Maternal and nenonatal tenofovir and emtricitabine to prevent vertical transmission of HIV-1: tolerance and resistance.
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.


METHODS
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.


CONCLUSIONS
The combination of TDF/FTC to delivering women and their neonates appears well tolerated and to minimize the occurrence of nevirapine viral resistance.
INSERM U897, Universite´ Victor Segalen Bordeaux 2, 33076 Bordeaux Cedex, France. elise.arrive@isped.u-bordeaux2.fr
Arrivé
Elise
E
Chaix
Marie-Laure
ML
Nerrienet
Eric
E
Blanche
Stéphane
S
Rouzioux
Christine
C
Avit
Divine
D
Kruy
Leang Sim
LS
McIntyre
James
J
Say
Leakhena
L
Gray
Glenda
G
Ekouévi
Didier K
DK
Dabis
François
F
D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D002160:Cambodia / Q000453:epidemiology; D007560:Cote d'Ivoire / Q000453:epidemiology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission / Q000821:virology; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D063065:Organophosphonates / Q000008:administration & dosage*; D011247:Pregnancy; D012367:RNA, Viral / Q000187:drug effects*; D013019:South Africa / Q000453:epidemiology; D000068698:Tenofovir; D019562:Viral Load
D000998:Antiviral Agents; D063065:Organophosphonates; D012367:RNA, Viral; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine