Table 3.
Summary of atazanavir/ritonavir efficacy in clinical trials.
| Study | Phase | Patient type (n) | HIV RNA <50 copies/ml (%) | Increase in CD4+ count (cells/μl) | Emergence of major genotypic resistance (n) | Discontinuation (%) | Follow-up (weeks) | Ref. |
|---|---|---|---|---|---|---|---|---|
| BATON | II | Naive (102) | 81 | +217 | 0 | 17 | 48 | [67] |
| COL102060 | II | Naive (112) | 77 | +188 | 1 | 14 | 48 | [68] |
| ARIES | III | Naive (515) | 80 | +171 | 0 | 14 | 36 | [74] |
| BMS AI424–089 | III | Naive (200) | ATV/r: 75 ATV: 70 |
ATV/r: +174 ATV: +213 |
ATV/r: 0 ATV: 3 |
ATV/r: 12 ATV: 10 |
48 | [64] |
| ACTG 5202 | III | Naive (1867) | NR (see text for virologic end point) | ATV/r + TDF/FTC: +252 EFV + TDF/FTC: +221 |
Greater emergence for EFV compared with ATV/r Numbers not reported |
NR | 96 | [76] |
| ARTEN | III | Naive (569) | ATV/r: 74 NVP: 70 |
ATV/r: +185 NVP: +170 |
NR | ATV/r: 9 NVP: 25 |
48 | [79] |
| ALERT | III | Naive (106) | ATV/r: 83 FPV/r: 75 |
ATV/r: +183 FPV/r: +170 |
NR | ATV/r: 8 FPV/r: 15 |
48 | [73] |
| CASTLE (results from week 48) | III | Naive (883) | ATV/r: 78 LPV/r: 76 |
ATV/r: +203 LPV/r: +219 |
ATV/r: 1 LPV/r: 0 |
ATV/r: 9 LPV/r: 13 |
48 | [72] |
| CASTLE (results from week 96) | III | Naive (883) | ATV/r: 74 LPV/r: 68 |
ATV/r: +268 LPV/r: +290 |
ATV/r: 2 LPV/r: 1 |
ATV/r: 16 LPV/r: 22 |
96 | [72] |
| BMS AI424–045 | III | Exp. (243) | ATV/r: 33 LPV/r: 36 |
ATV/r: +160 LPV/r: +142 |
NR | ATV/r: 44 LPV/r: 47 |
96 | [69] |
| A4001078 | II | Naive (121) | MVC: 80 TDF/FTC: 89 |
MVC: +195 TDF/FTC: +173 |
NR | MVC: 8 TDF/FTC: 7 |
24 | [84] |
ALERT: Atazanavir or Lexiva with Ritonavir and Truvada; ARIES: Atazanavir Ritonavir Induction with Epzicom Study; ARTEN: Atazanavir/Ritonavir on a Background of Tenofovir and Emtricitabine (Truvada) Versus Nevirapine; ATV/r: Atazanavir/ritonavir; BATON: Boosted Atazanavir and Truvada Given Once-Daily; BMS: Bristol-Myers Squibb; CASTLE: Comparison of Atazanavir/Ritonavir in Naive Subjects in Combination with Tenofovir/Emtricitabine Versus Lopinavir/Ritonavir in Combination with Tenofovir/Emtricitabine to Assess Safety and Efficacy; EFV: Efavirenz; Exp.: ART-experienced; FPV/r: Fosamprenavir/ritonavir; LPV/r: Lopinavir/ritonavir; MVC: Maraviroc; Naive: ART-naive; NR: Not reported; NVP: Nevirapine; TDF/FTC: Tenofovir/emtricitabine.