Abstract

BackgroundHepatitis B virus (HBV) remains a global health issue, leading to complications including cirrhosis and hepatocellular carcinoma. Individuals co-infected with Human Immunodeficiency Virus (HIV) and HBV have increased liver-related morbidity and mortality compared to those with HBV mono-infection. Vaccination can effectively prevent HBV infection, but certain critical populations including people living with HIV (PLWH) are less likely to achieve seroprotection (antibody to hepatitis B surface antigen (HBsAb) titer ≥ 10 IU/mL) after vaccination; seroprotection rates (SPR) in PLWH range from 34 to 88% in clinical trials, with improved SPR in those with immunologic reconstitution and viral suppression. With improved immunologic status, SPR have dramatically improved in our Veteran Infectious Disease clinic population. However, a subset of patients remain HBV vaccine nonresponders despite re-vaccination attempts, perhaps due to intrinsic immunologic anergy. We hypothesized that Veterans with HIV who were nonresponders to prior HBV vaccines may respond to a more immunogenic vaccine. Heplisav-B is a 2-dose series, with improved SPR in other classically difficult to vaccinate groups (including the elderly and those with diabetes), but has not yet been studied in individuals with HIV.MethodsHBV vaccine nonresponders who had previously been vaccinated and boosted with median 3 and up to 8 doses of alum-adjuvanted HBV vaccines were re-vaccinated with Heplisav-B. HBsAb titers were assessed at days 0, 30, and 60 to follow vaccine responses.ResultsParticipants had a median age of 65 (range 44 to 83) and were virologically suppressed on antiretroviral therapy. Enrollment and vaccination was interrupted by the COVID-10 pandemic, but 8 of 10 (80%) enrolled participants had seroprotective titers at day 60, with 6 having titers > 1000 IU/mL. Of the 8 additional participants who had available serologies after the first dose, all were seroprotected, and 3 had titers > 1000 IU/mL.16 of 18 (89%) participants achieved seroprotection with Heplisav-B.ConclusionHeplisav-B is immunogenic in persons with HIV and should be a reasonable option for HBV vaccination of PLWH who are previous nonresponders.Disclosures Shyam Kottilil, MD PhD, Arbutus Pharmaceuticals (Grant/Research Support)Gilead Sciences (Grant/Research Support)Merck Inc (Grant/Research Support, Advisor or Review Panel member)

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