Document Detail

Early virological suppression with three-class antiretroviral therapy in HIV-infected African infants.
MedLine Citation:
PMID:  18580613     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: Infants infected with HIV-1 perinatally despite single-dose nevirapine progress rapidly. Data on treatment outcome in sub-Saharan African infants exposed to single-dose nevirapine are urgently required. This feasibility study addresses efficacy of infant antiretroviral therapy in this setting.
METHODS: HIV-infected infants in Durban, South Africa, received randomized immediate or deferred (when CD4 cell count reached <20%) four-drug antiretroviral therapy (zidovudine/lamivudine/nelfinavir/nevirapine). Genotyping for non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance was undertaken pre-antiretroviral therapy. Monthly follow-up to 1-year post-antiretroviral therapy included viral load, CD4 cell count and verbal/measured adherence monitoring.
RESULTS: All 63 infants were exposed to single-dose nevirapine. Twenty-one out of 51 (39%) infants with baseline genotyping results had NNRTI resistance (most frequently Y181C; 20%). Forty-three infants were randomized to immediate antiretroviral therapy (ART): three withdrew pre-antiretroviral therapy; 36 out of 40 completed 1-year of ART. Twenty infants received deferred ART: 17 reached CD4 cell counts less than 20% (median d99) and 13 out of 17 started antiretroviral therapy in year 1. Verbal and measured adherence was 99% and 95%, respectively. One-year post-ART, 49 out of 49 (100%) infants had a viral load less than 400 copies/ml; 46 out of 49 (94%) had viral load less than 50 copies/ml. Ten infants (20%) required second-line ART due to virological failure or tuberculosis treatment, therefore 39 out of 49 (80%) achieved viral load less than 400 copies/ml by intention-to-treat. Time to viral load less than 50 copies/ml correlated with maternal CD4 cell count (r = -0.42; P = 0.005) and infant pre-ART viral load (r = 0.64; P < 0.001). NNRTI mutations had no significant effect on virological suppression. Infants starting immediate compared with deferred ART had fewer illness episodes (P = 0.003), but no significant difference in virological suppression.
CONCLUSION: Excellent adherence and virological suppression are achievable in infants, despite high-frequency NNRTI mutations and rapid disease progression. Infants remain relatively neglected in roll-out programmes and ART provision must be expanded.
Andrew Prendergast; Wendy Mphatswe; Gareth Tudor-Williams; Mpho Rakgotho; Visva Pillay; Christina Thobakgale; Noel McCarthy; Lynn Morris; Bruce D Walker; Philip Goulder
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  AIDS (London, England)     Volume:  22     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2008 Jul 
Date Detail:
Created Date:  2008-06-26     Completed Date:  2008-08-21     Revised Date:  2014-02-19    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  1333-43     Citation Subset:  IM; X    
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MeSH Terms
Anti-HIV Agents / administration & dosage*,  therapeutic use
Antiretroviral Therapy, Highly Active / methods
CD4 Lymphocyte Count
Drug Administration Schedule
Drug Resistance, Viral / genetics
Feasibility Studies
HIV Infections / drug therapy*,  immunology,  transmission,  virology
HIV-1* / drug effects,  genetics
Infant, Newborn
Infectious Disease Transmission, Vertical
Nevirapine / therapeutic use
Patient Compliance
Pilot Projects
Pregnancy Complications, Infectious
Socioeconomic Factors
Treatment Outcome
Viral Load
Grant Support
2R01-AI-46995/AI/NIAID NIH HHS; G0500384//Medical Research Council; R37 AI067073/AI/NIAID NIH HHS; U62/CCU022901-1//PHS HHS; //Wellcome Trust
Reg. No./Substance:
0/Anti-HIV Agents; 99DK7FVK1H/Nevirapine
Comment In:
Expert Rev Anti Infect Ther. 2008 Oct;6(5):585-9   [PMID:  18847398 ]
AIDS. 2008 Jul 11;22(11):1365-8   [PMID:  18580616 ]

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