India: Much-delayed daily TB regimen to roll out by October
The much-delayed daily regimen of tuberculosis will be rolled out by the government in a phased manner across the country by October this year. The rollout of the daily drug therapy, considered a game changer in the fight against tuberculosis by experts, doctors and activists, was to be piloted under the Revised National Tuberculosis Control Programme (RNTCP) in five states by March, after a delay of roughly two years.
India is perhaps the only country in the world, still following the intermittent regimen, as against the daily therapy recommended by World Health Organisation.
At present, under the government's tuberculosis control programme, seven to eight drugs are dispensed to patients three times a week, which is not only cumbersome, but leads to adherence issues, and further development of drug resistance.
The government-run tuberculosis control programme has been following a drug regimen of three drug-days a week, while all private sector physicians preferred to put their patients on a daily drug regimen of tailor-made drug combinations and dosages. The Revised National TB Control Programme recognised the need for daily fixed dose combination (FDC) regimen for treatment of drug-sensitive TB, and had announced the pilot in the most vulnerable five states in December 2014. A fixed dose combination (FDC) is a combination of two or more drugs in a fixed dose, particularly useful for treating ailments like HIV and TB, where the pill burden is high.
Saying the roll-out of the daily regimen was delayed due to "technical" issues, official sources added that it would be implemented by the fourth quarter this year.
Industry sources say the roll-out of the fixed dose regimen has been delayed due to procurement of medicines, resulting in the drug tender being scrapped.
A fresh tender has been recently floated and the procurement issue will be resolved soon, sources added.
"The delay has been caused by the mismanagement of the procurement and tendering process for essential medicines particularly to treat TB and HIV, despite the availability of affordable medicines", a patient group, Delhi Network of Positive People, said in a recent letter to the health minister.
Madhukar Pai, Canada Research Chair in Epidemiology , and associate director, McGill International TB Centre, said, "Daily TB regimens offer the highest cure rates and fixed dose combinations (FDCs) reduce the chance of patients missing doses. So, WHO recommends daily FDCs as the best treatment option, and many countries are implementing this. India should implement daily FDCs, along with the necessary adherence support mechanisms (eg 99DOTS), at the earliest to improve outcomes for patients in the country. RNTCP and the Ministry of Health and Family Welfare must resolve procurement issues and ensure a good supply chain for daily FDCs".
99DOTS is a low-cost, low tech method that could be useful to improve TB treatment completion, where patients make a free call each time they take their medication, so that providers can monitor adherence records. The calls are toll-free, so patients do not have any additional costs.
While it is understood that "daily FDCs will be rolled out for HIV positive people across the country by July as the tender is in process. Also, these will be made available for paediatric cases as well", according to Paul Lhungdim, president, The Delhi Network of Positive People.
With almost 120,000 HIV-associated TB cases emerging annually in India, FDCs need to be rolled out in a majority of HIV treatment centres across the country . Also, dispersible paediatric FDCs or the newly introduced flavoured syrups need to be procured and scaled up, for treating kids suffering from TB. While RNTCP has taken some steps towards adopting daily FDC regimen for drug-sensitive TB treatment, concrete steps need to be taken towards implementing the recommended changes, experts say .
Mario Raviglione director Global TB Programme, World Health Organization told TOI, "Like all member states of WHO which signed the new End TB Strategy resolution in May 2014, India needs to scale up. This underlines a few crucial points: Ensure that the epidemic is properly mapped and risk groups vulnerable populations geographical settings with high burden are prioritised for early detection; provision of universal drug susceptibility testing which is now feasible using the Xpert technology; appropriate treatment of all cases including MDR-TB and children, and prophylaxis for people at high risk.
"Of course, all these on top of proper basic elements of TB care and control: Diagnosis using rapid tests as much as possible, standard treatment with supervision and support, and having medicines where they are needed. A special effort is that related to engaging the private sector, which proves to be a challenge everywhere but also a great opportunity," he said.
Source: The Times of India
