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Efficacy and safety of atazanavir/r vs. lopinavir/r in treatment-naïve patients with advanced disease: CASTLE study 96-week results
J. Uy1, R. Yang2, V. Wirtz2, L. Sheppard3, J. Absalon2
1Bristol-Myers Squibb, Research & Development, Plainsboro, NJ, United States, 2Bristol-Myers Squibb, Research & Development, Wallingford, CT, United States, 3Bristol-Myers Squibb, Research & Development, Braine-l'Alleud, Belgium
Background: In CASTLE, non-inferiority of ATV/r vs. LPV/r in antiretroviral-naive patients was confirmed at week 96. Efficacy and safety in patients with advanced HIV disease (high HIV RNA/low CD4 cell count) are presented.
Methods: International 96-week randomized, open-label study comparing ATV/r with LPV/r, both with TDF/FTC in 883 treatment-naive patients. 96 week treatment outcomes of HIV RNA < 50 c/mL using confirmed virologic response (CVR) and grade 2-4 treatment-related AEs are presented by pre-specified baseline HIV RNA and CD4 cell count strata.
Results: The proportion of responders (CVR HIV RNA < 50 c/mL, ITT, NC=F) at week 96 by HIV RNA strata (< 100,000, 100,000-< 500,000, and ≥500,000 c/mL) were 75%, 76%, and 66% for ATV/r and 68%, 68%, and 68% for LPV/r.
| CVR Treatment Outcomes of HIV RNA <50 c/mL at Week 96 by Baseline CD4 Cell Count (cells/mm3), n (%) | | As-Randomized ITT (NC=F) | ATV/r <50 (n=58) | 50-<100 (n=45) | 100-<200 (n=106) | ≥200 (n=222) | LPV/r <50 (n=48) | 50-<100 (n=29) | 100-<200 (n=134) | ≥200 (n=228) | | Responder | 45 (78) | 32 (71) | 75 (71) | 169 (76) | 28 (58) | 20 (69) | 94 (70) | 157 (69) | | Virologic failure | 4 (7) | 8 (18) | 15 (14) | 24 (11) | 4 (8) | 7 (24) | 15 (11) | 27 (12) | | Discontinued | 9 (16) | 5 (11) | 16 (15) | 27 (12) | 16 (33) | 2 (7) | 24 (18) | 42 (18) | | On-treatment (NC=M) CVR responder, n/N (%) | 45/48 (94) | 32/39 (82) | 75/82 (91) | 169/185 (91) | 28/31 (90) | 20/24 (83) | 94/103 (91) | 157/179 (88) |
Incidence of grades 2-4 treatment-related AEs through week 96 by HIV RNA strata (< 100,000, 100,000-< 500,000, and ≥500,000) were 33%, 29%, and 23% for ATV/r, and 32%, 31%, and 34% for LPV/r and by CD4 cell count strata (< 50, 50-< 100, 100-< 200, and ≥200) were 25%, 24%, 25%, and 36% for ATV/r, and 43%, 34%, 29%, and 30% for LPV/r.
Conclusions: Higher response rates at lower baseline HIV RNA were seen for ATV/r vs. LPV/r. High response rates across all CD4 cell count strata were observed for ATV/r. ATV/r and LPV/r had consistent AE profiles within each arm by baseline HIV RNA. More grade 2-4 treatment-related AEs were observed with LPV/r at low baseline CD4 cell counts.
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