96-Week Follow-up for Neflinavir Twice Daily in Combination with d4T+3TC

Study 542 compares twice daily nelfinavir + d4T/3TC (n=344) to nelfinavir three times daily (n=210) in essentially treatment-naïve group.. Prior to week 24 most of the 124 patients who were initially randomized to NFV 750 mg or 1000 mg tid were switched to 1250 NFV bid. Median baseline viral load and CD4 were similar in both groups—100,000 copies/ml and 296, respectively. Investigator reported no difference between discontinuation rate between tid and bid arms but discontinuations due to NFV related adverse events appear to be greater in bid than tid arm  (3.8% versus 1.9%). Using observed data analysis about 80% had below 400 copies/ml at week 96, and 62% using ITT analysis. There appeared to be no differences between bid and tid arms at week 24. Visual observation of slide graph showed about 65% had below 50 copies/ml at week 96 by observed data analysis. Investigator reported 54% by ITT analysis below 50 at week 96. Mean CD4 increase was about 260 at week 96.They reported 21% diarrhea in bid arm and 15% in the tid arm. Median cholesterol values increased in first 3 months from about 150 to 200 mg/dl and appeared to be same at week 48. Although there were outlyers on graph who had higher cholesterol increases. Median glucose remained about 100 mg/dl to 48 weeks but there were outlyers on graph with elevated glucose and some cases of diabetes. The same results were observed regarding tryglcerides: no change in median values out to week 48, but there were outlyers with elevations. In conclusion investigator reported mild increases in cholesterol of 0-12% in bid, and 0-21% in tid arms, respectively.