Three-dose regimen of hepatitis B vaccine fully protects patients with HIV, study

USA: Three-dose course of HEPLISAV-B, a hepatitis B vaccine, provided complete protection to adults with HIV who had never been vaccinated against or infected with the hepatitis B virus (HBV), according to findings from Phase 3ACTG A5379 clinical study. The study findings were presented at the IDWeek conference in Washington, D.C.

HBV is spread primarily through sexual contact and sharing of contaminated needles. It causes chronic hepatitis B infection and can lead to progressive liver disease. 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. The HEPLISAV-B vaccine, made by Dynavax Technologies Corp. based in Emeryville, California, 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 on people living with HIV.

Led by study chairs Kenneth E. Sherman, M.D., Ph.D., of the University of Cincinnati College of Medicine, and Kristen Marks, M.D., of Weill Cornell Medical College, New York City, 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.