scholarly journals Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial

Pathogens ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. 1440
Author(s):  
Sheikh Mohammad Fazle Akbar ◽  
Mamun Al Mahtab ◽  
Julio Cesar Aguilar ◽  
Osamu Yoshida ◽  
Eduardo Penton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Immune Therapy ◽  
Hbv Dna ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Liver Protection

A phase III clinical trial in treatment-naïve patients with chronic hepatitis B (CHB) revealed the safety and considerable therapeutic efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) at the end of treatment (EOT) and 24 weeks after EOT. Two years after EOT, we checked HBV DNA, alanine aminotransferase (ALT), and hepatitis B e antigen (HBeAg). The data reveal that 33 of 66 NASVAC-recipient CHB patients became negative for HBV DNA in the blood two years after EOT. The ALT levels were within the upper limit of normal (ULN) in 37 patients, although all 66 CHB patients had elevated ALT (above ULN) before the start of therapy. Out of the total twelve HBeAg-positive patients, eight patients became negative for HBeAg. None of the patients developed cirrhosis of the liver within this period. NASVAC is a finite treatment regimen with sustained antiviral and liver-protecting properties. This study is the first to report follow-up data of immune therapy for CHB. NASVAC, an immune therapy of finite duration, is endowed with sustained antiviral and liver protection properties in CHB patients.

scholarly journals The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial

Vaccines ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 45
Author(s):  
Sheikh Mohammad Fazle Akbar ◽  
Mamun Al Mahtab ◽  
Julio Cesar Aguilar ◽  
Osamu Yoshida ◽  
Sakirul Khan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Therapeutic Vaccine ◽  
Hbv Dna ◽  
Phase Iii ◽  
Safety And Efficacy ◽  
Phase Iii Clinical Trial

The objective of the present study was to assess the safety and efficacy of a therapeutic vaccine containing both HBsAg and HBcAg (NASVAC) in patients with chronic hepatitis B (CHB) three years after the end of treatment (EOT) as a follow-up of a phase III clinical trial. NASVAC was administered ten times by the nasal route and five times by subcutaneous injection. A total of 59 patients with CHB were enrolled. Adverse events were not seen in any of the patients. Out of the 59 CHB patients, 54 patients exhibited a reduction in HBV DNA, compared with their basal levels. Although all the patients had alanine transaminase (ALT) above the upper limit of normal (>42 IU/L) before the commencement of therapy, the levels of ALT were within the ULN level in 42 patients. No patient developed cirrhosis of the liver. The present study, showing the safety and efficacy of NASVAC 3 years after the EOT, is the first to report follow-up data of an immune therapeutic agent against CHB. NASVAC represents a unique drug against CHB that is safe, of finite duration, can be administered by the nasal route, is capable of reducing HBV DNA and normalizing ALT, and contains hepatic fibrosis.

scholarly journals Treatment of chronic hepatitis B naïve patients with a therapeutic vaccine containing HBs and HBc antigens (a randomized, open and treatment controlled phase III clinical trial)

PLoS ONE ◽  
2018 ◽  
Vol 13 (8) ◽  
pp. e0201236 ◽  
Author(s):  
Mamun Al Mahtab ◽  
Sheikh Mohammad Fazle Akbar ◽  
Julio Cesar Aguilar ◽  
Gerardo Guillen ◽  
Euduaro Penton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Therapeutic Vaccine ◽  
Phase Iii ◽  
Phase Iii Clinical Trial

P0610 : Dynamic prediction of inactive chronic hepatitis B using repeated HBsAg and HBV DNA level measurements through long-term follow-up

2015 ◽  
Vol 62 ◽  
pp. S545-S546
Author(s):  
W.P. Brouwer ◽  
H.L.-Y. Chan ◽  
M.R. Brunetto ◽  
M. Martinot-Peignoux ◽  
P. Arends ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbv Dna ◽  
Dynamic Prediction ◽  
Long Term Follow Up

scholarly journals A Dose Ranging Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of Lamivudine in Children and Adolescents with Chronic Hepatitis B

2000 ◽  
Vol 44 (3) ◽  
pp. 590-597 ◽  
Author(s):  
Etienne M. Sokal ◽  
Eve A. Roberts ◽  
Giorgina Mieli-Vergani ◽  
Penny McPhillips ◽  
Mark Johnson ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Limit Of Detection ◽  
Laboratory Data ◽  
Hbv Dna ◽  
Phase Iii ◽  
Time Curve ◽  
Once Daily ◽  
Active Viral Replication

ABSTRACT Fifty-three patients with chronic hepatitis B and active viral replication were studied for 4 weeks while on treatment and for 12 weeks after treatment with the oral nucleoside analogue lamivudine. Children aged 2 to 12 years were randomized to receive twice-daily doses of 0.35, 1.5, or 4 mg of lamivudine solution per kg of body weight or once-daily doses of 3 mg of lamivudine solution per kg. Adolescents aged 13 to 17 years received lamivudine at 100 mg (as tablets). Blood samples for pharmacokinetic assay were taken on days 1 and 28. Lamivudine was rapidly absorbed following oral administration, with the maximum concentration in serum being reached 0.5 to 1 h postdosing. Apparent oral clearance (CL/F) was higher in younger children and decreased with age, with CL/F values for adolescents reaching those seen for adults by the age of 12. All doses produced a dramatic fall in serum hepatitis B virus (HBV) DNA levels, with a median reduction of ≥99.5% after 4 weeks of treatment and with the levels returning to the baseline levels posttreatment. The correlation of dose, area under the concentration-time curve (AUC), and changes in HBV DNA levels, as measured by the Chiron Quantiplex assay, showed maximal antiviral effects (99.9% inhibition and a reduction of the amount of HBV DNA of approximately 3 log10) at 3 mg/kg/day, with no discernible increase in effect seen whether the drug was given at 4 mg/kg twice daily or whether it was given once daily or twice daily. The limit of detection of the assay (2.5 pg/ml) was reached for some but not all patients across the dose ranges, with the smallest number (n = 2) of those having values negative by the Chiron Quantiplex assay being in the lowest-dose group. The 13- to 17-year-olds showed a similar overall response in terms of the HBV DNA level reduction compared to that for patients younger than age 13. Analysis of the same samples by PCR, which has a lower limit of sensitivity than the Chiron Quantiplex assay, also showed average drops in HBV DNA levels of about 3 log10 at 4 weeks for patients for which the AUC was ≥4,000 ng · h/ml, confirming the conclusions given above. Lamivudine treatment was well tolerated at all doses, with no significant adverse events or laboratory data changes. On the basis of pharmacokinetic and pharmacodynamic data, a 3-mg/kg/day dose in children (ages 2 to 12 years) with chronic hepatitis B provides levels of exposure and trough concentrations similar to those seen in adults following the receipt of doses of 100 mg. The 100-mg dose is being evaluated in a large phase III study with HBV-infected pediatric patients.

STUDY THE BIOCHEMICAL, VIRAL AND LIVER FIBROSIS RESPONSES IN PATIENTS WITH CHRONIC HEPATITIS B AFTER 12 MONTH-TREATMENT BY ENTECAVIR

2015 ◽  
pp. 36-43
Author(s):  
Viet Thinh Nguyen ◽  
Van Huy Tran
Keyword(s):  
Chronic Hepatitis ◽  
Liver Fibrosis ◽  
Hepatitis B ◽  
Liver Biopsy ◽  
Key Words ◽  
Chronic Hepatitis B ◽  
Hbv Dna ◽  
Controlled Study ◽  
Viral Responses

Introduction: Assessing the histological character liver fibrosis by transient hepatic elastography (TE) by Fibroscan has several advantages when compared with liver biopsy and can indicate repeatedly; therefore it can help us to follow up the treatment of chronic hepatitis B. This study is aimed at assessing the biochemical, viral and liver elasticity responses in patients with chronic hepatitis B after 12 months of entecavir treatment. Methods: Prospective, open, non-controlled study. 75 patients over 16 years old were diagnosed with chronic hepatitis B and treated with Entecavir 0.5 mg orally 2 hours after meal during 12 months. Using Fibroscan to assess the liver fibrosis according to the METAVIR classification. Results: ALT decreased rapidly after 3 months of treatment. There were differences in ALT at baseline, compared with ALT at 3 months, 6 months and 12 months (p < 0.05). HBV-DNA responsed below detection thredsold is 32%, 54.7% and 84% after 3, 6, 12 months of treatment, respectively (p<0.05). The change in the Fibroscan value > 1KPa at 6 months was 53.3% after treatment, and this was lower than this proportion at 12 months (61.3%) (p<0.001). Conclusion: Fibroscan may be used as a mean to monitor the responses to HBV treatment besides the biochemical and viral responses. Key words: Chronic B hepatitis, Entecavir, Elastography, Fibroscan

scholarly journals Comparison of serum hepatitis B virus replication markers in patients with chronic hepatitis B: studies on HBeAg/Anti-HBe system, viral dna polymerase and HBV-DNA

1989 ◽  
Vol 31 (5) ◽  
pp. 328-335 ◽  
Author(s):  
João Renato Rebello Pinho ◽  
Luís Edmundo Pinto da Fonseca ◽  
Yu Song ◽  
Yuriko Miyamoto ◽  
Flair José Carrilho ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Dna Polymerase ◽  
Hbv Dna ◽  
Specific Marker ◽  
Chronic Patients ◽  
B Virus

The detection of HBV-DNA in serum by molecular hybridization is the most sensitive and specific marker of replication and infectivity of hepatitis B virus and currently is proposed as a routine diagnostic technique in the follow-up of HBV - related diseases. Comparing different techniques already described, we found that direct spotting of serum samples on nitrocellulose membranes under vacuum filtration, followed by denaturing and neutralizing washes is more practical, simple, sensible and reproducible. DNA polymerase assay using phosphonoformic acid as specific viral inhibitor has shown 86.8% of concordance with HBV-DNA detection, and so, it is an useful alternative in the follow-up of hepatitis B chronic patients. We found 19.2% HBeAg positive samples with no other markers of viral replication and no anti-HBe positive sample had detectable HBV-DNA. Discordance between the 2 systems have been extensively described, and we confirm this for the first time in our country. Molecular biological techniques are essential to determine the replication status of chronic hepatitis B patients.

scholarly journals Fibrosis and HBV-DNA Determine the Prognosis of Chronic Hepatitis B Patients: Long-Term Follow-up

2003 ◽  
Vol 15 (2) ◽  
pp. 129-142
Author(s):  
Masami MATSUOKA ◽  
Minoru SHIBATA ◽  
Masayuki NAKANO ◽  
Yukihiro SAKURAI ◽  
Noboru GOTO ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbv Dna ◽  
Long Term Follow Up
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