Long-term safety and efficacy of atazanavir-based therapy in HIV-infected infants, children and adolescents: The Pediatric AIDS Clinical Trials Group Protocol 1020A

Journal of Pediatric Infectious Diseases

Volumn 34, Issue 2, 2015, Pages 162-167

  Rutstein, Richard M ^a   Samson, Pearl ^b   Fenton, Terry ^b   Fletcher, Courtney V ^c   Kiser, Jennifer J ^d   Mofenson, Lynne M ^e   Smith, Elizabeth ^f   Graham, Bobbie ^g   Mathew, Marina ^h   Aldrovani, Grace ⁱ  

^a CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^d UNIVERSITY OF COLORADO   (United States)

^e NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^f EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^g FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^h BRISTOL MYERS SQUIBB   (United States)

ⁱ CHILDREN S HOSPITAL LOS ANGELES   (United States)

Author keywords

Antiretroviral treatment; Atazanavir; Pediatric HIV

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; ATAZANAVIR; BILIRUBIN; BILIRUBIN GLUCURONIDE; CHOLESTEROL; POTASSIUM; RITONAVIR; SODIUM; VIRUS RNA; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; OLIGOPEPTIDE; PYRIDINE DERIVATIVE;

ADOLESCENT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACTERIAL MENINGITIS; BILIRUBIN BLOOD LEVEL; BRADYCARDIA; CARDIOMYOPATHY; CD4 LYMPHOCYTE COUNT; CHILD; CHOLESTEROL BLOOD LEVEL; CLINICAL PROTOCOL; CONTROLLED STUDY; DRUG CAPSULE; DRUG EFFICACY; DRUG FATALITY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HEART BLOCK; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERBILIRUBINEMIA; HYPERCHOLESTEROLEMIA; IMMUNE RESPONSE; INFANT; JAUNDICE; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PLASMA; PNEUMONIA; POTASSIUM BLOOD LEVEL; POWDER; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SODIUM BLOOD LEVEL; SOUTH AFRICA; TREATMENT DURATION; TREATMENT RESPONSE; UNITED STATES; VIROLOGY; ADVERSE EFFECTS; CLINICAL TRIAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HIV INFECTIONS; PROCEDURES; TREATMENT OUTCOME; VIRUS LOAD;

ADOLESCENT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; ATAZANAVIR SULFATE; CD4 LYMPHOCYTE COUNT; CHILD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HIV INFECTIONS; HUMANS; INFANT; OLIGOPEPTIDES; PYRIDINES; SOUTH AFRICA; TREATMENT OUTCOME; UNITED STATES; VIRAL LOAD;

EID: 84925584969     PISSN: 13057707     EISSN: 13057693     Source Type: Journal    
DOI: 10.1097/INF.0000000000000538     Document Type: Article

References (31)

1. Gortmaker SL, Hughes M, Cervia J, et al Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001;345:1522-1528.
2. Patel K, Hernán MA, Williams PL, et al; Pediatric AIDS Clinical Trials Group 219/219C Study Team. Long-term effectiveness of highly active antiretroviral therapy on the survival of children and adolescents with HIV infection: a 10-year follow-up study. Clin Infect Dis. 2008;46:507-515.
3. Brady MT, Oleske JM, Williams PL, et al; Pediatric AIDS Clinical Trials Group219/219C Team. Declines in mortality rates and changes in causes of death in HIV-1-infected children during the HAART era. J Acquir Immune Defic Syndr. 2010;53:86-94.
4. Viani RM, Araneta MR, Deville JG, et al. Decrease in hospitalization and mortality rates among children with perinatally acquired HIV type 1 infection receiving highly active antiretroviral therapy. Clin Infect Dis. 2004;39:725-731.
5. Hazra R, Siberry GK, Mofenson LM. Growing up with HIV: children, adolescents, and young adults with perinatally acquired HIV infection. Annu Rev Med. 2010;61:169-185.
6. Rivas P, Morello J, Garrido C, et al. Role of atazanavir in the treatment of HIV infection. Ther Clin Risk Manag. 2009;5:99-116.
7. Molina JM, Andrade-Villanueva J, Echevarria J, et al CASTLE Study Team. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008;372:646-655.
8. Squires K, Lazzarin A, Gatell JM, et al. Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV. J Acquir Immune Defic Syndr. 2004;36:1011-1019.
9. Johnson M, Grinsztejn B, Rodriguez C, et al. 96-week comparison of oncedaily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures. AIDS. 2006;20:711-718.
10. Santoro MM, Bertoli A, Lorenzini P, et al CARe Study Group. Viroimmunologic response to ritonavir-boosted or unboosted atazanavir in a large cohort of multiply treated patients: the CARe Study. AIDS Patient Care STDS. 2008;22:7-16.
11. Cohen C, Nieto-Cisneros L, Zala C, et al; BMS AI424-043 Study Group. Comparison of atazanavir with lopinavir/ritonavir in patients with prior protease inhibitor failure: a randomized multinational trial. Curr Med Res Opin. 2005;21:1683-1692.
12. Carey D, Amin J, Boyd M, et al. Lipid profiles in HIV-infected adults receiving atazanavir and atazanavir/ritonavir: systematic review and meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2010;65:1878-1888.
13. Tsiodras S, Mantzoros C, Hammer S, et al. Effects of protease inhibitors on hyperglycemia, hyperlipidemia, and lipodystrophy: a 5-year cohort study. Arch Intern Med. 2000;160:2050-2056.
14. Malan N, Su J, Mancini M, et al CASTLE Study Team. Gastrointestinal tolerability and quality of life in antiretroviral-naive HIV-1-infected patients: data from the CASTLE study. AIDS Care. 2010;22:677-686.
15. Kiser JJ, Rutstein RM, Samson P, et al. Atazanavir and atazanavir/ritonavir pharmacokinetics in HIV-infected infants, children, and adolescents. AIDS. 2011;25:1489-1496.
16. Malan DR, Krantz E, David N, et al; 089 Study Group. Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients. J Acquir Immune Defic Syndr. 2008;47:161-167.
17. Pham PA. Drug profile: fosamprenavir (Lexiva). Hopkins HIV Rep. 2003;15:10-11.
18. Sáez-Llorens X, Violari A, Deetz CO, et al. Forty-eight-week evaluation of lopinavir/ritonavir, a new protease inhibitor, in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2003;22:216-224.
19. Johnson M, Grinsztejn B, Rodriguez C, et al. Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures. AIDS. 2005;19:153-162.
20. Blanche S, Bologna R, Cahn P, et al. Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents. AIDS. 2009;23:2005-2013.
21. Food and Drug Administration. Lexiva FDA Label. Available at http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/021548s028,022116s012 lbl.pdf. Accessed February 1, 2014.
22. Salazar JC, Cahn P, Yogev R, et al; PACTG 1051/BI Study Team. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008;22:1789-1798.
23. Kiser JJ, Fletcher CV, Flynn PM, et al Adolescent Trials Network for HIV/AIDS Interventions. Pharmacokinetics of antiretroviral regimens containing tenofovir disoproxil fumarate and atazanavir-ritonavir in adolescents and young adults with human immunodeficiency virus infection. Antimicrob Agents Chemother. 2008;52:631-637.
24. Moltó J, Santos JR, Valle M, et al. Monitoring atazanavir concentrations with boosted or unboosted regimens in HIV-infected patients in routine clinical practice. Ther Drug Monit. 2007;29:648-651.
25. Rodríguez-Nóvoa S, Martín-Carbonero L, Barreiro P, et al. Genetic factors influencing atazanavir plasma concentrations and the risk of severe hyperbilirubinemia. AIDS. 2007;21:41-46.
26. Nso Roca AP, Nso AP, Larru B, et al. HIV-infected adolescents: relationship between atazanavir plasma levels and bilirubin concentrations. J Adolesc Health. 2011;48:100-102.
27. McDonald C, Uy J, Hu W, et al. Clinical significance of hyperbilirubinemia among HIV-1-infected patients treated with atazanavir/ritonavir through 96 weeks in the CASTLE study. AIDS Patient Care STDS. 2012;26:259-264.
28. Busti AJ, Tsikouris JP, Peeters MJ, et al. A prospective evaluation of the effect of atazanavir on the QTc interval and QTc dispersion in HIV-positive patients. HIV Med. 2006;7:317-322.
29. Gianotti N, Guffanti M, Galli L, et al. Electrocardiographic changes in HIVinfected, drug-experienced patients being treated with atazanavir. AIDS. 2007;21:1648-1651.
30. Tassiopoulos K, Williams PL, Seage GR 3rd, et al; International Maternal Pediatric Adolescent AIDS Clinical Trials 219C Team. Association of hypercholesterolemia incidence with antiretroviral treatment, including protease inhibitors, among perinatally HIV-infected children. J Acquir Immune Defic Syndr. 2008;47:607-614.
31. Kim JY, Zaoutis T, Chu J, et al. Effects of highly active antiretroviral therapy (HAART) on cholesterol in HIV-1 infected children: a retrospective cohort study. Pharmacoepidemiol Drug Saf. 2009;18:589-594.