Hengmu (tenofovir amibufenamide) / Jiangsu Hansoh Pharma - LARVOL DELTA

EFFICACY AND SAFETY OF TENOFOVIR AMIBUFENAMIDE IN PATIENTS WITH CHRONIC HEPATITIS B: A SYSTEMATIC REVIEW AND META-ANALYSIS (DDW 2025) - "While clinical trials have demonstrated the potent antiviral efficacy of TMF, real-world data comparing the TMF with other tenofovir prodrugs including tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) is limited. Conclusion TMF demonstrated improved eGFR compared to other tenofovir prodrugs, while showing similar viral response and ALT normalization rates. Other metabolic and renal outcomes were comparable, indicating TMF's potential as an alternative therapy with enhanced renal safety."

Retrospective data • Review • Dyslipidemia • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Efficacy and safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in patients with hepatitis B cirrhosis: a retro-prospective observational study (EASL 2025) - "Both TMF and TAF have profound antiviral effectiveness and improvement of liver fibrosis among patients with hepatitis B cirrhosis. The effects on blood lipids are mild and regular monitoring of blood lipid profiles is recommended."

Clinical • Observational data • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Immunological correlates of rapid HBsAg decline in chronic HBV hepatitis patients undergoing Tenofovir Amibufenamide treatment (EASL 2025) - "TMF antiviral treatment leads to a more pronounced HBsAg reduction in HBeAg positive naïve patients accompanied by consistent activation of B cells and monocytes, as well as a gradual decline in T cell activation. Only the HBeAg negative group exhibits a stronger HBV-specific T cell response. Our findings suggest potential differential immunological mechanisms underlying TMF's antiviral effect between HBeAg negative and positive patients, along with significant reduction of HBsAg during the early stage of TMF treatment."

Clinical • IO biomarker • Hepatitis B • Hepatitis C • Hepatology • Inflammation • CD4 • CD8 • CD80 • CD86 • IL2RA • ISG20 • PD-L1

Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide and entecavir in the hepatitis B virus related acute-on-chronic liver failure patients: a single-centre retrospective study (EASL 2025) - "TMF, TAF, and ETV exhibited no differences in the 60 - day overall survival rate among patients with HBV-ACLF. However, TMF and TAF showed a greater improvement in renal function compared to ETV."

Retrospective data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Failure

Effectiveness and safety of tenofovir amibufenamide and tenofovir alafenamide in treating elderly patients diagnosed with decompensated hepatitis B cirrhosis: a retrospective cohort study. (PubMed, Front Pharmacol) - "TMF treatment in elderly patients with decompensated hepatitis B cirrhosis had a good antiviral effect, no adverse drug reaction on renal function and blood lipids, and high safety. TMF is not inferior to TAF in antiviral efficacy and safety."

Clinical • Journal • Retrospective data • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation

Pharmacoeconomic analysis of tenofovir amibufenamide versus entecavir for the treatment of patients with chronic hepatitis B (ChiCTR) - P4 | N=200 | Completed | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New P4 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Efficacy and Safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in Patients with Hepatitis B Cirrhosis: A Retro-prospective Observational Study (APASL 2025) - "Supported by: Hansoh"

Clinical • Observational data • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation

Evaluation of Antiviral and Immunomodulatory Effects of Tenofovir Amibufenamide in Chronic HBV-replication Mouse Models (APASL 2025) - "Supported by: Hansoh"

Immunomodulating • Preclinical • Hepatitis B

Evaluation of the therapeutic efficacy of alafenamide fumarate and tenofovir amibufenamide in the treatment of chronic hepatitis B patients with concomitant hyperlipidemia (APASL 2025) - "Tenofovir amibufenamide (TMF) and tenofovir alafenamide fumarate (TAF), advanced nucleos(t)ide analogs, offer targeted liver delivery, potent antiviral effects, and improved safety profiles. We demonstrated TMF and TAF therapies were effective for CHB treatment. Also, our results showed that either TMF or TAF did not affect glycolipid metabolism of the patients. Table and Figure:Figure 1.Virological outcomes in TMF and TAF treated patients during 18 months follow-up."

Clinical • Dyslipidemia • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Metabolic Disorders

Efficacy and Safety of Tenofovir Amibufenamide (TMF) in HBV-Related End-Stage Liver Disease (HBV-ESLD) Patients: A Real-world Study (APASL 2025) - "In conclusion, TMF appears to be a highly effective option for managing HBV-ESLD, with similar safety outcomes to ETV, although further research is warranted to assess long-term benefits and risks. Table and Figure:Figure 1.Flowchart of participant enrollment.TMF, tenofovir amibufenamide; ETV, entecavir. Figure 2.Comparison of changes inprognostic scoring models between the TMF and ETV groups."

Clinical • Real-world • Real-world evidence • CNS Disorders • Gastrointestinal Disorder • Hepatic Encephalopathy • Hepatitis B • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Analysis of the Short-term Efficacy and Safety of Tenofovir Amibufenamide in the Treatment of Patients with HBV-related Acute-on-chronic Liver Failure (APASL 2025) - "TMF, as monotherapy or in combination with ETV, is not inferior in efficacy, renal and bone safety to TAF, ETV monotherapy, or TAF, TDF combined ETV therapy in treating HBV-ACLF patients. These findings provide a theoretical basis for using TMF in the management of HBV-ACLF patients. However, the study's limitations include a small sample size, missing blood lipid data, and short follow-up duration."

Clinical • Fibrosis • Hepatitis B • Hepatology • Immunology • Inflammation • Liver Failure

Therapeutic effect and influencing factors analysis of TMF and other nucleoside (acid) analogues combined with Peg-IFN-a-2b in treatment of CHB (APASL 2025) - "Background: To investigate the efficacy and influencing factors of tenofovir amibufenamide (TMF) and other nucleoside (acid) analogues (NAs) combined with Peg-IFN-α-2b in treatment of chronic hepatitis B(CHB) patients... Treatment of TMF combined with Peg-IFN-α-2b can rapidly achieve a significant decline in HBsAg at the early stage (12w) and continue to 24w, which is similar to the clinical efficacy of other NAs combined with PEG-IFN-α2b in the treatment of CHB. High ALT level and low GGT level at baseline were associated with significant HBsAg decline after early TMF combined with Peg-IFN-α-2b treatment. Table and Figure:Figure 1.Figure 1: Therapeutic effect of TMf combined with Peg-IFN-α-2b group and other NAs combined with Peg-IFN-α-2b group Figure 2.Figure 2 : Multiple linear regression analysis of TMF combined with Peg-IFN-α-2b therapy resulted in significant early (24w) HBsAg decline"

Hepatitis B • Hepatitis C • Hepatology • Inflammation • IFNA1

Effectiveness and Safety of 48-Week Tenofovir Amibufenamide in Patients with Hepatitis B Virus-Related Hepatocellular Carcinoma: A Retrospective Real-World Study (APASL 2025) - " This retrospective study enrolled HBV-related HCC patients who underwent antiviral treatment with TMF (25 mg/day) or entecavir (ETV) (0.5 mg/day) following HCC surgery, at The First Affiliated Hospital of Zhengzhou University, China, from August 2018 to August 2024. This study is the first to demonstrate that TMF exhibits favorable effectiveness and safety in the treatment of HBV-related HCC patients; notably, TMF showed a significantly higher rate of ALT normalization and a better lipid profile compared to ETV, with similar renal safety. Further large-scale studies are needed to confirm these findings. Table and Figure:Figure 1.Table 1 Laboratory parameters at baseline and 48 weeks in patients with hepatitis B virus-related hepatocellular carcinoma treated with TMF or ETV"

Real-world • Real-world evidence • Retrospective data • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Solid Tumor

Evaluation of Antiviral and Immunomodulatory Effects of Tenofovir amibufenamide in Chronic HBV-replication Mouse Models (APASL 2025) - "Mice were treated with AMI, Entecavir (ETV), or Tenofovir (TAF) orally from 14 to 27 days post HBV challenge. AMI demonstrated significant antiviral activity and immunomodulatory effects in both chronic HBV infection and replication mouse models. These findings suggest that AMI has potential as a therapeutic agent for chronic HBV infection by modulating T cell responses and reducing viral load."

Immunomodulating • Preclinical • Hepatitis B • Hepatology • Inflammation • CD4 • CD69 • CD8 • IFNG • IL2

Effectiveness and Safety of 48-Week Tenofovir Amibufenamide in Patients with Hepatitis B Virus-Related Cirrhosis: A Retrospective Real-World Study (APASL 2025) - "TMF and TAF exhibited similar 48-week effectiveness and safety profiles for patients with CHB-related cirrhosis in real-world settings. Future prospective, long-term validation studies are warranted. Table and Figure:Figure 1.Table 1."

Real-world • Real-world evidence • Retrospective data • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation

Efficacy and Safety of Tenofovir Amibufenamide and Tenofovir Alafenamide in Patients with Hepatitis B Cirrhosis: A Retro-Prospective Observational Study (APASL 2025) - "Both TMF and TAF have profound antiviral effectiveness and improvement of liver fibrosis among patients with hepatitis B cirrhosis. The effects on blood lipids are mild and regular monitoring of blood lipid profiles is recommended."

Clinical • Observational data • Dyslipidemia • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

The impact of switching from entecavir to tenofovir amibufenamide on HBsAg levels in patients with chronic hepatitis B: A real-world study (APASL 2025) - "Switching from entecavir to tenofovir amibufenamide in CHB patients resulted in a significant decrease in HBsAg levels. Switching from entecavir to tenofovir amibufenamide in chronic hepatitis B patients has good antiviral efficacy."

Clinical • Real-world • Real-world evidence • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Clinical research on early efficacy and safety of TMF for the treatment of patients with chronic hepatitis B (APASL 2025) - "Background: This study aimed to reveal the effectiveness and safety of tenofovir amibufenamide (TMF)in the real world, compared with tenofovir alafenamide (TAF) in patients with chronic hepatitis B (CHB). TMF had profound antiviral effectiveness and no adverse effects on renal function or blood lipids. Additionally, TMF was more efficient than TAF in inhibiting viral replication for treatment-naive patients ."

Clinical • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

New-generation nucleotide analogues in treating chronic hepatitis B within Asian population: a systematic review and network meta-analysis of randomized controlled trials (APASL 2025) - "Randomized controlled trials of new-generation NAs, including tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF), besifovir (BSV) and pradefovir (PDV), in Asian patients with CHB were selected...In addition, TMF ranked first regarding the effect on bone density of hip and spine (SUCRA=0.786 and 0.834) at week 48 followed by TAF (SUCRA=0.776 and 0.753) and BSV (SUCRA=0.0.463 and 0.540), as well as estimated glomerular filtration rate (TMF: 0.787, entecavir: 0.562, TAF: 0.541)... Among Asian patients with CHB, new-generation NAs have favorable virological responses and second generation tenofovir had better improvement of liver function. TMF appears to have advantages in improving liver cirrhosis and has less of an effect on bone density and renal function. The impact of second-generation tenofovir on blood lipids profiles needs to be confirmed."

Retrospective data • Review • Dyslipidemia • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Liver Cirrhosis

Efficacy and safety of tenofovir amibufenamide in the treatment of patients over 65 years of age with chronic hepatitis B (APASL 2025) - "In patients over 65 years of age with chronic hepatitis B and cirrhosis, TMF significantly inhibits HBV DNA replication and is well tolerated with a high rate of ALT reversion. Table and Figure:Figure 1.Complete virologic response rate in different patient populations after 12, 24, and 48 weeks of treatment with tenofovir amibufenamide Figure 2.Changes in HBsAg and ALT levels after 48 weeks of treatment with tenofovir amibufenamide"

Clinical • Dyslipidemia • Fibrosis • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Cirrhosis

Efficacy of Zhenqifuzheng capsule combined with Tenofovir Amibufenamide in treating chronic hepatitis B (APASL 2025) - "Zhenqifuzheng capsule combined with TMF in the treatment of CHB was superior to TMF alone in regulating immune function, and also superior to TMF alone in reducing HBVDNA load and enhancing HBeAg seroconversion rate."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • CD4 • CD8

Changes of HBV RNA in HBeAg-Positive Chronic Hepatitis B Patients with Low-Level Viremia Following Maintenance or Modification of Treatment Regimens with Nucleos(t)ide Analogues or Interferon Add-On Therapy (APASL 2025) - "Among the patients, 54 continued or modified NAs regimens (including single application of tenofovir, tenofovir alafenamide fumarate, or tenofovir amibufenamide, or combination therapy with entecavir), while eight modified their regimens with interferon add-on therapy. HBeAg-positive CHB patients with LLV showed elevated circulating HBV RNA levels compared to those achieving MVR. Interferon add-on therapy appeared to reduce HBV RNA more rapidly than NAs, suggesting its potential therapeutic value in mitigating viral transcription and replication activity in LLV patients. Table and Figure:Figure 1.Figure 1."

Clinical • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Cost-effectiveness of antiviral treatment for chronic hepatitis B virus infection in China under a standard clinical pathway (APASL 2025) - "High-barrier-to-resistance nucleos(t)ide analogues (NAs) have demonstrated significant efficacy in suppressing HBV DNA replication and delaying HBV-associated complications and the Chinese Medical Association recommends entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), and tenofovir amibufenamide (TMF) as the first-line therapeutics for CHB patients. For HBeAg+CHB patients, TDF/TMF>ETV is more cost-effective, whereas for HBeAg-CHB patients, TMF>ETV is more likely to be cost-effective than other treatment regimens, despite exceeding WTP. Table and Figure:Figure 1.Markov disease state transfer model Figure 2.Results"

Clinical • Cost effectiveness • HEOR • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Efficacy and Safety of Tenofovir Amibufenamide in Chronic Hepatitis B: A Real-World Analysis of Monotherapy and Combination Therapy with Pegylated Interferon Alpha (APASL 2025) - "This study aimed to evaluate the real-world effectiveness and safety of TMF, with comparisons to entecavir (ETV) and tenofovir disoproxil fumarate (TDF) in monotherapy and combination therapy with pegylated interferon alpha (Peg-IFNα). TMF demonstrates potential in achieving HBsAg clearance, and TMF combined with Peg-IFNα presents an effective option for achieving a functional cure for chronic hepatitis B. These findings support TMF as a safe and effective treatment option for CHB, offering a foundation for further studies to optimize treatment strategies."

Clinical • Combination therapy • Monotherapy • Real-world • Real-world evidence • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • IFNA1

The effect of tenofovir amibufenamide on lipid metabolism in patients with chronic hepatitis B is less than that of tenofovir alafenamide (APASL 2025) - "Both TMF and TAF can effectively inhibit HBV replication and promote liver function recovery without significantly impacting renal function. However, TAF may affect lipid metabolism, whereas the effect of TMF on lipid metabolism is not as pronounced. Table and Figure:Figure 1.Table 1."

Clinical • Dyslipidemia • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Metabolic Disorders