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Session 105 Poster Abstracts
Antiretroviral Pharmacokinetics during Pregnancy
Session Day and Time: Monday, 1-4 pm
Room: Hall A


627a    
Safety and Efficacy of Tenofovir in Pregnant Women
Annette Haberl*1, R Linde1, A Reitter1, P Gute2, G Knecht2, M Mosch3, T Lennemann1, G Nisius1, C Stephan1, and S Staszewski1
1Hosp of JW Goethe Univ, Frankfurt, Germany; 2Infektiologikum, Frankfurt, Germany; and 3Medical Practice, Frankfurt, Germany

Background:  The use of tenofovir (TDF) for the treatment of pregnant women is one of the most controversially discussed issues of the revised European AIDS Clinical Society (EACS) guidelines. Because of the lack of data, the EACS guidelines recommend not initiating TDF, but possibly continuing during pregnancy. Furthermore a triple NRTI combination is contra-indicated. Therefore the safety and efficacy of TDF-containing regimens in pregnancy must be assessed.

Methods:  All pregnant women from the Frankfurt HIV Cohort who had received TDF were analyzed. The main indication for TDF was zidovudine (AZT) intolerance or resistance. When the woman could not use nevirapine (CD4 >250), had poor adherence or was intolerant to protease inhibitors (PI), triple NRTI combination of TDF, AZT plus emtricitabine (FTC) or lamivudine (3TC) was initiated. The safety and efficacy during the pregnancy and the fetal outcome were analyzed.

Results:  From December 2002 until December 2007, 76 pregnant woman received TDF-containing regimens. All 78 children were delivered by caesarean section; there was no HIV transmission; no TDF-related toxicity was observed in the children; 2 women stopped TDF, because of exanthema (1) and nausea (1). The tables below summarize the data of mothers and children.

Mothers (n = 76)

Mean age (years)

32

Ethnic origin (%)

African 53, caucasian 36, Hispanic 7, others 4

AIDS (%)

12

ART-naοve (%)

68

Mean onset of TDF in pregnancy (weeks)

pregnancy week 24

ART

 

               TDF+AZT+FTC or 3TC

n = 53 (70%)

               TDF+NRTI+PI/r

n = 13 (17%)

               TDF+NRTI+NNRTI

n = 5 (6.5%)

               other

n = 5 (6.5%)

Mean baseline CD4 (cells/΅L)

384 (10–1390)

Mean baseline viral load (copies/mL)

41,970 (<40–559,000)

Mean CD4 at delivery (cells/΅L)

447 (80–1247)

Mean viral load at delivery (copies/mL)

128 (<40–1780)

Adverse events (n)

cystitis (12), early contractions (6), gestational diabetes (4), nausea (3), rupture of membranes (3), pyelonephritis (1), pre-eclampsy (1), exanthema (1)

 

Children (n=78)

Mean time of caesarean (weeks)

37 (31–40)

Mean birth weight (g)

2880 (1525–4270)

Mean intrauterine TDF exposure (weeks)

12 (1–40)

Mean follow-up (months)

20.5 (1–62)

Malformations (n)

Polydactily (3)*, diaphragm hernia (1)*, renal cyst (1)*, cardial malformation in one child with down syndrome

 

*diagnosed before the onset of TDF

Conclusions:  In our study, TDF was effective and safe. All 78 exposed children were HIV– and had no signs of TDF-related toxicity. None of the observed birth malformations was associated with TDF. Therefore, TDF should be reconsidered for mother-to-child-transmission prophylaxis.