Safety of Tenofovir During Pregnancy for the Mother and Fetus: A Systematic Review

Abstract

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 1800 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.

Management of Chronic Hepatitis B in Patients from Special Populations

“…The frequencies of birth defects with the other three agents are not as well established because of the paucity of their use in pregnant women. Although the APR cautions that the accuracy of the data is limited by potential under and differential reporting as well as under and differential ascertainment of birth defects, the birth defect frequencies of tenofovir and lamivudine are quite low, and comparable to the birth defect rates of normal pregnancy, estimated to be 2.7% from the Centers for Disease Control and Prevention surveillance (Wang et al 2013). Both drugs can be used for viral suppression in the third trimester, tenofovir being preferred if the mother requires long-term therapy after delivery because of the high resistance rate associated with lamivudine.…”

Prevention of mother to child transmission of hepatitis B virus infection in Nigeria: A call to action

“…Use of tenofovir in pregnancy has resulted in significant reductions among mothers, without any remarkable adverse effects. 44,45 Based on safety data from the ARV in Pregnancy Registry in pregnant HIV positive women who have received tenofovir and/or lamivudine or emtricitabine; tenofovir appears to be the preferred ARV, owing to its better resistance profile, and more extensive safety data in pregnant HBV positive mothers. 23,43 As ongoing caution is being advised on the use of ART in pregnancy; the absence of adverse drug events in mothers and their infant pairs who received ART in pregnancy up to date offers promise in their use.…”

“…23,43 As ongoing caution is being advised on the use of ART in pregnancy; the absence of adverse drug events in mothers and their infant pairs who received ART in pregnancy up to date offers promise in their use. 44 Some guidelines recommend treatment for non-cirrhotic patients (including pregnant woman) with serum HBV DNA levels greater than 20,000 iu/mL (> 10 5 copies/ mL) and evidence of liver disaes. 45 …”

Perinatal Hepatitis B Virüs Bulaşı

“…Bu nedenlerden ötürü gebelik süresince antiviral ilaç kullanımı tartışmalı bir konudur. Ancak birçok çalışma gebelik süresince lamuvudin, tenofovir veya telbuvudin kullanımı ile immunoprofilaksiye ek uygulanacak antiviral profilaksinin, HBV replikasyonunu baskılayarak tek başına uygulanacak immünoprofilaksiye kıyasla perinatal HBV bulaş riskini %70'e kadar azaltabileceğini bildirmiştir [33][34][35][36][37][38][39][40][41] . Gebelikte son trimesterde uygulanan antiviral profilaksinin etkinliği, güvenirliği ve ekonomik değeri ile ilgili artan kanıtlar ile 2012 yılında EASL ve Asian Pacific Association for the Study of the Liver (APASL) yüksek HBV DNA yükü olan gebelerde 3. trimesterde antiviral profilaksi kullanımının değerlendirilmesini önermişlerdir 22,33 .…”

“…Bu oran Center of Disease Control ve Prevention (CDC) tarafından bütün doğumlar için verilen rakamlar (%2,72) ile istatistiksel olarak anlamlı farklılık göstermemektedir 44 . Birçok klinik çalışma ve APR'ye göre gebelik süresince en çok kullanılan ajanlar olan lamivudin ve tenofovir güvenli görünmektedirler [34][35][36][37][38]44 .…”