studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 1195A
Robert Gish - Advisory Committees or Review Panels: Gilead, AbbVie, Arrowhead;
Consulting: Eiger, Isis, Genentech; Speaking and Teaching: Gilead, Abb-
Vie; Stock Shareholder: Arrowhead
Stephen Locarnini - Consulting: Gilead, Arrowhead; Employment: Melbourne
Health
Robert E. Lanford - Grant/Research Support: Arrowhead Research
David L. Lewis - Employment: Arrowhead Research Corporation
The following authors have nothing to disclose: Deborah Chavez, Jason E. Goetzmann,
Lena M. Notvall-Elkey, Helen Lee, Bernadette Guerra, Courtney N. Johnson,
Christopher R. Anzalone
2023
Efficacy and Safety of Peginterferon alfa-2b (40kD,
Y Shape) (Pegberon) in HBeAg- positive CHB Patients
—- A Phase III, Randomized, Multi-center, Positive-Controlled,
Open-label Clinical Study
Gui-Qiang Wang 1 , Feng-Qin Hou 1 , Wei Lu 2 , Jia Shang 3 , Guo-
Zhong Gong 4 , Chen Pan 5 , Ming-Xiang Zhang 6 , Chi-Biao Yin 7 ,
Qing Xie 8 , Yan-Zhong Peng 9 , Shi-Jun Chen 10 ; 1 Peking University
First Hospital, Beijing, China; 2 Xiamen Amoytop Biotech Co.,Ltd,
Xiamen, China; 3 Henan Provincial People’s Hospital, Zhengzhou,
China; 4 The Second Xiangya Hospital of Central South University,
Changsha, China; 5 Mengchao Hepatobiliary Hospital of Fujian
Medical University, Fuzhou, China; 6 The Sixth People’s Hospital
of Shenyang, Shenyang, China; 7 Guangzhou Eighth People’s
Hospital, Guangzhou, China; 8 Rui Jin Hospital, Shanghai, China;
9 Peking University Shenzhen Hospital, Shenzhen, China; 10 Jinan
Infectious Diseases Hospital, Jinan, China
Background: Chronic hepatitis B (CHB) is a life-threatening
liver disease caused by the hepatitis B virus in the world including
China. Peginterferon is one of the first-line drugs recommended
for CHB in guidelines. Thusit is necessary to develop
new peginterferon in China and construct higher-level basis of
evidence-based medicine in Chinese CHB patients. Objective:
Evaluate efficacy and safety of Pegberon (180μg), that developed
in Chinese domestic company with gobal patent 40kD
Y-shape peglated interferon α-2b, by the head-to-head, randomized,
multi-center, positive controlled and open label clinical
study with PEG IFNα-2a (180μg). Provide a higher level
basis of evidence-based medicine for peginterferon treatment.
Methods: Open-label Phase III study enrolled 538 patients for
Pegberon group and 282 patients for PEG IFNα-2a group
with 48 weeks treatment and 24 weeks follow up. The proportion
of patients with HBeAg seroconversion and the safety
were evaluated. HBV DNA analyzed by COBAS ® , Version
2.0. Serum markers including quantitative HBsAg and HBsAb
were analyzed by cobas e 411 analyzer, and HBeAg was
analyzed by Elecsys HBeAg, HBeAb was analyzed by Elecsys
anti-HBe. Results: Pegberon group and PEG IFNα-2a group
had similar baseline virological and serological characteristics.
30.82%(102/331) patients in Pegberon group and
27.27%(48/176) patients in PEG IFNα-2a group achieved
HBeAg seroconversion respectively in the 507 patients that
completed the 72 weeks clinical trial at present. In intent-to
treat populationsboth groups had similar trends of HBV DNA,
HBeAg and HBsAg during 48-week treatment. At 48w, HBV
DNA negative rate in Pegberon group was 11.90%(64/538)
while 9.93%(28/282) in PEG IFNα-2a group. In addition,
rate of HBV DNA10 6 IU/mL enrolled were
treated with antiviral therapy from 24-32 weeks of gestation
using NUCs,except for LDT+TDF at the first trimester, including
330 in LdT group, 25 in TDF group, 27 in TDF+LdT group due
to LdT resistance, respectively. 171 cases who were unwilling
to take antiviral drugs served as controls. All infants were
vaccinated with recombinant HBV vaccine and hepatitis B
immune globulin (HBIG) according to standard immunoprophylaxis
procedure. MTCT rate was determined by HBV markers
including HBsAg and HBV DNA detection in 6 months after
birth. Results: Significantly lower HBV DNA levels were noted
in all the enrolled mothers when delivery. The rate of HBsAg
positive and HBV DNA detectable in infants at 6 months was
0% in each group. The incidence of undetectable cord blood
HBV DNA levels has no significant difference among the three
groups (LdT group, 99.2%; TDF group, 100%, LdT+TDF group,
100%, P>0.05),which were significantly higher than the controls(61.5%),No
severe adverse events or complications were
observed in all the mothers and infants. Conclusions: LdT and
TDF monotherapy or combotherapy were all effective and
well-tolerated in HBeAg positive high viral load mothers and
their infants on short term follow up, and these were associated
with significant reduction of MTCT.
Disclosures:
The following authors have nothing to disclose: yanqiong zhang, Hongfei Huang,
Quanxin Wu, Yuming Wang