Efficacy and safety of Truvada^®in HIV-1 pregnant women: report of 23 cases

Background

Because of its good efficacy and tolerance, the association of tenofovir and emtricitabine (Truvada^®) is recommended for treatment of naïve HIV patients by local, European and North American HIV guidelines. Despite reduced bone mineral density during preclinical studies in animals at supraclinical dosages, there is no contra-indication for young women who could become pregnant. As a consequence more and more pregnant women under Truvada^® are seen in OBGYN units. Since 2004, 125 pregnant women under tenofovir are registered in the French perinatal cohort. Therefore the question arises: continue tenofovir or not?

Methods

For all the pregnant women receiving Truvada^® seen in the OBGYN department of Lariboisière Hospital, close follow-up of the pregnancy was made through clinical, biological, test for tolerance and efficacy (monthly), and ultrasound exams. As for all HIV-exposed babies, a close exam at birth and pediatric follow-up during 2 years were scheduled.

Summary of results

23 pregnant women were enrolled between 2006 and 2008. Two had hepatitis B. Most patients were seen after the first trimester of pregnancy. Generally, Truvada^® was associated with protease inhibitor. Twenty-one women were on Truvada^® before pregnancy; for 50% of them this was the first-line treatment. Truvada^® was initiated during pregnancy, once because of severe hepatitis B, once due to to failure of previous ARV regiment. One patient experienced mild toxemia during her pregnancy. All the ultrasound exams were normal; no ARV toxicity was reported, viral loads were under 50 copies/ml. Twenty women terminated their pregnancy: one early miscarriage; two premature births at 29 and 30 weeks of gestation; 17 full-term babies; 13 vaginal deliveries; five Caesarean sections. At birth and during follow-up, clinical and biological pediatric exams of the babies were normal. All exposed babies were negative.

Conclusion

Most of the pregnancies under Truvada^® were discovered after the first trimester. In this cohort, use of Truvada^® is effective and safe; the data are in line with the guidelines which allow the continuation of this association in pregnant women.