抗病毒治疗的重要性和必要性.ppt

* * * * * * ETV在2005年3月29日在美国获FDA批准上市，2005年11月获SFDA批准，2006年2月在中国正式上市。 * * * * ADV, adefovir; ETV, entecavir; LAM, lamivudine, LdT, telbivudine; L-FMAU, clevudine; TDF, tenofovir. This slide demonstrates the HBV?DNA reduction with oral agents in HBeAg–positive patients with chronic hepatitis?B. A word of caution is that these data are from individual reports and do not represent direct comparisons, but you can see a general sense of the variable potency of the different agents. The least potent agent is adefovir, on the left, with a 3.5 log reduction at the end of 1 year using the 10-mg dose, and then moving to the right, you see the 3 most potent agents—tenofovir, telbivudine, and entecavir—ranging from 6.2 to 6.9 log reductions in serum HBV?DNA from baseline at the end of 1 year of therapy. In addition, when these studies were done, entecavir and telbivudine were directly compared with lamivudine and were shown to have superior efficacy. In the recent pivotal trials of tenofovir, tenofovir was directly compared with adefovir and likewise shown to have superior efficacy. * * ADV, adefovir; ETV, entecavir; LAM, lamivudine; LdT, telbivudine; TDF, tenofovir. * * * * * Speaker notes The grey bar shows that 67% of patients achieved undetectable HBV DNA at Week 48 among the 354 patients treated with ETV in Study ETV-022. The turquoise bars show the progressive increase in proportion of patients who achieved undetectable HBV DNA at Weeks 48, 96, 144 and 192 among the patients treated with ETV in the 4-year cohort The results are consistent at Week 48 between the ETV 3-year cohort (55%) and the overall ETV-022 population (67%), indicating, that the 4-year cohort is representative of the overall study population from a virologic perspective. Note that: The majority of the incremental benefit occurs between years 1 and 2 Treatment after Year 2 represents an effective maintenance of virologic efficacy The mean change in HBV DNA levels from baseline for this cohort w