P. De Truchis, on behalf of the Francilienne Study Group, reported preliminary 24 week data from a small study of 31 treatment-naïve individuals who received this 4 drug PI-sparing regimen. Median baseline viral load and CD4 was 4.7 log (50,000 copies/ml; range 3.1- 6.2 log) and 322 (range 98-858), respectively.

At week 16 25/25 evaluable patients had viral load below 400 copies/ml and 21/25 (84%) had below 50 copies/ml. Three patients modified their study drugs due to adverse events, 2 stopped efavirenz (dizziness), 1 stopped AZT (myostosis) and 1 stopped abacavir (mild isolated rash). Depression was reported for 2 patients without treatment discontinuation. At week 24, 94% (ITT, missing=failure) had below 50 copies/ml. ITT and as-treated at week 24 were about the same (ITT n=31, AT n=26). De Truchis said 26 patients were still receiving drugs at week 24, 96% had below 50 copies/ml, and two were considered failures: one lost to follow-up and 1 with 51 copies/ml at week 24. For patients with baseline viral load above 100,000 copies/ml (n=13) the median HIV-PCR reduction from baseline was 4 log (ITT, missing=locf), and for those with below 100,000 copies the reduction was 3.1 log (n=18).

Median absolute CD4 at baseline and week 24 was about 330 and 370, respectively. The CD4/CD8 percentage was .30 and .55 at baseline and week 24. Although study is small and results preliminary (study ongoing to 48 weeks), investigator concluded regimen was potent with 2.63 log reduction at week 4 (ITT), and had similar efficacy in those with above 100,000 copies/ml (n=13). No abacavir hypersensitivity was observed although 1 person had rash and stopped abacavir.

72-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 resulte 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 chelesterol of 0-12% in bid, and 0-21% in tid arms, respectively.