A milestone in global health: Child friendly TB medicines become a reality

Shobha Shukla, CNS (Citizen News Service)
Thanks to the untiring efforts of TB Alliance (Global Alliance for TB Drug Development), and its partners: World Health Organization (WHO), UNITAID and US Agency for International Development (USAID) - the world's first appropriate, child-friendly fixed dose combination (FDC) medicines to treat children suffering from drug-sensitive TB were announced today, just ahead of the 46th Union World Conference on Lung Health in Cape Town, South Africa.

Dr Mel Spigelman, TB Alliance
Photo courtesy: TB Alliance
Initial roll-out of the new medicines, that will be manufactured by the Indian pharmaceutical company Macleods, is expected in early 2016 and would go a long way in improving treatment adherence and survival for the 1 million odd children who become ill with TB every year, with an estimated 140,000 of them dying every year.

 This new, appropriate, and child-friendly TB medication in correct doses comes in the form of a flavoured and palatable pill that dissolves in water in 12 seconds. A 6 months’ supply will cost USD 15.5 as informed by Dr Mel Spigelman, President and CEO of TB Alliance. Countries will be able to access the new medicine through the Global Drug Facility (GDF).

Calling this a historical event, Dr Mario Raviglione, Director of WHO's Global TB Programme said that, “If we are to end the TB epidemic by 2030, we must ensure that children with TB are properly diagnosed, treated and cured. Urgent action is needed to ensure these medicines reach those in need and rapidly improve child survival from TB.”
While transition from the old to new is not easy, Dr Raviglione promised that WHO will help facilitate the maximum roll out of this FDC by pre-qualifying it and putting it on its Essential Medicines List, within the next few months.

It is unfortunate that till to date there had been no appropriate first-line TB treatment designed for children. The disease is curable, with treatment consisting of multiple drugs that must be taken for a minimum of 6 months. Children need different doses of TB medicines than adults. In fact, WHO revised their guidelines for childhood TB treatment in 2010, recognizing that children need higher doses of the medicines than what they were actually receiving. Pharmaceutical companies, however, did not produce any products conforming to the new guidelines, lacking incentives and clear market information.

As of now, children with drug-sensitive TB are typically treated with multiple pills intended for adults that must be split or crushed to try to achieve an appropriate dose for a child. Splitting TB pills, not only gives the medication a bitter taste but also usually results in imprecise dosing. This can make treatment less effective, leading to poor health outcomes and the development of more difficult to treat MDR-TB in children.

Philippe Duneton, Deputy Executive Director of UNITAID lamented that there are rarely child friendly formulations, whether it be TB or other diseases. He reiterated UNITAID’s commitment to bring innovations like this to the ground. The next obstacle to overcome, according to him, is to have improved, shorter and simpler regimens for treating drug resistant TB in adults as well as in children.

The new TB medicines are the first to meet the dosage guidelines set by WHO in 2010. Each pill is a fixed dose combination (FDC) of the three most commonly used drugs to treat drug-sensitive TB (rifampicin, isoniazid, and pyrazinamide). The pills are simple for providers and parents to administer and easy for children to take. The FDCs are rifampicin + isoniazid + pyrazinamide, used for the initial 2 months of treatment, followed by 4 months of rifampicin + isoniazid. The formulations are in the process of being prequalified by WHO but are now available under the WHO’s Expert Review Panel mechanism.

Monique Davids, from Cape Town, South Africa, a mother of 4 children  shared her personal struggles as a care provider for 2 of her kids who suffered from TB. “My three-year old daughter and my infant son had TB—they were so sick and it was so difficult to give them the medication that I began to lose hope. TB is already such a long struggle for families; with these new simpler medicines, at least the treatment does not have to be such an ordeal anymore,” she said.

“I am proud to say Kenya plans to adopt these new products for our children immediately, which will greatly improve our response to treating drug-sensitive TB,” said Dr Enos Masini, National Tuberculosis Programme Manager, Kenya.

The new formulation is bound to improve treatment outcomes and save lives. However, as  Dr Mel Spigelman, President and CEO of TB Alliance conceded, this is just the beginning of the journey of making the new formulation available to those in need of it. Governments now need to put in the political commitment and investment to move fast to make them available to those who need them and help in the global fight to end TB by seeing that no child dies of TB. Together we can do it.

Shobha Shukla, CNS (Citizen News Service)
2 December 2015 
(Shobha Shukla is providing thematic coverage from the 46th Union World Conference on Lung Health in Cape Town, South Africa, with kind support from TB Alliance. Follow her on Twitter @Shobha1Shukla)