Hepavir B (pradefovir) / Ligand, Bausch Health, Xi’an XinTong Pharma - LARVOL DELTA

96-week treatment of Pradefovir vs. Tenofovir Disoproxil Fumarate in chronic hepatitis B patients (APASL 2025) - "Background: Pradefovir (PDF) is a liver-targeted prodrug of adefovir, a nucleoside/nucleotide analogue developed to treat the patients with hepatitis B virus (HBV) infection. After 96-week treatment of the patients with HBV infection, PDF remained its viral suppression rate as good as TDF with a significant reduction of the serum HBsAg level; a continued better safety profiles and a better bone and renal safety suggesting that PDF maybe a better choice of NUCs in hepatitis cure regimen. Table and Figure:Figure 1.Proportion of patients with virological suppression (LLOQ=29IU/mL) at week 48w and 96w in HBeAg-positive patients (A) and HBeAg-negative patients (B). Proportion of patients whose serum HBsAg level declined more than 1log10 IU/mL in HBeAg-positive patients (C)."

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

A RANDOMISED, DOUBLE-BLIND, PHASE 3, NON-INFERIORITY TRIAL OF PRADEFOVIR MESYLATE VERSUS TENOFOVIR DISOPROXIL FUMARATE FOR PAITENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION (AASLD 2023) - "Background: Pradefovir is a liver-targeted prodrug of adefovir, a nucleoside/nucleotide analogue with antiviral activity against hepatitis B virus (HBV) DNA polymerase. These findings suggest that the efficacy of Paladofovir 45mg QD is equal to or better than TDF 300mg, and the safety of Paladofovir 45mg QD has significant advantages, which can be used in the treatment of HBeAg-positive or HBeAg-negative adult patients with chronic hepatitis B."

Clinical • Head-to-Head • P3 data • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation

Pradefovir Treatment in Patients with Chronic Hepatitis B: Week 24 Results from a Multicenter, Double-blind, Randomized, Noninferiority, Phase 2 Trial. (PubMed, Clin Infect Dis) - "Pradefovir exhibited comparable reductions in HBV DNA levels to TDF. All treatments were safe and well tolerated."

Clinical • Head-to-Head • Journal • P2 data • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study (clinicaltrials.gov) - P3; N=900; Recruiting; Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Clinical • New P3 trial • Hepatitis B • Hepatology • Infectious Disease

[VIRTUAL] Pradefovir in naive or experienced adult patients with chronic infection of hepatitis B virus: week24 results from 23 multicentre, double-blind, randomised, non-inferiority, phase2 trials (EASL-ILC-I 2020) - "The phase 2 study is to evaluate the safety and tolerability of multiple oral doses of pradefovir 30 mg, 45 mg, 60 mg, and 75 mg, compared to tenofovir disoproxil fumarate (TDF) 300 mg. The reductions in HBV DNA with pradefovir treatment groups demonstrated comparable /or superior to the control TDF once daily group. A higher rate of HBeAg loss in receiving pradefovir treatment groups were observed comparing to the TDF 300mg treatment group."

Clinical • Head-to-Head • P2 data • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Renal Disease

Simultaneous determination of pradefovir, PMEA and tenofovir in HBV patient serum using liquid chromatography-tandem mass spectrometry and application to phase 2 clinical trial. (PubMed) - J Chromatogr B Analyt Technol Biomed Life Sci - "The assays were validated according to current bioanalytical guidelines including specificity, linearity (2.0-500ng/mL for pradefovir and PMEA, 4.0-1000ng/mL for tenofovir), accuracy and precision, extraction recovery, matrix effect and stability. The validated method has been successfully applied to the pharmacokinetic study of pradefovir, adefovir dipivoxil and tenofovir disoproxil fumarate in a set of HBV patients."

Journal • Biosimilar

Pradefovir in naive or experienced adult patients with chronic infection of hepatitis b virus: week24 results from 23 multicentre, double-blind, randomised, non-inferiority, phase2 trials (EASL-ILC 2020) - No abstract available

Clinical • Head-to-Head • P2 data

Safety, efficacy, and pharmacokinetics of pradefovir for the treatment of chronic hepatitis B infection. (PubMed, Antiviral Res) - "Short-term use of pradefovir was well tolerated. A decline in HBV DNA levels was superior to TDF at higher doses of pradefovir. 30-60 mg pradefovir is recommended for CHB treatment."

Clinical • Journal • PK/PD data

Association of pharmacogenomics and pharmacokinetics with antiviral activity of Pradefovir for treatment of chronic hepatitis B infection (EASL-ILC 2019) - "The aim of this study was to evaluate the association of pharmacogenomics and pharmacokinetics with antiviral activity of pradefovir for treatment of chronic hepatitis B infection(CHB). 50 CHB patients were divided into five groups (10 for each group) and randomized within each group in the ratio 6:2:2 to receive an ascending dose of 30, 60, 75, 90, or 120 mg of pradefovir, adefovir dipivoxil 10mg or tenofovir disoproxil 300mg once a day for twenty eight days. Pradefovir was found to be well tolerated and effectively inhibit hepatitis B virus in this study. Drug Metabolizing Enzymes and Transporter gene polymorphism was associated with the exposure of PMEA and antiviral effect. On the basis of these results, The gene polymorphism should be explored in phase- trials of treating CHB patients.Figure 1: The drop value of HBV DNALog10, IU/mL"

Biomarker • Late-breaking abstract • PK/PD data