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Chewable integrase inhibitor tablets helped control HIV-1 in pediatric patients
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Chewable tablets containing the integrase inhibitor raltegravir appeared to help pediatric patients aged 2 to 5 years control HIV-1, according to a poster presentation.
Sharon Nachman, MD, professor of pediatrics at Stony Brook University Medical Center in New York, and colleagues enrolled 12 HIV-1 patients, aged 2 to 5 years, in a dose-finding study with intensive pharmacokinetic and safety and virologic response. Only children with HIV RNA of more than 1,000 copies/mL and prior exposure to antiretroviral therapy, but no exposure to integrase inhibitors, were included. The median age for participants was 3 years; 67% were girls, 75% were black, and all were within 1 year of 3 years of age.
Besides their existing ART regimen, participants were given a twice-daily weight-based dosing (6 mg/kg, 300-mg dose maximum) of raltegravir (Isentress, Merck Sharp & Dohme) in a chewable tablet. The blood levels of raltegravir were tested after the children had been on raltegravir for at least 5 days. Results were compared with existing data from 6- to 18-year-old HIV patients (n=10) who received the adult formulation, and to 6- to 11-year-old HIV patients (n=10) given the chewable raltegravir tablet.
By week 12, researchers noted virologic success in 75% (95% CI, 43-95) of patients; and by week 24, 60% (95% CI, 26-88) of participants showed virologic success.
Nachman and colleagues said administering chewable tablets of raltegravir to 2- to 5-year-olds with HIV-1 appeared to be generally safe and well tolerated.
For more information:
- Nachman S. Abstract #715.
Disclosure: Dr. Nachman reports no relevant financial disclosures.