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

Promote: The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT. (clinicaltrials.gov) - P=N/A | N=200 | Active, not recruiting | Sponsor: Ruijin Hospital | Trial completion date: Apr 2026 ➔ Apr 2028

Trial completion date • Hepatitis B • Infectious Disease • Inflammation

Efficacy of TDF, TAF, TMF, and TDF-to-TAF switch in chronic hepatitis B: a network meta-analysis. (PubMed, BMC Gastroenterol) - "Our findings may help guide the selection of individualized CHB treatment strategies. However, given the limited evidence and potential bias, these results are preliminary and must be interpreted with caution. For regimens such as TMF that lack robust data, well-established alternatives should be preferred. Long-term, multi-endpoint studies are required to confirm both efficacy and safety before routine clinical adoption."

Clinical • Journal • Retrospective data • Review • Hepatitis B • Infectious Disease • Inflammation

A Real-World Pharmacological Assessment of Tenofovir Amibufenamide and Tenofovir Alafenamide in 48-Week Chronic Hepatitis B Treatment: Efficacy, Safety, and Cost-Effectiveness. (PubMed, Curr Med Sci) - "TMF demonstrates stronger antiviral efficacy than both TAF formulations, with comparable safety profiles. Despite the cost advantages of CVBP-TAF resulting from procurement policies, the clinical benefits of TMF support its use. Future strategies should improve the affordability of TMF to expand its accessibility."

HEOR • Journal • Real-world evidence • Hepatitis B • Infectious Disease • Inflammation

EFFICACY AND SAFETY OF TENOFOVIR AMIBUFENAMIDE FUMARATE IN PATIENTS WITH ACUTE-ON-CHRONIC LIVER FAILURE: A MULTI-CENTER, PROSPECTIVE COHORT STUDY (AASLD 2025) - " A total of 196 patients with ACLF from 13 tertiary hospitals in China were divided into TMF, tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF), and entecavir (ETV) groups based on the antiviral drugs used. TMF exhibits an antiviral activity in patients with HBV-related ACLF, enhances liver and coagulation functions, and without adverse effects on renal function."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Failure

TREATMENT OF TENOFOVIR AMIBUFENAMIDE VERSUS TENOFOVIR ALAFENAMIDE IN PATIENTS WITH CHRONIC HEPATITIS B-RELATED CIRRHOSIS: EVIDENCE FROM A MULTICENTER REAL-WORLD STUDY (AASLD 2025) - "TMF was non-inferior to TAF in terms of anti-HBV efficacy and showed blood lipid and renal safety in compensated chronic hepatitis B related cirrhosis in 48 weeks."

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

UPDATE OF 96 WEEKS TENOFOVIR AMIBUFENAMIDE TREATMENT IN CHRONIC HBV-INFECTED PATIENTS WITH NORMAL ALANINE AMINOTRANSFERASE (THE PROMOTE STUDY) (AASLD 2025) - P=N/A | "TMF demonstrated sustained potent antiviral efficacy, while maintaining favorable safety profiles and tolerability. TMF treatment appears to reduce the incidence of virus replication associated ALT flare. Long-term follow up are required to observe the benefit of outcome improvement after antiviral treatment in such population."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

EFFECT OF FINITE DURATION PEGINTERFERON ALPHA-2B WITH OR WITHOUT NUCLEOS(T)IDE ANALOGUES ON LONG-TERM PROGNOSIS IN CHRONIC HEPATITIS B: PRELIMINARY 24-WEEK RESULTS: FROM THE MULTICENTER REAL-WORLD "VISION" STUDY IN CHINA (AASLD 2025) - "In the NA monotherapy group, 2, 14, 3, and 4 patients received entecavir (ETV), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), and tenofovir amibufenamide (TMF), respectively. These findings suggest that a HBsAg loss may be attainable with currently approved antiviral agents, even following a fixed 24-week treatment course, warranting further long-term investigation."

Clinical • Real-world • Real-world evidence • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Solid Tumor • IFNA1

INFLUENCING FACTORS OF BONE MINERAL DENSITY DECLINE IN CHRONIC HEPATITIS B PATIENTS TREATED WITH TENOFOVIR AMIBUFENAMIDE OVER 5 YEARS (AASLD 2025) - "In a phase III, double-blind, randomized controlled trial, TMF demonstrated non-inferior antiviral efficacy compared to tenofovir disoproxil fumarate (TDF), along with superior bone and renal safety profiles. After five years of treatment, half of the patients had an increased BMD Z score and the other decreases may be related to risk factors such as baseline high viral load and high serum calcium."

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

SAFETY AND EFFECTIVENESS OF TENOFOVIR AMIBUFENAMIDE FOR PREGNANT WOMEN WITH CHRONIC HEPATITIS B (AASLD 2025) - "This study preliminarily suggests that TMF treatment for pregnant women with chronic hepatitis B has favorable maternal and infant safety and effectiveness profiles. Combined with the hepatitis B immunization, it can successfully prevent HBV mother-to-child transmission. Future studies with larger sample sizes are needed to validate this conclusion."

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

SAFETY AND EFFECTIVENESS OF PEGINTERFERON ALFA-2B COMBINED WITH TENOFOVIR AMIBUFENAMIDE IN PATIENTS WITH CHRONIC HEPATITIS B (AASLD 2025) - "At week 48 of treatment, the switch combination group exhibited significantly higher rates of HBsAg loss and HBeAg seroconversion compared to the treatment-naïve combination group. Both groups maintained a favorable overall safety profile throughout the treatment period. These findings suggest that initiating therapy with nucleos(t)ide analogs followed by combination with Peg-IFN α may be a reasonable and promising strategy to promote HBsAg loss."

Clinical • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Leukopenia • Neutropenia • Thrombocytopenia • IFNA1

Interim Analysis of 48-week Tenofovir Amibufenamide Treatment in Chronic Hepatitis B Patients with Normal Alanine Aminotransferase Levels: The PROMOTE Study. (PubMed, J Clin Transl Hepatol) - P=N/A | "TMF treatment demonstrates significant efficacy in chronic HBV-infected patients with normal ALT levels and shows a favorable safety profile regarding bone, renal, and lipid parameters. The PROMOTE study is ongoing, and further results at 96 and 144 weeks are expected to provide additional insights."

Clinical • Journal • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Serum TNF-a and biomarkers levels after tenofovir therapy in patients with serum HBeAg-positive chronic hepatitis B. (PubMed, J Med Biochem) - "Moreover, it had a minimal impact on renal function and presented a higher safety profile compared to entecavir. These findings suggest Tenofovir Amibufenamide as a promising alternative for the treatment of HBeAg-positive CHB."

Biomarker • Journal • Hepatitis B • Infectious Disease • Inflammation • Renal Disease • TNFA

Tenofovir amibufenamide in chronic hepatitis B: Lipid changes and 144-week safety with tenofovir disoproxil fumarate-to-tenofovir amibufenamide switch. (PubMed, World J Gastroenterol) - "TMF provides sustained antiviral efficacy and maintains a favourable long-term lipid and renal safety profile. These findings support TMF as a viable first-line therapy and a switch option for CHB management in clinical practice."

Clinical • Journal • Retrospective data • Dyslipidemia • Hepatitis B • Infectious Disease • Inflammation • Metabolic Disorders

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