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