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Efficacy and safety by racial group in ARV-naive subjects treated with atazanavir/ritonavir or lopinavir/ritonavir: 48 week results for the CASTLE study (AI424138)
D. McGrath1, J. Uy2, R. Yang1, A. Thiry1, M. Mancini1, J. Absalon1, for the CASTLE Study Group
1Bristol Myers Squibb, Research and Development, Wallingford, United States, 2Bristol Myers Squibb, Research and Development, Lawrenceville, United States
Background: The CASTLE study has shown that ATV/r is non-inferior to LPV/r in antiviral efficacy in treatment-naive patients, with significantly less elevation of lipids and better GI tolerability. Race-based differences in efficacy and safety have been reported among HIV-infected individuals receiving HAART. Data from randomized clinical trials are limited.
Methods: CASTLE is a randomized, open-label prospective study comparing once-daily ATV/r with twice-daily LPV/r, both in combination with fixed-dose tenofovir/emtricitabine in 883 patients. The proportion of subjects with HIV RNA <50c/mL (confirmed virologic response, CVR), CD4 cell count changes, adverse events (AEs), and fasting lipid changes are presented by race through Week 48.
Results:
| Randomized Subjects | HIV RNA <50 c/mL at Week 48 [Responder/Evaluable (%)], Intent-to-Treat | CD4 cell count change from Baseline at Week 48 (cells/mm3) Median (Q1,Q3)[N observed] | | Race | ATV/r N=440 | LPV/r N=443 | ATV/r N=440 | LPV/r N=443 | | All | 343/440 (78) | 338/443 (76) | 191 (114, 271)[370] | 200(122, 291)[363] | | White | 159/207 (77) | 162/221 (73) | 226 (135, 313)[170] | 204 (126, 299)[181] | | Black | 59/83 (71) | 62/80 (78) | 142 (85, 222)[66] | 190 (133, 261)[65] | | Asian | 35/42 (83) | 37/41 (90) | 198 (135, 240)[36] | 220 (100, 330)[37] | | Other | 90/108 (83) | 77/101 (76) | 188 (110, 255)[98] | 193 (124, 274)[80] |
| | Grade 2-4 Treatment-Related AEs through Week 48 - Treated Subjects: All AEs and Selected AEs of Clinical Interest | | | All | | Diarrhea | | Nausea | | Jaundice | | | Race | ATV/r n/N (%) | LPV/r n/N (%) | ATV/r | LPV/r | ATV/r | LPV/r | ATV/r | LPV/r | | White | 59/207 (29) | 63/221 (29) | 4% | 14% | 5% | 8% | 6% | 0 | | Black | 20/85 (24) | 12/77 (16) | 1% | 5% | 1% | 3% | 0 | 0 | | Asian | 10/42 (24) | 17/40 (43) | 0 | 10% | 0 | 8% | 5% | 0 | | Other | 26/107 (24) | 37/99 (37) | <1% | 10% | 5% | 11% | 2% | 0 |
Conclusions: Once-daily ATV/r and twice-daily LPV/r varied in efficacy and immunologic response by race. Subjects on ATV/r had less elevation in TC, non-HDL and TG and fewer GI AEs, regardless of race.
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