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Once-daily dosing with ER nevirapine efficient, well-tolerated in pediatric patients
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Once-daily dosing with extended-release nevirapine demonstrated pharmacokinetic efficiencies in pediatric patients with HIV-1 vs. twice-daily dosing with immediate release of the drug, according to new data presented.
In a phase 1, open-label, multidose crossover study, Carlo Giaquinto, MD, from the department of pediatrics at the University of Padova, and colleagues switched 85 pediatric patients (aged 3 years and older, up to age 18 years) previously treated for 18 weeks or more with an immediate-release nevirapine to an ER version of the drug.
Patients were grouped by age (3-5, 6-11 and 12-17 years) and given the ER nevirapine based on the immediate-release version’s dose as calculated by body weight or body surface area. Patients were treated with twice-daily immediate-release nevirapine in either tablet or suspension form for 11 days, then with ER nevirapine for 10 days. ER daily doses were 200 mg, 300 mg (as 100-mg tablets) or 400 mg (as one 400-mg tablet).
Of those enrolled, 80 completed the study; 74 had steady-state concentration rates and 45 had intensive pharmacokinetic data available for analysis. The adjusted geometric mean steady-state concentration rate values for ER nevirapine and immediate-release nevirapine exceeded the target steady-state concentration rates (4,149 ng/mL and 4,518 ng/mL, respectively). The adjusted geometric mean ER to immediate-release ratios for daily dose normalized and un-normalized steady-state concentration rates were 91.2% (90% CI, 83-100) and 91.8% (90% CI, 84-101). Adjusted geometric mean 24-hour area under curve ER to immediate-release ratio for un-normalized dose was 90.3% (90% CI, 82-99); un-normalized steady-state concentration rate ER to immediate-release ratios were 91% for the 3- to 5-year-old group, 81.8% for the 6- to 11-year-old group and 103.7% for the 12- to 17-year-old group.
Adverse events, including infections, occurred in 47% of patients with ER and 28.2% with immediate release; these were mild in intensity and were similar between age groups.
For more information:
- Giaquinto C. Abstract #716.
Disclosure: Dr. Giaquinto reports no relevant financial disclosures.