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14th International AIDS ConferenceBarcelona, Spain — July 7-12, 2002 |
Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. MoOrB1129
BACKGROUND: Triple drug regimens fail to suppress HIV in more than 50% of sick infants. Protease inhibitors for children have problems with adherence, pharmacodynamics, and long term toxicities. We have designed a protease-sparing combination with 4 palatable suspensions that require no food restrictions.
METHODS: The regimen is given in divided doses twice daily: zidovudine (360 mg/m2/day), lamivudine (8mg/kg/day), abacavir (16mg/kg/day) and nevirapine [NVP] (120 mg/m2/day, then 300mg/m2/day from Day 14 if no rash). Data on 17 infants treated for up to 108 weeks (median 48 weeks) are presented.
RESULTS: Median age at diagnosis = 3 months (range 0.5-39 months). Presentations: 9 PCP, 6 cytomegalovirus disease (4 had PCP also), 2 failure to thrive, 2 non-PCP pneumonia, 1 erosive tracheitis and 1 asymptomatic. Baseline median viral load = >750,000 copies/ml (>5.8 log, range 4.6 to at least 6.8 log), median CD4 count z score = -3.2 (range -0.6 to -4.4), and median weight z score = -2.46 (range -1.0 to -4.4).
2 children developed hepatitis due to NVP after 1 and 10 weeks (data excluded, on Kaletra). 3 children developed rash, but continued treatment. No cases of abacavir hypersensitivity. 1 child stopped abacavir at 14 weeks and 1 child stopped zidovudine at week 24, each due to GI intolerance (data included, on 3 drugs). The 15 children achieved undetectable VL (<400 copies) by a median of 16 weeks, and all were consistently undetectable from week 48 including 2 children with rebound at weeks 24 and 36 due to transient illness/non-adherence. CD4 counts were slower to reach normal (median = week 48). Weight z scores mirrored CD4 counts but with greater variability, the median time to reach normal weight for age = 48 weeks.
CONCLUSIONS: In a cohort of predominantly sick infants, 15 of 17 children achieved sustained viral suppression and subsequent normalisation of CD4 counts and weight for age on a twice-daily, protease-sparing 4 drug combination.
Presenting author: Gareth Tudor-Williams
1St. Mary's Hospital / Imperial College, Dept of Paediatrics, St. Mary's Hospital, London, W2 1NY, United Kingdom.
2Charité, Otto Heubner Center, Berlin, Germany.
3Hvidovre Hospital, Copenhagen, Denmark.
4John Radcliffe Hospital, Oxford, United Kingdom.
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MoOrB1129
Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.