Besivo (besifovir) / Gilead, LG Chem, Ildong - LARVOL DELTA

Besifovir dipivoxil maleate versus other antivirals in reducing hepatocellular carcinoma in chronic hepatitis B. (PubMed, Sci Rep) - "We conducted a retrospective cohort study on treatment-naïve patients with CHB who initiated an AVT between 2017 and 2022 with BSV (n = 486), entecavir (ETV) (n = 852), tenofovir alafenamide (TAF) (n = 801), or tenofovir disoproxyl fumarate (TDF) (n = 750). Similarly, compared to BSV users, the adjusted HRs for ETV, TAF, and TDF users were higher after stabilized inverse probability of treatment weighting (2.836, 2.784, and 3.294, respectively) and pairwise propensity score matching (3.200, 3.250, and 3.750, respectively) (all P < 0.05). BSV demonstrated comparable efficacy in HCC reduction compared to other AVTs."

Clinical • Journal • Retrospective data • Hepatitis B • Hepatocellular Cancer • Infectious Disease • Oncology • Solid Tumor

Besifovir reduces hepatocellular carcinoma risk compared to Tenofovir Disoproxil Fumarate: large-scale cohort study (EASL 2025) - "This analysis suggests that BSV is more effective than TDF in reducing the incidence of HCC."

Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Oncology • Solid Tumor

Comparative renal safety of besifovir dipivoxil maleate and tenofovir disoproxil fumarate in chronic hepatitis B patients: insights from a nationwide cohort study (EASL 2025) - "BSV is linked to a lower incidence of CKD compared to TDF, particularly in patients aged 60 and older, suggesting it may be a safer treatment option for CHB, especially in elderly patients at higher risk of renal impairment."

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

Correspondence to Editorial on "Switching to Besifovir in Patients with Chronic Hepatitis B Receiving Tenofovir Disoproxil Fumarate: A Randomized Trial". (PubMed, Clin Mol Hepatol) - No abstract available

Journal • Hepatitis B • 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

Besifovir Reduces Hepatocellular Carcinoma Risk Compared to Tenofovir Disoproxil Fumarate: Large-Scale Cohort Study (APASL 2025) - "This analysis suggests that BSV is more effective than TDF in reducing the incidence of HCC. Table and Figure:Figure 1.Kaplan-Meier plots for hepatocellular carcinoma (HCC) incidence by antiviral agents in all patients Figure 2.Kaplan-Meier plots for cirrhosis incidence by antiviral agents in non-cirrhotic patients"

Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Oncology • Solid Tumor

Comparative Renal Safety of Besifovir Dipivoxil Maleate and Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients: Insights from a Nationwide Cohort Study (APASL 2025) - "BSV is linked to a lower incidence of CKD compared to TDF, particularly in patients aged 60 and older, suggesting it may be a safer treatment option for CHB, especially in elderly patients at higher risk of renal impairment. Table and Figure:Figure 1.Kaplan-Meier analysis of chronic kidney disease incidence between BSV and TDF groups (total patients). Figure 2.Kaplan-Meier analysis of chronic kidney disease incidence between BSV and TDF groups (60 years and older group)."

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

Besifovir: a viable option for long-term disease control in chronic hepatitis B. (PubMed, Clin Mol Hepatol) - No abstract available

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Comparison of hepatocellular carcinoma incidence after long-term treatment with besifovir vs. tenofovir AF. (PubMed, Sci Rep) - "This study aimed to compare the incidence of hepatocellular carcinoma (HCC) following long-term use of BSV versus tenofovir alafenamide fumarate (TAF), utilizing large-scale national data. These findings suggest that BSV offers comparable efficacy to TAF in preventing HCC and is a promising option for CHB management. Longer-term studies with larger cohorts are necessary to confirm these results and assess the full impact of BSV on HCC prevention."

Clinical • Journal • Fibrosis • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Oncology • Solid Tumor

Switching to Besifovir in Patients with Chronic Hepatitis B Receiving Tenofovir Disoproxil Fumarate: A Randomized Trial. (PubMed, Clin Mol Hepatol) - P4 | "In patients with CHB receiving long-term TDF, switching to BSV may improve renal and bone safety with non-inferior antiviral efficacy compared to that of maintaining TDF. ClinicalTrials.gov Identifier: NCT04202536."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

COMPARABLE OUTCOMES BETWEEN BESIFOVIR AND OTHER ANTIVIRAL THERAPIES IN HEPATOCELLULAR CARCINOMA DEVELOPMENT AMONG PATIENTS WITH CHRONIC HEPATITIS B (AASLD 2024) - "Background: Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, has potent antiviral efficacy against chronic hepatitis B (CHB), similar to other antiviral agents, such as entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF). BSV showed comparable outcomes in HCC development among patients with CHB compared to TAF, ETV, and TDF. Given the small number of events and the relatively short follow-up duration observed in BSV users, further long-term analysis is warranted."

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

KINETICS AND PREDICTION OF HBSAG SEROCLEARANCE DURING LONG-TERM TREATMENT WITH NUCLEOS(T)IDE ANALOGUES IN PATIENTS WITH CHRONIC HEPATITIS B (AASLD 2024) - " We conducted a retrospective observational study of patients treated with one of the following NUCs: entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or besifovir (BSV). Consistent HBsAg reduction was observed throughout treatment with no significant differences among the four NUCs. However, further decrease in HBsAg level can be expected in TAF treated patients after a prolonged treatment duration compared to other treatment groups. Low baseline HBsAg levels and higher reduction rates of HBsAg in the first year of treatment, may be reliable factors in predicting HBsAg seroclearance."

Clinical • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Efficacy comparison of high-genetic barrier nucleos(t)ide analogues in treatment-naïve chronic hepatitis B patients: a network meta-analysis. (PubMed, Korean J Intern Med) - "Four high-genetic barrier nucleos(t)ide analogues (NAs) for chronic hepatitis B (CHB), namely entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and besifovir dipivoxil maleate (BSV), have been established. In the sensitivity analyses, 48-week VR from randomized-controlled trials were compiled, and the same trend toward the superiority of TDF over ETV was found (OR, 1.51; p = 0.030). Four high-genetic barrier NAs were compared, and TDF was more likely to achieve a VR after 48 weeks, while ETV provided a superior BR after 48 weeks."

Journal • Retrospective data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Comparable outcomes between Besifovir and other antiviral therapies in hepatocellular carcinoma development among patients with chronic hepatitis B (EASL-ILC 2024) - "Background and Aims: Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, has potent antiviral efficacy against chronic hepatitis B (CHB), similar to other antiviral agents, such as entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF). BSV showed comparable outcomes in HCC development among patients with CHB compared to TAF, ETV, and TDF. Given the small number of events and the relatively short follow-up duration observed in BSV users, further long-term analysis is warranted."

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

Reduced Risk of Hepatocellular Carcinoma in Patients with Chronic Hepatitis B Receiving Long-Term Besifovir Therapy. (PubMed, Cancers (Basel)) - P3 | "In conclusion, BSV decreased the risk of HCC in patients with CHB, and prediction models were applicable. Clinical trial registry website and trial number: ClinicalTrials.gov no: NCT01937806."

Journal • Fibrosis • Gastroenterology • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Cancer • Liver Cirrhosis • Oncology • Solid Tumor

Noninferiority Outcomes of Besifovir Compared to Tenofovir Alafenamide in Treatment-Naïve Patients with Chronic Hepatitis B. (PubMed, Gut Liver) - "The absolute value of the 95% confidence interval for the difference (-0.04 to 0.12) satisfied the a priori limit of a noninferiority of 0.15. : BSV is noninferior to TAF in terms of VR, and their clinical outcomes are comparable to CHB."

Head-to-Head • Journal • Addiction (Opioid and Alcohol) • Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Oncology • Solid Tumor

DECREASED RISK OF HEPATOCELLULAR CARCINOMA IN PATIENTS WITH CHRONIC HEPATITIS B TREATED WITH BESIFOVIR (AASLD 2023) - "We aimed to assess the incidence of HCC under BSV therapy using clinical trial and real-world BSV data and to compare it with that observed during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) therapy. BSV therapy may improve prognosis of patients with CHB by decreasing the incidence of HCC."

Clinical • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Solid Tumor

EFFICACY COMPARISON OF HIGH GENETIC BARRIER NUCLEOS(T)IDE ANALOGUES IN TREATMENT-NAÏVE CHRONIC HEPATITIS B PATIENTS: A NETWORK META-ANALYSIS (AASLD 2023) - "Four high genetic barrier nucleos(t)ide analogues (NA) for CHB, namely entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and besifovir dipivoxil maleate (BSV) have been established. Four high genetic barrier NAs were compared and TDF and TAF were more likely to achieve a virologic response after 48 weeks and ETV provided a superior biochemical response after 48 weeks. Additional studies with longer treatment durations and large-sample studies are needed to determine the benefit of each of these drugs."

Retrospective data • Fibrosis • Gastroenterology • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Oncology • Solid Tumor

A 7th-YEAR INTERIM ANALYSIS OF PROSPECTIVE AND LONGITUDINAL KOREAN CHRONIC HEPATITIS B COHORT (AASLD 2023) - "The most favored AVT regimen was tenofovir disoproxyl fumarate (TDF) (40.0%), followed by entecavir (33.0%). However, during the recent two years, an increasing proportion of patients are starting the first AVT with tenofovir alafenamide (5.9% to 13.5%) or besifovir dipivoxil maleate (2.8% to 7.5%)... This cohort study will evaluate long-term liver-related outcomes among Korean CHB patients. Future research using the cohort data and blood samples after the data purification could reveal the unmet needs to manage CHB."

Clinical • Addiction (Opioid and Alcohol) • Chronic Kidney Disease • Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Nephrology • Oncology • Renal Disease • Solid Tumor

Comparison of kidney function decline between chronic hepatitis B patients with versus without antiviral therapy (EASL-ILC 2023) - "Compared with untreated patients, TAF or BSV users showed a similar risk, whereas ETV users showed a higher risk of kidney function decline. Figure: Cumulative incidence of progression in CKD stage ≥1 among (A) untreated patients vs. ETV, TAF, or BSV users, (B) untreated patients vs."

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

Switching to Besifovir in chronic hepatitis B patients receiving Tenofovir Disoproxil Fumarate: 96 weeks results of phase 4 trial (EASL-ILC 2023) - "In this extensional study, antiviral efficacies were comparable between the groups at 96 weeks. Patients receiving BSV for up to 96 weeks showed improved bone and renal safety after the completion of 48 weeks of BSV or TDF therapy in virologically-suppressed CHB patients. Figure: Figure 1."

Clinical • P4 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Comparison of kidney function decline between chronic hepatitis B patients with or without antiviral therapy. (PubMed, Aliment Pharmacol Ther) - "Compared with untreated patients, TAF or BSV users showed similar risk, whereas ETV users showed a higher risk of kidney function decline."

Journal • Chronic Kidney Disease • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

Evolution of Liver Fibrosis in Patients With Chronic Hepatitis B under Long-term Nucleos(t) ide Analogue Therapy (APASL 2023) - "Of 57 patients with adequate biopsy sample who received at least 3 years of cumulative entecavir therapy in phase 3 studies, 88% showed regression of ≥1 Ishak fibrosis score, including all 10 patients with advanced fibrosis or cirrhosis at the study baseline...Moreover, in the phase 3 trial comparing besifovir (BSV) with TDF, the proportion of subjects with Ishak score ≥3 decreased from 77.7% to 55.5% in BSV group and from 72.7% to 45.4% in the TDF group, respectively (all P<0.05), after 48 weeks of AVT...Therefore, NFMs can be useful for clinicians to assess the evolution of liver fibrosis during the long-term AVT. However, patients with CHB cannot completely regress their baseline liver fibrosis in spite of the long-term AVT and even remain at risk for HCC, early detection of CHB activation and regular HCC surveillance should be continued even in the era of potent AVT."

Clinical • Cardiovascular • Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Liver Failure • Oncology • Portal Hypertension • Solid Tumor

Similar Risk of Kidney Function Decline Between Tenofovir Alafenamide and Besifovir Dipivoxil Maleate in Chronic Hepatitis B (KIDNEY WEEK 2022) - "Conclusion TAF and BSV showed similar risk of kidney function decline in patients with treatment-naïve CHB. Further prospective randomized studies are warranted for validation."

Chronic Kidney Disease • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Nephrology • Renal Disease

BESIFOVIR DIPIVOXIL MALEATE VS. TENOFOVIR ALAFENAMIDE FOR TREATMENT-NAÏVE CHRONIC HEPATITIS B: A REAL-WORLD COHORT STUDY (AASLD 2022) - "These drugs showed equivalent efficacy and fewer side effects compared to entecavir and tenofovir disoproxil fumarate in previous clinical trials. BSV is non-inferior to TAF for VR and their clinical outcomes are comparable."

Clinical • Real-world evidence • Acute Kidney Injury • Addiction (Opioid and Alcohol) • Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Nephrology • Oncology • Renal Disease • Solid Tumor