Serological response with Heplisav-B® in prior Hepatitis B vaccine non-responders living with HIV

Khaimova, Rebecca; Fischetti, B; Cope, Rebecca; Berkowitz, Leonard; Bakshi, Anjali

doi:10.1016/j.vaccine.2021.09.050

Cited by 13 publications

(4 citation statements)

References 14 publications

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“…13 Strategies to improve immunogenicity include double-dose vaccination, which is a recommended primary strategy among PWH, 9,14 repeated vaccination with a booster or three-dose series, 15 or adjuvants such as granulocyte-macrophage colony-stimulating factor. 16 Studies of cytosine phosphoguanine-conjugated vaccine (Heplisav; Dynavax, Emeryville, CA) among PWH have shown responses up to 86% with 2-dose series 17,18 and up to 100% with 3-dose series. 19 Although the HIV Medicine Association and US Department of Health and Human Services endorse Heplisav for PWH, 9,20 this vaccine remains costly with limited global access, and further studies in PWH are underway.…”

Section: Discussionmentioning

confidence: 99%

Brief Report: Hepatitis B Infection or Reactivation After Switch to 2-Drug Antiretroviral Therapy: A Case Series, Literature Review, and Management Discussion

Vasishta

Dieterich

Mullen

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: Two-drug antiretroviral therapy (ART) without hepatitis B virus (HBV) activity is prescribed for persons with HIV as simplified or salvage therapy. Although two-drug regimens are not recommended for persons with chronic HBV infection, guidelines do not address their use in those with HBV susceptibility and/or core antibody reactivity. We present a case series of individuals with HBV infection or reactivation following switch to two-drug, non-HBV-active ART. Setting: HIV primary care clinics of an academic medical center in New York, NY. Methods: Case surveillance was conducted to identify persons with HBV surface antigenemia and viremia following two-drug ART switch. Clinical characteristics and outcomes were ascertained through chart review. Results: Four individuals with HBV infection or reactivation after ART switch were identified. Two had HBV susceptibility, 1 had core antibody reactivity, and 1 had surface antigen reactivity preswitch. All eligible persons had received HBV vaccination: 2 with low-level antibody response and 1 with persistent nonresponse. Two presented with fulminant hepatitis, with 1 required liver transplantation. Conclusion: Two-drug ART switch may pose risk of HBV infection or reactivation. We propose careful patient selection and monitoring through the following: (1) assessment of HBV serologies before switch and periodically thereafter, (2) vaccination and confirmation of immunity before switch, (3) risk stratification and counseling about HBV reactivation for those with core antibody, (4) preemptive HBV DNA monitoring for those at the risk of reactivation, (5) continuation of HBV-active prophylaxis when above measures are not feasible, and (6) continuation of HBV-active therapy and surveillance for chronic HBV infection.

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Section: Discussionmentioning

confidence: 99%

Brief Report: Hepatitis B Infection or Reactivation After Switch to 2-Drug Antiretroviral Therapy: A Case Series, Literature Review, and Management Discussion

Vasishta

Dieterich

Mullen

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…Also, most included studies had used the old 2nd generation HBV vaccine, except for one study 21 . The limited data on Heplisav‐B (recombinant yeast‐derived HbsAg with CpG 1018 adjuvant) have revealed better seroconversion rates in prior non‐responders as well as in immunosuppressed patients 63,64 . More studies should evaluate the effectiveness of this newer vaccine in IBD patients.…”

Section: Discussionmentioning

confidence: 99%

“…21 The limited data on Heplisav-B (recombinant yeast-derived HbsAg with CpG 1018 adjuvant) have revealed better seroconversion rates in prior non-responders as well as in immunosuppressed patients. 63,64 More studies should evaluate the effectiveness of this newer vaccine in IBD patients. Lastly, this meta-analysis could not provide the data on the decay of protective antibodies over time with the long-term use of immunosuppressive therapies.…”

Section: Discussionmentioning

confidence: 99%

Meta‐analysis: hepatitis B vaccination in inflammatory bowel disease

Singh

Jena

Mahajan

et al. 2022

Aliment Pharmacol Ther

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Background:The response rate of hepatitis B virus (HBV) vaccination in patients with inflammatory bowel disease (IBD) is variable. Increasing dose or accelerated schedule is the suggested strategy to improve seroconversion. Aim:We performed a meta-analysis to determine the pooled response rate of HBV vaccination and to identify the predictors of seroconversion. Methods:We searched PubMed, Embase and Cochrane library databases. Studies reporting the response of HBV vaccination in IBD patients were included. Response was recorded as adequate immune response (AIR, >10 IU/L) and Effective immune response (EIR, >100 IU/L). Pooled AIR and EIR rates were calculated for different doses (10-20 μg or 40 μg) and schedules (standard: 0, 1 and 6 months or accelerated: 0, 1 and 2 months). Meta-analysis was performed to identify the predictors of response.Results: Twenty-one studies including 2602 patients were eligible. Pooled AIR and EIR rates after HBV vaccination were 62% (95% CI, 55-68) and 42% (95% CI, 37-48), respectively. Pooled AIR and EIR rates for standard and double dose were similar.Pooled AIR and EIR rates were also comparable for different schedules of HBV vaccination. Gender, IBD subtype and disease activity did not affect the response rate.Use of immunosuppression [immunomodulators (RR: 0.73, 95% CI, 0.62-0.87) and anti-TNFs (RR: 0.72, 95% CI, 0.60-0.87)] was a predictor of poor immune response compared to no immunosuppressive therapy. Conclusion:Patients with IBD have a poor serological response after HBV vaccination. HBV screening and vaccination should preferably be done before starting the immunosuppressive drugs.

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“…[47] This CpG adjuvant vaccine, marketed as HEPLISAV-B, may increase the seroprotection rates in SA HIV-infected patients, should it become available. [48] Other priority groups for a more immunogenic vaccine may be individuals with diabetes mellitus, due to its high burden in SA, and their lower vaccine response rates. However, data on the safety and efficacy of this vaccine in children are still lacking.…”

Section: The Potential Role Of Novel Hepatitis B Vaccinesmentioning

confidence: 99%

The role of new hepatitis B vaccines in South Africa

Van Zyl,

Maponga,

Rabie

et al. 2024

S Afr Med J

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Vaccination is key to eliminating hepatitis B virus infection in South Africa (SA). Despite introducing immunisation in 1995, as part of the expanded programme of immunisation (EPI), hepatitis B virus infection remains endemic, and EPI vaccine coverage is incomplete. In addition to infants, non-immune adults at risk of infection through their occupation or with behavioural risk factors should receive vaccination. SA has many individuals with diabetes mellitus (a prevalence of almost 13%), obesity, HIV (8.45 million) or older age (5 million >60 years old), associated with a poorer vaccine response. Recently two new hepatitis B vaccines have been licensed: HEPLISAV-B includes an adjuvant that improves immunogenicity and has shown improved vaccine response in individuals with HIV, old age or diabetes mellitus. PreHevbrio, which includes three hepatitis B surface protein domains, instead of one, may also be more immunogenic, although clinical study data are still limited. These two novel vaccines have not yet been investigated in children and licensed in SA. Should HEPLISAV-B become available in SA, it may be particularly valuable to target high-risk groups in the country, such as people living with HIV, who show a poor response to the currently licensed vaccine.

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Serological response with Heplisav-B® in prior Hepatitis B vaccine non-responders living with HIV

Cited by 13 publications

References 14 publications

Brief Report: Hepatitis B Infection or Reactivation After Switch to 2-Drug Antiretroviral Therapy: A Case Series, Literature Review, and Management Discussion

Brief Report: Hepatitis B Infection or Reactivation After Switch to 2-Drug Antiretroviral Therapy: A Case Series, Literature Review, and Management Discussion

Meta‐analysis: hepatitis B vaccination in inflammatory bowel disease

The role of new hepatitis B vaccines in South Africa

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