16th International AIDS Conference Toronto, Canada - August 13 - 18, 2006

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

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. TuAb0102

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)
¹ Wayne State University, Infectious Diseases, Detroit, United States, ² University of Illinois, Infectious Diseases, Chicago, United States, ³ University of Minnesota, Biostatistics, Minneapolis, United States, ⁴ Yale University, Infectious Diseases, New Haven, United States, ⁵ Temple University, Infectious Diseases, Philadelphia, United States, ⁶ Southern New Jersey AIDS Clinical Trials, Camden, United States, ⁷ Social & Scientific Systems, Silver Spring, United States, ⁸ NIH/NIAID, Division of AIDS, Bethesda, United States

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.

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2006-08-13
TuAb0102

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