- Email: [email protected]
ANTI-HBC-POSITIVE LYMPHOMA PATIENTS UNDERGOING RITUXIMAB-BASED CHEMOTHERAPY: PRELIMINARY REPORT
POSTERS that in Group II (Figure 2). No VBT or GR were observed in Group I-A. In Group I-B or II patients with GR, the developed mutation patterns included rtM204I (36/36), rtL180M/P (2/36), rtV173E/L (4/36) without ADV related mutation. A multivariate logistic analysis found that W24 HBV DNA ≥300 copies/ml (OR, 11.769; 95% CI, 2.764–50.120; p = 0.001) was associated with higher risk of VBT in telbivudine monotherapy group (Group II). Conclusions: The W24 optimized strategy improves the HBV DNA surpression and reduces the incidences of VBT and GR dramatically. RtM204I was the dominant pattern for telbivudine resistance mutations. The failure to achieve early virological response predicts the development of VBT.
Figure 1. The design of EFFORT STUDY.
Methods: Eligible patients were histologically proven CD20-positive NHL, and negative for HBsAg but positive for serum anti-HBc antibody. Patients were randomized into two groups to receive either entecavir (ETV) prophylactic (one day before rituximabbased chemotherapy and up to three months after the end of chemotherapy) or ETV therapeutic (with the evidence of HBV reactivation and HBsAg seroreversion) therapy. The primary endpoint of this study was to compare the incidence of HBV reactivation between the two groups. Results: From Jul 2009 to Oct 2011, 87 lymphoma patients were enrolled in this study. Among them, 22 did not complete at least 2 sessions of chemotherapy were excluded from this study. For the rest of patients, 33 were in ETV prophylactic group and 32 were in therapeutic group. The mean age was 68 y/o for both groups. AntiHBs-positive rates were 79% (26/33) and 69% (22/32) in ETV prophylactic and therapeutic groups, respectively (p = 0.24). There were no differences in baseline HBV viral loads and serum ALT levels between the two groups. Till the end of Oct 2011, no case (0%) in prophylactic group and 6 cases (18.8%) in therapeutic group developed virological reactivation (p = 0.011), defined as sustained HBV DNA higher than 2,000 IU/ml for at least twice of one month apart. Of the 6 cases, two became positive for HBsAg (HBsAg seroreversion). Conclusions: HBV reactivation induced by rituximab-based chemotherapy is not uncommon in NHL patients with resolved hepatitis B. Antiviral prophylaxis during chemotherapy can prevent such event. 517 EFFICACY OF ANTIVIRAL THERAPY IN 102 ROMANIAN PATIENTS WITH CHRONIC HEPATITIS DELTA L. Gheorghe1 , S. Iacob1 , I. Simionov1 , R. Vadan1 , I. Constantinescu2 . 1 Center of Gastroenterology & Hepatology, 2 Department of Virology and Immunology, Fundeni Clinical Institute, Bucharest, Romania E-mail: [email protected]
Figure 2. Distribution of HBV DNA levels at W76.
516 RANDOMIZED CONTROLLED TRIAL OF PROPHYLACTIC ENTECAVIR IN HBSAG-NEGATIVE/ANTI-HBC-POSITIVE LYMPHOMA PATIENTS UNDERGOING RITUXIMAB-BASED CHEMOTHERAPY: PRELIMINARY REPORT Y.-H. Huang1,2 , Y.-C. Hong3 , L.-T. Hsiao3 , T.-J. Chiou3 , C.-H. Tzeng3 , H.-C. Lin1 , S.-D. Lee1 . 1 Division of Gastroenterology, Taipei Veterans General Hospital, 2 Institute of Clinical Medicine, National Yang-Ming University, 3 Division of Hematology and Oncology, Taipei Veterans General Hospital, Taipei, Taiwan R.O.C. E-mail: [email protected] Background and Aims: Hepatitis B (HBV) reactivation can occur among non-Hodgkin’s lymphoma (NHL) patients who are HBsAg negative but anti-HBc positive (resolved hepatitis B) at the time of rituximab-based chemotherapy. It is unknown whether such patients should routinely receive antiviral agents for prevention of HBV reactivation during chemotherapy. S204
Background: Therapy for chronic hepatitis D is not yet satisfactory, although it is the only mean to alter the natural course of liver disease. In practice, monotherapy with conventional or pegylated interferons remains the only available option. Aim: To evaluate the virological (negative HDV RNA), biochemical and histological response (end of treatment – EOT after 52 weeks and end of follow up – EOF after 104 weeks) in a Romanian cohort of hepatitis delta infected naïve patients treated with standard interferon (IFN) alpha or Pegylated Interferon (Peg-IFN) alpha. Results: One hundred and two Caucasians (56.9% men and 43.1% females), with a mean age of 39.4±7.3years, received medication (49 patients Peg-IFN and 53 patients standard IFN). There was no significant difference between the 2 groups regarding HDV RNA, HBV DNA, necroinflammatory activity and fibrosis stage at the beginning of antiviral therapy. Virological response at EOT was present in 33.3% of patients treated with Peg-IFN and at EOF was maintained in 25% patients. Patients treated with standard IFN had a virological response of 18.8% at EOT and 11.3% at EOF. 50% of patients showed normalization of ALT level at EOT and 25% at EOF in the Peg-IFN treated group compared to 37.7% at EOT and 22.6% at EOF in the standard IFN group. A combined biochemical and virological response was observed in 19.4% at EOT and 16.7% at EOF in the Peg-IFN group. Patients treated with standard IFN had a combined biochemical and virological response of 9.4% at EOT and 7.5% at EOF. Conclusions: Treatment with Peg-Interferon alpha had a higher success rate of virological and biochemical response rate. Standard of care for HBV-HDV coinfected patients is nowadays pegylated interferon. However, longer treatment periods and probably combined interferon-nucleotide analogues should be tested in order to increase the benefit on combined virological and biochemical responses.
Journal of Hepatology 2012 vol. 56 | S71–S224
Figure 1. The design of EFFORT STUDY.
Methods: Eligible patients were histologically proven CD20-positive NHL, and negative for HBsAg but positive for serum anti-HBc antibody. Patients were randomized into two groups to receive either entecavir (ETV) prophylactic (one day before rituximabbased chemotherapy and up to three months after the end of chemotherapy) or ETV therapeutic (with the evidence of HBV reactivation and HBsAg seroreversion) therapy. The primary endpoint of this study was to compare the incidence of HBV reactivation between the two groups. Results: From Jul 2009 to Oct 2011, 87 lymphoma patients were enrolled in this study. Among them, 22 did not complete at least 2 sessions of chemotherapy were excluded from this study. For the rest of patients, 33 were in ETV prophylactic group and 32 were in therapeutic group. The mean age was 68 y/o for both groups. AntiHBs-positive rates were 79% (26/33) and 69% (22/32) in ETV prophylactic and therapeutic groups, respectively (p = 0.24). There were no differences in baseline HBV viral loads and serum ALT levels between the two groups. Till the end of Oct 2011, no case (0%) in prophylactic group and 6 cases (18.8%) in therapeutic group developed virological reactivation (p = 0.011), defined as sustained HBV DNA higher than 2,000 IU/ml for at least twice of one month apart. Of the 6 cases, two became positive for HBsAg (HBsAg seroreversion). Conclusions: HBV reactivation induced by rituximab-based chemotherapy is not uncommon in NHL patients with resolved hepatitis B. Antiviral prophylaxis during chemotherapy can prevent such event. 517 EFFICACY OF ANTIVIRAL THERAPY IN 102 ROMANIAN PATIENTS WITH CHRONIC HEPATITIS DELTA L. Gheorghe1 , S. Iacob1 , I. Simionov1 , R. Vadan1 , I. Constantinescu2 . 1 Center of Gastroenterology & Hepatology, 2 Department of Virology and Immunology, Fundeni Clinical Institute, Bucharest, Romania E-mail: [email protected]
Figure 2. Distribution of HBV DNA levels at W76.
516 RANDOMIZED CONTROLLED TRIAL OF PROPHYLACTIC ENTECAVIR IN HBSAG-NEGATIVE/ANTI-HBC-POSITIVE LYMPHOMA PATIENTS UNDERGOING RITUXIMAB-BASED CHEMOTHERAPY: PRELIMINARY REPORT Y.-H. Huang1,2 , Y.-C. Hong3 , L.-T. Hsiao3 , T.-J. Chiou3 , C.-H. Tzeng3 , H.-C. Lin1 , S.-D. Lee1 . 1 Division of Gastroenterology, Taipei Veterans General Hospital, 2 Institute of Clinical Medicine, National Yang-Ming University, 3 Division of Hematology and Oncology, Taipei Veterans General Hospital, Taipei, Taiwan R.O.C. E-mail: [email protected] Background and Aims: Hepatitis B (HBV) reactivation can occur among non-Hodgkin’s lymphoma (NHL) patients who are HBsAg negative but anti-HBc positive (resolved hepatitis B) at the time of rituximab-based chemotherapy. It is unknown whether such patients should routinely receive antiviral agents for prevention of HBV reactivation during chemotherapy. S204
Background: Therapy for chronic hepatitis D is not yet satisfactory, although it is the only mean to alter the natural course of liver disease. In practice, monotherapy with conventional or pegylated interferons remains the only available option. Aim: To evaluate the virological (negative HDV RNA), biochemical and histological response (end of treatment – EOT after 52 weeks and end of follow up – EOF after 104 weeks) in a Romanian cohort of hepatitis delta infected naïve patients treated with standard interferon (IFN) alpha or Pegylated Interferon (Peg-IFN) alpha. Results: One hundred and two Caucasians (56.9% men and 43.1% females), with a mean age of 39.4±7.3years, received medication (49 patients Peg-IFN and 53 patients standard IFN). There was no significant difference between the 2 groups regarding HDV RNA, HBV DNA, necroinflammatory activity and fibrosis stage at the beginning of antiviral therapy. Virological response at EOT was present in 33.3% of patients treated with Peg-IFN and at EOF was maintained in 25% patients. Patients treated with standard IFN had a virological response of 18.8% at EOT and 11.3% at EOF. 50% of patients showed normalization of ALT level at EOT and 25% at EOF in the Peg-IFN treated group compared to 37.7% at EOT and 22.6% at EOF in the standard IFN group. A combined biochemical and virological response was observed in 19.4% at EOT and 16.7% at EOF in the Peg-IFN group. Patients treated with standard IFN had a combined biochemical and virological response of 9.4% at EOT and 7.5% at EOF. Conclusions: Treatment with Peg-Interferon alpha had a higher success rate of virological and biochemical response rate. Standard of care for HBV-HDV coinfected patients is nowadays pegylated interferon. However, longer treatment periods and probably combined interferon-nucleotide analogues should be tested in order to increase the benefit on combined virological and biochemical responses.
Journal of Hepatology 2012 vol. 56 | S71–S224