- Email: [email protected]
Twenty-Five Years of Chronic Hepatitis B – Clinical Outcome
POSTER PRESENTATIONS conducted for 144 hours post dose. Safety was assessed throughout study and during follow-up. The 90% confidence intervals (CI) were constructed about the ratio of geometric means (GMR) of logtransformed TAF and TFV exposures in the impairment group (test) versus control group (reference). Plasma protein binding of TAF and TFV was measured using equilibrium dialysis. Results: Following administration of TAF in the severe impairment group, the total exposure of TAF and its metabolite, TFV were lower, relative to the normal matched control group (Table 1). However, the lower total TAF exposure was accompanied by an increase in free fraction (as percentage of unbound TAF) in subjects with severe hepatic impairment (38%) relative to normal matched control subjects (20%). As such, the exposure of free TAF (the moiety associated with therapeutic effect) was comparable between both groups (Table 1). The percentage of unbound TFV was high in all subjects (>95%) and no correlations were observed between TAF or TFV exposures versus CPT score. TAF was generally well tolerated. All subjects completed the study and the majority of adverse events (AEs) were mild in severity. One subject in the severe hepatic impairment group had a Grade 3 AE of hepatic failure during post treatment follow-up considered by the investigator as unrelated to study drug. No clinically relevant changes in laboratory abnormalities were observed in either group. Conclusions: Severe hepatic impairment does not result in clinically relevant changes in TAF or TFV exposures. Accordingly, dose adjustment of TAF is not necessary in patients with severe hepatic impairment. FRI-128 TENOFOVIR VERSUS TENOFOVIR PLUS ENTECAVIR FOR CHRONIC HEPATITIS B WITH LAMIVUDINE-RESISTANCE AND ENTECAVIRRESISTANCE S. Lee1,2, S.H. Ahn1, K.S. Jung1, D.Y. Kim1, B.K. Kim1, S.U. Kim1, O. Baatarkhuu1,3, H.J. Ku1, K.-H. Han1, J.Y. Park1. 1Internal Medicine, Yonsei University College of Medicine, Seoul; 2Internal Medicine, Catholic Kwandong University College of Medicine, Incheon Metropolitan city, South Korea; 3Infectious Diseases, Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia E-mail: [email protected] Background and Aims: We compared the viral suppressive efficacy of tenofovir disoproxil fumarate (TDF) mono-rescue therapy (TDF group) and TDF plus entecavir (ETV) combination-rescue therapy (TDF + ETV group) in chronic hepatitis B (CHB) patients with lamivudine resistance (LAM-R) and ETV resistance (ETV-R). Methods: One hundred and thirty-three CHB patients with LAMR and ETV-R were investigated. Ninety-six patients were treated with TDF and 37 with TDF + ETV for at least 6 months. We compared the virologic response rate (HBV DNA level <20 IU/mL) between the two groups and identified the predictive factors of treatment outcome. Results: There were no significant differences between the two groups in demographic characteristics. Up to 24 months [median: 18 (range 6–24) months], 85.4% and 89.2% of the TDF group and TDF + ETV group, respectively, achieved a virologic response ( p = 0.068). Only the HBV DNA level at baseline was significantly associated with a virologic response in the multivariate analysis. In a subanalysis of patients with HBV DNA levels ≥4 log (IU/mL) at baseline, a higher proportion of patients in the TDF + ETV group than the TDF group achieved a virologic response (92.9% vs. 68.3%; p < 0.001), while 90% of patients with HBV DNA (IU/mL) levels <4 log in all both TDF and TDF + ETV groups achieved a virologic response. Conclusions: TDF mono-rescue therapy is a reasonable option in patients with LAM-R + ETV-R. However, the combination strategy should be considered in patients with high baseline HBV DNA levels.
FRI-129 ENTECAVIR VERSUS LAMIVUDINE FOR PREVENTION OF LIVERRELATED EVENTS IN PATIENTS WITH HBV-RELATED ADVANCED LIVER DISEASE: A MULTICENTER, PROSPECTIVE STUDY J.Y. Park1,2, S.G. Kim2,3, W.Y. Tak2,4, H.J. Yim2,5, B.K. Jang2,6, M.Y. Kim2,7, B.I. Kim2,8, J.-W. Lee2,9, K.T. Yoon2,10, J.Y. Cheong2,11, S.Y. Kwon2,12, T.Y. Kim2,13, S.H. Bae2,14, Y.S. Seo2,5, J.H. Kwon2,15, D.J. Kim2,16, J.-K. Kim1,2, S.W. Jeong2,17, S.H. Ahn1,2, K.-H. Han1,2, on behalf of the SOUL Study Group. 1Yonsei University College of Medicine; 2Liver Cirrhosis Clinical Research Center, Seoul; 3Soonchunhyang University College of Medicine, Bucheon; 4Kyungpook National University School of Medicine, Daegu; 5Korea University College of Medicine, Seoul; 6 Keimyung University College of Medicine, Daegu; 7Yonsei University Wonju College of Medicine, Wonju; 8Sungkyunkwan University College of Medicine, Kangbuk Samsung Hospital, Seoul; 9Inha University School of Medicine, Incheon; 10Pusan National University College of Medicine, Busan; 11Ajou University School of Medicine, Suwon; 12Konkuk University School of Medicine, Seoul; 13Hanyang University Guri Hospital, Guri; 14The Catholic University of Korea, College of Medicine, Seoul; 15The Catholic University of Korea, Incheon St. Mary’s Hospital, Incheon; 16Hallym University College of Medicine, Chuncheon; 17 Soonchunhyang University College of Medicine, Seoul, South Korea E-mail: [email protected] Background and Aims: High potent drug is being recommended as first-line agent for chronic hepatitis B. However, whether high potent drug reduce the risk of liver- related events (LREs) to a greater extent than lamivudine is known, especially in patients with advanced fibrosis. We aimed to compare the clinical benefits of entecavir (ETV) 0.5 mg versus lamivudine (LAM) 100 mg for prevention of LREs in patients with HBV-related advanced liver disease. Methods: Randomized, open-label, phase 4 study conducted from December 2008 through April 2015 at 18 medical centers in South Korea. Patients who had histologically confirmed advanced fibrosis or cirrhosis or clinically evidence of overt cirrhosis with a high viral loads (HBV DNA ≥ 2,000 IU/mL) and normal or slightly elevated transaminase and no prior antiviral therapy were assigned to receive ETV (n = 231) or LAM (n = 231) for 5 years. If the patients confirmed to have HBV-resistance mutations, adefovir or tenofovir-based rescue therapy was added. LREs included hepatocellular carcinoma (HCC), decompensation, or liver-related death or transplantation. Results: The baseline characteristics were comparable between these two groups. During the study period, 100 (21.6%) patients experienced LREs (ETV vs LAM: 50 vs 50). The rates were no difference for the ETV group vs the LAM group for HCC development (14.3% vs 14.7%, respectively), Child–Pugh score increase (3.9% vs 3.9%), variceal bleeding (2.6% vs 1.3%) and liver-related death or transplantation (0.9% vs 2.6%). The cumulative incidence rates of genotypic resistance to LAM and ETV at 5-year treatment was 49.8% and 1.2%, respectively. Multivariable analyses showed that age, male gender and a primary nonresponse to antiviral therapy were associated with a high likelihood of a development of LREs, irrespective of the type of antiviral agent. Conclusions: In this prospective long-term study, there was no difference between the ETV arm and the LAM arm for prevention of LREs in patients with HBV-related advanced liver disease, if applied the appropriate rescue therapy. FRI-130 TWENTY-FIVE YEARS OF CHRONIC HEPATITIS B – CLINICAL OUTCOME L.C. Meireles1, S. Vitor1, L.C. Freitas1, J. Granada2, I. Santos2, R.T. Marinho1, J. Velosa1. 1Gastrenterology and Hepatology, Centro Hospitalar Lisboa Norte; 2Faculdade de Medicina – Universidade de Lisboa, Lisbon, Portugal E-mail: [email protected]
Journal of Hepatology 2016 vol. 64 | S425–S630
S595
POSTER PRESENTATIONS Background and Aims: The natural history of infection with hepatitis B virus (HBV) is variable and complex. Between 15% to 40% of patients who develop chronic hepatitis can progress to cirrhosis and hepatocellular carcinoma (HCC). Treatment with nucleos(t)ide analogues (NUCs) prevents liver complications associated with HBV infection. Methods: We intend to evaluate the efficacy and safety of treatment with NUCs in patients with chronic HBV infection. One hundred and eighty-nine patients with chronic hepatitis B, were retrospectively evaluated, in a period of 25 years. Demographic data were analyzed. Serological response, biochemical response and HBV-DNA clearance, add-on therapy and safety were evaluated. Development of cirrhosis and HCC during the follow-up were the main endpoints, as the complication-free survival. Results: We analyzed 189 patients (19% with cirrhosis). Seventythree patients were treated with interferon, 177 patients received at least one NUC (58.8% two or more NUCs). The main reason for therapy switch was appearance of resistant mutations. During a median follow-up of 11 years, while on continuous therapy with NUCs for a median time of 8 years, viral clearance was achieved in 98.4% of patients, HBsAg and HBeAg seroclearance was obtained in 36% and 5.3% respectively. Seven patients with chronic hepatitis progressed to cirrhosis, 5 patient developed a HCC (2 cases without cirrhosis) and 10 patients died (only 2 death directly related to infection with HBV). Conclusions: Treatment with oral NUCs is very effective and affects the natural history of chronic HBV infection by reducing the incidence of cirrhosis and risk of complications. FRI-131 COST-EFFECTIVENESS ANALYSIS OF HEPATITIS B VIRUS SCREENING TO PREVENT HEPATITIS B VIRUS REACTIVATION IN PATIENTS RECEIVING RITUXIMAB BASED CHEMOTHERAPY FOR HEMATOLOGIC MALIGNANCY M. Buti1, J. Crespo2, R. Esteban1, C. Torres3, I. Oyagüez3, M.Á. Casado3. 1 Hospital Universitari Vall d’Hebrón, Barcelona; 2Hospital Universitario Marqués de Valdecilla, Santander; 3Pharmacoeconomics & Outcomes Research Iberia, Madrid, Spain E-mail: [email protected] Background and Aims: Patients with hematologic malignancy under chemotherapy may be at particularly high risk of hepatitis B virus (HBV) reactivation. Antiviral prophylaxis after HBV screening could avoid this reactivation. The aim was to assess the short-term cost-effectiveness of HBV screening in patients with hematologic malignancy before undergoing chemotherapy. Methods: A decision tree model was developed to compare the costs and effectiveness for a 18-month period, comparing HBV screening (based on HBsAg, antiHBc and HBV-DNA tests) versus non-screening, before R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. Third-party payer perspective was applied. Health outcome was the number of HBV reactivation avoided. Patients testing HBsAg + or/and antiHBc + plus HBV-DNAwere administered oral antiviral prophylaxis (tenofovir disoproxil fumarate [TDF] 245 mg once daily) since chemotherapy starting until 1 year after completion of chemotherapy. In those nonscreening patients, TDF was dosed only if HBV reactivation occurred. Probabilities for outcomes derived from literature. Total costs (€, 2015) included direct medical resources: oral antiviral prophylaxis, R-CHOP, HBV screening and liver function (bilirubin and transaminases) tests. Drug costs were calculated based on published ex-factory prices with mandatory deduction. Incremental cost-effectiveness ratio (ICER) in terms of cost per reactivations averted of the most effective strategy versus the comparator was calculated. Results: A hypothetical 1,000 patient’s cohort was run through the model. HBV screening versus non-screening strategy avoid 7.36 reactivations (14.9 HBV reactivations versus 22.3). Total cost per patient (including €8,282 of R-CHOP chemotherapy) was €8,584 and S596
€8,449 for HBV screening strategy and non-screening strategy, respectively. ICER for HBV screening versus non-screening strategy was €18,376 per reactivation averted. Conclusions: HBV screening followed of oral antiviral prophylaxis, yielded higher health benefits than non-screening, decreasing HBV reactivation in patients with hematologic malignancy undergoing chemotherapy. FRI-132 QUANTIFICATION OF SERUM HBSAG IS A USEFUL PARAMETER TO OPTIMIZE ANTIVIRAL NUC THERAPY SCHEDULE IN CHRONIC HEPATITIS B M. Guarino1, G. Portella2, R. Bonavolta2, F. Auriemma1, V. Cossiga1, R. Granata1, L. Donnarumma1, N. Caporaso1, F. Morisco1. 1Department of Clinical Medicine and Surgery, Gastroenterology Unit, University of Naples “Federico II”; 2Department of Translational Medical Science, University of Naples “Federico II”, Naples, Italy E-mail: [email protected] Background and Aims: Serum HBsAg loss is the recommended stopping rule in nucleo(t)side-analogues (NUC) responders, even if this event occurs rarely. The predictive value of baseline and ontreatment quantitative serum of HBsAg levels in the therapeutic response to NUC in chronic hepatitis B (CHB) patients has not been sufficiently investigated. We aimed to investigate the kinetics of HBsAg levels during NUC therapy to evaluate the predictive value of decrease to achieve HBsAg seroclearance. Methods: Patients with CHB, receiving NUC antiviral therapy with stable viral suppression (HBV-DNA < 20 IU/mL), were recruited at the Gastroenterology Unit of the University of Naples “Federico II”. Sequential serum samples from these patients were tested for quantification of HBsAg with the Elecsys HBsAg II Quant immunoassay (Roche Diagnostics, Indianapolis, IN, USA). HBsAg levels were determined before to start NUC treatment, when available, and on-treatment every 12 months. Results: A total of 95 HBsAg-positive, HBeAg-negative patients (M/F: 73/22, median age 58 yrs [range 35–79], 33% cirrhotic) virally suppressed with different NUCs, were enrolled. Precisely 56 patients underwent to Tenofovir (TDF), 22 Entecavir (ETV) and 17 Lamivudine (LAM). The median treatment duration was 110 months, range 48–183 months. There was a significant decrease of the HBsAg levels during NUC therapy, at time of enrollment, the HBsAg mean value was 3471 UI/ mL [range 450–28948], while the mean value at the last determination was 1758 IU/mL [range 20–21905] ( p value < 0.001). Only 2/95 patients (1.9%) didn’t show a substantial decrease in HbsAg levels. The statistically significant decrease of HBsAg levels was also maintained when the patients were clustered according to antiviral therapy, presence of cirrhosis and previous treatment with interferon. Of particular interest, HBsAg seroclearance occurred in 18/95 patients (19%). Moreover, HBsAg seroconversion to HBsAb occurred in 3/18 patients, in which undetectable HBsAg value was evidenced at least two years before the seroconversion. In these 3 patients NUC therapy was successfully stopped, without relapse after a mean follow-up period of 26 months. Conclusions: The results of this study suggest a role of on-treatment HBsAg quantification in the management of NUC-treated patients. HBsAg measurement would be a useful parameter to optimize antiviral treatment schedule.
Journal of Hepatology 2016 vol. 64 | S425–S630
FRI-129 ENTECAVIR VERSUS LAMIVUDINE FOR PREVENTION OF LIVERRELATED EVENTS IN PATIENTS WITH HBV-RELATED ADVANCED LIVER DISEASE: A MULTICENTER, PROSPECTIVE STUDY J.Y. Park1,2, S.G. Kim2,3, W.Y. Tak2,4, H.J. Yim2,5, B.K. Jang2,6, M.Y. Kim2,7, B.I. Kim2,8, J.-W. Lee2,9, K.T. Yoon2,10, J.Y. Cheong2,11, S.Y. Kwon2,12, T.Y. Kim2,13, S.H. Bae2,14, Y.S. Seo2,5, J.H. Kwon2,15, D.J. Kim2,16, J.-K. Kim1,2, S.W. Jeong2,17, S.H. Ahn1,2, K.-H. Han1,2, on behalf of the SOUL Study Group. 1Yonsei University College of Medicine; 2Liver Cirrhosis Clinical Research Center, Seoul; 3Soonchunhyang University College of Medicine, Bucheon; 4Kyungpook National University School of Medicine, Daegu; 5Korea University College of Medicine, Seoul; 6 Keimyung University College of Medicine, Daegu; 7Yonsei University Wonju College of Medicine, Wonju; 8Sungkyunkwan University College of Medicine, Kangbuk Samsung Hospital, Seoul; 9Inha University School of Medicine, Incheon; 10Pusan National University College of Medicine, Busan; 11Ajou University School of Medicine, Suwon; 12Konkuk University School of Medicine, Seoul; 13Hanyang University Guri Hospital, Guri; 14The Catholic University of Korea, College of Medicine, Seoul; 15The Catholic University of Korea, Incheon St. Mary’s Hospital, Incheon; 16Hallym University College of Medicine, Chuncheon; 17 Soonchunhyang University College of Medicine, Seoul, South Korea E-mail: [email protected] Background and Aims: High potent drug is being recommended as first-line agent for chronic hepatitis B. However, whether high potent drug reduce the risk of liver- related events (LREs) to a greater extent than lamivudine is known, especially in patients with advanced fibrosis. We aimed to compare the clinical benefits of entecavir (ETV) 0.5 mg versus lamivudine (LAM) 100 mg for prevention of LREs in patients with HBV-related advanced liver disease. Methods: Randomized, open-label, phase 4 study conducted from December 2008 through April 2015 at 18 medical centers in South Korea. Patients who had histologically confirmed advanced fibrosis or cirrhosis or clinically evidence of overt cirrhosis with a high viral loads (HBV DNA ≥ 2,000 IU/mL) and normal or slightly elevated transaminase and no prior antiviral therapy were assigned to receive ETV (n = 231) or LAM (n = 231) for 5 years. If the patients confirmed to have HBV-resistance mutations, adefovir or tenofovir-based rescue therapy was added. LREs included hepatocellular carcinoma (HCC), decompensation, or liver-related death or transplantation. Results: The baseline characteristics were comparable between these two groups. During the study period, 100 (21.6%) patients experienced LREs (ETV vs LAM: 50 vs 50). The rates were no difference for the ETV group vs the LAM group for HCC development (14.3% vs 14.7%, respectively), Child–Pugh score increase (3.9% vs 3.9%), variceal bleeding (2.6% vs 1.3%) and liver-related death or transplantation (0.9% vs 2.6%). The cumulative incidence rates of genotypic resistance to LAM and ETV at 5-year treatment was 49.8% and 1.2%, respectively. Multivariable analyses showed that age, male gender and a primary nonresponse to antiviral therapy were associated with a high likelihood of a development of LREs, irrespective of the type of antiviral agent. Conclusions: In this prospective long-term study, there was no difference between the ETV arm and the LAM arm for prevention of LREs in patients with HBV-related advanced liver disease, if applied the appropriate rescue therapy. FRI-130 TWENTY-FIVE YEARS OF CHRONIC HEPATITIS B – CLINICAL OUTCOME L.C. Meireles1, S. Vitor1, L.C. Freitas1, J. Granada2, I. Santos2, R.T. Marinho1, J. Velosa1. 1Gastrenterology and Hepatology, Centro Hospitalar Lisboa Norte; 2Faculdade de Medicina – Universidade de Lisboa, Lisbon, Portugal E-mail: [email protected]
Journal of Hepatology 2016 vol. 64 | S425–S630
S595
POSTER PRESENTATIONS Background and Aims: The natural history of infection with hepatitis B virus (HBV) is variable and complex. Between 15% to 40% of patients who develop chronic hepatitis can progress to cirrhosis and hepatocellular carcinoma (HCC). Treatment with nucleos(t)ide analogues (NUCs) prevents liver complications associated with HBV infection. Methods: We intend to evaluate the efficacy and safety of treatment with NUCs in patients with chronic HBV infection. One hundred and eighty-nine patients with chronic hepatitis B, were retrospectively evaluated, in a period of 25 years. Demographic data were analyzed. Serological response, biochemical response and HBV-DNA clearance, add-on therapy and safety were evaluated. Development of cirrhosis and HCC during the follow-up were the main endpoints, as the complication-free survival. Results: We analyzed 189 patients (19% with cirrhosis). Seventythree patients were treated with interferon, 177 patients received at least one NUC (58.8% two or more NUCs). The main reason for therapy switch was appearance of resistant mutations. During a median follow-up of 11 years, while on continuous therapy with NUCs for a median time of 8 years, viral clearance was achieved in 98.4% of patients, HBsAg and HBeAg seroclearance was obtained in 36% and 5.3% respectively. Seven patients with chronic hepatitis progressed to cirrhosis, 5 patient developed a HCC (2 cases without cirrhosis) and 10 patients died (only 2 death directly related to infection with HBV). Conclusions: Treatment with oral NUCs is very effective and affects the natural history of chronic HBV infection by reducing the incidence of cirrhosis and risk of complications. FRI-131 COST-EFFECTIVENESS ANALYSIS OF HEPATITIS B VIRUS SCREENING TO PREVENT HEPATITIS B VIRUS REACTIVATION IN PATIENTS RECEIVING RITUXIMAB BASED CHEMOTHERAPY FOR HEMATOLOGIC MALIGNANCY M. Buti1, J. Crespo2, R. Esteban1, C. Torres3, I. Oyagüez3, M.Á. Casado3. 1 Hospital Universitari Vall d’Hebrón, Barcelona; 2Hospital Universitario Marqués de Valdecilla, Santander; 3Pharmacoeconomics & Outcomes Research Iberia, Madrid, Spain E-mail: [email protected] Background and Aims: Patients with hematologic malignancy under chemotherapy may be at particularly high risk of hepatitis B virus (HBV) reactivation. Antiviral prophylaxis after HBV screening could avoid this reactivation. The aim was to assess the short-term cost-effectiveness of HBV screening in patients with hematologic malignancy before undergoing chemotherapy. Methods: A decision tree model was developed to compare the costs and effectiveness for a 18-month period, comparing HBV screening (based on HBsAg, antiHBc and HBV-DNA tests) versus non-screening, before R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. Third-party payer perspective was applied. Health outcome was the number of HBV reactivation avoided. Patients testing HBsAg + or/and antiHBc + plus HBV-DNAwere administered oral antiviral prophylaxis (tenofovir disoproxil fumarate [TDF] 245 mg once daily) since chemotherapy starting until 1 year after completion of chemotherapy. In those nonscreening patients, TDF was dosed only if HBV reactivation occurred. Probabilities for outcomes derived from literature. Total costs (€, 2015) included direct medical resources: oral antiviral prophylaxis, R-CHOP, HBV screening and liver function (bilirubin and transaminases) tests. Drug costs were calculated based on published ex-factory prices with mandatory deduction. Incremental cost-effectiveness ratio (ICER) in terms of cost per reactivations averted of the most effective strategy versus the comparator was calculated. Results: A hypothetical 1,000 patient’s cohort was run through the model. HBV screening versus non-screening strategy avoid 7.36 reactivations (14.9 HBV reactivations versus 22.3). Total cost per patient (including €8,282 of R-CHOP chemotherapy) was €8,584 and S596
€8,449 for HBV screening strategy and non-screening strategy, respectively. ICER for HBV screening versus non-screening strategy was €18,376 per reactivation averted. Conclusions: HBV screening followed of oral antiviral prophylaxis, yielded higher health benefits than non-screening, decreasing HBV reactivation in patients with hematologic malignancy undergoing chemotherapy. FRI-132 QUANTIFICATION OF SERUM HBSAG IS A USEFUL PARAMETER TO OPTIMIZE ANTIVIRAL NUC THERAPY SCHEDULE IN CHRONIC HEPATITIS B M. Guarino1, G. Portella2, R. Bonavolta2, F. Auriemma1, V. Cossiga1, R. Granata1, L. Donnarumma1, N. Caporaso1, F. Morisco1. 1Department of Clinical Medicine and Surgery, Gastroenterology Unit, University of Naples “Federico II”; 2Department of Translational Medical Science, University of Naples “Federico II”, Naples, Italy E-mail: [email protected] Background and Aims: Serum HBsAg loss is the recommended stopping rule in nucleo(t)side-analogues (NUC) responders, even if this event occurs rarely. The predictive value of baseline and ontreatment quantitative serum of HBsAg levels in the therapeutic response to NUC in chronic hepatitis B (CHB) patients has not been sufficiently investigated. We aimed to investigate the kinetics of HBsAg levels during NUC therapy to evaluate the predictive value of decrease to achieve HBsAg seroclearance. Methods: Patients with CHB, receiving NUC antiviral therapy with stable viral suppression (HBV-DNA < 20 IU/mL), were recruited at the Gastroenterology Unit of the University of Naples “Federico II”. Sequential serum samples from these patients were tested for quantification of HBsAg with the Elecsys HBsAg II Quant immunoassay (Roche Diagnostics, Indianapolis, IN, USA). HBsAg levels were determined before to start NUC treatment, when available, and on-treatment every 12 months. Results: A total of 95 HBsAg-positive, HBeAg-negative patients (M/F: 73/22, median age 58 yrs [range 35–79], 33% cirrhotic) virally suppressed with different NUCs, were enrolled. Precisely 56 patients underwent to Tenofovir (TDF), 22 Entecavir (ETV) and 17 Lamivudine (LAM). The median treatment duration was 110 months, range 48–183 months. There was a significant decrease of the HBsAg levels during NUC therapy, at time of enrollment, the HBsAg mean value was 3471 UI/ mL [range 450–28948], while the mean value at the last determination was 1758 IU/mL [range 20–21905] ( p value < 0.001). Only 2/95 patients (1.9%) didn’t show a substantial decrease in HbsAg levels. The statistically significant decrease of HBsAg levels was also maintained when the patients were clustered according to antiviral therapy, presence of cirrhosis and previous treatment with interferon. Of particular interest, HBsAg seroclearance occurred in 18/95 patients (19%). Moreover, HBsAg seroconversion to HBsAb occurred in 3/18 patients, in which undetectable HBsAg value was evidenced at least two years before the seroconversion. In these 3 patients NUC therapy was successfully stopped, without relapse after a mean follow-up period of 26 months. Conclusions: The results of this study suggest a role of on-treatment HBsAg quantification in the management of NUC-treated patients. HBsAg measurement would be a useful parameter to optimize antiviral treatment schedule.
Journal of Hepatology 2016 vol. 64 | S425–S630