ArticleAlimentary pharmacology & therapeutics2021
Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B.
Article in Alimentary pharmacology & therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 52 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Multicenter, Double-blind, Double-dummy, Parallel-controlled Study to Evaluate the Safety and Efficacy of HS-10234 25 mg QD Versus TDF 300 mg QD for the Treatment of Patients With HBeAg+/- Chronic HBV Infection.
To Evaluate the Efficacy and Safety of Tenofovir Amibufenamide in Chronic Hepatitis B (CHB) Patients With Low-level Viraemia (LLV) After Entecavir Treatment
A Prospective, Randomized, Blank Control, Multicenter Study to Evaluate the Efficacy and Safety of Alanine Aminotransferase（TMF）in the Treatment of Chronic Hepatitis B Patients With Normal Alanine Aminotransferase.
Who cites it
52 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Efficacy of TDF, TAF, TMF, and TDF-to-TAF switch in chronic hepatitis B: a network meta-analysis.BMC gastroenterology · 2025Pooled it
- Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update.Hepatology international · 2024Guideline
- [Chinese guideline for diagnosis and management of drug-induced liver injury (2023 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2023Guideline
- [Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024Trial
- [Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024Trial
- Effect of Food on the Pharmacokinetics of Tenofovir Amibufenamide: A Phase I, Randomized, Open-Label, Two-Period Crossover Trial in Healthy Adult Subjects.Drug design, development and therapy · 2023Trial
- [Effect of switching from entecavir to tenofovir amibufenamide on HBsAg levels in patients with chronic hepatitis B: a 96-week real-world study].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026Article
- Effectiveness and safety of tenofovir amibufenamide in the treatment of chronic hepatitis B patients with low-level viremia: a retrospective real-world study.BMC gastroenterology · 2026Article
- Effectivity and safety of TAF in CHB patients with concurrent MASLD: a real-world study.BMC gastroenterology · 2026Article
- Effects of tenofovir amibufenamide and entecavir on estimated glomerular filtration rate in treatment-naïve patients with chronic hepatitis B.World journal of hepatology · 2026Article
- [Advances in clinical features, diagnosis, and treatment of pre-acute-on-chronic liver failure].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026Review
- Efficacy and safety of tenofovir amibufenamide in patients with chronic hepatitis B: a real-world clinical study.Frontiers in medicine · 2026Article
- Real-world effectiveness and safety of tenofovir amibufenamide in treatment-naïve chronic hepatitis B: a 48-week retrospective cohort study.Frontiers in medicine · 2026Article
- Efficacy and Cost-Effectiveness Analyses of Entecavir versus Tenofovir Amibufenamide in Patients with Chronic Hepatitis B.Drug design, development and therapy · 2026Article
- Pradefovir mesylate and tenofovir amibufenamide for chronic hepatitis B: a systematic review and pragmatic treatment algorithm.Frontiers in pharmacology · 2026Review
- A Real-World Pharmacological Assessment of Tenofovir Amibufenamide and Tenofovir Alafenamide in 48-Week Chronic Hepatitis B Treatment: Efficacy, Safety, and Cost-Effectiveness.Current medical science · 2025Article
- Interim Analysis of 48-week Tenofovir Amibufenamide Treatment in Chronic Hepatitis B Patients with Normal Alanine Aminotransferase Levels: The PROMOTE Study.Journal of clinical and translational hepatology · 2025Article
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- Serum TNF-a and biomarkers levels after tenofovir therapy in patients with serum HBeAg-positive chronic hepatitis B.Journal of medical biochemistry · 2025Article
- Effectiveness and Safety of Tenofovir Amibufenamide in the Treatment of Chronic Hepatitis B: A Real-world, Multicenter Study.Journal of clinical and translational hepatology · 2025Article
Corrections and comments
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Authors and funding
26 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTenofovir amibufenamide (TMF) can provide more efficient delivery than tenofovir disoproxil fumarate (TDF).
aimTo compare the efficacy and safety of TMF and TDF for 48 weeks in patients with chronic hepatitis B (CHB).
methodsWe performed a randomised, double-blind, non-inferiority study at 49 sites in China. Patients with CHB were assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo. The primary efficacy endpoint was the proportion of patients with hepatitis B virus (HBV) DNA less than 20 IU/mL at week 48. We also assessed safety, particularly bone, renal and metabolic abnormalities.
resultsWe randomised 1002 eligible patients. The baseline characteristics were well balanced between groups. After a median 48 weeks of treatment, the non-inferiority criterion was met in all analysis sets. In the HBeAg-positive population, 50.2% of patients receiving TMF and 53.7% receiving TDF achieved HBV DNA less than 20 IU/mL. In the HBeAg-negative population, 88.9% and 87.8%, respectively, achieved HBV DNA less than 20 IU/mL in the TMF and TDF groups. Patients receiving TMF had significantly less decrease in bone mineral density at both hip (P < 0.001) and spine (P < 0.001), and a smaller increase in serum creatinine at week 48 (P < 0.05). Other safety results were similar between groups.
conclusionTMF was non-inferior to TDF in terms of anti-HBV efficacy and showed better bone and renal safety. (NCT03903796).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.