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Shortened regimen for MDR-TB shows good results for children
Lesley Odendal, 2016-07-18 20:30:00

The use of the shortened 9-month treatment regimen for multidrug-resistant tuberculosis (MDR-TB), known as the ‘Bangladesh regimen’ has shown to be successful in 83% of children and adolescents diagnosed with rifampicin-resistant (RR) TB.

The findings were presented at TB2016, a two-day pre-meeting focused on the intersection between TB and HIV in the run up to the 21st International AIDS Conference in Durban, South Africa.

A second study presented at the meeting showed that the antibiotic levofloxacin can be used to treat MDR-TB in children.

TB treatment for children remains a neglected area, especially the diagnosis and treatment of drug-resistant TB (DR-TB) in children. Challenges include a lack of research in TB in children, a lack of proper dosing recommendations and formulations for children, a high cost of treatment and a growing gap in access to treatment for children each year. Treatment regimens for children also take up to two years, creating the need for research in shorter regimens for children.

The shortened regimen for children study was conducted during the inclusion period of an observational study conducted among adults in nine African countries (Benin, Burkina Faso, Burundi, Cameroon, Côte d'Ivoire, Niger, Central African Republic, Democratic Republic of Congo and Rwanda), according to findings presented by Bassirou Souleymane from Action Damien Niger.

“The regimen for treatment of multidrug-resistant tuberculosis (MDR-TB) has been more than 80% effective in adults in different settings, but its effectiveness and tolerance in children/adolescents is poorly documented, in the context of few effective treatment options for children with TB,” said Souleymane. The nine-month regimen had been shown to cure 82% of cases in adults in an African study, presented at the 46th Union World Conference on Lung Health in 2015.

Treatment was successful in 83% (56% cured, 27% treatment completed), of the 48 children (less than 18 years of age) that were started on treatment with the Bangladesh regimen. Twenty-three (48%) were girls, 5 (10%) were aged 0-9 years, 9 were (19%) HIV-positive, and 30 had been (63%) previously treated for TB.

There was no significant difference in successful treatment outcomes by age (85% in 15 to 17 year-olds vs 80% in 0 to 9 and 10 to 15 year-old children, p < 0.05). The case fatality rate was higher among children living with HIV (22% vs 5% in HIV-negative children), but treatment success was similar according to HIV status among surviving children (100% vs 92%). Adverse events were reported in 62% of the children, none of which was severe. Among 24 children assessed after treatment termination, 21 were alive with confirmed treatment success, two had died and one had recurrence.

The Bangladesh regimen is made up of four months of kanamycin, moxifloxacin, prothionamide, isoniazid, clofazamine, ethambutol, and pyrazinamide (abbreviated as 4Km Mfx Pto H Cfz E Z), followed by five months of moxifloxacin, clofazamine, ethambutol and pyrazinamide (5 Mfx Cfz E Z).

“Treatment results of the Bangladesh regimen appear excellent in children and adolescents, regardless of their HIV status, with very limited side effects. This should encourage countries to adopt this shortened MDR-TB treatment regimen for children,” said Souleymane.