|
|
Abstract
Long-term clinical and immunologic outcomes are similar in HIV-infected persons randomized to NNRTI vs PI vs NNRTI+PI-based antiretroviral regimens as initial therapy: results of the CPCRA 058 first study
R.D. MacArthur1, R.M. Novak2, G. Peng3, L. Chen3, Y. Xiang3, M.J. Kozal4, M. van den Berg-Wolf5, C. Henely6, K. Huppler-Hullsiek3, B. Schmetter7, M. Dehlinger8, for the CPCRA 058 Study Team and the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA)
Background: Clinical outcomes data are lacking on the long-term consequences of initiating therapy with a PI, NNRTI, or both.
Methods: Between 1999 and 2002, 1397 treatment-naïve persons were randomized 1:1:1 to 1) PI+NRTIs, 2) NNRTI+NRTIs, or 3) PI+NNRTI+NRTI(s). Primary endpoints were a composite of AIDS events, death, and CD4+ cell count decline to <200 cells/mm3 (PI vs NNRTI comparison); and CD4+ cell count change after 32 months (3-class vs combined 2-class comparison).
Results: Median age was 38 years; 21% were female; 54% were black, 17% were Latino. Median CD4+ cell count was 163 cells/mm3. Median follow-up was 5 years. 302 persons developed an AIDS event or died; 188 died; 388 developed the composite clinical/CD4+ cell count endpoint. NNRTI vs PI hazard ratios (HRs) for the composite endpoint, AIDS or death, and virologic failure (VF) (HIV RNA >1000 copies/mL after 4 months) were 1.02 (95% CI: 0.79-1.31), 1.07 (0.80-1.41), and 0.66 (0.56-0.78), respectively. Mean increases in CD4+ cell counts after 32 months were 227 and 234 cells/mm3 for the combined 2-class and 3-class strategies (p=0.62), respectively. HRs (3-class vs combined 2-class) for AIDS or death and VF were 1.14 (95% CI: 0.91-1.45) and 0.87 (0.75-1.00), respectively. HRs (3-class vs combined 2-class) for AIDS or death and VF were similar for persons with baseline CD4+ cell counts <200 and >200 cells/mm3 (p=ns for interaction). Persons assigned the 3-class arm discontinued therapy due to toxicity more than those assigned the 2-class arms (HR=1.58, p<0.01).
Conclusions: NNRTI-based and PI-based strategies for initial therapy do not differ for a composite outcome based on CD4+ cell count decline, AIDS events, and death after a median follow-up of 5 years. The NNRTI strategy was superior virologically to the PI-based strategy. A 3-class strategy is not superior to a 2-class strategy for immunologic or clinical outcomes, and is associated with more drug toxicity.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
TUAB0102
Suggested Citation
"R.D.MacArthur, et al.
Long-term clinical and immunologic outcomes are similar in HIV-infected persons randomized to NNRTI vs PI vs NNRTI+PI-based antiretroviral regimens as initial therapy: results of the CPCRA 058 first study.
Oral abstract session:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
TUAB0102"
|
|
|