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

Real-world effectiveness and safety of tenofovir amibufenamide in treatment-naïve chronic hepatitis B: a 48-week retrospective cohort study. (PubMed, Front Med (Lausanne)) - "Tenofovir amibufenamide (TMF) is a newly recommended first-line nucleos(t)ide analogues for chronic hepatitis B (CHB) in China. Because the study lacked a comparator group, these findings should be regarded as observational. Comparative conclusions about the safety or superiority of TMF relative to tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) require dedicated head-to-head studies."

Journal • Real-world evidence • Retrospective data • Dyslipidemia • Hepatitis B • Infectious Disease • Inflammation

Pradefovir mesylate and tenofovir amibufenamide for chronic hepatitis B: a systematic review and pragmatic treatment algorithm. (PubMed, Front Pharmacol) - "Their clinical positioning relative to the guideline-endorsed benchmark tenofovir alafenamide (TAF) for chronic hepatitis B management remains undefined, particularly regarding renal/bone safety and drug-drug interaction profiles. TMF may represent an alternative to TAF for patients with renal/bone risk or anticipated long-term therapy, though definitive equivalence requires prospective head-to-head randomized trials. PDV offers comparable short-term efficacy to TDF, with longer-term data now available; continued follow-up will define its role among nucleotide prodrugs."

Journal • Review • Dyslipidemia • Hepatitis B • Infectious Disease • Inflammation • Metabolic Disorders • CYP3A4

Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response (clinicaltrials.gov) - P3 | N=930 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P3 trial • Hepatitis B • Infectious Disease • Inflammation

Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Beijing Continent Pharmaceutical Co, Ltd. | Not yet recruiting ➔ Completed

Trial completion • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Effectiveness and safety of tenofovir amibufenamide in the treatment of chronic hepatitis B patients with low-level viremia: a retrospective real-world study. (PubMed, BMC Gastroenterol) - "TMF combined with ETV was found to be effective in CHB patients with LLV and appeared to have a favorable safety profile within the limitations of the available data. It exhibits robust antiviral activity and can improve the liver function of patients."

Journal • Real-world evidence • Retrospective data • Dyslipidemia • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

A Study on the Efficacy and Pharmacoeconomics of Tenofovir Alafenamide versus Tenofovir Amibufenamide in the Treatment of Chronic Hepatitis B (ChiCTR) - P=N/A | N=270 | Completed | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University | N=138 ➔ 270 | Initiation date: Apr 2025 ➔ Jan 2026

Enrollment change • HEOR • Trial initiation date • Hepatitis B • Infectious Disease • Inflammation

A prospective, multicenter, controlled study of pegylated interferon α-2b in patients with high HBV-related hepatocellular carcinoma risk and post-radical resection (ChiCTR) - P=N/A | N=1000 | Recruiting | Sponsor: Shengjing Hospital of China Medical University; Shengjing Hospital of China Medical University

New trial • Hepatitis B • Hepatocellular Cancer • Infectious Disease • Oncology • Solid Tumor • AFP

Safety and Effectiveness of Peginterferon Alfa-2b Combined with Tenofovir Amibufenamide in Patients with Chronic Hepatitis B (APASL 2026) - No abstract available

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Related Factors for Low-Level Viremia and the Comparative Efficacy of Management Strategies in Treatment-Naïve Chronic Hepatitis B Patients Receiving Entecavir or Tenofovir Amibufenamide: A Real-World Study (APASL 2026) - No abstract available

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

Real-world impact of 48-week tenofovir amibufenamide therapy on lipid profiles in chronic hepatitis B (APASL 2026) - No abstract available

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

Real-World Study of Tenofovir Amibufenamide in the Treatment of Hepatitis B-Related Liver Cirrhosis (APASL 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Efficacy and Safety of Tenofovir Amibufenamide in the Treatment of Elderly Patients with Chronic Hepatitis B and Liver Cirrhosis (APASL 2026) - No abstract available

Clinical • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Safety and Effectiveness of Peginterferon Alfa-2b Combined with Tenofovir Amibufenamide in Patients with Chronic Hepatitis B (APASL 2026) - No abstract available

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Effectiveness and Safety of 96-Week Tenofovir Amibufenamide in Patients with Hepatitis B Virus-Related Hepatocellular Carcinoma: A Retrospective Real-World Study (APASL 2026) - No abstract available

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

Efficacy and safety of tenofovir amibufenamide in patients with chronic hepatitis B:An observational study (APASL 2026) - No abstract available

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

Efficacy and Cost-Effectiveness Analyses of Entecavir versus Tenofovir Amibufenamide in Patients with Chronic Hepatitis B. (PubMed, Drug Des Devel Ther) - "ETV showed better virologic response and lower drug-related costs than TMF in this single-center retrospective study, especially in HBeAg-negative patients. Further validation in multicenter prospective studies is needed."

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

Efficacy and safety of tenofovir amibufenamide in patients with chronic hepatitis B: a real-world clinical study. (PubMed, Front Med (Lausanne)) - "This study enrolled 186 patients with CHB, of whom 93 received TMF and 93 received tenofovir disoproxil fumarate (TDF) for 48 weeks. In real-world clinical practice, TMF is an effective treatment for CHB. Compared with TDF, TMF is associated with superior ALT normalization and higher HBeAg seroconversion rates, along with a more favorable renal safety profile."

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

Effects of tenofovir amibufenamide and entecavir on estimated glomerular filtration rate in treatment-naïve patients with chronic hepatitis B. (PubMed, World J Hepatol) - "In treatment-naïve patients with CHB, ETV treatment exhibited a strong association with an increased risk of decreased eGFR levels at 48 weeks in comparison with TMF."

Journal • Hepatitis B • Infectious Disease • Inflammation

A Study on the Efficacy and Pharmacoeconomics of Tenofovir Alafenamide versus Tenofovir Amibufenamide in the Treatment of Chronic Hepatitis B (ChiCTR) - P=N/A | N=138 | Completed | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New trial • Hepatitis B • Infectious Disease • Inflammation

Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P1 trial • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Efficacy and safety of PEG-IFN α-2b and tenofovir amibufenamide in combination therapy for chronic hepatitis B. (PubMed, BMC Infect Dis) - "PEG-IFN α-2b and TMF combination therapy effectively reduced HBsAg levels in CHB patients. Baseline HBsAg levels and the magnitude of their decline by week 24 served as robust predictors of serological response, exhibiting high diagnostic value."

Clinical • Journal • Alopecia • Fatigue • Hematological Disorders • Hepatitis B • Immunology • Infectious Disease • Inflammation • Neutropenia • Thrombocytopenia • IFNA1

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