Vemlidy (tenofovir alafenamide) / Gilead - LARVOL DELTA

Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads (clinicaltrials.gov) - P=N/A | N=210 | Recruiting | Sponsor: Guangzhou 8th People's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Hepatitis B • Infectious Disease • Inflammation

Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis (Businesswire) - "New data to be presented at EASL will include a subgroup analysis from ASSURE, an ongoing open-label study, and an analysis of the Phase 3 RESPONSE trial and the open-label extension. Data will reinforce the effectiveness of Livdelzi (seladelpar), known as Lyvdelzi in the European Union, in reducing pruritus (chronic itch), a debilitating common symptom of primary biliary cholangitis (PBC). Moreover, the results will highlight seladelpar’s ability to deliver a sustained biochemical response regardless of prior treatment history, and as an option for a broad range of people with PBC....Key findings from 29 accepted abstracts will include two oral presentations showcasing new data on the critical goal of maintained virologic response following treatment with 2 mg and 10 mg bulevirtide in people living with hepatitis delta virus (HDV). These findings build on the wealth of long-term data for the treatment of chronic HDV."

Clinical data • Hepatitis B • Primary Biliary Cholangitis

Tenofovir Alafenamide Therapy Throughout Pregnancy in Mothers With Hepatitis B. (PubMed, Aliment Pharmacol Ther) - "This study suggests that TAF treatment throughout pregnancy is safe for mothers with chronic hepatitis B and their infants. TAF therapy represents a viable treatment option for these mothers."

Journal • Diabetes • Fibrosis • Gestational Diabetes • Gynecology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Renal Disease

Dual therapy with nucleos(t)ide analogues in the prevention of hepatitis B virus recurrence after liver transplantation: Two case reports. (PubMed, World J Hepatol) - "These cases suggest the efficacy of dual NA therapy in post-transplant HBV management, emphasizing the need to reconsider traditional treatment approaches."

Journal • Fibrosis • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Failure • Oncology • Respiratory Diseases • Solid Tumor • Transplantation

Comparison of Two Antiviral Medications in Preventing Hepatitis B Transmission From Mother to Child in Pregnancies With High Viral Loads (clinicaltrials.gov) - P=N/A | N=210 | Not yet recruiting | Sponsor: Guangzhou 8th People's Hospital

Head-to-Head • New trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum (clinicaltrials.gov) - P=N/A | N=205 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=325 ➔ 205

Enrollment change • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults with HIV/HBV Coinfection: An Open-Label, Single-Arm, Safety and Efficacy Switch Study. (PubMed, Viruses) - "BIC/FTC/TAF is a safe and suitable option for the treatment of HIV/HBV-coinfected patients."

Journal • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Virological and Biochemical Effects of Tenofovir Alafenamide in Different Patient Groups With Chronic Hepatitis B Virus Infection in Real-World Cohort. (PubMed, Int J Hepatol) - "No serious adverse events associated with TAF occurred, and discontinuation was not required in the total cohort. Our findings support that TAF treatment is well-tolerated and effective in patients with chronic HBV infection."

Journal • Real-world evidence • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Failure • Nephrology • Oncology • Osteoporosis • Renal Disease • Rheumatology • Solid Tumor • Transplantation

Revisiting the safety profile of tenofovir alafenamide: methodological reflections on real-world data. (PubMed, Hepatol Int) - No abstract available

Journal • Real-world evidence

Enhanced 2- and 3-Year recurrence-free survival rates with switching from Entecavir to Tenofovir post-radiofrequency ablation treatment in HBV-HCC patients (EASL 2025) - "This retrospective study aimed to compare the 3-year recurrence-free survival (RFS) rates among HBV- related HCC patients who switched from entecavir (ETV) to tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) after RFA with those who continued long-term ETV therapy. In HBV-HCC patients after RFA treatment, switching from ETV to NtAs (TDF or TAF) results in higher 2- and 3-year RFS rates compared to continuous NA therapy, indicating that NtAs may be superior to NAs in reducing the recurrence rate following curative treatment of HBV-related HCC."

Clinical • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology

Treatment duration, adherence and persistence in patients with chronic hepatitis B virus infection treated with long-term nucleos(t)ide analogues in Germany (EASL 2025) - "Adult patients who initiated single-drug formulation second-generation NA treatment (entecavir, telbivudine, tenofovir disoproxil fumarate, and tenofovir alafenamide) between January 1, 2015–August 31, 2022, and had a recorded diagnosis for chronic HBV infection in the year prior to their initial NA prescription, were selected. Treatment discontinuation remains a key challenge in the management of chronic HBV infection. This study highlights the unmet need for additional support to help patients persist with NA treatment. These results also underscore the critical need for alternative therapies for chronic HBV infection with shorter and finite treatment durations with a reduced need for rigid monitoring to mitigate the high discontinuation rate while ensuring optimal clinical outcomes."

Adherence • Clinical • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Atherosclerotic cardiovascular risk in patients with chronic hepatitis B: Tenofovir Disoproxil fumarate vs Tenofovir Alafenamide from a korean nationwide study (EASL 2025) - No abstract available

Clinical • Atherosclerosis • Cardiovascular • 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

Comparing Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in reducing hepatocellular carcinoma risk in chronic hepatitis B: a propensity score matching study (EASL 2025) - "TAF treatment was associated with a 66% lower risk of HCC compared to TDF treatment. Further studies with larger sample sizes and longer follow-up periods are needed to confirm these findings."

Addiction (Opioid and Alcohol) • Diabetes • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Metabolic Disorders • Oncology • Solid Tumor

Comparison of the effects of tenofovir alafenamide and entecavir on renal function and serum lipids in liver transplant recipients: a retrospective observational study (EASL 2025) - "We found no significant difference in renal safety between tenofovir alafenamide and entecavir. Switching from tenofovir disoproxil to either tenofovir alafenamide or entecavir did not improve kidney function in the short or long term. Entecavir demonstrated fewer dyslipidemic effects compared to tenofovir alafenamide, with lipid-lowering effects observed during the first two years of treatment."

Observational data • Retrospective data • Hepatology • Inflammation • Metabolic Disorders • Transplantation

Treatment persistence, discontinuation, and health care cost among chronic hepatitis B (CHB) patients initiating antiviral treatment (EASL 2025) - "TX-naïve CHB patients initiating tenofovir alafenamide fumarate (TAF), entecavir (ETV), or tenofovir disoproxil fumarate (TDF) between 01Nov2016 and 30Nov2022 were identified. Despite having greater pharmacy costs, TAF was found to have higher adherence, longer persistence, and similar medical cost versus ETV and TDF, especially among patients 65+ years old. These findings have clinical implications for patient engagement, therapy selection, and achieving long-term treatment success and should be considered when formulary decisions and exclusions are implemented as they may impact patient outcomes."

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

Effectiveness and renal safety following switching to tenofovir alafenamide in patients with chronic hepatitis B: Results from a five-year, multicenter cohort study (EASL 2025) - "Prior treatments included entecavir (ETV) for 177 patients, tenofovir disoproxil fumarate (TDF) for 122, and combination therapy for 115: 52 patients (12.6%) remained HBV DNA positive. This five-year follow-up of CHB patients who had been switched to TAF found sustained high virological and biochemical efficacy. Treatment efficacy and renal safety for patients with CKD were comparable to that of non-CKD patients."

Clinical • Chronic Kidney Disease • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

Impact of long-term tenofovir-based treatment on hepatocellular carcinoma risk in patients with chronic hepatitis B using the reREACH-B score (EASL 2025) - " In 2 Phase 3 studies evaluating tenofovir alafenamide (TAF), HBeAg-positive (n = 1039) and -negative (n = 593) patients were randomised (2:1) to receive either once-daily TAF 25 mg or tenofovir disoproxil fumarate (TDF) 300 mg for up to 3 years (Y), followed by open-label TAF through Y8... Using data from studies of patients receiving tenofovir-based therapy, we highlight the importance of treatment to reduce HCC risk. Application of reREACH-B risk scores supports that few patients at low risk for HCC at treatment initiation developed HCC, while many high-risk patients improved to a lower risk after long-term treatment."

Clinical • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Solid Tumor

Identifying risk factors linked to metabolic-associated steatotic hepatitis in people living with HIV in Newark, New Jersey (EASL 2025) - "No statistically significant differences were found between the groups in gender, race, ethnicity, use of tenofovir alafenamide, second-generation integrase inhibitors, diabetes mellitus, or concurrent statin use (p ≥ 0.05)... The strongest predictors of MASH were VAI, waist-hip ratio, BMI, and age. Refining MASH screening recommendations for PLWH involves prioritizing high-risk individuals based on specific metabolic indicators, integrating non-invasive tools into routine HIV care, and addressing health disparities through resource allocation and tailored guidelines. These efforts can improve early detection, intervention, and overall outcomes for this vulnerable population."

Clinical • Diabetes • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Impact of long-term oral antiviral treatment on hepatocellular carcinoma risk in patients with chronic hepatitis B who are hepatitis B e antigen positive using the PAGED-B score (EASL 2025) - " In a Phase 3 multicentre study (GS-US-320-0110), patients who were HBeAg positive with HBV DNA ≥ 20,000 IU/mL and alanine aminotransferase > 60 U/L (males) or > 38 U/L (females) were randomised to receive tenofovir alafenamide (TAF) 25 mg or tenofovir disoproxil fumarate (TDF) 300 mg once daily for up to 3 years... The application of the PAGED-B risk score demonstrates that among HBeAg-positive patients, most (69%) high-risk patients experienced a decrease in risk with long-term treatment, whereas shifts from low risk of HCC at the start of treatment to a higher risk category were rare (1%)."

Clinical • Diabetes • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Metabolic Disorders • Oncology • Solid Tumor

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

Atherosclerotic cardiovascular risk in patients with chronic hepatitis B: Tenofovir Disoproxil fumarate vs Tenofovir Alafenamide from a korean nationwide study (EASL 2025) - "TAF showed a significantly lower risk of ASCVD compared to TDF in patients with CHB, providing valuable guidance for clinicians in selecting the appropriate initial treatment for these patients."

Clinical • Atherosclerosis • Cardiovascular • Hepatitis B • Hepatitis C • Hepatology • Hypertension • Infectious Disease • Inflammation

Hepatocellular carcinoma risk in patients with chronic hepatitis B: Tenofovir Disoproxil Fumarate vs Tenofovir Alafenamide from a korean nationwide study (EASL 2025) - "This study showed that TAF had a protective effect against HCC in patients with CHB, providing valuable guidance for clinicians in selecting the appropriate initial treatment for these patients."

Clinical • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Solid Tumor

Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Humanis Saglık Anonim Sirketi | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pediatrics

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