adefovir dipivoxil / Generic mfg. - LARVOL DELTA

Drug-induced osteoporosis/osteopenia: a pharmacovigilance analysis using the FDA Adverse Event Reporting System database. (PubMed, Clin Exp Rheumatol) - "This FAERS-based study identified multiple drug classes associated with OP/OPN-related adverse event signals, with anti-viral drugs - particularly tenofovir disoproxil and its combination therapies - exhibiting the strongest signal. Although glucocorticoids had a lower reporting proportion, their short onset time underscores the need for vigilance. These findings provide real-world evidence for drug safety management and highlight the necessity of bone health monitoring in long-term medication users. Future studies should integrate clinical data to validate these findings and explore underlying mechanisms."

Adverse events • Journal • Osteoporosis • Rheumatology

Monkeypox Virus Is Inhibited by Nucleoside Analogues Including the Acyclic Phosphonates Adefovir and Tenofovir In Vitro. (PubMed, J Med Virol) - "We developed in vitro screening assays using recombinant strains of vaccinia virus and MPXV to measure the antiviral potency of compounds, finding that adefovir dipivoxil and tenofovir alafenamide had potent anti-orthopoxvirus activity and low toxicity. These data reinforce interest in repurposing nucleoside analogues as antivirals to treat poxvirus infections and provide a basis for high throughput screening and mechanistic and antiviral resistance studies."

Journal • Preclinical • Infectious Disease

Entecavir-Associated Fanconi Syndrome in a Liver Transplant Recipient (KIDNEY WEEK 2025) - "While nucleos(t)ide analogs such as adefovir and tenofovir are well-established culprits, especially in HIV or HBV populations, Entecavir is rarely implicated...Case Description A 60-year-old male with HBV-related cirrhosis status-post liver transplantation, chronic antibody-mediated rejection (on Tacrolimus and Prednisone), type 2 diabetes mellitus, and chronic kidney disease (baseline Creatinine (Cr) 1.4–1.6 mg/dL) presented with recurrent falls and altered mental status. Notable medications included Entecavir started 5 years prior , Voriconazole (for phaeohyphomycosis), and Atovaquone/Sulfadiazine (for disseminated toxoplasmosis)...Discussion Occurrence of hallmark features—including phosphaturia, uricosuria, and hyperchloremic metabolic acidosis—suggests a potential class effect of nucleos(t)ide analogs in susceptible individuals. Thus, clinicians should maintain a high index of suspicion for Fanconi syndrome in patients receiving long-term nucleos(t)ide analog..."

Clinical • Antibody-mediated Rejection • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Fibrosis • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease • Transplantation • Type 2 Diabetes Mellitus

A RARE CASE OF GUILLAN-BARRE SYNDROME RESULTING FROM HEPATITIS B FLARE IN A CHRONIC CARRIER (UEGW 2025) - "Clinical Case Summary: Our patient was a 66yr Chinese man who was treated for active Chronic Hepatitis B from 2009 with Lamivudine, Adefovir and then switched to Tenofovir from 2020 with long term undetectable Hepatitis B viral load (HBV VL) and normal Liver function tests...Nerve Conduction study (NCS) reported acute inflammatory demyelinating polyneuropathy.EMG was unremarkable.A probable diagnosis of GBS was made.His ALT was down to 304 and HBV VL 3.82 log.NCS repeated 2 months later and showed similar inflammatory demyelinating polyneuropathy.NCS repeated 4 months later showed significant improvement which confirmed a diagnosis of GBS1 year from his first presentation, he recovered fully.Only 7 cases of Hepatitis B related GBS have been reported in the literature. Our case highlights GBS resulting from Hepatitis B flare"

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

EXPOSURE TO TENOFOVIR ALAFENAMIDE AND TENOFOVIR DISOPROXIL FUMARATE AND THE RISK OF HEPATOCELLULAR CARCINOMA (AASLD 2025) - "Many, though not all, studies have suggested that tenofovir-based therapies are more effective than entecavir in reducing HCC risk...These included Studies 102 and 103, in which patients were randomized (2:1) to TDF vs adefovir dipivoxil (ADV) for 48 weeks, followed by open-label TDF (up to 8 years' total treatment [384 weeks]), and Studies 108 and 110, in which patients were randomized (2:1) to TAF vs TDF for up to 144 weeks, followed by open-label TAF (up to 8 years' total treatment)... Long-term TAF treatment was associated with a greater reduction in HCC risk than TDF treatment. Differences in study design, population, and timing should be considered, and real-world data may help to confirm these findings."

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

Human Embryoid Body-Based Assays for Preclinical Screening of Potential Teratogenic Drugs: Antiviral Drugs for Hepatitis B Virus as Examples. (PubMed, Stem Cells Dev) - "Animal tests are not always reliable for accurately identifying human teratogens, as evidenced by the infamous thalidomide case...Additionally, we subjected our hEB systems to Cmax doses of four nucleoside/nucleotide analogs (adefovir dipivoxil [ADV], entecavir [ETV], lamivudine [LAM], and tenofovir disoproxil fumarate [TDF]), which are used for anti-hepatitis B virus treatment and belong to different pregnancy-related risk categories...TDF and ADV appear to be safer options during the very early stages of embryonic development compared with LAM and ETV. Our findings indicate that EB transcriptomics-based analyses can accurately identify potent teratogens and aid in assessing the potential risk of commonly prescribed drugs during pregnancy."

Journal • Preclinical • Hepatitis B • Infectious Disease • Inflammation

Investigation of hepatitis B virus mutations associated with immune escape and drug resistance in human immunodeficiency virus-infected patients. (PubMed, F1000Res) - "Mutations causing resistance to lamivudine and telbivudine were M204V, L180M, V163I, and S202K; with S202K also causing resistance to entecavir and adefovir resistance mutation were I253Y, I223V and M250I...Although there is no statistical significance amongst the mutations associated with drug resistance and vaccine escape. These mutations could have clinical implications that could have therapeutic repercussions by influencing the correct clinical diagnosis and treatment in HBV/ HIV co-infected individuals."

Journal • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Liver Cancer • Oncology • Solid Tumor

Hepatitis B virus rtCYE/rtCYEI mutations may contribute limited tenofovir resistance: Analysis of a large sample of Chinese patients. (PubMed, World J Hepatol) - "HBV rtCYE/rtCYEI mutations have a limited effect on TDF susceptibility and are not sufficient to cause TDF resistance."

Journal • Hepatitis B • Infectious Disease • Inflammation

Adefovir dipivoxil-associated Fanconi syndrome combined with peripheral neuropathy: a case report and literature review. (PubMed, Front Pharmacol) - "Long-term use of low-dose adefovir dipivoxil (ADV) has been increasingly associated with Fanconi syndrome; however, cases of Fanconi syndrome combined with peripheral neuropathy remain rare. He was diagnosed with ADV-associated Fanconi syndrome accompanied by peripheral neuropathy. Following the substitution of ADV with entecavir and 5 months to 6 months of phosphate supplementation, the patient's muscle weakness nearly resolved, and peripheral nerve damage showed significant improvement."

Journal • Nephrology • Pain • Renal Disease

Structural insights into human polyspecific organic anion transporters OAT1 and OAT4. (PubMed, Cell Rep) - "Here, we resolved the cryo-electron microscopy structures of human OAT1 in its apo form and bound to probenecid, adefovir, cefazolin, and para-aminohippuric acid (PAH), as well as human OAT4 in its apo form and in complex with dehydroepiandrosterone sulfate (DHEAS). DHEAS in OAT4 exhibits a different binding mode, illustrating the multispecific ligand-binding characteristics of OATs. Our findings provide a framework for drug design and management of drug-drug interactions involving OAT1."

Journal

An in-depth investigation of NAs-induced osteoporosis adverse events: a real-world, network toxicology and molecular docking analysis. (PubMed, Front Med (Lausanne)) - "In this study, four pharmacovigilance analysis methods and Bonferroni-corrected p-values were used to analyze the FDA Adverse Event Reporting System database to investigate the relationship between adefovir and tenofovir and osteoporosine-related adverse events...Molecular docking technology further reveals that the two drugs can produce pathological effects by binding to osteoporosis-related genes such as ADORA1 and JAK1. This study comprehensively reported the risk and mechanisms of osteoporosis caused by the clinical use of NAs drugs, and provided more detailed recommendations for clinical improvement and prevention of adverse events."

Adverse events • Journal • Real-world evidence • Hepatitis B • Infectious Disease • Inflammation • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology • JAK1

Protective Effects of Adefovir Dipivoxil in Pancreatic β Cell Lines (ENDO 2025) - "These data show that ADV can protect against fatty acid toxicity and increase insulin secretion in pancreatic β cells, potentially through mitohormesis. This drug can elucidate the role of mitochondria in the pathogenesis of type 2 diabetes mellitus, which may lead to new understandings and therapeutic approaches."

Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Molecular Mechanism of Tenofovir Nephrotoxicity When Combined with an ABCC Inhibitor (ASM Microbe 2025) - "However, it is still unclear as to how PIs such as ritonavir (RTV) and Lopinavir (LPV) increase the risk for nephrotoxicity...Additional data will be further presented for other ANPs such as adefovir combined with escalating PIs or cobicistat on cytotoxicity... These findings suggest that overexpression of MRP4 and MRP5 could render resistance toward TFV-mediated toxicities, while MRP2 is most efficient in transporting TFV out of the cells. These findings affirmed that intracellular levels of ANPs such as TFV may be regulated by MRP2-mediated activity."

Human Immunodeficiency Virus • Infectious Disease • Nephrology • ABCB1 • ABCC2 • ABCC4

Transcriptomic insights into the mechanism of action of telomere-related biomarkers in rheumatoid arthritis. (PubMed, Front Immunol) - "Five drugs-methotrexate, adefovir, furosemide, azathioprine, and cefmetazole-were also identified as targeted biomarkers. The results of the in vitro experiments were consistent with those obtained from the bioinformatics analysis. This study identified five biomarkers-ABCC4, S100A8, VAMP2, PIM2, and ISG20-and offered new insights into potential therapeutic strategies for RA."

Biomarker • Journal • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Transplant Rejection • CD4 • S100A8 • VAMP2

QuEChERS and UPLC-MS/MS-Based Quantification of Human Plasma of Eight Nucleoside Reverse Transcriptase Inhibitors and Platinum Anticancer Drugs for Hepatocellular Carcinoma. (PubMed, Molecules) - "The target analytes-lamivudine, telbivudine, emtricitabine, entecavir, tenofovir, nedaplatin, oxaliplatin, and adefovir dipivoxil-exhibited strong linearity within the 10-1000 ng/mL and 1-100 ng/mL ranges, showing correlations (r2) ≥ 0.9962. Overall, this analytical approach can be used to detect the combination of eight NRTIs and platinum-based drugs in human plasma. This method enables plasma drug-level monitoring in real time, with applications for individualized treatment approaches."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

A global comparison of hepatitis B & C drug pricing. (PubMed, Ann Hepatol) - "HBV and HCV originator medications cost significantly more in the US compared to seven other major industrial countries. However, the introduction of HBV generic medications has lowered the cost of treatment for patients in the US. Future adoption of international reference pricing may help bridge remaining pricing disparities."

Journal • Pricing • Hepatitis B • Hepatitis C • Infectious Disease • Inflammation

EFFICACY AND SAFETY OF TREATMENTS FOR CHRONIC HEPATITIS D: A SYSTEMATIC REVIEW AND META-ANALYSIS OF 19 RANDOMIZED CONTROLLED TRIALS (DDW 2025) - "Objective: This meta-analysis evaluates the efficacy and safety of pharmacological treatments for chronic HDV, including Lamivudine, Peg-IFN, Ribavirin, IFN alfa-2a, Adefovir, Bulevirtide, Lonafarnib, TDF, and Entecavir... Bulevirtide with Peg-IFN is the most effective and safest treatment for chronic HDV, particularly in cirrhotic patients. TDF shows potential but requires further study in larger, long-term trials. Adverse effects from therapies like Peg-IFN and Lonafarnib emphasize the need for careful monitoring."

Retrospective data • Review • Anemia • Fatigue • Gastrointestinal Disorder • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Cirrhosis • Pain

FDA-approved drug repurposing screen identifies inhibitors of SARS-CoV-2 pseudovirus entry. (PubMed, Front Pharmacol) - "Pyridoxal 5'-phosphate, Dovitinib, Adefovir dipivoxil, and Biapenem potently inhibit ACE2-dependent viral entry with inhibitory concentration 50% (IC50) values of 57nM, 74 nM, 130 nM, and 183 nM, respectively. We identified four novel FDA-approved candidate drugs for anti-SARS-CoV-2 combination therapy. Our findings contribute to the growing body of evidence supporting drug repurposing as a viable strategy for rapidly developing COVID-19 treatments."

FDA event • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Use of Sodium-Glucose Co-Transporter-2 Inhibitors and Risk of Hepatocellular Carcinoma in Patients with Chronic Hepatitis B, Type 2 Diabetes, and Varying Fibrosis Status (APASL 2025) - "Patients with T2D and CHB who received SGLT-2i (empagliflozin, dapagliflozin, canagliflozin or ertugliflozin) or sulfonylureas between 2015 and 2021 were enrolled from Hong Kong and all patients were followed from the first prescription of study medication till 2022. In this population-based cohort study, use of SGLT-2i, compared with sulfonylureas, decreased the risk of HCC among individuals with T2D and CHB especially in more severe liver fibrosis, suggesting a potential chemopreventive role of SGLT-2i in patients with both chronic diseases. Table and Figure:Figure 1.Table. Association between SGLT-2i use and the risk of hepatocellular carcinoma in patients with type 2 diabetes and chronic hepatitis B. *adjusted for demographic data (age and sex), lifestyle factors (alcohol, smoking, and body mass index), comorbidities (hypertension, hyperlipidemia, heart failure, coronary heart disease, stroke, atrial fibrillation, and chronic kidney disease), HBV medications..."

Clinical • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Coronary Artery Disease • Diabetes • Diabetic Nephropathy • Dyslipidemia • Fibrosis • Heart Failure • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Infectious Disease • Liver Cirrhosis • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • Type 2 Diabetes Mellitus

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

Tenofovir-based antiviral therapy reduces long-term incidence of hepatocellular carcinoma in chronic hepatitis B patients (APASL 2025) - "Studies 102 and 103 randomized patients 2:1 to double-blind (DB) treatment with tenofovir disoproxil fumarate (TDF) or adefovir dipivoxil (ADV) for 48 weeks, then open-label (OL) TDF, whereas Studies 108 and 110 randomized patients 2:1 to DB treatment with tenofovir alafenamide (TAF) or TDF for up to 144 weeks, then OL TAF. In this large dataset of prospectively followed CHB patients, HCC risk was significantly impacted with long-term TFV-based treatment in CHB patients with and without cirrhosis."

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

Comprehensive study of clinical features and laboratory findings of chronic viral hepatitis (APASL 2025) - "A history of HBV antiviral therapy was reported by 112 (44.4%) patients, of whom 72.5% used tenofovir, 27.1% entecavir, and 0.4% adefovir. Two patients began receiving bulevirtide injections against HDV in 2023... Young adults in their prime are affected by chronic HDV infection, with 21.8% diagnosed with liver cirrhosis. Laboratory tests revealed elevated transaminase activity above normal levels, and 44.9% of HDV-RNA levels exceeded 106."

Clinical • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Cirrhosis • Oncology • Solid Tumor

Effect of emitinofovir combined with thymidin a 1 treatment on surface antigen in patients with compensatory stage of hepatitis B cirrhosis (APASL 2025) - "In HBeAg-negative patients with compensated hepatitis B cirrhosis, regardless of whether HBV DNA is low-positive (<1.0E+04) or negative, the combination effectively reduces hepatitis B surface antigen levels."

Clinical • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation

Adefovir anticancer potential: Network pharmacology, anti-proliferative & apoptotic effects in HeLa cells. (PubMed, Biomol Biomed) - "In vitro, adefovir significantly suppressed HeLa cell viability, with an Inhibitory Concentration 50 (IC50) of 7.8 μM, outperforming 5-Fluorouracil (5-FU). These integrated computational and experimental findings suggest that adefovir exerts multi-targeted effects against cervical cancer. Its promising preclinical efficacy warrants further investigation as a potential alternative therapy."

Journal • Cervical Cancer • Oncology • Solid Tumor • MAPK3

Evaluation of Adefovir PBPK Model to Assess Biomarker-Informed OAT1 Drug-Drug Interaction and Effect of Chronic Kidney Disease. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "A previously verified probenecid model, incorporating in vivo OAT1/3 inhibitory constant estimated using OAT1/3 endogenous biomarker (4-pyridoxic acid) clinical data, was utilized. The model successfully predicted 3-fold higher adefovir Cmax and 6-fold higher AUC in patients with severe CKD relative to healthy individuals. This study reinforces the role of PBPK modeling to predict transporter-mediated DDI (coupled with biomarker-informed approach to optimize in vivo inhibitory constant) and the effect of renal impairment on OAT1/3 drugs in lieu of clinical studies."

Biomarker • Journal • Chronic Kidney Disease • Nephrology • Renal Disease