The new fixed-dose formulations for children will offer hope for the 400 children who needlessly die of TB each day
WHO and the TB Alliance have announced the availability of child-friendly tuberculosis (TB) medicines in the correct doses. The improved treatments are the first to meet the dosage guidelines set by the WHO in 2010. They are dispersible and palatable, simple to administer and affordable. The availability of these products is a result of a project largely funded by UNITAID.
According to WHO, at least one million children become ill with TB each year and 140,000 children die of this curable disease. To date, children around the world have not yet had access to appropriate TB medicines. ‘The availability of correctly dosed medications will improve treatment for children everywhere,’ said Dr Mel Spigelman, President and CEO of TB Alliance. ‘This is an important step toward ending the neglect that has characterised the care of children with TB for far too long.’
TB now ranks as the world’s leading infectious disease killer, along with HIV. The disease is curable with treatment, which consists of multiple drugs and must be taken for a minimum of 6 months. Children need different doses of TB medicines than adults. Today, for parents and care providers to approximate the correct dose for a child, they must crush or chop available drugs, and piece together the treatment regimen. Splitting TB pills, which gives the medication a bitter taste and usually results in imprecise dosing, makes the treatment journey even more difficult for children and their families.
‘No child should die of TB; yet, for too long, we have not had the medicines or the market needed to mount a sustainable response against childhood TB,’ said Mr Lelio Marmora, Executive Director of UNITAID. ‘UNITAID’s investment in addressing this problem will increase access to correctly dosed, quality-assured, affordable TB medicines for children that will help save lives.’
WHO revised their guidelines for childhood TB treatment in 2010, recognising that children need higher doses of the medicines than what they were receiving. Lacking incentives and clear market information, companies, however, did not produce any products conforming to the new guidelines.
The new TB medicines are fixed dose combinations (FDCs) of the three most commonly used drugs to treat drug-sensitive TB (rifampicin, isoniazid, and pyrazinamide). These are not new drugs, but rather improved formulations that are dissolvable and flavoured so that they are simple for providers and parents to administer and easy for children to take.
The FDCs are rifampicin + isoniazid + pyrazinamide, which is 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. TB Alliance is working with WHO, UNICEF, Management Sciences for Health and other organisations to encourage uptake in countries with high TB burdens and to reach children affected by TB at all levels or sectors of healthcare. Initial rollout of the new medicines is expected in early 2016.