PENTA 15

19

Apr, 2010

Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months.

 

Authors: Paediatric European Network for Treatment of AIDS (PENTA)

Published in: Antivir Ther. 2010;15(3):297-305.

Background Once-daily dosing of abacavir and lamivudine has been approved for adults, but paediatric data are insufficient. We conducted a pharmacokinetic study of once-daily and twice-daily abacavir and lamivudine in children aged 3-<36 months.

Methods Children with stable HIV type-1 (HIV-1) RNA levels after 12 weeks treatment with twice-daily abacavir (8 mg/kg) with or without lamivudine (4 mg/kg) underwent plasma pharmacokinetic sampling. Children then switched to once-daily abacavir (16 mg/kg) with or without lamivudine (8 mg/kg), and sampling was repeated 4 weeks later. The area under the plasma concentration-time curve over 24 h (AUC(0-24)) and the maximum concentration (C(max)) were compared using geometric mean ratios (GMRs); 90% confidence intervals (CIs) within the range of 0.80-1.25 were considered bioequivalent.

Results A total of 18 children (4, 6 and 8 in the 3-<12, 12-<24 and 24-<36 month age ranges, respectively) provided pharmacokinetic data for abacavir (17 for lamivudine). The GMR of AUC(0-24), once-daily versus twice-daily, was 1.07 (90% CI 0.92-1.23) for abacavir and 0.91 (90% CI 0.79-1.06) for lamivudine. C(max) almost doubled on once-daily versus twice-daily dosing: abacavir and lamivudine GMRs were 2.04 (90% CI 1.73-2.42) and 1.78 (90% CI 1.52-2.09), respectively. At baseline, 12, 24 and 48 weeks, 89%, 94%, 100% and 89% of children had HIV-1 RNA<400 copies/ml, respectively.

Conclusions Bioequivalence was demonstrated on AUC(0-24) between twice-daily and once-daily abacavir; very similar AUC(0-24) values were seen for twice-daily and once-daily lamivudine. Given that viral load suppression rates were maintained, these data suggest that once-daily abacavir and lamivudine might be an option for children aged 3-<36 mont

 

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19

Nov, 2009

PENTA 15: plasma pharmacokinetic study of once versus twice daily abacavir and lamivudine as part of combination antiretroviral therapy in HIV-1 infected children aged 3 to <36 months.

 

Authors: Jacqz-Aigrain, Farrelly L, Compagnucci A, Harrison L, Zhao W, Hamadache D, Welch S, Wintergerst U, Firtion G, Burger D

Published in: CROI 2009. February 8-11, 2009. Palais des Congres de Montreal, Canada , Poster S-154.

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19

Jul, 2009

PENTA 15: Once-daily abacavir and lamivudine as part of combination antiretroviral therapy to 48 weeks in HIV-1 infected children aged 3 to 36 months.

 

Authors: Zhao W, Farrelly L, Compagnucci A, Harrison L, Jacqz-Aigrain E, Hamadache D, Welch S, Wintergerst U, Burger D on behalf of the PENTA Trial Steering Committee .

Published in: 1st International Workshop on HIV Pediatrics, 17 – 18 July 2009, Cape Town, South Africa

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