慢性乙性肝炎.ppt

Key Message: 3 month double-blind data has already been published 1 year, 2 year, 3 year, 4 year and 5 year data has been presented Previous publications: - 3 month data: Chinese Medical Journal, May 1999;112(5):387-91 - 2 yr data (minus YMDD): Chin J Hepat, June 1999;7(2)80-83 - 2yr YMDD data included in YMDD management paper: Chinese Hepatology, December 1999; 4(4): 194-196 - Key Points After the initial 12 week placebo controlled double-blind period, all patients received open label lamivudine for up to 5 years. From the start of the 4th year, patients who had seroconverted and were negative for HBV DNA were eligible to stop therapy and enter an observation phase. If patients relapsed (defined as positive HBV DNA on two successive occasions with return of HBeAg) then they were eligible for re-treatment with lamivudine. Results from Wk 0 to Wk 52 have been converted from Abbott pg/mL to Chiron MEq/ml Pla/Lam Wk 208 Median HBV DNA: 62.3 MEq/ml* (0.4-2575) Lam/Lam Wk 208 Median HBV DNA: 90.6 MEq/ml (0.4-4811) Key Message: Median ALT values show a decrease over time in the elevated ALT group Median ALT is normalised by 12 weeks in the elevated ALT group and remains below the ULN for 180 weeks and below baseline throughout The normal ALT group remain below the ULN throughout Key Message: Higher baseline ALT also results in increased HBeAg seroconversion Incremental increases are seen, after 1, 2, 3 and 4 years treatment, shown in the total patient group. Patient numbers for ALT 5 x ULN are small therefore any change to “n= ” will have an impact on percentages and conclusions are difficult to draw. Key Message: 53 SAEs reported during the study The 8 SAEs reported as drug related were viewed as such by the reporting investigator This data further supports the view that lamivudine is well tolerated Key Message: Higher baseline ALT also results in increased HBeAg seroconversion Incremental increases are seen, after 1, 2 and 3 yea