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Antiviral prophylaxis cost-effective to prevent perinatal HBV transmission
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The use of an antiviral prophylaxis strategy in pregnant women with high hepatitis B virus infection viral load was more cost-effective for reducing the number of perinatal transmissions vs. current and universal vaccination strategies, according to a new study.
“An increase in immigrants and refugees from HBV-endemic countries accounts for a relatively stable number of [hepatitis B surface antigen (HBsAg)]-positive pregnant women nationally identified during the past several decades. ... An antiviral prophylaxis strategy in which pregnant women with high HBV DNA load are identified and receive antiviral prophylaxis is likely to be cost-effective, even cost-saving compared to the current strategy in an era of highly effective antiviral treatment,” Lin Fan, PhD, from the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and colleagues wrote.
Fan and colleagues used a decision tree and Markov model to estimate the cost-effectiveness of three strategies for the prevention of perinatal HBV transmission. In the universal HepB strategy, all infants received the first dose of the HBV vaccination series before hospital discharge and completed the series over time, no pregnant woman was screened for HBsAg or other HBV markers and no infants received hepatitis B immunoglobulin (HBIG). For the current strategy, all pregnant women received prenatal screening for HBsAg and all infants born to HBsAg-positive mothers received HepB and HBIG within 12 hours of birth, followed by completion of the vaccination series. In a third strategy, all pregnant women receiving prenatal screening for HBsAg and all pregnant women with high HBV DNA viral load underwent antiviral prophylaxis for 4 months, beginning in the last trimester and up to 1 month after birth.
The researchers estimated the number of infants with perinatal HBV and their lifetime complications under each strategy. The Markov model was used to measure the lifetime costs and effects associated with chronic HBV for infants with perinatal HBV and were measured in quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs).
Results showed that the current strategy prevented 1,006 chronic HBV infections and saved 13,600 QALYs compared with the universal HepB strategy (ICER: $6,957 per QALY saved). The antiviral prophylaxis strategy also was more cost-effective compared with the universal HepB strategy, with an ICER of $6,376 per QALY saved. Antiviral prophylaxis prevented an additional 489 chronic infections and saved 800 QALYs and $2.8 million compared with the current strategy, suggesting it was the most cost-effective of the three strategies.
“The current strategy was dominated by the antiviral prophylaxis strategy because the antiviral prophylaxis strategy accumulated more QALYs and cost less than the current strategy,” the researchers wrote.
When the current strategy was compared with the universal HepB strategy, researchers found that as the prevalence of HBsAg decreased, the current strategy became less cost-effective. At a 0.2% HBsAg prevalence, the current strategy had an ICER of $15,552 per QALY saved compared with the universal HepB strategy. At a 7% prevalence, the current strategy had an ICER of $2,886 per QALY saved compared with the universal HepB strategy.
The researchers said the antiviral prophylaxis strategy accumulated more QALYs and cost less than the current strategy. However, when the perinatal transmission rate for the current strategy decreased to 1%, the ICER of the antiviral prophylaxis strategy increased to $269,796 per QALY saved. When the reduction of perinatal transmission from antiviral prophylaxis decreased to 20%, the ICER of that strategy increased to $97,749 per QALY saved. When 10% of pregnant women with high HBV DNA viral load received antiviral prophylaxis, the ICER of the antiviral prophylaxis strategy increased to $68,509 per QALY saved.
“An important determinant of cost-effectiveness of the antiviral prophylaxis strategy is the proportion of women with high HBV DNA viral load who receive prophylaxis,” the researchers wrote. “The smaller the proportion of women who receive prophylaxis, the less cost-effective the strategy becomes, emphasizing the importance of a policy that encourages antiviral prophylaxis among pregnant women with high HBV DNA load.” – by Melinda Stevens
- Reference:
- Fan L, et al. Hepatology. 2016;doi:10.1002/hep.28310.
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Jamile Wakim-Fleming, MD FACG
The global health burden of hepatitis B remains high due to complications associated with this viral infection. These include cirrhosis, decompensated cirrhosis, development of liver cancer, liver failure and the need for liver transplantation to prevent death, and death.
What is important about hepatitis B infection is the fact that this infection and its complications can be easily prevented. There are rare illnesses where a vaccine can prevent cancer, and hepatitis B vaccine is one of them. Therefore, it is important to prevent this infection before it happens by vaccinating newborns at birth before they spread it or suffer the consequences of its complications later in life. That was the basis of the universal vaccination programs, adopted as strategy 1 in the study by Fan and colleagues.
Since the introduction of these programs about 20 years ago, study after study has shown their remarkable benefits. However, a relatively small percentage of children remained infected. This led to the second strategy that is currently adopted. It consists of screening the mother during the second half of the pregnancy with HBsAg and vaccinating all newborns. The current strategy (strategy 2 in the study), however, was not 100% effective, and mothers with high HBV DNA continued to transmit the infection to their newborns. Antiviral treatment was then introduced to pregnant mothers with high viral loads greater than 106 copies/mL in addition to vaccinations to their newborns. This last strategy constitutes the third strategy in the study in which HBV DNA testing was added to mothers with positive HBsAg.
The authors compared the cost-effectiveness of these three strategies. They presumed that cirrhotic patients received treatment of hepatitis B indefinitely, and those without cirrhosis were presumed to have received treatment for 2 years, whereas treatment of mothers with high viral load was presumed to have lasted 4 months beginning in the third trimester.
The aim of the study was to update the cost-effectiveness of the current U.S. strategy (strategy 2) and compare it with the two alternate strategies (strategies 1 and 3). They found that the current U.S. strategy for preventing perinatal HBV remains cost-effective compared with the universal HepB strategy. They also state that an antiviral prophylaxis strategy (strategy 3) was cost-saving compared with the current strategy and should be considered to continue to decrease the burden of perinatal hepatitis B in the U.S.
There is no doubt that preventing transmission of hepatitis B has shown numerous health benefits, and there is no doubt that eliminating viral hepatitis B by adapting prophylactic measures not only in the U.S. but worldwide should be a top priority because we can do it, and we should not waiver on this issue.
What this study has shown is a bonus, the bonus of cost-effectiveness. Although the authors were not clear if the last antiviral strategy (3) was cost-effective (they showed that it was cost-saving, prevented more infections and added quality-adjusted life years), and they presumed the duration of therapy (which is not universally adopted but also not universally clarified as some patients may need therapy for a longer duration), these limitations are meager, and the overall message should be to continue to eradicate hepatitis B.
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