מתוך medicontext.co.il
WESTPORT, CT (Reuters Health) – Nelfinavir added to a regimen of zidovudine and lamivudine further reduces HIV load over that achieved with the two nucleoside reverse transcriptase inhibitors alone, according to results of a randomized, blinded, phase III study.
A total of 297 patients naןve to antiretroviral therapy, who had plasma HIV RNA levels of at least 15,000 copies/ml, were included in the intent-to-treat analysis. Patients were randomized to receive nelfinavir 500 mg t.i.d., nelfinavir 750 mg t.i.d., or placebo, with randomization stratified according to CD4 cell counts. Patients also took zidovudine 200 mg t.i.d. and lamivudine 150 mg b.i.d.
Dr. Michael S. Saag, of the University of Alabama at Birmingham, and members of the Viracept Collaborative Study Group, assigned 101 patients to the placebo-controlled arm, 97 patients to nelfinavir 500 mg t.i.d., and 99 patients to nelfinavir 750 mg t.i.d. The study was completed in 1997.
Viral load responses were significantly different (p < 0.001) between the control group and each of the triple combination groups, the researchers report in the October 19th issue of AIDS.
Differences between the two nelfinavir arms were also significantly different. Patients taking the 750-mg doses exhibited viral loads less than 50 copies/ml more frequently at 24 weeks and at 12 months compared with those taking the 500-mg doses. Viral loads were significantly lower in the higher dose group after 1 year than in the lower dose group.
"In the assessment of absolute CD4 cell counts, triple therapy including nelfinavir 750 mg t.i.d. produced increases of 150 cells per microliter after 6 months, rising to 198 cells per microliter above baseline after 12 months," Dr. Saag's group writes. "This compares with CD4 cell increases with the 500 mg t.i.d. regimen of 138 cells per microliter and 192 cells per microliter after 6 and 12 months of treatment, respectively." A CD4 increase greater than 30% occurred among patients who switched from placebo to either nelfinavir regimen.
Calling this a "pivotal study," Dr. Saag and his associates conclude that "this nelfinavir combination confers marked therapeutic advantages in both potency and durability" compared with double-combination therapy.
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