EASL2020[SAT468] 經鼻給藥可抗HBS誘導和HBsAg降低 含有HBsAg和HBcAg

StephenW

SAT468
Anti-HBS induction and HBsAg reduction by nasal administration
of a therapeutic vaccine containing HBsAg and HBcAg (NASVAC) in
patients with chronic HBV infection
Osamu Yoshida1, Akbar Sheikh Mohammad Fazle2, Takahiro Sanada3,
Michinori Kohara3, Kyoko Tsukiyama-Kohara4, Takashi Miyazaki5,
Taizo Kamishita5, Mamun Al-Mahtab6, Aguilar Julio7,
Gerardo Guillen7, Yoichi Hiasa1. 1Ehime University Graduate School of
Medicine, Department of Gastroenterology and Metabology, Toon, Japan;
2Ehime University Graduate School of Medicine, Department of
Pathology , Toon, Japan; 3Tokyo Metropolitan institute of Medical
Science, Department of Microbiology and Cell Biology, Japan;
4Kagoshima University, Joint Faculty of Veterinary Medicine, Kagoshima,
Jersey; 5TOKO YAKUHIN KOGYO CO., LTD, Osaka, Japan; 6Bangabandhu
Sheikh Mujib Medical University, Department of Hepatology, Dhaka,
Bangladesh; 7Center for Genetic Engineering and Biotechnology,
Biomedical Research Department, Havana, Cuba
Email: [email protected]
Background and Aims: HBs antigen (HBsAg) loss is termed
functional cure and recognized as an ideal treatment goal for the
patients with chronic hepatitis B virus (HBV) infection. However, it is
difficult to achieve functional cure by nucleos(t)ide analogs (NAs) or
interferon. Thus NAs require long-term treatment. Further, chronic
HBV infection without hepatitis, not recommended for anti-HBV
therapy by current guidelines, needs suitable drugs for achieving
functional cure, because these patients owe a risk for hepatic flare
and hepatocellular carcinoma. This study was aimed to assess the
efficacy of nasal administrative therapeutic vaccine, NASVAC, containing
both HBsAg and HBcAg, on kinetics of HBsAg in CHB patient under
NAs and chronic HBV infection without hepatitis.
Method: CHB patient with NAs and HBV carrier enrolled in an open label
clinical trial at Ehime University Hospital, Japan, after obtaining
written consent and permission from institutional review board and
enrollment of study to the clinical trial authority of Japan(IRB#18EC003; registered to jRCT (#jRCTs061180100). NASVAC was
emulsified in carboxyl vinyl polymer to increase the viscosity, then
administrated for 10 times, once in every 2 weeks, by a special device
designed for durable existence of NASVAC in nasal mucosa. Data were
analyzed at 6 months after end of treatment (EOT).
Results: Twenty nine HBV patients under NAs treatment (NA group:
age: 49–66 years, ALT: 16–28 U/L, HBsAg: 93–1942 IU/mL) and forty
two chronic HBV infection without hepatitis (w/o NA group: age: 44–
64 years, ALT: 16–29 U/L, HBsAg: 311–3706 IU/mL) were enrolled.
75% of NA and 74.3% of w/o NA displayed HBsAg reduction, the mean
HBsAg reduction was 16.7% in NA and 18.3% in w/o NA at 6 months
after EOT. 37.9% in NA and 58.5% in w/o NA developed anti-HBs. HBVDNA
reduction was observed in 68.2% of w/o NA and 3 patients
showed sustained HBV-DNA negativity. 4 patients, two in NA and two
in w/o NA, achieved functional cure.
Conclusion: NASVAC induced anti-HBs, and reduced HBsAg in CHB
with NAs and chronic HBV infection. Overall 4 patients achieved
functional cure byNASVAC. NASVAC could be a novel immune therapy
for achieving functional cure in HBV infected patients.

StephenW

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