Table 2.
Efficacy results of the interim analysis in the TALENT study.
| Parameters | ABT group | NRTI group | Difference (95% CI; P value) |
| Week 48 | n = 46 | n = 50 | |
| HIV-1 RNA <50 copies/mL (mITT) | 37/46 (80.4) | 33/50 (66) | 14.4 (–3.0 to 31.9) |
| HIV-1 RNA <50 copies/mL (PP) | 37/39 (94.9) | 32/43 (74.4) | 20.5 (5.7 to 35.2; P = 0.01) |
| HIV-1 RNA <400 copies/mL | 39 (84.8) | 37 (74) | 10.8 (–5.2 to 26.8) |
| HIV-1 RNA log10 copies/mL change | –2.27 ± 0.96 | –1.77 ± 1.33 | P = 0.015∗ |
| CD4 T-cell count change (cells/μL) | 120.5 (27.4–254.9) | 150.3 (72.3–244.5) | P = 0.557† |
| Week 24 | n = 83 | n = 92 | |
| HIV-1 RNA <50 copies/mL (mITT) | 66/83 (79.5) | 72/92 (78.3) | 1.2 (–10.8 to 13.4) |
| HIV-1 RNA <50 copies/mL (PP) | 64/76 (84.2) | 71/85 (83.5) | 0.7 (–10.7 to 12.1) |
| HIV-1 RNA <400 copies/mL | 74 (89.2) | 76 (82.6) | 6.6 (–3.7 to 16.8) |
| HIV-1 RNA log10 copies/mL change | –2.00 ± 1.01 | –1.85 ± 1.16 | P = 0.137∗ |
| CD4 T-cell count change (cells/μL) | 79.0 (35.2–156.5) | 86.0 (19.8–159.6) | P = 0.521† |
Data are n (%), n/N (%), mean ± standard deviation, median (Q1–Q3) or % (95% CI). ∗ANCOVA: Analysis of covariance, with the baseline as a covariate; †Wilcoxon test. ABT: Albuvirtide; CI: Confidence interval; HIV: Human immunodeficiency virus; NRTI: Nucleoside/Nucleotide reverse transcriptase inhibitor; mITT: modified intention-to treat; PP: Per-protocol.