Safety of tenofovir during pregnancy

Safety of tenofovir during pregnancy for the mother and fetus: a systematic review.

Wang L, Kourtis AP, Ellington S, Legardy-Williams J, Bulterys M. Clin Infect Dis. 2013 Dec;57(12):1773-81. doi: 10.1093/cid/cit601. Epub 2013 Sep 17.

Tenofovir disoproxil fumarate (TDF) safety during pregnancy has important public health implications. This review summarizes TDF safety during pregnancy, focusing on pregnancy outcomes, congenital anomaly risk, and other potential toxicities on neonates. Although information is limited, TDF appears to be safe during pregnancy. In 6 studies of human immunodeficiency virus type 1 (and/or hepatitis B virus)-infected women receiving TDF during pregnancy, adverse events were mild to moderate; none were considered to be TDF-related. Five studies that followed in utero TDF-exposed infants showed no increased risk of growth or bone abnormalities. One study showed slightly lower infant height at age 1 year, but the significance is unclear. The Antiretroviral Pregnancy Registry database, with 1 800 pregnancies exposed to TDF in the first trimester, does not indicate increased congenital anomaly risk with TDF exposure. More evidence collected prospectively, ideally with bone density measurements and randomized trial design, will be optimal to determine the effects of antenatal TDF exposure on children's health.

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Editor’s notes: Tenofovir is a well-tolerated antiretroviral drug which is effective against HIV and hepatitis B. Due to these favourable characteristics and its once-daily dosing, tenofovir is increasingly used in clinical practice. As a result, more women are exposed to this drug at conception and during pregnancy. Tenofovir is classified by the US Food and Drug Administration as a pregnancy category B drug. This means that there is insufficient evidence to determine risk in humans. The authors of this paper provide the reader with an updated systematic review of the safety of tenofovir in pregnancy. Amongst the studies looking at adverse events in infants and mothers, no serious adverse events occurred which were attributed to tenofovir. Likewise, no study identified an increased risk of growth or bone abnormalities in infants up to two years of age. These studies need to be interpreted with caution as many studies had small sample sizes and in some studies the duration of exposure to tenofovir was short (single dose-seven days). Arguably, the most reassuring evidence comes from the antiretroviral pregnancy registry database report, which showed no increased risk of congenital anomalies amongst 1 800 infants exposed to tenofovir in utero. This systematic literature review notes the paucity of available evidence to guide decision-making and highlights the need for further studies to determine the risk to humans of tenofovir exposure during pregnancy.

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Cambodia [10], Côte d'Ivoire [11], Italy [12], Japan [13], Puerto Rico [14], South Africa [15], Uganda [16], United States of America [17], Zambia [18], Zimbabwe [19]
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