Switching children previously exposed to nevirapine to nevirapine-based treatment after initial suppression with a protease-inhibitor-based regimen: Long-term follow-up of a randomised, open-label trial

The Lancet Infectious Diseases

Volumn 12, Issue 7, 2012, Pages 521-530

  Kuhn, Louise ^a   Coovadia, Ashraf ^d   Strehlau, Renate ^d   Martens, Leigh ^d   Hu, Chih Chi ^b   Meyers, Tammy ^e   Sherman, Gayle ^d,f   Hunt, Gillian ^g   Persaud, Deborah ^h   Morris, Lynn ^g   Tsai, Wei Yann ^b   Abrams, Elaine J ^c  

^a Vagelos College of Physicians and Surgeons   (United States)

^b College of Physicians and Surgeons Columbia University ^*  (United States)

^c Department of Medicine   (United States)

^d UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^e UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^f NATIONAL HEALTH LABORATORY SERVICE   (South Africa)

^g NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES   (South Africa)

^h JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; RITONAVIR; STAVUDINE; VIRUS RNA;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CAUSE OF DEATH; CD4 LYMPHOCYTE COUNT; CHILD; CONTROLLED STUDY; DRUG EXPOSURE; DRUG SUBSTITUTION; FEMALE; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PATIENT COMPLIANCE; PREMEDICATION; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOUTH AFRICA; VIREMIA; VIRUS LOAD; VIRUS REPLICATION;

ALANINE TRANSAMINASE; ANTI-HIV AGENTS; BODY HEIGHT; BODY WEIGHT; CHI-SQUARE DISTRIBUTION; CHILD, PRESCHOOL; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; INFANT; KAPLAN-MEIER ESTIMATE; LOPINAVIR; MALE; MEDICATION ADHERENCE; NEVIRAPINE; RITONAVIR; STATISTICS, NONPARAMETRIC; TIME FACTORS; VIRAL LOAD;

EID: 84862760166     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(12)70051-8     Document Type: Article

References (34)

1. Report of the WHO Technical Reference Group, Paediatric HIV/ART Care Guideline Group Meeting WHO, (accessed Aug 31, 2008). http://www.who.int/hiv/pub/paediatric/WHO_Paediatric_ART_guideline_rev_mreport_2008.pdf.
2. Eshleman SH, Mracna M, Guay LA, et al. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS 2001, 15:1951-1957.
3. Lockman S, Shapiro RL, Smeaton LM, et al. Response to antiretroviral therapy after a single, peripartum dose of nevirapine. N Engl J Med 2007, 356:135-147.
4. Palumbo P, Lindsey JC, Hughes MD, et al. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med 2010, 363:1510-1520.
5. Palumbo P, Violari A, Lindsey J, et al. NVP- vs LPV/r-based ART among HIV+ infants in resource-limited settings: the IMPAACT P1060 trial. 18th Conference on Retroviruses and Opportunistic Infections; Boston, MA, USA; Feb 27-Mar 2, 2011. Abstract 129LB.
6. Violari A, Cotton MF, Gibb DM, et al. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med 2008, 359:2233-2244.
7. Sohn AH, Nuttall JJC, Zhang F Sequencing of antiretroviral therapy in children in low- and middle-income countries. Curr Opin HIV AIDS 2010, 5:54-60.
8. Davies MA, Boulle A, Fakir T, Nuttall J, Eley B Adherence to antiretroviral therapy in young children in Cape Town, South Africa, measured by medication return and caregiver self-report: a prospective cohort study. BMC Pediatr 2008, 8:34.
9. McComsey GA, Leonard E Metabolic complications of HIV therapy in children. AIDS 2004, 18:1753-1768.
10. Aldrovandi GM, Lindsey JC, Jacobson DL, et al. Morphologic and metabolic abnormalities in vertically HIV-infected children and youth. AIDS 2009, 23:661-672.
11. Bitnun A, Sochett E, Babyn P, et al. Serum lipids, glucose homeostasis and abdominal adipose tissue distribution in protease inhibitor-treated and naive HIV-infected children. AIDS 2003, 17:1319-1327.
12. Farley J, Gona P, Crain M, et al. Prevalence of elevated cholesterol and associated risk factors among perinatally HIV-infected children (4-19 years old) in Pediatric AIDS Clinical Trials Group 219C. J Acquir Immune Defic Syndr 2005, 38:480-487.
13. Ciaranello AL, Lockman S, Freedberg KA, et al. First-line antiretroviral therapy after single-dose nevirapine exposure in South Africa: a cost-effectiveness analysis of the OCTANE trial. AIDS 2011, 25:479-492.
14. Coovadia A, Abrams EJ, Stehlau R, et al. Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: a randomized controlled trial. JAMA 2010, 304:1082-1090.
15. Guidelines for the management of HIV-infected children 2005, Department of Health, Department of Health, Pretoria.
16. Reitz C, Coovadia A, Ko S, et al. Initial response to protease-inhibitor-based antiretroviral therapy among children less than 2 years of age in South Africa: effect of cotreatment for tuberculosis. J Infect Dis 2010, 201:1121-1131.
17. Division of AIDS table for grading the severity of adult and pediatric adverse events version 1.0, December, 2004; clarification august 2009 DAIDS, (accessed March 8, 2012). http://rsc.tech-res.com/Document/safetyandpharmacovigilance/Table_for_Grading_Severity_of_Adult_Pediatric_Adverse_Events.pdf.
18. Child growth standards: WHO anthro 2005 software and macros WHO, (accessed March 8, 2012). http://www.who.int/childgrowth/software/en/.
19. Hunt GM, Coovadia A, Abrams EJ, et al. HIV-1 drug resistance at antiretroviral treatment initiation in children previously exposed to single-dose nevirapine. AIDS 2011, 25:1461-1469.
20. Moorthy A, Kuhn L, Coovadia A, et al. Induction therapy with protease-inhibitors modifies the effect of nevirapine resistance on virologic response to nevirapine-based HAART in children. Clin Infect Dis 2011, 52:514-521.
21. Hammer SM, Eron JJ, Reiss P, et al. Antiretroviral treatment of adult HIV infection: 2008 recommendations of the international AIDS society-USA panel. JAMA 2008, 300:555-570.
22. Fleiss JL Statistical methods for rates and proportions 1981, Wiley, New York, NY. 2nd edn.
23. Schneider K, Puthanakit T, Kerr S, et al. Economic evaluation of monitoring virologic responses to antiretroviral therapy in HIV-infected children in resource-limited settings. AIDS 2011, 25:1143-1151.
24. Walker AS, Gibb DM Monitoring of highly active antiretroviral therapy in HIV infection. Curr Opin Infect Dis 2011, 24:27-33.
25. Keiser O, Chi BH, Gsponer T, et al. Outcomes of antiretroviral treatment in programmes with and without routine viral load monitoring in southern Africa. AIDS 2011, 25:1761-1769.
26. Babiker A, Compagnucci A, et al. First-line antiretroviral therapy with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor and switch at higher versus low viral load in HIV-infected children: an open-label, randomised phase 2/3 trial. Lancet Infect Dis 2011, 11:273-283. Castro nee Green H.
27. Turner D, Brenner BG, Routy JP, Petrella M, Wainberg MA Rationale for maintenance of the M184v resistance mutation in human immunodeficiency virus type 1 reverse transcriptase in treatment experienced patients. New Microbiol 2004, 27:31-39.
28. Cohen C Low-level viremia in HIV-1 infection: consequences and implications for switching to a new regimen. HIV Clin Trials 2009, 10:116-124.
29. Bonora S, Nicastri E, Calcagno A, et al. Ultrasensitive assessment of residual HIV viraemia in HAART-treated patients with persistently undetectable plasma HIV-RNA: a cross-sectional evaluation. J Med Virol 2009, 81:400-405.
30. Haim-Boukobza S, Morand-Joubert L, Flandre P, et al. Higher efficacy of nevirapine than efavirenz to achieve HIV-1 plasma viral load below 1 copy/mL. AIDS 2011, 25:341-344.
31. Nachman SA, Lindsey JC, Pelton S, et al. Growth in human immunodeficiency virus-infected children receiving ritonavir-containing antiretroviral therapy. Arch Pediatr Adolesc Med 2002, 156:497-503.
32. Lockman S, Hughes MD, McIntyre J, et al. Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med 2010, 363:1499-1509.
33. Mulenga V, Cook A, Walker AS, et al. Strategies for nevirapine initiation in HIV-infected children taking pediatric fixed-dose combination "baby pills" in Zambia: a randomized controlled trial. Clin Infect Dis 2010, 51:1081-1089.
34. Moorthy A, Gupta A, Bhosale R, et al. Nevirapine resistance and breast-milk HIV transmission: effects of single and extended-dose nevirapine prophylaxis in subtype C HIV-infected infants. PLoS One 2009, 4:e4096.