An important advance in Hepatology -more data showing efficacy of a Hepatitis E vaccine (N Engl J Med 2015; 372:914-922).
Here’s the abstract:
Hepatitis E virus (HEV) is a leading cause of acute hepatitis. The long-term efficacy of a hepatitis E vaccine needs to be determined.
In an initial efficacy study, we randomly assigned healthy adults 16 to 65 years of age to receive three doses of either a hepatitis E vaccine (vaccine group; 56,302 participants) or a hepatitis B vaccine (control group; 56,302 participants). The vaccines were administered at 0, 1, and 6 months, and the participants were followed for 19 months. In this extended follow-up study, the treatment assignments of all participants remained double-blinded, and follow-up assessments of efficacy, immunogenicity, and safety were continued for up to 4.5 years.
During the 4.5-year study period, 60 cases of hepatitis E were identified; 7 cases were confirmed in the vaccine group (0.3 cases per 10,000 person-years), and 53 cases in the control group (2.1 cases per 10,000 person-years), representing a vaccine efficacy of 86.8% (95% confidence interval, 71 to 94) in the modified intention-to-treat analysis. Of the participants who were assessed for immunogenicity and were seronegative at baseline, 87% of those who received three doses of the hepatitis E vaccine maintained antibodies against HEV for at least 4.5 years; HEV antibody titers developed in 9% in the control group. The rate of adverse events was similar in the two groups.
Immunization with this hepatitis E vaccine induced antibodies against HEV and provided protection against hepatitis E for up to 4.5 years. (Funded by the Chinese Ministry of Science and Technology and others; ClinicalTrials.gov number, NCT01014845.)
Related blog post:
Experience with molecular adsorbent recirculating system (MARS). Lexmond WS, et al. Liver Transpl 2015; 21: 369-80. Editorial 277-78. n=20 over 10 years. From the editorial: “Although MARS therapy has been available for more than a decade, there have been no randomized controlled trials of its use in children…the time has come to get the data necessary to prove whether MARS has utility or not.” Related blog post: Living on MARS | gutsandgrowth
“Unrecognized Chronic Hepatitis C Virus Infection Among Baby Boomers in the Emergency Department.” Hepatology 2015; 61: 776-82. 102 of 1529 individuals were confirmed to have HCV infection. Interestingly, only 54% were successfully contacted by phone and of these only 21 had attended their initial visit with a liver specialist. Related blog post: Wiping out Hepatitis C | gutsandgrowth
Unrelated story/link (from NY Times): FDA Slow to Act on Diet Supplement Dangers