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Once-daily extended-release nevirapine effective in treatment of children with HIV-1
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Once-daily extended-release nevirapine exhibited pharmacokinetic efficiencies among children with HIV-1 vs. twice-daily immediate-release nevirapine in a recent study.
The phase 1, multidose, crossover study included 85 patients with HIV-1, aged 3 to 17 years, who were previously treated with immediate-release nevirapine (NVP; Viramune, Boehringer Ingelheim) once for at least 18 weeks. Within the study, participants received immediate-release nevirapine twice daily for 11 days and then extended-release nevirapine (NVP XR; Viramune XR, Boehringer Ingelheim) once daily for 10 days.
Researchers found 74 participants had steady-state concentration rates. The adjusted geometric mean early-release nevirapine to immediate-release nevirapine ratio for once-daily normalized and un-normalized steady-state concentration rates were 91.2% and 91.8%, respectively. Adverse events, such as rash, headache and respiratory infection, occurred in 24 patients treated with immediate-release nevirapine and 39 patients treated with extended-release nevirapine.
“This trial demonstrated that, in HIV-1 infected pediatric patients aged between 3 and less than 18 years, administration of two or three tablets of NVP XR 100 mg [once daily] or one tablet of NVP XR 400 mg QD (dependent on the individual body surface area or body weight), provides steady-state trough concentrations of NVP substantially greater than the concentration at which risk of virologic doses administered. These findings show that NVP XR is a viable, effective and convenient therapeutic option for the treatment of HIV-1 infection in children and adolescents,” study researcher Carlo Giaquinto, MD, of the University of Padua, Italy, and colleagues concluded.
Disclosure: Six of the researchers are employees of Boehringer Ingelheim Pharmaceuticals or associated companies, and six other researchers have received financial support from Boehringer Ingelheim Pharmaceuticals.
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