A new year gift: Child friendly drugs to cure paediatric TB

Dr Richa Sharma, CNS Correspondent, India
TB has been known to mankind since ancient times and has claimed many lives every year since then. Children form a vulnerable category for many infections and TB is no different in this regard. According to the World Health Organization (WHO), 1 million children became infected with TB in 2014 and 140,000 died because of it. Yet children remain largely neglected in this regard.

TB in children is often missed or overlooked due to non-specific symptoms and difficulties in diagnosis. This has made it difficult to assess the actual magnitude of the childhood TB epidemic, which may be higher than that currently estimated. The paucibacillary nature of paediatric TB leading to difficulty in diagnosis, perception of low prevalence and the misconception that use of BCG could prevent all forms of childhood TB, could be some of the reasons for paediatric TB receiving low priority. Then again, along with the deadly nature of the disease in children, the treatment regimen prescribed for them is very child-unfriendly and often inadequate. In the absence of fixed dose medication, the norm is to crush the bitter pills meant for adults and approximate the dosage, depending on the weight band of the child. Public health professionals have been advocating the establishment of newer modified regimens, along with introduction of innovative medicines for children to improve treatment compliance.

The difference in the pharmacokinetics of TB drugs in children varies from that in adults. Young children tend to absorb and eliminate drugs from the body at a much faster rate than adults. In cognizance of this, WHO revised the dosage guidelines for children in 2010 and recommended the fixed dose combination (FDC) medicines in 2012. However, the pharmaceutical companies failed to pick on the production of the FDCs as it did not seem to be a profitable venture for them -- mainly because the number of paediatric TB cases often is grossly underestimated, resulting in lower demand for paediatric TB drugs.

Dr Cherise P Scott, Director of Paediatric Programme at TB Alliance, said in a webinar hosted by CNS, that although the guidelines changed, the product did not change, which led providers in various countries to experiment with different ways to ensure the administration of right dosage to the affected population. The children are usually given the medicines by crushing and cutting the regular adult anti TB pills which make them bitter resulting in major adherence issues. Moreover, administration of incorrect doses can lead to poor treatment outcomes and also lead to drug resistance. Dr Scott gave the example of Philippines where they used syrups for children but it required logistics like cold chain and transport issues and was not found feasible over a longer duration.

However, now there seems to be a glimmer of hope with the recent launch of the world's first appropriate, child-friendly FDC medicines to treat children suffering from drug-sensitive TB, thanks to concerted efforts of agencies like the TB Alliance (Global Alliance for TB Drug Development), WHO, UNITAID and US Agency for International Development (USAID).These pills are dispersible in water, have a fruity palatable flavour, adhere to the correct WHO dosages and cost around USD 16 for a 6 months treatment course. With a shelf life of 2 years and no requirement of a cold chain, the introduction of this child friendly formulation, is set to revolutionize paediatric TB treatment. 

Dr Brenda Waning, Head of Global Drug Facility (Stop TB Partnership), in the webinar gave a simple answer to the question-“What’s the other half of the paediatric TB battle?”- by saying that, Now that we have the product, it just needs to be made available to children who need it, which can be done by (i) increasing awareness and demand for the product, (ii) securing substantial financing, (iii) supporting the countries to procure the available drugs and initiate treatments and maintain the market supply and demand”.

It is indeed a matter of pride for India as initially its Mumbai based Macleods pharmaceutical company will be manufacturing this new formulation to meet the global demand and expect to roll it out in early 2016. Moreover, as reported in the reputed national newspaper, The Hindu, India has made childhood TB a priority in its National Tuberculosis Control Programme and, to begin with, will pilot the introduction of these FDCs in 100 districts to make it accessible for the children who need them the most. Hopefully this will go a long way in giving respite to children suffering from drug sensitive TB by improving treatment adherence (and hence cure rates) and eliminating chances of inappropriate dosages.

Dr Richa Sharma, Citizen News Service - CNS
January 5, 2016

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