Cost-effectiveness of Suppressing Hepatitis B Virus DNA
Cost-effectiveness of Suppressing Hepatitis B Virus DNA
Background: For patients with hepatitis B virus (HBV) infection in the immune tolerant phase, the current standard of care is to not offer treatment. However, the recent Risk Evaluation of the Viral Load Elevation and Associated Liver Disease/Cancer-In study results show a striking relationship between high HBV DNA levels and risk for hepatocellular carcinoma and cirrhosis.
Aim: In a cost effectiveness analysis, to assess whether immune tolerant patients with high HBV DNA levels should undergo treatment.
Methods: We created a lifetime Markov model to evaluate the cost-effectiveness of two strategies for immune tolerant hepatitis B: (i) HBV DNA suppression with lamivudine, (ii) no treatment. Patients cycled between the following health states: viral suppression, ongoing viremia, seroconversion, hepatocellular carcinoma, cirrhosis and death.
Results: Compared with the no treatment strategy, lamivudine therapy was more expensive but more cost-effective with an additional cost of $5784 and $12,584 per quality adjusted life year gained in males and females, respectively. Treatment resulted in a gain in life expectancy and a decrease in lifetime risk of hepatocellular carcinoma and cirrhosis.
Conclusions: Suppressing HBV DNA to prevent hepatocellular carcinoma and cirrhosis in immune tolerant patients is very cost-effective, and treatment of these patients may be considered. Future prospective clinical trials will need to be undertaken to confirm our findings.
An estimated 350 million persons worldwide are chronically infected with the hepatitis B virus (HBV) with an estimated 1.25 million hepatitis B carriers in the US. 15-40% of those infected with HBV will develop sequelae of cirrhosis, hepatic decompensation and/or hepatocellular carcinoma (HCC). In regions where HBV infection is endemic, perinatal transmission typically results in a prolonged "immune tolerant" phase characterized by extensive HBV replication without evidence of active liver inflammation or fibrosis. This phase usually lasts 10-30 years but can continue indefinitely. In the US, prevalence of HBV in immigrants from endemic areas is high. For example, 10-13% of Asian-Americans are infected with HBV, many of whom are in the immune tolerant phase. Current American Association for the Study of Liver Disease guidelines do not recommend treating patients with immune tolerant hepatitis B due to the lack of significant liver disease and low chance for hepatitis B e antigen (HBeAg) seroconversion on therapy.
The Risk Evaluation of the Viral Load Elevation and Associated Liver Disease/Cancer-In (REVEAL) HBV Study Group prospectively followed over 3500 Taiwanese individuals with chronic HBV infection from 1991-2004. The authors showed that HBV DNA level was a strong risk predictor of HCC, independent of HBeAg status, serum alanine aminotransferase (ALT) level and cirrhosis. Furthermore, HBV DNA level was also a strong predictor of cirrhosis, independent of HBeAg status and ALT level. These findings may have important implications for immune tolerant patients with high HBV DNA levels. Whereas treatment of HBV in this group may not result in seroconversion, it is possible that treatment-induced viral suppression may protect against cirrhosis and development of HCC. These possible benefits need to be balanced against the costs and resistance rates of currently available oral therapies for the long-term treatment of HBV. Against this background, we sought to determine whether treatment of immune tolerant HBV patients was cost-effective.
Background: For patients with hepatitis B virus (HBV) infection in the immune tolerant phase, the current standard of care is to not offer treatment. However, the recent Risk Evaluation of the Viral Load Elevation and Associated Liver Disease/Cancer-In study results show a striking relationship between high HBV DNA levels and risk for hepatocellular carcinoma and cirrhosis.
Aim: In a cost effectiveness analysis, to assess whether immune tolerant patients with high HBV DNA levels should undergo treatment.
Methods: We created a lifetime Markov model to evaluate the cost-effectiveness of two strategies for immune tolerant hepatitis B: (i) HBV DNA suppression with lamivudine, (ii) no treatment. Patients cycled between the following health states: viral suppression, ongoing viremia, seroconversion, hepatocellular carcinoma, cirrhosis and death.
Results: Compared with the no treatment strategy, lamivudine therapy was more expensive but more cost-effective with an additional cost of $5784 and $12,584 per quality adjusted life year gained in males and females, respectively. Treatment resulted in a gain in life expectancy and a decrease in lifetime risk of hepatocellular carcinoma and cirrhosis.
Conclusions: Suppressing HBV DNA to prevent hepatocellular carcinoma and cirrhosis in immune tolerant patients is very cost-effective, and treatment of these patients may be considered. Future prospective clinical trials will need to be undertaken to confirm our findings.
An estimated 350 million persons worldwide are chronically infected with the hepatitis B virus (HBV) with an estimated 1.25 million hepatitis B carriers in the US. 15-40% of those infected with HBV will develop sequelae of cirrhosis, hepatic decompensation and/or hepatocellular carcinoma (HCC). In regions where HBV infection is endemic, perinatal transmission typically results in a prolonged "immune tolerant" phase characterized by extensive HBV replication without evidence of active liver inflammation or fibrosis. This phase usually lasts 10-30 years but can continue indefinitely. In the US, prevalence of HBV in immigrants from endemic areas is high. For example, 10-13% of Asian-Americans are infected with HBV, many of whom are in the immune tolerant phase. Current American Association for the Study of Liver Disease guidelines do not recommend treating patients with immune tolerant hepatitis B due to the lack of significant liver disease and low chance for hepatitis B e antigen (HBeAg) seroconversion on therapy.
The Risk Evaluation of the Viral Load Elevation and Associated Liver Disease/Cancer-In (REVEAL) HBV Study Group prospectively followed over 3500 Taiwanese individuals with chronic HBV infection from 1991-2004. The authors showed that HBV DNA level was a strong risk predictor of HCC, independent of HBeAg status, serum alanine aminotransferase (ALT) level and cirrhosis. Furthermore, HBV DNA level was also a strong predictor of cirrhosis, independent of HBeAg status and ALT level. These findings may have important implications for immune tolerant patients with high HBV DNA levels. Whereas treatment of HBV in this group may not result in seroconversion, it is possible that treatment-induced viral suppression may protect against cirrhosis and development of HCC. These possible benefits need to be balanced against the costs and resistance rates of currently available oral therapies for the long-term treatment of HBV. Against this background, we sought to determine whether treatment of immune tolerant HBV patients was cost-effective.
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