The pharmacokinetics and acceptability of lopinavir/ritonavir minitab sprinkles, tablets and syrups in African HIV-infected children

Abstract

Background: Guidelines recommend lopinavir/ritonavir (LPV/r) as first- and second-line therapy for young and older HIV-infected children, respectively. Available formulations have limitations making their widespread use complex

Methods: An open-label, comparative-bioavailability (randomized cross-over) study compared a novel twice-daily minitab sprinkle formulation (40mg/10mg, Cipla Pharmaceuticals) versus innovator syrup in HIV-infected Ugandan infants 3-
Results: 77 infants/children were included in cohort-A(n=19)/B(n=26)/C(n=32). Among 132 evaluable pharmacokinetic profiles, there were 13/21/25 within-child comparisons in cohort-A/B/C. For minitabs versus syrup, geometric mean (GM)(95%CI) AUC0-12h was 88.6(66.7-117.6) versus 77.6(49.5-121.5) h.mg/L in cohort-A (ratio(GMR)(90%CI)=1.14 (0.71-1.85)) and 138.7 (118.2-162.6) versus 109.1 (93.7-127.1) h.mg/L in cohort-B (GMR(90%CI)=1.27 (1.10-1.46)). For minitabs versus tablets, GM(95%CI) AUC0-12h was 83.1(66.7-103.5) versus 115.6(103.0-129.7) h.mg/L; GMR(90%CI)=0.72(0.60-0.86). Subtherapeutic levels (
Conclusions: LPV/r exposure from minitabs was comparable with syrup, but lower than tablets, with no significant differences in subtherapeutic concentrations. Minitabs were more acceptable than syrups for younger children, but older children preferred tablets.

Citation

Musiime, V.; Fillekes, Q.; Kekitiinwa, A.; Kendall, L.; Keishanyu, R.; Namuddu, R.; Young, N.; Opilo, W.; Lallemant, M.; Walker, A.S.; Burger, D.; Gibb, D.M. The pharmacokinetics and acceptability of lopinavir/ritonavir minitab sprinkles, tablets and syrups in African HIV-infected children. JAIDS Journal of Acquired Immune Deficiency Syndromes (2014) : [DOI: 10.1097/QAI.0000000000000135]

The pharmacokinetics and acceptability of lopinavir/ritonavir minitab sprinkles, tablets and syrups in African HIV-infected children

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.