Plain language summary Antiviral drugs for prevention of hepatitis B virus mother‐to‐child transmission in pregnant women living with both human immunodeficiency virus and hepatitis B virus Review question Can antenatal (administered during pregnancy) antiviral combination drugs prevent transfer of hepatitis B virus from mother to baby in pregnant women suffering from both human immunodeficiency virus (HIV) and hepatitis B virus (HBV)? Key messages The evidence from five small randomised clinical trials showed neither beneficial nor harmful effects of tenofovir‐containing antiviral combination drugs compared with zidovudine alone or non‐tenofovir‐containing antiviral drugs, in pregnant women suffering from both HIV and HBV, measured by infant death from any cause, or serious adverse events in infants and mothers. Only one trial reported on infant death from any cause or serious adverse events in infants while only two trials reported on serious adverse events in mothers. Whilst this trial indicated that a tenofovir‐based antiviral combination regimen could increase the number of infants with serious adverse events, this result is very uncertain due to the lack of studies (i.e. only one was found) and the low number of participants. What is HBV‐HIV co‐infection in pregnancy? The HBV‐HIV co‐infection in pregnancy is the occurrence of the two infections in one pregnant individual. When the two infections co‐exist in an individual, HIV actively encourages the worsening of hepatitis B disease progression. When a pregnant woman is living with both HBV and HIV, treatment of HBV alone, without treating the HIV she also suffers from, may lead to the emergence of HIV types that are resistant to anti‐HIV drugs. How is HBV‐HIV co‐infection in pregnancy treated? HBV‐HIV co‐infection in pregnancy can be treated with tenofovir‐based antiviral combination regimens (drugs). They could be in the form of tenofovir alone or in combination with lamivudine, or emtricitabine, or zidovudine, or any other antiviral drugs. What did we want to find out? We wanted to find out whether antenatal use of tenofovir‐containing antiviral combination drugs (drugs administered during pregnancy) was better than placebo, or tenofovir alone, or any non‐tenofovir‐containing antiviral drugs (either alone or in combination with at least two), for improving all causes of death for both baby and mother, transfer of HBV infection from mother to baby, mothers with detectable HBV DNA (hepatitis B hereditary material) before delivery, or maternal hepatitis B seroconversion (recovery from hepatitis B) before delivery in pregnant women living with both HIV and HBV. We also wanted to find out if antenatal use of tenofovir‐containing antiviral combination drugs (drugs administered during pregnancy) compared with placebo, or tenofovir alone, or any non‐tenofovir‐containing antiviral drugs (either alone or in combination with at least two), was associated with any unwanted effects in the baby and mother. What did we do? We searched for randomised clinical trials (studies in which participants are allocated to groups by a play of chance) that assessed the benefits and harms of antenatal use of tenofovir‐containing antiviral combination drugs (drugs administered during pregnancy), compared with placebo, or tenofovir alone, or any non‐tenofovir‐containing antiviral drugs (either alone or in combination), for pregnant women living with both HIV and HBV infection. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes. What did we find? We found five randomised trials that included 533 pregnant women suffering from both HIV and HBV who were followed up throughout pregnancy and delivery with their infants being followed up to two years after birth. All the results were inconclusive between groups. The evidence from five small randomised clinical trial showed neither beneficial nor harmful effects of tenofovir‐containing antiviral combination drugs compared with zidovudine alone, or non‐tenofovir‐containing antiviral drugs, in pregnant women suffering from both HIV and HBV, measured by infant death from any cause, or serious adverse events in infants and mothers. Only one trial reported on infant death from any cause or serious adverse events in infants, while only two trials reported on serious adverse events in mothers. Whilst this trial indicated that a tenofovir‐based antiviral combination regimen could increase the number of infants with serious adverse events, this result is very uncertain due to the lack of studies (i.e. only one was found) and the low number of participants. We did not find data on the other outcomes of interest. None of the studies used placebo or tenofovir alone. All the trials received support from industry. What are the limitations of the evidence? We are not confident in the evidence because not all the studies provided data about everything that we were interested in. It was not clear whether people in the studies were aware of which treatment they were receiving. Also, there were not enough studies to be certain about the results of our outcomes. How up‐to‐date is this evidence? The evidence is up‐to‐date to 30 January 2023.
【저자키워드】 HIV, Lopinavir, Ritonavir, Infant, pregnant women, Coinfection, Pregnancy, humans, Antiviral agents, female, Hepatitis B virus, zidovudine, lamivudine, tenofovir, HIV infections, emtricitabine, Infectious Disease Transmission, Vertical, Hepatitis B e antigens, DNA, viral, HIV seropositivity,