This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.

Start Date15 Jun 2024

Sponsor / Collaborator-

ChiCTR2300074909

/ RecruitingPhase 1IIT

Evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of nebulized inhalation of pegylated interferon alpha-2b injection in healthy adult subjects

Start Date10 Aug 2023

Sponsor / Collaborator-

CTRI/2020/12/029855

/ Active, not recruitingPhase 3

A Phase III, Randomized, Controlled, Open-Label Studyto Evaluate the Efficacy and Safety of PegylatedInterferon Alfa-2b In the Treatment of Adult PatientsDiagnosed With SARS-CoV-2 (COVID-19).

Start Date17 Dec 2020

Sponsor / Collaborator-

100 Clinical Results associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

100 Translational Medicine associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

100 Patents (Medical) associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

469

Literatures (Medical) associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

01 Dec 2025·Journal of Virus Eradication

Efficacy and predictors of pegylated-interferon in hepatitis B surface antigen seroclearance in immune active and inactive chronic hepatitis B patients

Article

Author: Han, Chao ; Zhu, Mujia ; Zhang, Xiaoyong ; Liu, Zhihong ; Li, Guiping ; Jin, Linlin ; Qin, Qiuying

Background and objectives:

Pegylated interferon (PegIFN) is one of the few strategies capable of achieving hepatitis B surface antigen (HBsAg) seroclearance in chronic hepatitis B (CHB) patients. However, its role in HBeAg-negative chronic HBV infection (also referred to as immune-inactive or "inactive carrier" phase) remains unclear. This study compared PegIFN efficacy between immune-inactive and immune-active patients and explored predictors of treatment response.

Research methods:

We retrospectively analyzed 211 consecutive HBeAg-negative patients treated with PegIFN α-2b in our center from 2019 to 2023, including 139 with immune-inactive chronic HBV infection and 72 immune-active CHB patients. Effectiveness was assessed in the full analysis set (FAS) and efficacy in the per-protocol set (PPS). Predictors of HBsAg seroclearance were identified using Cox regression.

Results:

At week 48, overall HBsAg seroclearance was 26.5 % (FAS), with comparable outcomes between immune-inactive and immune-active groups (26.6 % vs. 26.4 %, P > 0.05). Inactive patients receiving PegIFN + nucleos(t)ide analogues (NAs) showed no added benefit. In the PPS, clearance reached 69.1 %, but 40.3 % discontinued prematurely-mostly due to subjective intolerance-highlighting a major gap between real-world effectiveness and theoretical efficacy. Multivariate analysis identified two independent predictors: baseline HBsAg <100 IU/mL (HR 2.999, 95 % CI 1.625-5.536, P < 0.001) and on-treatment HBsAg decline ≥1 log₁₀ IU/mL within any 12-week interval (HR 11.205, 95 % CI 4.379-28.674, P < 0.001).

Conclusions:

PegIFN α-2b achieved clinically meaningful HBsAg seroclearance in both immune-inactive and immune-active patients. Early discontinuation markedly reduced real-world effectiveness. Baseline low HBsAg and dynamic on-treatment decline are pragmatic predictors for optimizing patient selection and guiding interferon-based strategies.

01 Dec 2025·Hepatology International

Machine learning prediction of rapid HBsAg seroclearance at week 24 in inactive carriers treated with pegylated interferon

Article

Author: Li, Jiabin ; Huang, Yan ; Yu, Zujiang ; Zeng, Yilan ; Gao, Haibing ; Chen, Xinyue ; Wang, Xiaozhong ; Zhao, Jing ; Dong, Jianxia ; Yu, Haitian ; Meng, Xinyue ; Ren, Shan ; Ye, Xiangyang ; Wu, Pengxuan ; Zhang, Wenhua ; Dang, Shuangsuo ; Zheng, Sujun

Abstract:

Background and aim:

To identify predictive factors for rapid hepatitis B surface antigen (HBsAg) seroclearance at week 24 in inactive HBsAg carriers (IHC) receiving pegylated interferon alpha-2b (Peg-IFN) therapy, and to develop a machine learning-based model to optimize individualized treatment strategies.

Methods:

This retrospective analysis was based on a multicenter, prospective cohort study involving 2882 IHC patients treated with Peg-IFN and followed for at least 24 weeks. Predictive variables for week 24 HBsAg seroclearance were selected using both LASSO regression and the Boruta algorithm. Nine machine learning models were developed, including logistic regression (LR), decision tree (DT), and random forest (RF), with performance assessed via tenfold cross-validation. External validation was conducted in an independent cohort ( n = 167) from three medical centers in Beijing. SHapley Additive Explanations (SHAP) were used to interpret model predictions and feature importance.

Results:

The overall HBsAg seroclearance rate at week 24 was 18.7% (541/2,882). Key predictive factors included baseline HBsAg level, ≥ 1 log IU/mL decline in HBsAg at week 12, the ratio of alanine aminotransferase (ALT) to HBsAg at week 12, the ratio of week 12 ALT to baseline HBsAg, week 12 hepatitis B virus (HBV) DNA level, and week 12 hepatitis B surface antibody (HBsAb) level. The Light Gradient Boosting Machine (Light GBM) model demonstrated the best performance, achieving an area under the receiver operating characteristic curve (AUC) of 0.902 (95% CI 0.881–0.923) and a sensitivity of 0.889 in the training cohort, and an AUC of 0.917 (95% CI 0.850–0.983) with a sensitivity of 0.879 in the external validation cohort. SHAP analysis revealed that the week 12 ALT/ HBsAg ratio was the most impactful feature.

Conclusions:

We developed a LightGBM-based machine learning model that accurately predicts rapid HBsAg seroclearance at week 24 among IHC patients receiving Peg-IFN therapy. This model offers a valuable tool for early identification of rapid responders, personalized treatment planning, and potential discontinuation strategies. The individualized stopping rules derived from model-predicted probabilities provide an evidence-based approach to precision therapy in IHC patients.

01 Nov 2025·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

High‐Throughput Viral Integration Detection Reveals Baseline Breakpoints Burden Associated With HBsAg Seroclearance

Article

Author: You, Jie ; Huang, Fei ; Wang, Peng ; Wang, Xiaojing ; Yan, Weiming ; Chen, Tao ; Wu, Qianjun ; Xi, Dong ; Wu, Di ; Ning, Qin ; Han, Meifang ; Wu, Wenyu ; Zhang, Yixuan ; Gu, Misi

ABSTRACT:

Background:

The profiles of hepatitis B virus (HBV) integration related to hepatitis B surface antigen (HBsAg) loss remain largely unknown.

Aims:

We aimed to delineate the patterns of HBV integration in virally suppressed chronic hepatitis B (CHB) patients and their association with HBsAg loss following antiviral therapy.

Methods:

Forty‐five patients with paired liver biopsies were randomly selected from the Anchor study for high‐throughput viral integration detection. The primary endpoint was HBsAg loss at Week 96. In Group II (pegylated interferon alpha‐2b & entecavir), 13 patients achieved HBsAg loss, whereas all patients in Group I (entecavir monotherapy) and 17 in Group II failed to achieve HBsAg loss.

Results:

At baseline, the level of clonal expansion was positively correlated with the duration of nucleos(t)ide analogue (NUC) treatment, the alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, whereas no association was observed with the HBsAg, hepatitis B core‐related antigen (HBcrAg), HBV RNA or covalently closed circular DNA (cccDNA) levels. Patients with less than 28 breakpoint types achieved a significantly higher rate of HBsAg loss following Peg‐IFN‐based therapy at Week 48 and 96, compared to those with more than 28.

Conclusions:

The duration of NUC treatment, as well as ALT and AST levels, were associated with the level of clonal expansion in virally‐suppressed patients. A lower number of breakpoint types at baseline may be related to a higher HBsAg loss rate following Peg‐IFN‐based treatment and serve as a useful marker in guiding treatment decision‐making (NCT02327416).

Trial Registration:

The Anchor study is registered at ClinicalTrials.gov, NCT02327416

News (Medical) associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

19 Sep 2025

·www.prnewswire.com

AusperBio Completes Enrollment in Two Phase II Clinical Trials of AHB-137 for Chronic Hepatitis B

SAN FRANCISCO, Sept. 18, 2025 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio), a clinical-stage biotechnology company advancing targeted oligonucleotide therapies for chronic hepatitis B (CHB) functional cure, today announced the completion of patient enrollment in two Phase II clinical trials evaluating its lead candidate, AHB-137, in patients with chronic hepatitis B ( CHB), marking an important milestone in the clinical development program. The Phase II study AB-10-8007 (NCT07069569) is a randomized, open-label, multicenter study to evaluate the efficacy and safety of AHB-137 Injection in combination with either a hepatitis B vaccine or pegylated interferon α-2b (Peg-IFN) in participants with HBeAg-negative CHB receiving nucleos(t)ide analogue (NA) therapy. The Phase II study AB-10-8008 (NCT06829329) is a randomized, multicenter study to evaluate the efficacy and safety of AHB-137 Injection in treatment-naïve participants with CHB. "Combination therapies have historically been a key to treat or cure chronic viral infections, including HIV and HCV." said Dr. Guofeng Cheng, Co-founder and CEO of AusperBio. "The AB-10-8007 study aims to combine AHB-137 with approved HBV treatments to further increase functional cure rates, while the AB-10-8008 study explores the potential to expand AHB-137 treatment to a broader patient population. Together, these studies could further establish AHB-137 as the potential backbone therapy for HBV functional cure. We look forward to sharing interim results at international conferences throughout 2026." "We are deeply grateful to the patients, investigators, site teams, and our AusperBio colleagues for their dedication and contributions to reaching this important milestone," said Dr. Chris Yang, Co-founder and CSO of AusperBio. "The completion of enrollment in these Phase II trials positions us well as we move into the pivotal Phase III study of AHB-137, which was recently approved in China. We are excited and committed to advancing new treatment options with the goal of bringing a functional cure to a broader population of patients living with HBV." About AHB-137 AHB-137, a novel unconjugated antisense oligonucleotide ( ASO) designed using AusperBio's proprietary Med-Oligo™ ASO technology platform and an investigational medicine, is being developed to achieve a functional cure for chronic hepatitis B. Its clinical development has generated promising data, with key preclinical and clinical results presented at global leading conferences including EASL (2023, 2024, 2025), AASLD (2024), and APASL (2025). This novel dual-mechanism ASO has completed its global Phase 1 trial and is currently advancing through multiple Phase 2 trials and a phase 3 trial in China. Supported by a clear global development strategy, AHB-137 is progressing rapidly toward delivering a potential cure for HBV. About AusperBio. AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on achieving functional cure for chronic hepatitis B infection. The company has developed a proprietary Med-Oligo™ ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining with efficient targeted delivery conjugation technologies, the modular Med-Oligo™ Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases. For further information, please contact: Media Contact Email: [email protected] Investor Relations Contact: Tel: 650-888-1756 (US) Email: [email protected] SOURCE AusperBio Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2OligonucleotidePhase 3Phase 1Vaccine

100 Deals associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Condylomata Acuminata	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014
Hepatitis B	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014
Hepatitis C	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	Mexico	Zydus Lifesciences Ltd.	11 Aug 2020

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PB2730 (EHA2025)	Not Applicable	Chronic phase chronic myeloid leukemia	17	PEG IFNα-2b + TKI	atfnondzkm(mwuskiozkc) = aqykrngucv miupwbcthi (ksjaefnfok ) View more	Positive	14 May 2025
EHA2024	Not Applicable	Polycythemia Vera \| Thrombocythemia, Essential	81	Peg-IFN-α-2b	jdvgukellu(diccjkrzva) = kxjntcmqnv nfeefasaqc (cwtmfrsndu )	Positive	14 May 2024
Pubmed \| J Clin Gastroenterol	Phase 3	Hepatitis C	125	Peginterferon-α-2b plus Ribavirin	wrvbfurmae(junhpumqvj) = ubayhhsady qkyszfdsog (klugmypjkn ) View more	-	01 Sep 2012
Pubmed \| Clin Genitourin Cancer	Phase 2	Advanced Renal Cell Carcinoma	32	Pegylated IFN-alpha 2b	plifkmhjhx(exagkzzzms) = fjkntljkep boipcsytfk (bwloycoqmu, 18 - not reached) View more	-	01 Mar 2008

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