- Email: [email protected]
P1067 RESPONSE-GUIDED PEGINTERFERON ALFA-2a (PegIFN alfa-2a) THERAPY IN PATIENTS WITH HBeAg-POSITIVE CHRONIC HEPATITIS B (CHB)
POSTERS P1065 EPIDEMIOLOGY OF HBV INFECTION IN A COHORT OF UGANDAN HIV-INFECTED PATIENTS AND RATE AND PATTERN OF LAMIVUDINE-RESISTANT HBV INFECTION IN PATIENTS RECEIVING ANTIRETROVIRAL THERAPY G. Calisti1 , R. Muhindo2 , Y. Boum2,3 , L.A. Wilson2 , G.M. Foster4 , A.M. Geretti4 , S. Bhagani5 . 1 Department of Virology, Royal Free London NHS Foundation Trust, London, United Kingdom; 2 Faculty of Medicine, Mbarara University of Science and Technology, 3 Epicentre Mbarara Research Base, Mbarara, Uganda; 4 Institute of Infection and Global Health, University of Liverpool, Liverpool, 5 HIV Medicine, Royal Free London NHS Foundation Trust, London, United Kingdom E-mail: [email protected] Background and Aims: Many HIV-infected patients in SubSaharian Africa are not routinely screened for HBV infection and are on ART regimens containing only lamivudine as anti-HBV active drug. Methods: In 2009–2011, all HIV-infected patients aged ≥16 years seen at the Mbarara Hospital Uganda were asked to complete a questionnaire assessing risk factors for HBV infection, be screened for HBsAg with the Determine™ Test and have samples of dried plasma or blood spots (DPS/DBS) collected. DBS/DPS samples of the HBsAg-positive patients on ART for ≥12 months were tested for HBV-DNA by quantitative PCR (lower limit of detection from DPS/DBS 250 IU/ml) and HBV drug resistance by sequencing. Results: Of the 2820 patients who agreed to participate to the study (93.3% uptake), 109 patients tested positive for HBsAg (3.9%). HBsAg-positive patients were more likely to have a family history of liver cancer (p0.02) and have had >4 lifetime sexual partners (p < 0.01). Of the 55 HBsAg-positive patients on ART for ≥12 months, 53 were on lamivudine-monotherapy for their HBV infection and 2 were on tenofovir and lamivudine. HBV-DNA was detected in 30 (54.5%) patients, all on lamivudinemonotherapy (for a median 46 months). Of the 23 patients in whom HBV-DNA sequencing was successful: 19 had genotype A and 4 genotype D; 17 had lamivudine-resistant HBV strains harbouring rtM204V/I mutations, accompanied by the rtL180M mutation in 12 cases. Conclusions: This confirms the importance of screening for HBV and of using ART regimens containing tenofovir and either lamivudine or emtricitabine in HIV/HBV co-infected patients in Sub-Saharian Africa, as lamivudine-resistance seems to develop quickly in this population. P1066 IMPROVED HBeAg SEROCONVERSION BY SEQUENTIAL TELBIVUDINE THERAPY FOLLOWING PARTIAL RESPONSE TO PEGYLATED INTERFERON TREATMENT IN HBeAg-POSITIVE CHRONIC HEPATITIS B PATIENTS Q. Zheng, Y.Y. Zhu, J. Chen, R.Y. Liu, J. Dong, W.D. Zeng, J.J. Jiang. Center of Liver Diseases, First Affiliated Hospital of Fujian Medical University, Fuzhou, China E-mail: [email protected] Background and Aims: To investigate the therapeutic benefit of sequential telbivudine (LdT) in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) who showed partial response to pegylated interferon treatment, and to explore the potential predictors for serologic response. Methods: A total 70 HBeAg-positive CHB patients without a complete (serologic) response to pegylated interferon therapy received sequential treatment with telbivudine for 2 to 4 years. All patients were visited included measurements of serum alanine aminotransferase (ALT), hepatitis B e antigen (HBeAg), and HBVDNA every 3–6 months. S432
Results: The median age and follow-up duration were 28 years and 3 years. All patients were followed up for at least 2 years, while data were collected for 70, 63, and 58 patients at 2, 3, 4 years respectively. The cumulative HBeAg seroconversion rates were 25.9%, 42.6%, 50%, 51.8% at 1, 2, 3, 4 years respectively. Undetectable HBV DNA rates were achieved by 75.9%, 88.8%, 94.44%, and 96.29% at each time point and only one patient (1.4%) presented with telbivudine resistance. The ALT normalization rates were 94.4% at 1 years and 100% at 2 years. The time of undetectable HBVDNA after telbivudine treatment were significantly associated with HBeAg loss (P = 0.022, OR = 1.040) based on multivariate analysis. Conclusions: Sequential telbivudine in patients with partial response to pegylated interferon treatment resulted in high rates of HBeAg seroconversion and low resistance rate. The time of undetectable HBVDNA after telbivudine treatment were potential predictors for HBeAg loss. P1067 RESPONSE-GUIDED PEGINTERFERON ALFA-2a (PegIFN alfa-2a) THERAPY IN PATIENTS WITH HBeAg-POSITIVE CHRONIC HEPATITIS B (CHB) J. Hou1 , H. Ma2 , J. Sun1 , Q. Xie3 , Y. Xie4 , Y. Sun5 , H. Wang6 , G. Shi7 , M. Wan8 , J. Niu9 , Q. Ning10 , Y. Yu11 , Y. Xie12 . 1 Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, 2 Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, 3 Department of Infectious Diseases, Jiaotong University School of Medicine, Shanghai Ruijin Hospital, Shanghai, 4 Liver Disease Department, Beijing Ditan Hospital, Beijing, 5 Department of Infectious Disease, The Fourth Military Medical University, Tangdu Hospital, Xi’an, 6 Liver Disease Department, Peking University People’s Hospital, Beijing, 7 Department of Infectious Diseases, Huashan Hospital, Fudan University, 8 Department of Infectious Diseases, Shanghai Changhai Hospital, Shanghai, 9 Department of Liver, First Hospital of Jilin University, Changchun, 10 Department of Infectious Diseases, Wuhan Tongji Hospital, Huazhong Technology University, Tongji Medical College, Wuhan, 11 Department of Infectious Diseases, Peking University First Hospital, Beijing, 12 Shanghai Roche Pharmaceuticals Co Ltd, Shanghai, China E-mail: [email protected] Background and Aims: We aimed to explore whether responseguided therapy can be used to optimise PegIFN alfa-2a treatment in patients with HBeAg-positive CHB. Methods: Early response was assessed after 24 weeks of PegIFN alfa-2a (180 mg/week). Early responders (HBsAg <1500 IU/mL and HBV DNA <105 copies/mL) received PegIFN alfa-2a for a further 24 weeks (total 48 weeks; Arm A), while patients not achieving the early response were randomised to PegIFN alfa-2a for a further 24 weeks (total 48 weeks; Arm B), a further 72 weeks (total 96 weeks; Arm C) or PegIFN alfa-2a for a further 72 weeks with the addition of adefovir (10 mg/day) for 36 weeks starting at Week 29 (total 96 weeks; Arm D). Response rates were determined at 24 weeks post-treatment. Results: An early response was achieved by 25% (66/264) of patients. Mean decline in quantitative HBsAg from baseline to 24 weeks post-treatment was higher in Arm A (−1.15 log10 IU/mL) than B, C or D (−0.67, −0.71 and −0.64 log10 IU/mL, respectively), with no significant difference among Arms B, C and D (B vs. p = 0.4072; B vs. D p = 0.5519). Furthermore, there were no significant differences in response rates for any other efficacy endpoints among Arms B, C and D. Treatment was generally well tolerated; four patients discontinued therapy due to adverse events. Conclusions: For HBeAg-positive CHB patients without an early response to PegIFN alfa-2a, a 48-week treatment duration has similar efficacy to 96 weeks of treatment, with or without the addition of adefovir. Funded by Roche.
Journal of Hepatology 2014 vol. 60 | S361–S522
POSTERS Table (abstract P1067): Summary of treatment responses at 24 weeks post-treatment (full analysis set) Response at 24 weeks post-treatment
Mean±SD decline from baseline HBsAg, log10 IU/mL Mean±SD decline from baseline HBV DNA, log10 copies/mL Mean±SD decline from baseline HBeAg, log10 PEIU/mL HBeAg seroconversion, n (%) HBeAg seroconversion and HBV DNA ≤105 copies/mL, n (%) HBsAg loss, n (%) Normalisation of ALT, n (%) Discontinuation of therapy due to adverse event, n (%)
Early responders Arm A (n = 66)
Arm B (n = 67)
Arm C (n = 67)
Arm D (n = 64)
B vs. C
B vs. D
−1.15±1.61 −3.28±3.12 −1.73±2.07 31 (47.0) 29 (43.9) 3 (4.5) 38 (57.6) 0
−0.67±0.92 −2.34±2.50 −1.57±1.78 21 (31.3) 16 (23.9) 0 28 (41.8) 0
−0.71±1.23 −2.68±2.50 −1.83±1.45 23 (34.3) 22 (32.8) 1 (1.5) 30 (44.8) 2 (3.0)
−0.64±1.18 −2.83±3.07 −1.63±1.71 22 (34.4) 20 (31.3) 2 (3.1) 34 (53.1) 2 (3.1)
0.4072 0.0609 0.1271 0.8830 0.4809 0.9618 0.6831 −
0.5519 0.1284 0.3711 0.8651 0.6381 0.9592 0.1639 −
P1068 EFFICACY OF PROLONGED TENOFOVIR THERAPY ON HEPATITIS DELTA IN HIV-INFECTED PATIENTS R. Sierra-Enguita, E. Vispo, P. Barreiro, C. de Mendoza, J.V. Fernandez-Montero, P. Labarga, V. Soriano. Infectious Diseases, Hospital Carlos III, Madrid, Spain E-mail: [email protected] Background and Aims: Hepatitis delta virus (HDV) produces the most severe form of chronic viral hepatitis. Since HDV replication requires HBsAg and tenofovir is amongst the most active antiHBV agents and is widely used as HIV drug, we explored whether prolonged tenofovir exposure might be beneficial on hepatitis delta in HIV-infected patients. Methods: All HIV-infected patients with hepatitis delta followed at our institution were retrospectively examined. Serum HBV-DNA and HDV-RNA were quantified using commercial assays. Liver fibrosis was measured using elastometry. Results: A total of 19 HIV/delta patients were identified. Nine (47%) were on lamivudine (median 59 months) before beginning tenofovir, being the rest naïve to any anti-HBV agent. All were viremic for HDV and 11 for HBV. After a median tenofovir exposure of 58 months, all had undetectable HBV-DNA and 10 (53%) had undetectable HDV-RNA. The median drop in HDV-RNA in the remaining 9 HDV viremic patients at the end of follow-up was 2.4 log copies/mL. A reduction above 30% in liver stiffness occurred in 6/10 (60%) patients who achieved undetectable HDV-RNA whereas hepatic stiffness did not modify in the remaining HDV viremic patients (p = 0.03). Median liver enzymes slightly declined but only normalized in 4 patients. Serum HBsAg concentrations did not decline significantly, although HBsAg seroclearance occurred in 3 patients, all of whom became negative for HDV-RNA. Conclusions: Long-term exposure to tenofovir significantly reduces serum HDV-RNA besides completely suppress HBV-DNA in HIVinfected patients with hepatitis delta. This virological benefit is accompanied by significant improvements in liver fibrosis. P1069 THE EFFICACY OF ENTECAVIR IN BOTH NAIVE AND LAMIVUDINE EXPERIENCED WITHOUT RESISTANCE CHRONIC HEPATITIS B PATIENTS S.J. Ahn1 , J.A. Hwang1 , K.B. Kim2 , H.J. Cho1 , S.S. Kim1 , J.Y. Cheong1 , S.W. Cho1 . 1 Department of Gastroenterology, Ajou University Hospital, Suwon, 2 Department of Gastroenterology, Sungae Hospital, Gwangmyeong-si, Korea, Republic of E-mail: [email protected] Background and Aims: Entecavir (ETV) has a potent antiviral efficacy in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B patients. However, data on the antiviral efficacy of ETV in patients who experienced lamivudine (LAM) without development of resistance are limited. This study evaluated the efficacy of ETV in both naïve and LAM experienced chronic hepatitis B patients.
Non-early responders
p-value
Methods: We retrospectively collected clinical data from 342 consecutive chronic hepatitis B patients who were treated with ETV 0.5 mg for at least 30 months from 2006 to 2012. The patients were devided into two groups: NA naïve patients (group1, n = 270) and patients who were exposed to LAM, but never developed LAM resistance (group2, n = 72). Results: During median follow up of 44.32 months, there was no significant difference in clinical efficacy between two groups. Biochemical response was observed in 94.5% and 88.8% of patients (p = 0.227) and virological response was observed in 95.7% and 89.1% of patients (p = 0.068) in group 1 and 2, respectively. HBeAg loss rate was 79.2% and 77% (p = 0.807) and HBeAg seroconversion rate was 29.7% and 17.4% (p = 0.623) in group 1 and 2, respectively. However, possibility of virological breakthrough was increased in group2 (18.8%), compared to group1 (3.5%) (p = 0.000). Furthermore, genotypic ETV resistance was developed more frequently in group2 (12.9%) compared to group1 (2.6%) (p = 0.019). Conclusions: The antiviral efficacy of ETV was not influenced by prior treatment with LAM in LAM responders without development of resistance. However, virological breakthrough and ETV resistance were more frequently developed in LAM experienced patients with chronic hepatitis B. P1070 FIRST LINE TREATMENT FOR CHRONIC HEPATITIS B (CH-B) IN REAL LIFE. AN ITALIAN MULTICENTER OBSERVATIONAL COHORT (HBV-RER) V. Borghi1 , P. Andreone2 , M. Massari3 , E. Villa4 , A. Pietrangelo5 , G. Verucchi6 , F. Levantesi7 , C. Ferrari8 , HBV-RER Study Group. 1 Infectious Disease, Azienda Ospedaliero Universitaria di Modena, Modena, 2 Internal Medicine, Azienda Ospedaliero Universitaria di Bologna, Bologna, 3 Infectious Disease, IRCCS – ASMN Reggio Emilia, Reggio Emilia, 4 Gastroenterology, Azienda Ospedaliero Universitaria di Modena, 5 Internal Medicine, Azienda Ospedaliero Universitaria Modena, Modena, 6 Infectious Disease, Azienda Ospedaliero Universitaria di Bologna, Bologna, 7 Internal Medicine, Ospedale di Bentivoglio, Bentivoglio, 8 Infectious Disease and Hepatology, Azienda Ospedaliero Universitaria di Parma, Parma, Italy E-mail: [email protected] Background and Aims: Treatment options for chronic hepatitis B (CHB) are pegylated interferon (PIFN) in minimal/mild liver fibrosis and nucleot(s)ide analogues (NUC) in more advanced disease. Since little is known about their use in daily clinical practice, we conducted a multicenter prospective study to investigate treatment regimens applied to naïve CHB patients in real life. Methods: HBV-RER is an observational multicenter Italian network that collect clinic and virologic data of patients with CHB. Results: Among the 2527 CHB patients seen during the study period (2009–2012), 502 patients started a first line antiviral treatment. Demographic and clinical characteristics are reported in he table. Liver biopsy was done in 31% of the patients and liver cirrhosis was detected in 20% of them. In 216 patients (43%) PIFN was
Journal of Hepatology 2014 vol. 60 | S361–S522
S433
Results: The median age and follow-up duration were 28 years and 3 years. All patients were followed up for at least 2 years, while data were collected for 70, 63, and 58 patients at 2, 3, 4 years respectively. The cumulative HBeAg seroconversion rates were 25.9%, 42.6%, 50%, 51.8% at 1, 2, 3, 4 years respectively. Undetectable HBV DNA rates were achieved by 75.9%, 88.8%, 94.44%, and 96.29% at each time point and only one patient (1.4%) presented with telbivudine resistance. The ALT normalization rates were 94.4% at 1 years and 100% at 2 years. The time of undetectable HBVDNA after telbivudine treatment were significantly associated with HBeAg loss (P = 0.022, OR = 1.040) based on multivariate analysis. Conclusions: Sequential telbivudine in patients with partial response to pegylated interferon treatment resulted in high rates of HBeAg seroconversion and low resistance rate. The time of undetectable HBVDNA after telbivudine treatment were potential predictors for HBeAg loss. P1067 RESPONSE-GUIDED PEGINTERFERON ALFA-2a (PegIFN alfa-2a) THERAPY IN PATIENTS WITH HBeAg-POSITIVE CHRONIC HEPATITIS B (CHB) J. Hou1 , H. Ma2 , J. Sun1 , Q. Xie3 , Y. Xie4 , Y. Sun5 , H. Wang6 , G. Shi7 , M. Wan8 , J. Niu9 , Q. Ning10 , Y. Yu11 , Y. Xie12 . 1 Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, 2 Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, 3 Department of Infectious Diseases, Jiaotong University School of Medicine, Shanghai Ruijin Hospital, Shanghai, 4 Liver Disease Department, Beijing Ditan Hospital, Beijing, 5 Department of Infectious Disease, The Fourth Military Medical University, Tangdu Hospital, Xi’an, 6 Liver Disease Department, Peking University People’s Hospital, Beijing, 7 Department of Infectious Diseases, Huashan Hospital, Fudan University, 8 Department of Infectious Diseases, Shanghai Changhai Hospital, Shanghai, 9 Department of Liver, First Hospital of Jilin University, Changchun, 10 Department of Infectious Diseases, Wuhan Tongji Hospital, Huazhong Technology University, Tongji Medical College, Wuhan, 11 Department of Infectious Diseases, Peking University First Hospital, Beijing, 12 Shanghai Roche Pharmaceuticals Co Ltd, Shanghai, China E-mail: [email protected] Background and Aims: We aimed to explore whether responseguided therapy can be used to optimise PegIFN alfa-2a treatment in patients with HBeAg-positive CHB. Methods: Early response was assessed after 24 weeks of PegIFN alfa-2a (180 mg/week). Early responders (HBsAg <1500 IU/mL and HBV DNA <105 copies/mL) received PegIFN alfa-2a for a further 24 weeks (total 48 weeks; Arm A), while patients not achieving the early response were randomised to PegIFN alfa-2a for a further 24 weeks (total 48 weeks; Arm B), a further 72 weeks (total 96 weeks; Arm C) or PegIFN alfa-2a for a further 72 weeks with the addition of adefovir (10 mg/day) for 36 weeks starting at Week 29 (total 96 weeks; Arm D). Response rates were determined at 24 weeks post-treatment. Results: An early response was achieved by 25% (66/264) of patients. Mean decline in quantitative HBsAg from baseline to 24 weeks post-treatment was higher in Arm A (−1.15 log10 IU/mL) than B, C or D (−0.67, −0.71 and −0.64 log10 IU/mL, respectively), with no significant difference among Arms B, C and D (B vs. p = 0.4072; B vs. D p = 0.5519). Furthermore, there were no significant differences in response rates for any other efficacy endpoints among Arms B, C and D. Treatment was generally well tolerated; four patients discontinued therapy due to adverse events. Conclusions: For HBeAg-positive CHB patients without an early response to PegIFN alfa-2a, a 48-week treatment duration has similar efficacy to 96 weeks of treatment, with or without the addition of adefovir. Funded by Roche.
Journal of Hepatology 2014 vol. 60 | S361–S522
POSTERS Table (abstract P1067): Summary of treatment responses at 24 weeks post-treatment (full analysis set) Response at 24 weeks post-treatment
Mean±SD decline from baseline HBsAg, log10 IU/mL Mean±SD decline from baseline HBV DNA, log10 copies/mL Mean±SD decline from baseline HBeAg, log10 PEIU/mL HBeAg seroconversion, n (%) HBeAg seroconversion and HBV DNA ≤105 copies/mL, n (%) HBsAg loss, n (%) Normalisation of ALT, n (%) Discontinuation of therapy due to adverse event, n (%)
Early responders Arm A (n = 66)
Arm B (n = 67)
Arm C (n = 67)
Arm D (n = 64)
B vs. C
B vs. D
−1.15±1.61 −3.28±3.12 −1.73±2.07 31 (47.0) 29 (43.9) 3 (4.5) 38 (57.6) 0
−0.67±0.92 −2.34±2.50 −1.57±1.78 21 (31.3) 16 (23.9) 0 28 (41.8) 0
−0.71±1.23 −2.68±2.50 −1.83±1.45 23 (34.3) 22 (32.8) 1 (1.5) 30 (44.8) 2 (3.0)
−0.64±1.18 −2.83±3.07 −1.63±1.71 22 (34.4) 20 (31.3) 2 (3.1) 34 (53.1) 2 (3.1)
0.4072 0.0609 0.1271 0.8830 0.4809 0.9618 0.6831 −
0.5519 0.1284 0.3711 0.8651 0.6381 0.9592 0.1639 −
P1068 EFFICACY OF PROLONGED TENOFOVIR THERAPY ON HEPATITIS DELTA IN HIV-INFECTED PATIENTS R. Sierra-Enguita, E. Vispo, P. Barreiro, C. de Mendoza, J.V. Fernandez-Montero, P. Labarga, V. Soriano. Infectious Diseases, Hospital Carlos III, Madrid, Spain E-mail: [email protected] Background and Aims: Hepatitis delta virus (HDV) produces the most severe form of chronic viral hepatitis. Since HDV replication requires HBsAg and tenofovir is amongst the most active antiHBV agents and is widely used as HIV drug, we explored whether prolonged tenofovir exposure might be beneficial on hepatitis delta in HIV-infected patients. Methods: All HIV-infected patients with hepatitis delta followed at our institution were retrospectively examined. Serum HBV-DNA and HDV-RNA were quantified using commercial assays. Liver fibrosis was measured using elastometry. Results: A total of 19 HIV/delta patients were identified. Nine (47%) were on lamivudine (median 59 months) before beginning tenofovir, being the rest naïve to any anti-HBV agent. All were viremic for HDV and 11 for HBV. After a median tenofovir exposure of 58 months, all had undetectable HBV-DNA and 10 (53%) had undetectable HDV-RNA. The median drop in HDV-RNA in the remaining 9 HDV viremic patients at the end of follow-up was 2.4 log copies/mL. A reduction above 30% in liver stiffness occurred in 6/10 (60%) patients who achieved undetectable HDV-RNA whereas hepatic stiffness did not modify in the remaining HDV viremic patients (p = 0.03). Median liver enzymes slightly declined but only normalized in 4 patients. Serum HBsAg concentrations did not decline significantly, although HBsAg seroclearance occurred in 3 patients, all of whom became negative for HDV-RNA. Conclusions: Long-term exposure to tenofovir significantly reduces serum HDV-RNA besides completely suppress HBV-DNA in HIVinfected patients with hepatitis delta. This virological benefit is accompanied by significant improvements in liver fibrosis. P1069 THE EFFICACY OF ENTECAVIR IN BOTH NAIVE AND LAMIVUDINE EXPERIENCED WITHOUT RESISTANCE CHRONIC HEPATITIS B PATIENTS S.J. Ahn1 , J.A. Hwang1 , K.B. Kim2 , H.J. Cho1 , S.S. Kim1 , J.Y. Cheong1 , S.W. Cho1 . 1 Department of Gastroenterology, Ajou University Hospital, Suwon, 2 Department of Gastroenterology, Sungae Hospital, Gwangmyeong-si, Korea, Republic of E-mail: [email protected] Background and Aims: Entecavir (ETV) has a potent antiviral efficacy in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B patients. However, data on the antiviral efficacy of ETV in patients who experienced lamivudine (LAM) without development of resistance are limited. This study evaluated the efficacy of ETV in both naïve and LAM experienced chronic hepatitis B patients.
Non-early responders
p-value
Methods: We retrospectively collected clinical data from 342 consecutive chronic hepatitis B patients who were treated with ETV 0.5 mg for at least 30 months from 2006 to 2012. The patients were devided into two groups: NA naïve patients (group1, n = 270) and patients who were exposed to LAM, but never developed LAM resistance (group2, n = 72). Results: During median follow up of 44.32 months, there was no significant difference in clinical efficacy between two groups. Biochemical response was observed in 94.5% and 88.8% of patients (p = 0.227) and virological response was observed in 95.7% and 89.1% of patients (p = 0.068) in group 1 and 2, respectively. HBeAg loss rate was 79.2% and 77% (p = 0.807) and HBeAg seroconversion rate was 29.7% and 17.4% (p = 0.623) in group 1 and 2, respectively. However, possibility of virological breakthrough was increased in group2 (18.8%), compared to group1 (3.5%) (p = 0.000). Furthermore, genotypic ETV resistance was developed more frequently in group2 (12.9%) compared to group1 (2.6%) (p = 0.019). Conclusions: The antiviral efficacy of ETV was not influenced by prior treatment with LAM in LAM responders without development of resistance. However, virological breakthrough and ETV resistance were more frequently developed in LAM experienced patients with chronic hepatitis B. P1070 FIRST LINE TREATMENT FOR CHRONIC HEPATITIS B (CH-B) IN REAL LIFE. AN ITALIAN MULTICENTER OBSERVATIONAL COHORT (HBV-RER) V. Borghi1 , P. Andreone2 , M. Massari3 , E. Villa4 , A. Pietrangelo5 , G. Verucchi6 , F. Levantesi7 , C. Ferrari8 , HBV-RER Study Group. 1 Infectious Disease, Azienda Ospedaliero Universitaria di Modena, Modena, 2 Internal Medicine, Azienda Ospedaliero Universitaria di Bologna, Bologna, 3 Infectious Disease, IRCCS – ASMN Reggio Emilia, Reggio Emilia, 4 Gastroenterology, Azienda Ospedaliero Universitaria di Modena, 5 Internal Medicine, Azienda Ospedaliero Universitaria Modena, Modena, 6 Infectious Disease, Azienda Ospedaliero Universitaria di Bologna, Bologna, 7 Internal Medicine, Ospedale di Bentivoglio, Bentivoglio, 8 Infectious Disease and Hepatology, Azienda Ospedaliero Universitaria di Parma, Parma, Italy E-mail: [email protected] Background and Aims: Treatment options for chronic hepatitis B (CHB) are pegylated interferon (PIFN) in minimal/mild liver fibrosis and nucleot(s)ide analogues (NUC) in more advanced disease. Since little is known about their use in daily clinical practice, we conducted a multicenter prospective study to investigate treatment regimens applied to naïve CHB patients in real life. Methods: HBV-RER is an observational multicenter Italian network that collect clinic and virologic data of patients with CHB. Results: Among the 2527 CHB patients seen during the study period (2009–2012), 502 patients started a first line antiviral treatment. Demographic and clinical characteristics are reported in he table. Liver biopsy was done in 31% of the patients and liver cirrhosis was detected in 20% of them. In 216 patients (43%) PIFN was
Journal of Hepatology 2014 vol. 60 | S361–S522
S433