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The Safety and Antiviral Effect of Protease Inhibitors in Children
Author(s) -
Temple Mary E.,
Koranyi Katalin I.,
Nahata Milap C.
Publication year - 2001
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.21.3.287.34202
Subject(s) - nelfinavir , saquinavir , indinavir , ritonavir , medicine , protease inhibitor (pharmacology) , adverse effect , pharmacology , lamivudine , gastroenterology , viral load , sida , virology , viral disease , human immunodeficiency virus (hiv) , virus , antiretroviral therapy , hepatitis b virus
Study Objective. To determine the safety and antiviral effect of protease inhibitors (PIs) over 36 months in pediatric patients infected with the human immunodeficiency virus (HIV). Design. Observational study. Setting. Pediatric immunodeficiency clinic. Patients. Twenty‐one children. Intervention. Demographics, dosage regimens, genotype data, viral RNA and CD4 + lymphocyte counts, adverse drug events (ADEs), laboratory tests, and compliance were evaluated over 3 years. Data were analyzed by X 2 , repeated measures analysis of variance, and paired t tests. Measurements and Main Results. Twenty‐one pediatric patients (aged 3 mo–15 yrs) received PIs over the study period. Average daily doses were ritonavir 26 mg/kg in 12 patients, nelfinavir 94 mg/kg in 16, indinavir 49 mg/kg in 5, and saquinavir 43 mg/kg in 4. Five patients developed resistance to an existing PI. Overall compliance was 70%. Baseline HIV‐1 RNA plasma concentrations were significantly higher than average follow‐up concentrations during 3–36 months in patients taking ritonavir (p<0.001) and nelfinavir (p<0.001). Sample size was insufficient for indinavir or saquinavir. Sixty ADEs occurred, diarrhea being most common. Of patients with ADEs, 55% required increased monitoring and 43% treatment. Ritonavir was associated with the most ADEs (28), followed by nelfinavir (16), indinavir (11), and saquinavir (5). Significant increases between baseline and follow‐up cholesterol levels were found with ritonavir (p=0.02) and nelfinavir (p=0.001), and for serum creatinine (p=0.02) and triglycerides (p=0.02) with ritonavir. Follow‐up triglycerides were significantly higher than baseline for indinavir (p=0.003). Conclusion. Nelfinavir and ritonavir were effective in decreasing HIV‐1 viral loads and improving CD4 + lymphocyte counts. Ritonavir was associated with more ADEs than other PIs. Changes in cholesterol, serum creatinine, and triglycerides were noted with some PIs.