scholarly journals Correlation between low-level viremia and hepatitis B-related hepatocellular carcinoma and recurrence: a retrospective study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Furong Sun ◽  
Zhifei Liu ◽  
Bingyuan Wang
Keyword(s):  
Hepatocellular Carcinoma ◽  
Hepatitis B ◽  
Limit Of Detection ◽  
Hbv Dna ◽  
Tumor Diameter ◽  
Low Level ◽  
Group 2 ◽  
Hepatocellular Carcinoma Recurrence ◽  
Curative Hepatectomy ◽  
Group 1

Abstract Background Low-level viremia generally refers to detectable HBV DNA levels lower than 2000 IU/mL. Studies show that low-level viremia is a risk factor for hepatocellular carcinoma. The aim of this study was to explore the characteristics of low-level viremia patients with hepatitis B-related hepatocellular carcinoma and identify prognostic factors after curative hepatectomy. Methods Data from chronic hepatitis B patients with hepatocellular carcinoma receiving curative hepatectomy for the first time in the first hospital of China Medical University were studied. Patients were divided into two groups based on preoperative HBV DNA levels: group 1 (low-level viremia group, HBV DNA < 2000 IU/mL) and group 2 (HBV DNA ≥ 2000 IU/mL). Results Of the 212 patients, 104 patients were in group 1 and 108 patients were in group 2. There was a lower proportion of patients with HBsAg levels > 250 IU/mL (the upper limit of detection in our laboratory) in group 1 than in group 2 (71.2% vs. 86.1%, P < 0.01). The percentage of patients with a tumor diameter < 5 cm was 67.3% in group 1 and 37.0% in group 2 (P < 0.000). The percentage of tumor recurrence was 40.4% (42) in group 1 and 54.6% (59) in group 2 (P < 0.05). Median recurrence-free survival was 30.1 months in group 1 and 17.6 months in group 2 (P < 0.01). Multivariate analysis showed that a tumor diameter ≥ 5 cm (hazard ratio [HR] = 1.819, 95% confidence interval [CI] 1.193–2.775, P = 0.005), intrahepatic metastasis (HR = 1.916, 95% CI 1.077–3.407, P = 0.027), and an HBV DNA level ≥ 100 IU/mL (the lower limit of detection in our laboratory, HR = 2.943, 95% CI 1.916–4.520, P < 0.000) were independent prognostic factors associated with an increased risk of hepatocellular carcinoma recurrence. Conclusion Preoperative low-level viremia was related with a long tumor recurrence interval and complete virologic response after curative hepatectomy was associated with a lower risk of hepatocellular carcinoma recurrence.

scholarly journals Correlation between Low-Level Viremia and Hepatitis B-Related Hepatocellular Carcinoma and Recurrence: A Retrospective Study

2021 ◽  
Author(s):  
Furong Sun ◽  
Zhifei Liu ◽  
Bingyuan Wang
Keyword(s):  
Hepatocellular Carcinoma ◽  
Hepatitis B ◽  
Tumor Recurrence ◽  
Hbv Dna ◽  
Tumor Diameter ◽  
Low Level ◽  
Group 2 ◽  
Hepatocellular Carcinoma Recurrence ◽  
Curative Hepatectomy ◽  
Group 1

Abstract Background Low-level viremia generally refers to detectable HBV DNA levels lower than 2,000 IU/mL. Studies show that low-level viremia is a risk factor for hepatocellular carcinoma. The aim of this study was to explore the characteristics of low-level viremia patients with hepatitis B-related hepatocellular carcinoma and identify patient prognostic factors following curative hepatectomy. Methods Data from chronic hepatitis B patients with hepatocellular carcinoma receiving curative hepatectomy for the first time in the first hospital of China Medical University were studied. Patients were divided into two groups based on preoperative HBV DNA levels: group 1 (low-level viremia group, HBV DNA < 2,000 IU/mL) and group 2 (HBV DNA ≥ 2,000 IU/mL). Results Of the 212 patients, 104 patients were in group 1 and 108 patients were in group 2. There was a lower proportion of patients with HBsAg levels > 250 IU/mL in group 1 than in group 2 (71.2% vs. 86.1%, P < 0.01). The proportion of patients with a tumor diameter < 5 cm was 67.3% in group 1 and 37.0% in group 2 (P < 0.000). Tumor recurrence was 40.4% (42) in group 1 and 54.6% (59) in group 2 (P < 0.05). Median recurrence-free survival was 30.1 months in group 1 and 17.6 months in group 2 (P < 0.01). Multivariate analysis showed that a tumor diameter > 5 cm (hazard ratio [HR] = 1.819, 95% confidence interval [CI] 1.193–2.775, P = 0.005), intrahepatic metastasis (HR = 1.916, 95% CI 1.077–3.407, P = 0.027), and an HBV DNA level > 100 IU/mL (HR = 2.943, 95% CI 1.916–4.520, P < 0.000) were independent prognostic factors associated with an increased risk of hepatocellular carcinoma recurrence. Conclusion Preoperative low-level viremia was related to a long tumor recurrence interval and post-operative virologic response was associated with a lower risk of hepatocellular carcinoma recurrence.

scholarly journals A new therapeutic option for chronic hepatitis B: Reduced dose and shorter duration of a combination therapy with pegylated interferon and entecavir

2019 ◽  
Vol 45 (3) ◽  
pp. 143-148
Author(s):  
Mamun Al Mahtab ◽  
Shahina Tabassum ◽  
Afzalun Nesa ◽  
Munira Jahan ◽  
Md. Sakirul Islam Khan ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Standard Dose ◽  
Pegylated Interferon ◽  
Hbv Dna ◽  
Control Group ◽  
Control Groups ◽  
Reduced Dose ◽  
Group 2 ◽  
Group 1

Background: Although several drugs are available for treatment of chronic hepatitis B (CHB), the outcome is still far from being satisfactory. The study was conducted to develop a therapeutic strategy for CHB by a combination therapy with reduced dose and duration of antiviral drugs. Objectives: Therapeutic effects of reduced dose and shorter duration of combination of pegylated interferon (Peg-IFN) and entecavir were evaluated in patients with CHB with two control groups. Methods: Fifty-four patients with CHB were treated with reduced dose of Peg-IFN (90 microgram in spite of standard dose of 180 microgram) and standard dose of entecavir (0.5 mg) for reduced duration of 24 weeks (Case of group). There were two control groups that adhered to inclusion and exclusion criteria. Patients of Control group-1 (n=50) received regular doses (180 microgram) of Peg-IFN, once weekly for 48 consecutive weeks. Patients of Control group-2 (n=50) were treated with regular does of entecavir (0.5 mg, daily) for 48 weeks. Results: The treatment regimens were safe for all patients. At the end of therapy (EOT), hepatitis B virus DNA negativity (HBV DNA <250 copies/mL) was found in 67%, 50% and 80% of patients of Control Group-1, Control group-2, and case group, respectively. HBV DNA negativity was found in more patients in cases (89% from 67%) 24 weeks after EOT. However, it declined in patients of Control group-1 (80% to 56%) and remained almost similar in Control group-2 (50% versus 56%). There was no significant difference in alanine transaminase (ALT) negativity and hepatitis E antigen (HBeAg) seronegativity among 3 groups at EOT and 24 weeks after EOT. Conclusion: A patient-friendlytherapeutic strategy with reduced dose of Peg-IFN and regular dose of entecavir for shortened duration for CHB patientshave been documented and it would be also cheap for usage of patients with CHB.

scholarly journals Seroprevalence of hepatitis A,B, and C viruses in Turkish alcoholic cirrhotics and the impact of hepatitis B on clinical profile

2015 ◽  
Vol 9 (03) ◽  
pp. 254-258 ◽  
Author(s):  
Fatih Tekin ◽  
Fulya Gunsar ◽  
Elvan Isik Erdogan ◽  
Ruchan Yazan Sertoz ◽  
Zeki Karasu ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Hepatitis B ◽  
Hepatitis A ◽  
Clinical Profile ◽  
Negative Group ◽  
Hbv Vaccination ◽  
Cirrhotic Patients ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Introduction: The aims of this study were to detect the seroprevalence of hepatitis A, B, and C viruses in Turkish alcoholic cirrhotics, and to evaluate the impact of hepatitis B infection on clinical profile at first admittance. Methodology: Serological markers for hepatitis A, B, and C viruses in 300 alcoholic cirrhotics diagnosed between January 1994 and December 2012 were retrospectively reviewed. Among them, 148 eligible patients were divided into group 1 (HBsAg positive, n = 43) and group 2 (HBsAg and anti-HBc negative, n = 105). Clinical characteristics at first admittance of groups 1 and 2 were compared. Results: The seroprevalence of anti-HAV total, HBsAg, and anti-HCV was found to be 91.5%, 16.3%, and 8.2%, respectively. The prevalence of hepatocellular carcinoma was higher in the HbsAg-positive group compared to HbsAg- and anti-HBc-negative group (16.3% vs. 2.9%, p = 0.007). Other clinical features were similar in the two groups. Conclusions: Alcoholic cirrhotics have higher frequencies of HBsAg and anti-HCV than the general population. These patients should be investigated for coexistent HBV and HCV infections, and HBV vaccination should not be neglected. Alcoholic cirrhotic patients with concomitant HBV infection should be closely screened for hepatocellular carcinoma.

scholarly journals EFFICACY AND SAFETY OF OZONE THERAPY FOR PATIENTS WITH CHRONIC HEPATITIS B: A MULTICENTER, RANDOMIZED CLINICAL TRIAL

2018 ◽  
Vol 2 (2) ◽  
Author(s):  
Hong Yu ◽  
Pingyan Chen ◽  
Jilin Chen ◽  
Wei Dai ◽  
Zhimin Wu ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Virologic Response ◽  
Hbv Dna ◽  
Ozone Therapy ◽  
Group 2 ◽  
Medical Ozone ◽  
Group 1

Background: Ozone therapy has a long history. Some studies proved that ozone therapy was useful in treatment of virus hepatitis.Objective: To evaluate the efficacy and safety of new medical ozone therapy system for the treatment of chronic hepatitis B.Method One hundred eighty-nine patients with chronic hepatitis B were included in this open-label, phase 3 study, and randomly assigned to receive ozone autohemotherapy with experimental ozone generator TianYi (group 1) or with ozone generator Humares (group 2) or oral diammonium glycyrrhizinate capsules (group 3) in a 1:1:1 ratio for 12 weeks. The primary efficacy end point was sera HBV DNA level of less than 1×103 IU/ml or having a more than 2 log10 reduction in HBV DNA level at the end of 12 weeks treatment as compared to baseline HBV DNA level. Secondary end points included HBeAg seroconversion, biochemical response, and combined response.Results At the end of 12 weeks treatment, the proportion of patients reached the primary end point of virologic response in group 1, group 2, and group 3 were 22.4% (13/58, 95% CI, 12.5 to 35.3), 14.7 (9/61, 95% CI, 7.0 to 26.2) and 3.9% (2/51, 95% CI, 0.5 to 13.5), respectively (p=0.021) in the pre-protocol population. Virologic response occurred in more patients receiving ozone therapy with experimental device than patients receiving oral diammonium glycyrrhizinate capsules (mean difference 18.5%, 95% CI 6.3 to 31.5, p=0.005). However, there was no statistical difference in VR12 rates between the treatment of medical ozone therapy system with experimental device (group 1) and with Humares (group 2) (mean difference 7.7%, 95% CI -6.5 to 22.0, p=0.282). More HBeAg seroconversion in patients treated by Tianyi ozone therapy system than those treated by Humares ozone therapy device and oral diammonium glycyrrhizinate capsules (14.8%, 5.1% and 7.3%, respectively, P = 0.272). Higher biochemical response rate was observes in patients receiving ozone therapy than oral diammonium glycyrrhizinate capsules (31.6%, 36.7% and 24.0%, respectively, p = 0.359). The safety profile was similar for the three treatment groups and adverse events were .scare infrequent and mild.Conclusions: Ozone therapy had superior antiviral efficacy with a similar safety profile as compared with oral diammonium glycyrrhizinate capsules through week 12 treatment. Ozone therapy is also associated with normalized ALT and AST levels, demonstrating that ozone therapy could benefit the patients with chronic hepatitis B.

scholarly journals SAT0140 SAFETY OF TOFACITINIB THERAPY IN HBSAG CARRIERS WITH RHEUMATOID ARTHRITIS: A PROSPECTIVE STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1008.2-1008
Author(s):  
L. Fang ◽  
Z. Lin ◽  
Z. Liao ◽  
O. Jin ◽  
Y. Pan ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Viral Load ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hbv Infection ◽  
Hbsag Carriers ◽  
B Virus ◽  
Group 2 ◽  
A Prospective Study ◽  
Group 1

Background:Targeted synthetic DMARDs (ts-DMARDs) are becoming more available and affordable in developing countries, where the prevalence of hepatitis B virus (HBV) infection is still an important public health issue. The safety of ts-DMARDs therapy in terms of the reactivation of hepatitis B virus (HBV) infection need more concern. Rare data from a prospective study focus on the use of ts-DMARDs in patients with concurrent rheumatoid arthritis (RA) and HBV infection were available by now.Objectives:To evaluate the influence of tofacitinib on reactivation of HBV infection in HBsAg carriers with RA.Methods:In this 52 weeks observation, HBsAg carriers with active RA (DAS28>5.1) despite failed combined treatment with MTX and other non-biological DMARDs were enrolled. Patients must have normal liver function prior to study. All patients received therapy with tofacitinib (5mg twice daily) and concomitant MTX (10-12.5mg/w). Entecavir was prescribed preventively for patients who had a baseline HBV load >2000 copy/ml (group 1), and Lamivudin for patients with HBV load ≤ 2000 copy/ml (group 2). Liver enzymes (AST/ALT) and HBV viral load were monitored every 4 weeks. Increased viral load and abnormal liver function were managed according to expert opinion.Results:Thirteen patients (10 female) were recruited. Nine patients had a baseline viral load >2000 copy/ml (group 1, with preventive Entecavir), and the other 4 patients had a viral load ≤ 2000 copy/ml (group 2, with preventive Lamivudin). Two patients from group 1 discontinued tofacitinib at week 12 due to ineffectiveness, and both continued taking Entecavir for another 3 months after the discontinuation of tofacitinib.No reactivation of hepatitis B was observed in patients from group 1. One patients (female, 54 years old) from group 2 underwent a mild increase of both ALT and AST (67 and 56 IU/L, respectively) at week 16. An elevated viral load (4.9e6 copies/ml, baseline 1.4e3) and a HBV YMDD mutant was also found. The tofacitinib treatment continued. After prescription of Adefovir (combined with the pre-existing Lamivudin), both liver enzyme and viral load decreased to normal range in 8 weeks and remained normal throughout the study.Conclusion:An aggressive Tofacitinib + MTX therapy may be a safe option for HBsAg carriers with cs-DMARDs refractory RA. More active and effective prophylaxis strategy may be recommended to reduce the risk of HBV reactivation during the treatment.References:[1]Chen YM, Huang WN, Wu YD, et al. Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study. Ann Rheum Dis 2018; 77:780-2.Disclosure of Interests: :None declared

272 Use of LioCyx-M, autologous hepatitis B virus (HBV)-Specific T cell receptor (TCR) T-cells, in advanced HBV-related hepatocellular carcinoma (HCC)

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A297-A297
Author(s):  
Fu-Sheng Wang ◽  
Fanping Meng ◽  
Jiehua Jin ◽  
Yuanyuan Li ◽  
Regina Wanju Wong ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
T Cells ◽  
Hepatitis B Virus ◽  
T Cell ◽  
Hepatitis B ◽  
T Cell Receptor ◽  
Dose Level ◽  
Cell Receptor ◽  
Hbv Dna ◽  
B Virus

BackgroundWe have demonstrated the ability of Hepatitis-B-virus (HBV)-specific T cell receptor (TCR) bioengineered T cells to recognize and lyse Hepatocellular carcinoma (HCC) cells expressing HBV antigens derived from HBV-DNA integration in patients with liver transplant.1 LioCyx-M is an immunotherapeutic product composing of autologous T cells transiently modified with in-vitro transcribed mRNA encoding HBV-specific TCR. The transient TCR expression makes LioCyx -M amenable to a dose escalating posology.MethodsThe primary endpoint of this phase 1 trial is to assess the safety and tolerability of LioCyx-M in patients with advanced HBV-HCC without curative treatment options. Eligible patients were diagnosed with Barcelona clinic liver cancer stage B or C HCC (Child-Pugh < 7 points), receiving >1 year antiviral treatment prior to enrollment. These patients had matching HLA class I genotypes which present HBV encoded antigen. Peripheral blood was collected from each patient prior to each dose for LioCyx-M manufacturing. Patients received 4 escalating doses of 1×104 cells/kg, 1×105 cells/kg, 1×106 cells/kg, 5×106 cells/kg bodyweight (BW) in the first treatment cycle, each intravenously administered weekly. Patients underwent 1-month safety assessment post the 4th infusion, according to Common Terminology NCI CTCAE Version 4.0.3. If there were no dose associated toxicities, patients were eligible to continue administration of LioCyx-M at dose of 5 × 106 cells/kg BW weekly. Tumor response per RECIST 1.1 criteria and survival time were assessed.ResultsAt data cutoff (30 April 2020), eight patients were enrolled, with a median age of 53 (range: 49 - 67). These patients received a median number of 6 (range: 4 - 12) infusions of LioCyx-M. 1 patient developed Grade 3 elevations in alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST) and bilirubin after receiving LioCyx-M at dose level of 1×105 cells/kg BW. Another patient had Grade 1 transient fever after receiving LioCyx-M at dose level 5×106 cells/kg BW in the 4th, 5th and 6th infusions. No treatment-related adverse events (trAEs) such as cytokine release syndrome or neurotoxicity were observed. No fatal trAEs were observed. The median time to progression was 1.9 months (range: 0.2 - 9.5 months). The median overall survival was 34 months (range: 3 - 38.2 months).ConclusionsThe encouraging clinical outcome and tolerable safety highlight the good benefit-risk profile of LioCyx-M. Therefore, further exploration of efficacy of LioCyx-M treatment for advanced HBV-HCC is warranted in a Phase 2 proof-of-concept clinical study.AcknowledgementsFunding: Lion TCR.Trial RegistrationNCT03899415Ethics ApprovalThe study was approved by Fifth Medical Center of Chinese PLA General Hospital’s Ethics Board, approval number R2016185DI010.ReferenceTan AT, Yang N, Lee Krishnamoorthy T, et al. Use of Expression Profiles of HBV-DNA Integrated Into Genomes of Hepatocellular Carcinoma Cells to Select T Cells for Immunotherapy. Gastroenterology 2019;156(6):1862–1876.e9.

Real-World Experience of Telbivudine and Lamivudine as Antiviral Prophylaxis for Chemotherapy-Related Hepatitis B Reactivation

2021 ◽  
Vol 15 (1) ◽  
pp. 11
Author(s):  
Lianda Siregar ◽  
Imelda Maria Loho ◽  
Agus Sudiro Waspodo ◽  
Siti Nadliroh ◽  
Rahmanandhika Swadari ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Medical Records ◽  
Antiviral Treatment ◽  
Hbv Dna ◽  
Hbv Reactivation ◽  
Lamivudine Therapy ◽  
Number Of Patients ◽  
Group 2 ◽  
Good Treatment Option ◽  
Hbs Ag

Background: There is currently no data regarding the efficacy of prophylactic telbivudine in hepatitis B patients undergoing chemotherapy. This study aims to describe the results of preemptive telbivudine and lamivudine to prevent chemotherapy-related HBV reactivation.Methods: The medical records of all patients with HBsAg positive or HBs-Ag negative, anti-HBc positive, who were referred to the hepatology clinic between May 2014 and December 2016, were retrospectively reviewed. As this is a descriptive study, no statistical analysis was done.Results: A total of 52 patients with prophylactic telbivudine or lamivudine therapy were included, with 26 patients in each group. Rituximab-based treatment was given in nine and five patients in the telbivudine and lamivudine group, respectively. The number of patients who completed antiviral treatment up to six months after chemotherapy was 17 patients in each group. There was less incidence of HBV reactivation in the telbivudine group (2 of 17 patients, 11.8%) than in the lamivudine group (7 of 17 patients, 41.2%). Delayed reactivation was noticed in 1 of 2 patients in the telbivudine group and 3 of 7 patients in the lamivudine group. The median log10[HBV DNA] at reactivation was 4.52 (1.70 – 8.35) IU/mL. Severe hepatitis was observed in two patients in the lamivudine group and one patient in the telbivudine group. Of 34 patients who completed antiviral treatment, two patients died due to primary cancer. No interruption of chemotherapy or mortality due to hepatitis was noticed in both groups.Conclusions: Preemptive telbivudine or lamivudine in HBsAg positive or HBsAg negative, anti-HBc positive patients seems to be a good treatment option.

scholarly journals Comparison between Y90 Radioembolization Plus Sorafenib and Y90 Radioembolization alone in the Treatment of Hepatocellular Carcinoma: A Propensity Score Analysis

Cancers ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 897
Author(s):  
Antonio Facciorusso ◽  
Irene Bargellini ◽  
Marina Cela ◽  
Ivan Cincione ◽  
Rodolfo Sacco
Keyword(s):  
Hepatocellular Carcinoma ◽  
Propensity Score ◽  
Liver Toxicity ◽  
Propensity Score Analysis ◽  
Objective Response ◽  
Progression Free Survival ◽  
Tumor Burden ◽  
Y90 Radioembolization ◽  
Group 2 ◽  
Group 1

Background: Adjuvant sorafenib may enhance the efficacy of transarterial radioembolization with yttrium-90 in hepatocellular carcinoma patients. The aim of this study is to assess the efficacy and safety of radioembolization plus sorafenib in comparison to radioembolization alone. Methods: Out of 175 hepatocellular carcinoma (HCC) patients treated with radioembolization between 2011 and 2018, after propensity score matching, two groups were compared: a group of 45 patients that underwent radioembolization while being on sorafenib (Group 1) and a second group of 90 patients that underwent radioembolization alone (Group 2). Results: Baseline characteristics of the two groups were well balanced concerning liver function and tumor burden. No significant differences in survival outcomes were identified (median overall survival 10 vs. 10 months; p = 0.711), median progression-free survival 6 vs. 7 months (p = 0.992) in Group 1 and Group 2). The objective response rate in Group 1 vs. Group 2 was 45.5% vs. 42.8% (p = 1) according to mRECIST. No differences in toxicity nor in liver decompensation rates were registered. Conclusions: The association of sorafenib does not prolong survival nor delay progression in patients treated with radioembolization. Liver toxicity does not differ among the two therapeutic schemes.

scholarly journals Ropeginterferon alfa-2b every 2 weeks as a novel pegylated interferon for patients with chronic hepatitis B

2020 ◽  
Author(s):  
Yi-Wen Huang ◽  
Chao-Wei Hsu ◽  
Sheng-Nan Lu ◽  
Ming-Lung Yu ◽  
Chien-Wei Su ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Pegylated Interferon ◽  
Preliminary Evaluation ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Ropeginterferon alfa-2b is a novel mono-pegylated interferon that has only one major form as opposed to 8–14 isomers of other on-market pegylated interferon, allowing injection every two or more weeks with higher tolerability. It received European Medicines Agency and Taiwan marketing authorization in 2019 and 2020, for treatment of polycythemia vera. This phase I/II study aimed to have preliminary evaluation of safety and efficacy in chronic hepatitis B. Methods Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status and randomized at 1:1:1 ratio to q2w ropeginterferon alfa-2b 350 μg (group 1), q2w 450 μg (group 2) or q1w PEG-IFN alfa-2a 180 μg (group 3). Each patient received 48-week treatment (TW48) and 24-week post-treatment follow-up (FW24). Results The baseline demographics were comparable among the three groups, except for mean HBeAg in HBeAg-positive patients (2.90, 2.23, 2.99 log10 S/CO, respectively). Cumulative HBeAg seroconversion rate at follow-up period was 27.3% (3/11), 36.4% (4/11), and 11.1% (1/9) with time to HBeAg seroconversion starting from TW24, TW16, and TW48 in group 1, 2, and 3, respectively. The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups. Ropeginterferon alfa-2b (group 1 & 2) had numerically lower incidence of rash (9.5% and 4.5%) as compared to PEG-IFN alfa-2a (36.8%). Ropeginterferon alfa-2b 350 μg (group 1) had more ALT elevation (38.1%), however the rate was comparable in group 2 (9.1%) and group 3 (10.5%). Conclusion In this preliminary study, ropeginterferon alfa-2b, although in only half the number of injections, is as safe and effective as pegylated interferon alfa-2a for chronic hepatitis B. Graphic abstract

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