Cl Lai

Recombinant α2 interferon is superior to doxorubin for inoperable hepatocellular carcinoma: A prospective randomised trial

In a prospective trial of 75 Chinese patients with histologically proven inoperable hepatocellular carcinoma (HCC), 25 patients were randomised to receive doxorubicin 60-75 mg m-2 intravenously once every 3 weeks, 25 to receive recombinant alpha 2 interferon (rIFN) (Roferon) 9-18 x 10(6) IU m-2 intramuscularly (i.m.) daily and 25 to receive rIFN 25-50 x 10(6) IU m-2 i.m. three times weekly. Patients were switched to the other drug if: (a) there was progressive disease after 12 weeks, (b) unacceptable toxicity developed and (c) they had received a total of 500 mg m-2 of doxorubicin. Six patients had switching over of therapy, three on doxorubicin and three on rIFN. In the remaining 69 patients on single drug therapy, the median survival rate of patients on doxorubicin and rIFN was 4.8 and 8.3 weeks respectively (P = ns.). rIFN induced tumour regression of 25-50% in 12% of patients and of over 50% in 10% of patients. When compared with doxorubicin, rIFN was associated with more tumour regression (P = 0.00199) and less progressive tumours (P = 0.00017). It caused less prolonged and less severe marrow suppression (P = 0.01217), and had significantly less fatal complications than doxorubicin (P = 0.01383). Doxorubicin caused fatal complications due to cardiotoxicity and neutropenia in 25% of patients. rIFN was associated with fatal complications due to dementia and renal failure in 3.8% of patients. In the treatment of inoperable HCC, rIFN is superior to doxorubicin in causing more tumour regression, less serious marrow suppression and less fatal complications.

Health-related quality of life of Southern Chinese with chronic hepatitis B infection

BackgroundFew studies have evaluated the health-related quality of life (HRQOL) of Southern Chinese with chronic hepatitis B (CHB) infection.AimTo evaluate the HRQOL of Chinese patients at different stages of CHB infection and to find out factors associated with HRQOL.Methods520 Chinese adult CHB patients of whom 156 were uncomplicated, 102 had impaired liver function, 139 had cirrhosis and 123 had hepatocellular carcinoma (HCC) were interviewed with a structured questionnaire, the SF-36 Health Survey version 2 (SF-36v2), and the Chronic Liver Disease Questionnaire (CLDQ). The differences in SF-6D health preference values and SF-36v2 scores between each CHB group and Hong Kong population norms were assessed by t-test. ANOVA was used to compare the mean SF-6D health preference, SF-36v2 scores, and CLDQ scores among CHB groups. Multiple linear regressions were performed to identify determinants of HRQOL.ResultsCHB patients had significantly lower SF-36v2 scores than the population norm. The SF-6D values of CHB patients with uncomplicated disease, impaired liver function, HCC and cirrhosis were 0.755, 0.745, 0.720 and 0.701, respectively, all significantly lower than the population norm of 0.787. Advanced stage of CHB illness, anti-viral treatment, bilirubin level, psychological co-morbidity, younger age and female were associated with poorer HRQOL.ConclusionCHB infection had a negative impact on HRQOL. There was a progressive decrease in health preference values with CHB disease progression. The results can be used for the estimation of quality adjusted life years (QALYs) for CHB patients in cost effectiveness or cost utility studies.Trial Registrationhttp://www.hkclinicaltrials.com; HKCTR-151.

Re-evaluation of α-interferon treatment of chronic hepatitis B using polymerase chain reaction

To re-evaluate the efficacy of 3 treatment trials involving 272 Chinese patients with chronic hepatitis B virus infection, serial serum samples were tested from 60 patients treated with α-interferon with or without prednisone priming and 12 control patients, who were negative for hepatitis B virus deoxyribonucleic acid using dot-blot hybridization. Serial samples were tested using nested polymerase chain reaction with primer sets chosen from the surface and core antigen coding regions. The 19 patients who did not show persistent serological change remained hepatitis B virus deoxyribonucleic acid positive using the polymerase chain reaction assay. Three of the 4 patients (75%) who lost hepatitis B surface antigen and 9 of 51 (17.6%) who lost hepatitis B e antigen became negative from 0 to 60 months after the e-seroconversion. All patients negative for the polymerase chain reaction assay had normal transaminase levels. Pooling the 3 trials together, 11 of 188 (5.9%) treated patients and 1 of 84 (1.2%) control patients became hepatitis B virus deoxyribonucleic acid negative. The difference was not statistically significant. As assayed by the polymerase chain reaction assay, patients who were treated with α-interferon with or without steroid priming and lost hepatitis B e antigen within 12 months were more likely to subsequently lose the virus completely from the serum (11 of 33) than those who lost hepatitis B e antigen after 12 months (none of 13; p = 0.029).

α-Interferon treatment in Chinese patients with chronic hepatitis B

alpha-Interferon has been shown to be the most promising antiviral agent in the treatment of chronic hepatitis B virus infection in Caucasian patients. The experience with recombinant interferon alfa-2a and alfa-2b in four randomized controlled trials in Chinese adults and children is reviewed here. alpha-Interferon alone has little long-term benefit in the treatment of Chinese patients with chronic hepatitis B virus infection, especially in patients who have normal or near normal serum aminotransferase levels. The response in patients with elevated aminotransferase levels appears to be better. The poor antiviral response in patients with normal aminotransferase levels is probably due to immunological tolerance to HBV induced by exposure to the virus in early life. Prednisone pretreatment does not seem to have any additional benefit to using interferon alone in these patients, while the effect in patients with elevated aminotransferase levels remains to be proven.

748 OUTCOME OF 4-YEAR TREATMENT OF ENTECAVIR FOR TREATMENT-NAIVE CHRONIC HEPATITIS B

This journal supplement is Abstract Book of the International Liver Congress 2011 by EASL (46th Annual Meeting)

Comparison of two plasma-derived hepatitis B vaccines: Long-term report of a prospective, randomized trial

Abstract Subjects at high risks for hepatitis B virus (HBV) infection were allocated randomly (n = 591) to receive one of the two plasma‐derived hepatitis B vaccines produced by the Institut Pasteur Production, Paris (HEVAC B) or the Green Cross Corporation, Osaka (GCC VAC). There are differences in the production of these two vaccines, with an added step of heat inactivation and longer formaldehyde treatment for the GCC VAC. Three doses of vaccines were given at 0, 1, and 5 months for both vaccines. Antibody to hepatitis B surface antigen (anti‐HBs) titres were tested at 1, 3, 6, 9, 12, 18, 24 months. Antibody to hepatitis B core antigen (anti‐HBc) was tested at 6 and 24 months. A fourth dose was given after 12 months to subjects who did not develop an anti‐HBs titre of 10 miu/mL at month 6. Two hundred and seventy‐four subjects received HEVAC B. Excluding nine subjects (3.4%) who became positive for anti‐HBc, the immunogenicity was 87.2%. For the 317 subjects receiving GCC VAC, excluding 17 subjects (5.4%) who became positive for anti‐HBc, the immunogenicity was 83.7% (the difference was not statistically significant). The anti‐HBs titres were significantly higher in those who received HEVAC B in the 3, 6, 9, 12 and 18 months but the anti‐HBs levels for GCC VAC recipients were still well above the ‘protective’ level of 10 miu/mL. Most hypo/non‐responders did not respond to the fourth dose of vaccine. The side‐effects were transient and mild, and occurred in 1.5% of subjects for both vaccines. Anti‐HBs response decreased significantly with increasing age of the recipents.

Hepatitis B surface antigen levels predict minimal histologic changes in hepatitis B e antigen positive chronic hepatitis B

The 22nd Conference of the Asian Pacific Association for the Study of the Liver APASL 2012—Taipei, Taiwan—16–19 February

1353 A PHASE IIB STUDY OF THE EFFICACY AND SAFETY OF LB80380 VS ENTECAVIR IN TREATMENT-NAIVE PATIENTS WITH CHRONIC HEPATITIS B

1353 A PHASE IIB STUDY OF THE EFFICACY AND SAFETY OF LB80380 VS ENTECAVIR IN TREATMENT-NAIVE PATIENTS WITH CHRONIC HEPATITIS B C.L. Lai, S.H. Ahn, K.S. Lee, S.H. Um, M. Cho, S.K. Yoon, J.W. Lee, N.W. Park, Y.O. Kwon, J.H. Sohn, J.Y. Lee, H.E. Park, J.A. Kim, K.H. Han, M.F. Yuen. The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong S.A.R., China; College of Medicine, Yonsei University, College of Medicine, Korea University, Seoul, College of Medicine, Pusan National University, Pusan, College of Medicine, The Catholic University of Korea, Seoul, College of Medicine, Inha University, Incheon, College of Medicine, University of Ulsan, Ulsan, College of Medicine, Kyungpook National University, Daegu, College of Medicine, Hanyang University, LG Life Sciences Ltd, Seoul, Republic of Korea E-mail: hrmelcl@hkucc.hku.hk

Hepatitis B virus serological and virological activities in blood donors with occult hepatitis B

23rd Annual Conference of APASL March 12–15, 2014, Brisbane, Australia Asian Pacific Association for the Study of the Liver 2014 Topic: 1 Acute Liver Failure

Elevation of ALT fails to predict significant histologic abnormalities in chronic hepatitis B patients

The 21st Conference of the Asian Pacific Association for the Study of the Liver