Personalised protocol


The fight against TB may have intensified, but there are more hurdles to overcome

Since December 2011, when a paper published by Mumbai-based chest physician Dr Zarir Udwadia described four patients with TDR (totally drug-resistant) TB—leading to global attention and criticism—there has been denial, slow acceptance and much needed reforms in the revised national tuberculosis control programme (RNTCP).

Earlier this year, it was announced that several states in the country would begin the daily regimen for TB, shifting from the alternate-day DOTS (Directly Observed Treatment, Short-course) programme that was in place since 1997. New multidrug resistant tuberculosis (MDR TB) patients will now get individualised treatment through the drug sensitivity test (DST). There will be new fixed drug combinations that will reduce the number of pills TB patients have to take every day. Bedaquiline, a new tuberculosis drug that has been showing good results, is part of the RNTCP and will be distributed in six centres across the country.

Mumbai, the epicentre of the MDR TB crisis, is at the heart of these changes. The last few years saw a number of Cartridge Based Nucleic Acid Amplification Tests (CBNAATs) performed in the city, which detected rifampicin drug resistance within two hours.

The number of MDR TB patients rose immediately, but further investigations were needed to treat them correctly. “We have rolled out DST-guided treatment in Mumbai, from June 16. All new MDR patients will get a DST for 13 drugs now; earlier it was for four drugs. This is part of our process to offer individualised treatment to patients,” says Dr Daksha Shah, Mumbai’s TB officer.

DST is a culture test that takes up to six weeks to throw up results, but the good news is that the regimen for TB patients will be modified as per their own resistance pattern. This is time-saving and a life-saving change because the resistant TB pattern in the city is very complex, with resistance not only to rifampicin but also to other first and second line drugs.

In order to help the TB programme in Mumbai to deal with the challenge of treating different drug resistant cases with individual drug regimen, Medecins Sans Frontieres (MSF) has partnered with RNTCP to run a new TB out-patient department at Shatabdi Hospital, Govandi. “Along with a DST for 13 drugs, all MDR TB samples are sent for line probe assays for first-line and second-line drugs, so we can diagnose MDR, XDR and XXDR TB cases within a week and start the treatment,” says Dr Sein Sein Thi, project medical referent for MSF.

Dr Soumya Swaminathan, director general of Indian Council of Medical Research, called for greater flexibility in dealing with the disease, during a stakeholders' meeting in Mumbai. “Interventions for TB have to be locally contextualised. It is okay to have broad frameworks in the national TB programme. What works in Mumbai may not work in a tribal belt and can be modified by state TB officers.”

This was missing in the guidelines. There was focus on treating only the drug-sensitive TB cases and following the protocol, even when it does not always work.

It was due to the World Health Organization’s recommendations that an alternate regimen, which included drugs to be given thrice a week, became part of the RNTCP as part of its DOTS programme. However, the flaws of this strategy like increasing relapses and drug resistance were observed in many countries, including India. In 2007, WHO recommended daily treatment for all TB patients.

Drug-resistant tuberculosis has been rising steadily in India. On an average, there are 28,000 MDR TB patients under the RNTCP programme. Says Dr Yatin Dholakhia, secretary of Maharashtra State Anti-Tuberculosis Association, “The recommendation for daily regimen of TB drugs was made and promised in 2012 after a group of 150 experts from all over the country demanded it. It has taken a long time to be implemented.”

He says that even with the changes in the guidelines, it is often not reflected in the field. For example, he says, in spite of the guidelines, there has been no liquid culture test done in Mumbai after a patient is diagnosed with MDR TB. Since a DST culture test costs about Rs 10,000 for all 13 drugs, funds need to be allocated for the same, he adds.

Even Dr Sunil Kharpade, deputy director general of RNTCP, says there are limitations to overcome before universal DST is implemented across the country. “We need to build lab capacities first. At present, we do not have the infrastructure to do DST for all four drugs in the government sector; hence we are starting in Mumbai, where there are enough labs.”

Tuberculosis cannot be fought only with drugs and new diagnostic tools, says Dr Nerges Mistry, director of The Foundation of Medical Research, though her organisation is currently working on a genome-sequencing project of the tuberculosis bacilli to create faster, effective diagnosis.

Filthy surroundings can increase endotoxins in the environment that can affect the mucosal immunity that makes one prone to not just tuberculosis but other pulmonary diseases as well. Unless problems of sanitation, over-crowding, housing and waste management are solved, tuberculosis cannot be conquered, she says.

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