title: Atazanavir: in pediatric patients with HIV-1 infection.
abstract: Atazanavir is a selective and potent inhibitor of the HIV-1 protease. The drug is administered in combination with low-dose ritonavir, to boost atazanavir pharmacokinetics (i.e. ritonavir-boosted atazanavir), and other antiretroviral agents. The efficacy of once-daily ritonavir-boosted atazanavir plus background therapy (BT) in establishing virologic suppression in treatment-naive pediatric patients (aged 6 to <18 years) infected with HIV-1 was demonstrated in an ongoing, open-label, multicenter, phase I/II trial (PACTG 1020A). HIV-1 RNA levels of <50 or <400 copies/mL were achieved by the majority of patients (>70%) after 24 weeks' therapy, with these benefits maintained at week 48. Some treatment-experienced pediatric patients (aged 6 to <18 years) also achieved HIV-1 RNA levels of <50 or <400 copies/mL in the PACTG 1020A trial after 24 (≤45% of patients) and 48 (≤32%) weeks of treatment with ritonavir-boosted atazanavir plus BT, although the benefits of the regimen in this patient population appeared to be limited by as few as one or two protease inhibitor resistance mutations. Treatment-experienced pediatric patients (aged 10-19 years) infected with HIV-1 had mixed success in establishing/maintaining virologic suppression when they were switched from their current antiretroviral treatment regimen to once-daily ritonavir-boosted atazanavir plus BT in a small, single-center, observational study. However, some patients may have received atazanavir at a suboptimal dosage or had suboptimal susceptibility to BT agents. In the PACTG 1020A trial, use of atazanavir (with or without ritonavir) in pediatric patients aged 6 to <18 years was associated with a similar safety profile to that reported in adults.
authors.affiliation: Adis, Auckland, New Zealand. demail@adis.co.nz
authors.forename: Emma D
authors.initials: ED
authors.lastname: Deeks
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000293:Adolescent; D019540:Area Under Curve; D000069446:Atazanavir Sulfate; D002648:Child; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D004347:Drug Interactions; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood / Q000493:pharmacokinetics; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D015337:Multicenter Studies as Topic; D009842:Oligopeptides / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood / Q000493:pharmacokinetics; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood / Q000493:pharmacokinetics; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult
chemical_list: D017320:HIV Protease Inhibitors; D009842:Oligopeptides; D011725:Pyridines; D000069446:Atazanavir Sulfate; D019438:Ritonavir