A three-dose course of the hepatitis B vaccine HEPLISAV-B fully
protected adults living with HIV who had never been vaccinated against or
infected with the hepatitis B virus (HBV), according to study findings
presented at the IDWeek conference in Washington, D.C.
People living with HIV, including those who are taking antiretroviral
therapy, are at greater risk of liver-related illness and death when
co-infected with HBV. According to the Centers for Disease Control and
Prevention, 10% of U.S. adults with HIV
also have hepatitis B. People living with HIV are less likely to produce a
protective immunological response to HBV vaccination. 3The HEPLISAV-B vaccine,
was approved in 2017 by the U.S. Food and Drug Administration as a two-dose
vaccine regimen for adults. However, little was known about its
protective effects in people living with HIV.
In this study the researchers tested a three-dose course
of HEPLISAV-B among 68 adults living
with HIV at 38 sites in the United States, South Africa, and Thailand. None
of the participants had received a previous HBV vaccination or had evidence of
a previous HBV infection; all were on antiretroviral therapy. Following the initial dose of HEPLISAV-B
vaccine 0.5 milliliter (mL) as an intramuscular injection, study participants
received additional doses at four weeks and 24 weeks. The objective of this
part of the study was to assess anti-HBV surface antibodies (HBsAbs) greater
than or equal to 10 milli-international units per milliliter (mIU/mL) at week
28 (defined as seroprotection from HBV) and to assess the vaccine’s safety.
All participants achieved seroprotection with 88% of participants achieving HbsAb levels
greater than 1000 mIU/mL, according to findings presented today. High
antibody levels are thought to be associated with long-term vaccine durability. At eight weeks after the second dose,
94.4% of participants achieved seroprotection; this percentage increased to
98.5% by week 24 prior to the third dose.
Kenneth E. Sherman et al,