Anti-HBV DNA vaccination does not prevent relapse after discontinuation of analogues in the treatment of chronic hepatitis B: a randomised trial—ANRS HB02 VAC-ADN

Fontaine, Hélène; Kahi, Sandrine; Chazallon, Cyrille; Bourgine, Maryline; Varaut, Anne; Buffet, Catherine; Godon, Ophélie; Méritet, Jean–François; Saïdi, Yacine; Michel, Marie‐Louise; Scott‐Algara, Daniel; Aboulker, J; Pol, Stanislas

doi:10.1136/gutjnl-2013-305707

Cited by 88 publications

(59 citation statements)

References 43 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…89 In a randomized controlled study of vaccine therapy in patients with HBV and undetectable HBV DNA after a median of three years of treatment with nucleos(t)ide analogs, discontinuation of treatment was associated with HBV reactivation in 97%, indicating that vaccination does not reduce the risk of relapse after discontinuation of nucleos(t)ide analogs. 90 Given the relatively high rate of relapse after withdrawal of nucleos(t)ide analogs, treatment discontinuation should be undertaken cautiously, particularly in HBeAg negative patients.…”

Section: Hbeag Positive Patientsmentioning

confidence: 99%

Management of chronic hepatitis B infection

Sundaram

Kowdley

2015

BMJ

View full text Add to dashboard Cite

Hepatitis B virus (HBV) is a global health problem that can lead to cirrhosis and hepatocellular carcinoma (HCC). Although HBV vaccination has reduced the prevalence Of HBV infection, the burden of disease remains high. Treatment with antiviral drugs reduces the risk of liver disease and the development of HCC, and it can even reverse liver fibrosis. However, challenges remain regarding optimal timing, as well as the modality and duration of treatment. Currently approved drugs include pegylated interferon and nucleos(t)ide analogs. Nucleos(t)ide analogs are better tolerated and provide excellent viral suppression with a low risk of antiviral resistance, but pegylated interferon offers the benefit of a finite duration of treatment. Monitoring of hepatitis B surface antigen (HBsAg) levels may help to predict the likelihood of response to treatment, particularly for pegylated interferon. Prolonged treatment is usually needed with oral antiviral agents, and relapse is common if treatment is discontinued. New treatments that result in sustained clearance of HBV DNA and the clearance of HBsAg are needed.

show abstract

Section: Hbeag Positive Patientsmentioning

confidence: 99%

Management of chronic hepatitis B infection

Sundaram

Kowdley

2015

BMJ

View full text Add to dashboard Cite

show abstract

“…This trial showed that pCMV-S2.S DNA vaccine was safe, but the relapse occurred in 97% of each group after a median 28 d. The pCMV-S2.S DNA vaccine did not decrease the rate of recurrence or virological breakthrough in HBV-treated patients, and did not restore the anti-HBV immune response despite effective viral suppression by NAs. 37,38 INO-1800 is another candidate HBV therapeutic DNA vaccine initiated by Inovio Pharmaceuticals. In a phase I, randomized, open label, active-controlled, dose escalation trial, 126 NAs treated patients were enrolled to evaluate the safety, tolerability and immunogenicity of dose combination of INO-1800 (DNA plasmid encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP).…”

Section: Dna-based Vaccinesmentioning

confidence: 99%

Research progress of therapeutic vaccines for treating chronic hepatitis B

Li¹,

Bao²,

Ge³

et al. 2017

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

Hepatitis B virus (HBV) is a member of Hepadnavirus family, which leads to chronic infection in around 5% of patients with a high risk of developing liver cirrhosis, liver failure, and hepatocellular carcinoma. Despite the availability of prophylactic vaccines against hepatitis B for over 3 decades, there are still more than 2 billion people have been infected and 240 million of them were chronic. Antiviral therapies currently used in the treatment of CHB (chronic hepatitis B) infection include peg-interferon, standard a-interferon and nucleos/tide analogs (NAs), but none of them can provide sustained control of viral replication. As an alternative strategy, therapeutic vaccines for CHB patients have been widely studied and showed some promising efficacies in dozens of preclinical and clinical trials. In this article, we review current research progress in several types of therapeutic vaccines for CHB treatment, including proteinbased vaccines, DNA-based vaccines, live vector-based vaccines, peptide-based vaccines and cell-based therapies. These researches may provide some clues for developing new treatments in CHB infection.

show abstract

“…In a randomized, controlled study of vaccine therapy in patients with CHB and undetectable HBV DNA after at least 1 year of Nucs, in 97% of cases discontinuation was associated with HBV reactivation and Nucs had to be resumed in patients with HBV DNA above 120 IU/ml [Fontaine et al 2014]. In a Greek cohort of 33 patients who were HBe -and discontinued Nucs after at least 5 years of viral suppression with adefovir, 100% had detectable HBV DNA at 1 month but at 1 year 67% had biochemical remission and 21% had HBV DNA less than 10,000 copies/ml; this reached 40% after 2 years.…”

Section: Stopping Nucsmentioning

confidence: 99%

Hepatitis B virus treatment beyond the guidelines: special populations and consideration of treatment withdrawal

Vallet-Pichard

Pol

2014

Therap Adv Gastroenterol

View full text Add to dashboard Cite

Abstract:The goal of chronic hepatitis B (CHB) treatment is to improve survival by preventing disease progression to decompensated cirrhosis and hepatocellular carcinoma which is the cause of over 1 million deaths annually. The risk of disease progression is reduced when a sustained reduction of hepatitis B virus (HBV) DNA to undetectable levels and suppression of HBV replication are obtained which can result in regression of liver fibrosis and may even reverse cirrhosis. However, even if HBsAg loss occurs, HBV is not completely eradicated by treatment, and long-term therapy is required in patients who are HBeAg -and HBeAg + who do not maintain off-treatment virological suppression and in those with advanced liver disease. The recently updated European Association of the Study of the Liver (EASL) clinical practical guidelines for HBV have clarified, first, how to treat HBV (interferon or the most potent oral drugs with optimal resistance profiles, i.e. entecavir and tenofovir disoproxil fumarate, should be used as first-line monotherapies); second, who should be treated (CHB in patients with significant liver disease but also patients who are HBsAg + and are receiving immunosuppressive treatment, patients coinfected with HBV and human immunodeficiency virus, mothers who are HBsAg + with high viral load in late pregnancy associated with sero vaccination to reduce the risk of vertical transmission of HBV; and third, when to stop antiviral therapies. The aim of this review was to clarify how to treat HBV and who should be treated, as well as when to stop treatment. Although the answer to these questions is clear for pegylated interferon, it is more debatable for nucleos(t)ide analogues (anti-HBe seroconversion, HBsAg loss or anti-HBs seroconversion with undetectable HBV DNA are clear indications to discontinue treatment but sustained undetectable HBV DNA in patients who are anti-HBe + without significant fibrosis might be another indication).

show abstract

Anti-HBV DNA vaccination does not prevent relapse after discontinuation of analogues in the treatment of chronic hepatitis B: a randomised trial—ANRS HB02 VAC-ADN

Abstract: NCT00536627.

Cited by 88 publications

References 43 publications

Management of chronic hepatitis B infection

Management of chronic hepatitis B infection

Research progress of therapeutic vaccines for treating chronic hepatitis B

Hepatitis B virus treatment beyond the guidelines: special populations and consideration of treatment withdrawal

Contact Info

Product

Resources

About