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Session 126 Poster Abstracts
Antiretroviral Therapy in Pregnant Women
Monday, 1:30 - 3:30 pm
Poster Hall


920
Tolerance, Safety, and Efficacy of Highly Active Antiretroviral Therapy in HIV-infected Pregnant Women in the Netherlands from January 1997 to June 2003
M van der Ende*1, C Tempelmans1, S Timmermans1, J Dieleman1, M Godfried2, J Nellen2, K Boer2, H Sprenger3, M Schneider4, R Kauffmann5, J Jutman6, and R Vriesendorp7
1Erasmus Med. Ctr., Rotterdam, The Netherlands; 2Academic Med. Ctr., Amsterdam, The Netherlands; 3AZG, Groningen, The Netherlands; 4UMCU, Utrecht, The Netherlands; 5Leyenburg Hosp., The Hague, The Netherlands; 6St. Elisabeth Ziekenhuis, Tilburg, The Netherlands; and 7MC Haaglanden, The Hague, The Netherlands

Background:  The success of HAART inspires many HIV-infected women to become pregnant. The potential impact of HAART on the women, the foetus, and the infant during pregnancy is still poorly understood. 

Methods: From January 1997 to June 2003 we identified HIV-positive pregnant women.  Women were included when they received at least a triple drug regimen and gave birth at 20 or more weeks of gestation. Data were obtained from medical records in 15 HIV-specialized centers in the Netherlands. The Pearson chi-squared test was used to test the differences between the various combinations of HAART. 

Results:  Of 420 identified pregnant women, 267 met the inclusion criteria of the study. The median age was 28 years. Most women (n = 199,75%) were antiretroviral naïve. They started HAART in the 21st to the 28th week of gestation, and used this for 13.3 weeks (1 to 29). The 2 most frequently prescribed regimens contained either nelfinavir (NFV, n = 153, 57%) or nevirapine (NVP, n = 82, 31%). Gastrointestinal side effects were observed more often in NFV then in NVP users (20% and 2%) (p = <0.001). Rash was reported in 6/58 naïve NVP users (10%), as opposed to none in the NFV group (p <0.001). Hepatotoxicity was observed more frequently in the NVP group (22%) then in the NFV group ( 5%), and more often in HAART-naïve compared to HAART-experienced women (20% and 9%) (p = 0.001). Stopping and switching HAART due to side effects occurred in 14% of the NVP and 5% of the NFV users. The efficacy of HAART, HIV-RNA <500 copies/mL before delivery, was similar in both groups (83,5%). Elective caesarean section was performed in 54 women (20.2%), secondary caesarean section in 73 women (27.3%). Prematurity, small and very small for gestational age occurred in 13.9%, 6.7%, and 4%, and did not differ between the NFV and the NVP group. Two infants (0.7%) were HIV-infected. Three pregnancies resulted in 4 stillborns. Two neonates died after delivery, 1 with congenital disorders, possibly due to HAART. 

Conclusions: HAART regimens containing NVP or NFV in HIV-infected pregnant women are safe, well tolerated, and efficacious. Regular monitoring of liver enzymes should be performed when NVP is used. The percentage of vertical transmission is <1%. The percentage of caesarean section is 47%. The rate of prematurity, small and very small for gestational age does not differ between the NFV and NVP group.

Keywords: HAART; vertical transmission; pregnancy