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Flavored levofloxacin more easily accepted by children with MDR-TB
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An orange-peppermint flavored, dispersible levofloxacin tablet was reported to be more palatable and easier to prepare by caregivers of children with multidrug-resistant tuberculosis, according to research published in The Pediatric Infectious Disease Journal. The researchers said the new formulation may be more acceptable for young children and improve adherence.
“Levofloxacin is one of the best anti-tuberculosis drugs currently available, and it is vitally important to have this drug available in a formulation that is palatable and easy to dose for young children,” study researcher Susan E. Purchase, MD, from the department of pediatrics and child health at Stellenbosch University and the Desmond Tutu TB Centre in South Africa, told Infectious Disease News. “Child-friendly formulations are likely to help children and their caregivers adhere better to anti-tuberculosis treatment.”
Children aged younger than 5 years in Cape Town, South Africa, who were exposed to a household contact with multidrug-resistant (MDR) TB were given standard care, which included an adult dose of levofloxacin (250 mg), ethambutol and high-dose isoniazid. When children enrolled in the study, the standard of care was interrupted, and the patients received a weight-balanced dose (15 mg/kg to 20 mg/kg) of the dispersible levofloxacin formulation.
The researchers evaluated the dispersible drug’s acceptability among children at follow-up visits 7 to 14 days after enrollment.
All 27 patients (median age, 1.9 years) were uninfected by HIV and clinically well at enrollment. Most children (85%) were able to take the full dose of the medication or swallowed it with only “minimal spillage,” the researchers said. The dose was refused by 12% of children, and 4% spat out the dose.
Most caregivers (93%) administered the medication dissolved in water at home, but one child swallowed the tablet whole and one child was administered the medication crushed into food.
Nearly all caregivers reported that the tablet size (82%) and volume of dispersion (93%) were acceptable. Additionally, caregivers reported that the flavor-masked medication was more palatable (69%) and easier to prepare (81%) than adult levofloxacin formulations.
“The levofloxacin 100-mg dispersible formulation is already WHO prequalified,” Purchase said. “Seventeen countries have received the formulation and will use them early this year. We hope this new formulation will be used more widely, especially if ongoing randomized controlled trials find that levofloxacin is effective and safe in preventing disease in child contacts of adults with MDR-TB.” – by Katherine Bortz
- Reference:
- Purchase SE, et al. Pediatr Infect Dis J. 2019;doi:10.1097/INF.0000000000002268.
Disclosures: The authors report no relevant financial disclosures.
Perspective
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Jeffrey R. Starke, MD
The treatment of TB infection and disease in children has been hampered significantly by the lack of child-friendly drug formulations for children. Because TB is considered an “orphan disease,” adequate pharmacokinetic (PK) studies in children and the development of pediatric formulations have not been required for TB drug licensing. As a result, children have been treated with pills and capsules that were designed for use in adults, which are often crushed or put into suspensions with unknown PK characteristics.
Imagine having to administer four different kinds of anti-TB pills and capsules designed for adults to a 2-year-old child every day. I have always admired the families of my patients who have been able to successfully complete TB therapy for their children.
In 2015, the TB Alliance and its partners developed child-friendly, dispersible, fixed-dose combination medications containing isoniazid, rifampicin and pyrazinamide for treating drug-susceptible TB. These formulations are being distributed all over the world and are having a large impact on treatment adherence and completion for children.
A 2016 modelling study estimated that in 2014, 25,000 children developed MDR-TB and 1,200 developed extensively drug-resistant (XDR) TB. An estimated 2 million children have MDR-TB infection and 100,000 have XDR-TB infection worldwide.
Levofloxacin is a particularly important drug to target for child-friendly formulations as it is part of the bulwark of treatment for MDR-TB disease and is the recommended drug for treatment of MDR-TB infection to prevent progression to disease, which is especially important for young children.
This South African study showed a high rate of acceptance and acceptability of a dispersible formulation of levofloxacin among 27 children with a median age of 1.9 years. This study, along with the pre-marketing studies conducted by the TB Alliance, have established a standard for testing the acceptability of child-friendly TB drug formulations in children. It is critical that all manufacturers of anti-TB drugs developed in the future be required to provide child-friendly formulations that have undergone this type of evaluation.
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