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SHARE THIS ABSTRACT WITH A COLLEAGUE ABT-378/r is a novel protease inhibitor that achieves trough concentrations exceeding the EC50 of ABT-378 relative to wild type virus by >75 fold when dosed at 400/100 mg BID. Study M98-863 is a multi-center, international, double-blind randomized study of 653 ARV-naïve subjects treated with either ABT-378/r 400/100 mg BID (N=326) or NFV 750 mg TID (N=327), each with d4T/3TC. Subjects with AST/ALT > 3xULN at screening were excluded from the study. At Week 40, 94% of ABT-378/r subjects vs. 82% of NFV subjects had HIV RNA levels <400 copies/mL (on treatment; p<0.001). Overall, 4% of subjects in both the ABT-378/r and the NFV treatment groups developed Grade 3/4 elevations of AST/ALT. Fifty-seven (17%) ABT-378/r subjects and 68 (21%) NFV subjects were positive at baseline for Hepatitis B surface antigen and/or Hepatitis C antibodies. Through Week 40, 91% and 76% of ABT-378/r and NFV-treated Hepatitis B/C+ subjects, respectively, had HIV RNA <400 copies/mL (on treatment; p=0.073). Mean changes from baseline for safety laboratory parameters of Hepatitis B/C+ subjects were generally similar to those of the overall groups. Incidence rates of Grade 3/4 AST or ALT elevations of Hepatitis B/C+ subjects were 6/57 (12%) for the ABT-378/r group and 13/68 (20%) for the NFV group. The relative risk (95% CI) of Grade 3/4 elevations of AST/ALT based on baseline hepatitis status was 5.2 (1.8,15.6) for the ABT-378/r group and 50.0 (6.7,375) for the NFV group. Hepatitis B/C+ subjects had a higher incidence of Grade 3/4 elevations of AST/ALT than did other subjects. Efficacy and other safety results for Hepatitis B/C+ subjects were generally similar to Hepatitis B/C negative subjects. Of the Hepatitis B/C+ subjects, there were no discontinuations due to elevated liver enzymes or clinical hepatitis.
Treatment of HIV + Subjects Co-infected with Hepatitis B or C: © 2000 Medical Advocates for Social Justice |
