替诺福韦进入中国早知道.pptVIP

Summary of Resistance Analyses Through Year 6 For Patients Originally Randomized to TDF or ADV TDF-TDF ADV-TDF *7, 5, 5, and 1 subjects on FTC+TDF at Yrs 3, 4, 5, and 6 Year Number of Subjects Total Subjects Subjects with Viremia Subjects with Confirmed Resistance *4, 1, and 1 subjects on FTC+TDF at Yrs 3, 4, and 5 426 389 (91%) 364 (85%) 348 (82%) 323 (76%) 39 (9%) 24 (6%) 13* (3%) 10* (3%) 9* (3%) 0 0 0 0 0 1 2 3 4 5 0 0 0 0 196 192 (98%) 180 (92%) 172 (88%) 16 (8%) 9* (5%) 2* (1%) 3* (2%) Year 1 2 3 4 5 ADV 301 (71%) 7* (2%) 0 6 0 166 (85%) 1 (0.6%) 6 No Patients with Persistent Viremia by the End of Year 5 All persistent viremia subjects had no TDF resistance detected * BACKGROUND Two separate studies examined the efficacy of TDF and ADV in chronic hepatitis B infection. Study 102 was performed in an HBeAg(-) population and Study 103 in an HBeAg(+) population. Both studies had a similar design which included an initial 2:1 randomization of TDF:ADV. During the initial 48 weeks of each study, TDF was compared to an active control arm utilizing ADV, a comparator chosen due to it being the standard of care at the time. MAIN MESSAGE From baseline through Week 48, patients were randomized to receive either TDF or ADV in double-blind fashion. After a Week 48 liver biopsy and laboratory assessment, all patients received TDF in open-label therapy. By protocol, if patients had not achieved HBV DNA 400 copies/mL by Week 72, the patient, at the discretion of the investigator, was allowed to add emtricitabine (FTC) to ongoing TDF. This presentation focuses on the safety and tolerability of TDF through Week 96 during these 8-year studies. Of the 426 patients initially randomized to receive TDF at study initiation, 389 (91.3%) continued into the second year of study and 370 (86.9%) have 96-week data available for analysis. TRANSITION The baseline patient characteristics of those enrolled into these 2 studies are presented on the next slide. * TRANSITION: This