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Comparable HIV-1 viral suppression and immunologic recovery of white and nonwhite antiretroviral-naïve subjects taking lopinavir/ritonavir (LPV/r) tablets + tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) through 48 weeks
B.A. da Silva, D. Cohen, S. Gibbs, C. Naylor, M. Woulfe, C. Marincic, L. Fredrick, B. Bernstein
Abbott, Abbott Park, United States
Background: Virologic and immunologic status at presentation and in response to combination antiretroviral therapy may vary by race.
Methods: Study M05-730 randomized 664 ARV-naïve subjects to LPV/r either QD or BID plus TDF+FTC. 48-week safety and efficacy compared between subjects self-reporting as white vs. nonwhite with respect to virologic response, CD4+ T-cell increase, adverse events (AEs) and lab abnormalities.
Results: 499 whites/165 nonwhites enrolled. Baseline CD4+ T-cell count higher in whites (225cells/mm3) compared to non-whites (188cells/mm3), p=0.002. Baseline HIV-RNA higher in whites vs. nonwhites.
| | Baseline HIV RNA (log10 c/mL) | Proportion <50c/mL at week 48 | | White (n=499) | 5.03 | 384 (77%) | | Nonwhite (n=165) | 4.88 | 124 (75%) | | P-value | P=0.014 | P=0.672 |
| Baseline CD4 cell count (cells/mm3) | Whites Mean increase | Non-whites Mean increase | P-value | | <50 | 176 | 191 | 0.521 | | 50-200 | 204 | 180 | 0.205 | | 201-350 | 207 | 195 | 0.580 | | >=350 | 152 | 166 | 0.839 | | All | 194 | 185 | 0.495 |
Overall moderate-severe/related AEs of diarrhea for the study was 16%. A similar rate (18%) was observed in whites, while nonwhites experienced a rate of 10% (p=0.014). No differences noted in grade3+ lab abnormalities.
Conclusions: Nonwhite subjects had lower baseline HIV-1 viral loads and CD4 cell counts. While later presentation may explain the lower CD4 cell counts, the potential causes for lower viral loads are less clear. Despite these differences, there was no difference in efficacy of a LPV/r-based regimen dosed QD or BID at 48 weeks in antiretroviral-naïve nonwhite vs. white subjects. Diarrhea was less commonly noted in nonwhites.
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