Interview with Professor Carla W. Brady from Duke University School of Medicine
Editor's note: Hepatitis B virus (HBV) and hepatitis C virus (HCV) can become chronic infection, affecting 325 million people worldwide, accounting for 96% of the mortality rate of viral hepatitis. Mother to child transmission is one of the main ways of transmission of these two viruses. Therefore, prevention of mother to child transmission is essential to reduce the burden of chronic viral hepatitis worldwide. Since the treatment of viral hepatitis in pregnancy must take into account the health of the mother and the developing fetus, and the immunosuppressive state, hormone changes and postpartum changes of pregnant women may change the natural process of infection, antiviral treatment in pregnancy is a topic of general concern. At the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in 2022, we invited Professor Carla W. Brady of Duke University School of Medicine to conduct an in-depth interview on this topic. Now we have compiled the content into a text for the readers.
iHepatology：There are differences among the guidelines in the recommendations on the initiation and discontinuation time of prophylactic antiviral therapy in pregnant women with chronic hepatitis B. In clinical practice, how to manage pregnant women with chronic hepatitis B?
Dr Brady: I think the management depends on what the woman’s hepatitis B status is at the time of pregnancy. There are situations where women will present in pregnancy with hepatitis B, and they will already meet guidelines for therapy at that particular time. However, for many women who are pregnant, they actually don’t fit nicely into any of the treatment guidelines for hepatitis B infection. Those are women that usually present in pregnancy without already being on hepatitis B treatment. If that is the case, at least in the United States, current guidance would suggest that if these women have elevated hepatitis B viral loads >200000 IU/ml, these women should be considered for prophylactic hepatitis B therapy across the time of their pregnancies. The time at which we typically start this is between the 28th and 32nd week of pregnancy. The reason why we choose this timeframe is because this is the timeframe that has been best studied historically in research. There are opportunities for these women though to actually just remain on therapy for the time of their pregnancies with consideration for discontinuation of their therapy early postpartum, either at the time of delivery, or within the first three months after delivery. But keep in mind, this is for women who did not already meet the guidelines for hepatitis B treatment prior to their pregnancies.
iHepatology：As evidence mounts on the safety and efficacy of tenofovir in pregnant women with chronic hepatitis B, should we consider initiating prophylactic antiviral therapy early during pregnancy and continuing long-term therapy rather than drug discontinuation after delivery?
Dr Brady: That’s a very interesting question. Actually, there was an abstract presented at yesterday’s Presidential Clinical Plenary that looked at the use of hepatitis B treatment earlier in pregnancy prophylactically in the absence of hepatitis B immune globulin, which we would typically think about giving to infants born to mothers with hepatitis B. In that particular study that was presented by Dr Calvin Pan, the goal was to figure out whether you could reduce or stop mother-to-child transmission of hepatitis B by giving prophylactic hepatitis B treatment earlier in the context of pregnancy, and then when the babies are born, rather than giving them immune globulin, you could just give them active immunoprophylaxis through vaccination. What they found in that study is that, indeed, there was a reduction in mother-to-child transmission with the use of earlier hepatitis B treatments (earlier than the 28th to 32nd week), and in those infants born to those mothers with hepatitis B infection, even though they were not given immunoprophylaxis and only given hepatitis B vaccination, they did not go on to develop chronic hepatitis B infection. So this is interesting data that gives one example of why it might be beneficial to actually start this type of treatment earlier in pregnant women. More research studies, I think, are needed, but certainly, these data are promising.
iHepatology：What are the risk factors for HCV infection in infants born to mothers with hepatitis C? Should antiviral therapy during pregnancy be urgently considered for pregnant women with a high risk of mother-to-child transmission?
Dr Brady: The general risk of mother-to-child transmission of hepatitis C in women who are mono-infected with hepatitis C is thought to be in the order of about 5-6%. However, that rate of transmission is actually doubled in the HIV/hepatitis C co-infected population. Having co-infection with HIV can increase the risk of mother-to-child transmission. There are some more recent data that will be published I believe this month in the Journal of Hepatology that actually show that it may also be the degree of hepatitis C viral load that may actually contribute to an increased risk of mother-to-child transmission. Viral load may actually turn out to make a big difference in terms of the rates of transmission. Indeed, there is concern about whether or not it would be beneficial to treat these mothers with hepatitis C therapy during the context of their pregnancy in order to prevent mother-to-child transmission. Certainly in the United States, it is important to consider this in regards to the fact that some women are going to be a more captive audience and more engaged in their healthcare in the context of pregnancy, and therefore, that might be the best time to really think about instituting treatment. We need more studies to figure out whether or not there will be any concerns with safety of treatment of hepatitis C in the context of pregnancy. There has been some case report data. There is one small clinical trial that has looked at this. Through that data, it seems as though it is promising that we may be able to do this safely in this population. But again, we will need more data.
iHepatology：Currently, are there any direct-acting antivirals that have been tested in pregnant women with hepatitis C and approved for use in these patients?
Dr Brady: We don’t have official approval for the use of the direct-acting antivirals agents in the context of pregnancy. What has been studied through one clinical trial that was actually registered in our national Clinical Trial Registry is the use of ledipasvir-sofosbuvir in the setting of pregnancy. The data from that study would suggest that it is probably safe for use. No significant adverse events have been seen thus far, but again, we need more research data.
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