is alternatively written as 2HREZ/4 – 6HRE. There will be no need for any extension of the continuation phase.
The drug dosages should be given according to the body weight of the patient. There will be four weight band categories.
All patients should receive their daily TB drugs under direct observation (DOTS). 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 are desirable as they simplify drug procurement and logistics and the delivery of DOTS. They may also increase adherence. Individually worked out drug dosing should be reserved for patients with toxicities or contraindications to one or more components of the FDC. Fixed dose combinations of four drugs (Isoniazid, Rifampicin, Pyrazinamide and Ethambutol), three drugs (Isoniazid, Rifampicin and Ethambutol) and two drugs (Isoniazid and Rifampicin) should be available. A fixed dose combination is when two or more drugs are combined together in a single pill or tablet.
The RNTCP has since the start of providing drug treatment, only provided treatment on three days a week. In 2014 the RNTCP recognised the need for daily dosing and announced a pilot in five states in December 2014. It was however very delayed. Only years later in 2017 was the pilot finally due to start. By this time most private sector physicians were providing their patients with a daily TB drug regimen. It was said that the delay in the rollout was “due to delays in procurement of the medicines needed for treatment”.
In February 2017 the Supreme Court directed that after a period of nine months, all new patients should be administered a daily regimen of TB drugs. A TB specialist Dr Raman Kakkar sought a change in the protocol for the treatment of TB. He had claimed that the current dosage practice was “unscientific” and “improper”. It promoted relapse and generated drug resistant strains in the patients. The relapsed cases were harder to treat than first time infections.
It was subsequently said by the RNTCP that:
“Under the new daily drug regimen, TB patients will be given fixed dose combinations (FDCs) – three or four drugs in specific dosages in a single pill – on a daily basis. The drugs will also be administered in a more scientific manner, according to the patient’s weight. The biggest advantage for the patient under the new regimen will be reduced pill burden, as instead of seven tablets, patients need consume only 2 or 3 tablets, according to their weight band” Senior RNTCP officials
However, as the drug regimen goes from three times a week to daily, more monitoring of patients may be required, as with the increased doses the patients may have more side effects.
In October 2017 the health minister Malladi Krishna Rao gave TB patients in Puducherry the first TB drugs to be taken by patients on a daily basis. 1“New drug regimen for TB patients”, the Hindu, October 27, 2017, www.thehindu.com/news/cities/puducherry/new-drug-regimen-for-tb-patients/ The quantity of the drugs to be taken will also depend on the patients weight. Each patient will receive through the RNTCP a month’s supply of drugs. The patients will be supervised taking the drugs using the DOTs strategy. The daily regimen will have to be followed by patients for six to eight months.
However, it is not clear whether this is daily treatment for all TB patients or whether it is only for paediatric patients and patients with HIV TB co-infection.
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 previously treated patient as defined above, they should then receive the retreatment regime 2HREZS/1HREZ/5HRE containing first line drugs in a similar way to new TB patients. The main difference is the addition of streptomycin to the intensive phase.
It is not usual to add one TB drug to a failing regimen as this can encourage the development of resistance. But it may be considered that this is still sensible guidance as MDR-TB and rifampicin resistance will have already been excluded.
However, the effect on the patients could still be considerable. Streptomycin has to be painfully injected, and its common side effects include a loss of hearing. Difficulties arise when testing for second line drugs is not available.
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.
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.
The response to therapy in patients with pulmonary TB, both new and retreatment patients, should be monitored. This should be done 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.
RNTCP Technical and Operational Guidelines for TB Control in India 2016 www.tbcindia.nic.in
Standards for TB Care in India www.tbcindia.nic.in
RNTCP National Strategic Plan 2017 – 2025 www.tbcindia.nic.in
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|1.||↑||“New drug regimen for TB patients”, the Hindu, October 27, 2017, www.thehindu.com/news/cities/puducherry/new-drug-regimen-for-tb-patients/|