A paper based on a study commissioned by the World Health Organisation (WHO), and published online in the Open Access journal PLoS Medicine, has clearly vindicated India’s position on treating newly diagnosed TB patients.
“The paper clearly endorses the stand taken by RNTCP [Revised National Tuberculosis Control Programme],” said Dr. V. Kumaraswami, Director-in-Charge of Tuberculosis Research Centre, Chennai.
India has been facing much criticism for treating patients by using a different regimen, especially since it has a huge disease burden. China is only other country that follows the same regimen as India.
India and China have opted for a thrice-a-week regimen during the six-month therapy period. Most developed countries have gone in for the daily regimen.
“There was little evidence of difference in failure or relapse with daily or intermittent schedules of treatment administration,” is one of the main findings of the paper.
The study, which reviewed 57 randomised controlled trials involving 21,000 patients, was undertaken to provide WHO the much needed evidence for a revision of TB treatment guidelines.
The paper looks at newly diagnosed patients undergoing treatment for the first time. The four antibiotics used for treating such patients are rifampicin, isoniazid, ethambutol and pyrazinamide.
According to WHO’s treatment guidelines, patients can be treated either by a six-month or an eight-month regimen.
In the case of the eight-month regimen, all four antibiotics are given for the first two months, and two drugs for the remaining six months. Rifampicin is not one of the drugs given during the remaining six months. This was the option given to resource-poor countries and where DOTS implementation was difficult.
In the case of the six-month regimen, all the four drugs are administered for the first two months, and rifampicin and another antibiotic for the remaining four months. The medicines can be given either daily or thrice a week (intermittent dosing schedule) during the entire course of the therapy.
India and China are the only two countries that have opted for thrice a week regimen during the six-month regimen. Most developed countries have gone in for the daily regimen.
There were two choices given by WHO for using rifampicin. Countries could either use it throughout the six-month therapy or go for the eight-month therapy where rifampicin is given daily only during the first two months and stopped thereafter.
The paper found that there was increased risk of poor treatment outcomes and drug resistance when rifampicin was not given throughout the six-month therapy period and when it was given only during the first two months in the case of the eight-month regimen.
To revisit guidelines
According to the paper, WHO had changed the treatment guidelines from six months to eight months for the 24-high-incidence countries for newly diagnosed untreated patients.
But the evidence from the study clearly indicates that such a change was not required.
“WHO will [now] recommend only the six-month (rifampicin throughout) regimen, and the eight-month regimen will no longer be recommended,” the paper states.
There are several reasons why India chose the thrice-a-week regimen. “It is convenient, reduces the cost by more than half, and adverse reactions are less when given intermittently,” said Dr. Kumaraswami. “It also enables the implementation of DOTS.”