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Tytuł:
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Maternal and nenonatal tenofovir and emtricitabine to prevent vertical transmission of HIV-1: tolerance and resistance.
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Autorzy:
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Arrivé E
Chaix ML
Nerrienet E
Blanche S
Rouzioux C
Avit D
Kruy LS
McIntyre J
Say L
Gray G
Ekouévi DK
Dabis F
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Corporate Authors:
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TEmAA ANRS 12109 Study Group; INSERM U897, Universite´ Victor Segalen Bordeaux 2, 33076 Bordeaux Cedex, France.
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Źródło:
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AIDS (London, England) [AIDS] 2010 Oct 23; Vol. 24 (16), pp. 2481-8.
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Typ publikacji:
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Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: 1998- : London, England : Lippincott Williams & Wilkins
Original Publication: London : Gower Academic Journals, c1987-
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MeSH Terms:
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Adenine/*analogs & derivatives
Antiviral Agents/*administration & dosage
Deoxycytidine/*analogs & derivatives
HIV Infections/*drug therapy
Infectious Disease Transmission, Vertical/*prevention & control
Organophosphonates/*administration & dosage
RNA, Viral/*drug effects
Adenine/administration & dosage ; Adult ; Cambodia/epidemiology ; Cote d'Ivoire/epidemiology ; Deoxycytidine/administration & dosage ; Drug Therapy, Combination ; Emtricitabine ; Female ; Genotype ; HIV Infections/transmission ; HIV Infections/virology ; Humans ; Infant, Newborn ; Pregnancy ; South Africa/epidemiology ; Tenofovir ; Viral Load
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Contributed Indexing:
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Investigator: E Arrivé; ML Chaix; E Nerrienet; S Blanche; C Rouzioux; D Avit; LS Kruy; J McIntyre; L Say; G Gray; DK Ekouévi; F Dabis; F Dabis; DK Ekouévi; C Rouzioux; S Blanche; JM Treluyer; ML Chaix; E Rey; N'Dri-Yoman; LS Kruy; E Nerrienet; G Gray; J McIntyre; E Arrivé; D Hirt; S Urien; A Pruvost; G Allou; D Avit; C Amani-Bosse; G Bédikou; K Brou; P Fian; E Kanga; B Kone; S Kouadio; JE Kouakou; S Ngatchou; T Pety; Z Seoue; M Kone; L Borand; P Chou; K Chhim; ML Ek; L Say; S Hout; S Im; S Keo; V Lim; S Ngin; V Ouk; V Ung; P Duma; P Duma; S Lalsab; S Legote; J Makhura; M Maphutha; S Naidoo; M Nyati; R Panchia; BK Ngoran; K Kanal; L Morris; S Blesson; C Aubron-Olivier; G Peytavin; K Van Rompay; V Leroy; J Sullivan; P Lepage; L Mandelbrot; ML Newell; AM Taburet
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Substance Nomenclature:
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0 (Antiviral Agents)
0 (Organophosphonates)
0 (RNA, Viral)
0W860991D6 (Deoxycytidine)
99YXE507IL (Tenofovir)
G70B4ETF4S (Emtricitabine)
JAC85A2161 (Adenine)
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Entry Date(s):
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Date Created: 20100910 Date Completed: 20110325 Latest Revision: 20151119
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Update Code:
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20240104
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DOI:
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10.1097/QAD.0b013e32833e1659
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PMID:
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20827166
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Objective: Viral resistance occurs with a high frequency after single-dose nevirapine. We aimed to evaluate the tolerance and resistance profiles of a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) given to HIV-1-infected delivering women and their newborns.
Design: An open-label phase I/II trial in Cambodia, Côte d'Ivoire and South Africa.
Methods: HIV-1-infected pregnant women received zidovudine from the enrollment until the beginning of labor, when single-dose nevirapine and two tablets of TDF/FTC were given. One daily tablet of TDF/FTC was then administered for 7 days postpartum. All infants received single-dose nevirapine with single-dose TDF (13 mg/kg) and single-dose FTC (2 mg/kg) and 1 week of zidovudine. Mothers and infants were followed for 2 months. Serious adverse events, kinetic of maternal plasma HIV-1 RNA, pediatric HIV infection and genotypic resistance and viral subtype were assessed.
Results: Thirty-six HIV-1-infected pregnant women were enrolled: median age 28 years (interquartile range: 26-31 years), median CD4 cell count 462 cells/μl (interquartile range: 376-632) and median HIV-1 RNA 3.7 log10 copies/ml (interquartile range: 2.95-4.11). Two infants had clinical serious adverse events, including one who died (neonatal sepsis). One transient grade 3 neutropenia and two grade 3/4 hyperbilirubinemia were also reported in neonates. One HIV pediatric in-utero infection was diagnosed (2.8%; 95% confidence interval 0-15.4%). Genotypic viral resistance to nevirapine was detected in one mother out of 34 (2.9%) at one month postpartum, but was also detectable at enrollment.
Conclusion: The combination of TDF/FTC to delivering women and their neonates appears well tolerated and to minimize the occurrence of nevirapine viral resistance.