Prof. Filomena Morisco：When should antiviral therapy be initiated for HBV infection in pregnant women?
On August 27, 17:00 -- 18:00, the first day of EASL2020 annual meeting, a special conference on "Management of gestational liver disease" focused on a special group that manages liver disease in pregnant women.Among them, Prof.Ilomena Morisco of Federico II University in Naples, Italy, will be the keynote speaker to give a wonderful lecture on management of HBV infection during pregnancy.
For this reason, we specially invited Professor Morisco to conduct an in-depth interview on the topic of antiviral treatment during pregnancy.
Now the content of the interview is sorted out for readers.
<Hepatology Digest>: What is the incidence of hepatitis B reactivation or hepatitis flare in mothers after discontinuation of tenofovir prophylactic antiviral therapy? Are there any factors associated with the risk of hepatitis flare?
Prof. Filomena Morisco：After the suspension of tenofovir, the increase of alanine aminotransferase levels is observed in a percentage ranging between 10 and 50% of mothers and usually arise in the subsequent 2 -4 weeks. This phenomenon, was attributable to the restoration after delivery of the immune system, whose functions were previously altered to prevent foetus rejection. The increase is often mild in severity showing in most of cases
spontaneous resolution. In some studies the presence of HBeAg positivity and elevated ALT during pregnancy are identifies as risk factor for subsequent post-partum hepatitis flare.
<Hepatology Digest>: The mother is at risk of hepatitis B reactivation after discontinuation of tenofovir, and breast-feeding is not contraindicated during tenofovir treatment. So, is it reasonable to consider continued treatment with tenofovir after delivery instead of treatment discontinuation?
Prof. Filomena Morisco：There is no consensus about when to stop prophylaxis. Some guidelines support its prolongation until 8-12 weeks after delivery. The point is to strike a balance between the potential risk of interfering with breastfeeding and the benefit on possible post partum hepatitis flares. Nevertheless, prolongation of antiviral prophylaxis might be useful at least for women with elevated ALT during pregnancy, since they present a higher risk of post partum hepatitis flare. As reported by AASLD and INASL-FOGSI guidelines breastfeeding is not contraindicated in HBsAg mothers on Tenofovir treatment or prophylaxis. Experiences in the HIV field indicate that antivirals are well tolerated and in particular TDF appears to be safe as to infant outcomes and breast-feeding. On the other hand TDF was detectable at low concentrations in breast milk even if are unlikely cause significant toxicity. I my opinion is important discuss with mothers about the unknown risk of low-level exposure to the infant because there are insufficient long-term data on safety in infants born to mothers who took antiviral agents.
<Hepatology Digest>: The renal and bone safety profile of TAF is improved compared with tenofovir, so, could pregnant women with high HBVDNA levels choose TAF for antiviral prophylaxis?
Prof. Filomena Morisco：After the suspension of tenofovir, the increase of alanine aminotransferase levels is observed in a percentage ranging between 10 and 50% of mothers and usually arise in the subsequent 2 -4 weeks. This phenomenon, was attributable to the restoration after delivery of the immune system, whose functions were previously altered to prevent foetus rejection. The increase is often mild in severity showing in most of cases
spontaneous resolution. In some studies the presence of HBeAg positivity and elevated ALT during pregnancy are identifies as risk factor for subsequent post-partum hepatitis flare.
<Hepatology Digest>: The mother is at risk of hepatitis B reactivation after discontinuation of tenofovir, and breast-feeding is not contraindicated during tenofovir treatment. So, is it reasonable to consider continued treatment with tenofovir after delivery instead of treatment discontinuation?
Prof. Filomena Morisco：There is no consensus about when to stop prophylaxis. Some guidelines support its prolongation until 8-12 weeks after delivery. The point is to strike a balance between the potential risk of interfering with breastfeeding and the benefit on possible post partum hepatitis flares. Nevertheless, prolongation of antiviral prophylaxis might be useful at least for women with elevated ALT during pregnancy, since they present a higher risk of post partum hepatitis flare. As reported by AASLD and INASL-FOGSI guidelines breastfeeding is not contraindicated in HBsAg mothers on Tenofovir treatment or prophylaxis. Experiences in the HIV field indicate that antivirals are well tolerated and in particular TDF appears to be safe as to infant outcomes and breast-feeding. On the other hand TDF was detectable at low concentrations in breast milk even if are unlikely cause significant toxicity. I my opinion is important discuss with mothers about the unknown risk of low-level exposure to the infant because there are insufficient long-term data on safety in infants born to mothers who took antiviral agents.
<Hepatology Digest>: The renal and bone safety profile of TAF is improved compared with tenofovir, so, could pregnant women with high HBVDNA levels choose TAF for antiviral prophylaxis?
Prof. Filomena Morisco：There are insufficient data to recommend the use of TAF in pregnancy. Initial data suggest that TAFs have high efficacy and a low risk of adverse effects during pregnancy and consequently appear to be an attractive alternative treatment option for pregnant women.
According to its preclinical evaluations, embryonic fetal development studies performed in rats and rabbits have revealed no evidence of TAF-related fetal harm however before TAF can be recommended for use in pregnancy, further safety data are needed on more women and their children.
A clinical study is currently underway (ClinicalTrials.gov Identifier: NCT04237376) in this special HBV population. The study aimed to evaluate the efficacy and safety of TAF in preventing mother-to-child transmission compared to mothers who have been treated with TDF. Results are expected by the end of 2020.
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