Abstract
Patients with advanced fibrosis are at increased risk of severe outcomes if they develop acute infection with hepatitis A (HAV) or hepatitis B (HBV) viruses. There are no data on the efficacy of combined HAV/HBV vaccination in patients with advanced fibrosis. Our aim was to evaluate the response to the HAV and HBV vaccine alone or in combination for patients with chronic hepatitis C (HCV) and advanced fibrosis and to evaluate the impact of administering the vaccine while patients were receiving peginterferon for treatment of chronic HCV. In this prospective study of patients with advanced fibrosis (Ishak 3–6), those without serologic evidence of prior exposure were vaccinated with either Havrix® HAV, Engerix® HBV, or the TWINRIX® HAV/HBV combination vaccine as appropriate, and response was defined as the development of anti-HAV or anti-HBV surface antibodies. Of the 162 eligible patients, the prevalence of prior exposure to HAV and HBV was 30 and 18%, respectively. Of the 84 patients vaccinated, 38% received Havrix, 14% Engerix, and 48% TWINRIX®. The response to the HAV vaccine was 75% in those receiving Havrix® compared to 78% receiving TWINRIX®. In contrast, the response to HBV vaccination was 42% in patients receiving Engerix® compared to 60% in those vaccinated with TWINRIX® (difference 18.3%; OR 0.29; 95% CI: 0.57–7.79). The presence of diabetes was the only risk factor identified for reduced HBV response (P = 0.01). Responses to both HAV and HBV vaccines when administered alone or in combination were lower than expected in patients with HCV and advanced fibrosis, especially in those with diabetes. The observation that the decline in HBV vaccine response was somewhat lower when this was administered alone as opposed to the combination A/B vaccine suggests that the administration of a combination vaccine may enhance the vaccination response to HBV.
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Acknowledgments
The authors wish to thank the nursing staff of the Clinical Research Center at the Virginia Commonwealth University Medical Center for administering the vaccinations and assisting in patient care during this study. We also wish to thank Kim Buttery MD, MPH, and Gayathri Sridhar MBBS, MPH, from the Department of Epidemiology and Community Health, for their ongoing guidance and assistance with data analysis.
Financial Support
This study was done without financial support of the HALT-C trial or industry. This study was supported by a grant to the General Clinical Research Center of Virginia Commonwealth University (M01 RR 00065). This work was presented in part at the annual American College of Gastroenterology meeting, Orlando, Florida, October, 2008.
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Kramer, E.S., Hofmann, C., Smith, P.G. et al. Response to Hepatitis A and B Vaccine Alone or in Combination in Patients with Chronic Hepatitis C Virus and Advanced Fibrosis. Dig Dis Sci 54, 2016–2025 (2009). https://doi.org/10.1007/s10620-009-0867-4
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DOI: https://doi.org/10.1007/s10620-009-0867-4