Outcomes (US FDA snapshot algorithm) for plasma HIV-1 RNA of <50 copies/mL at week 48 (ITT-exposed population)
| . | Experimental, n = 45 . | Control, n = 45 . |
|---|---|---|
| Virological success at week 48 | ||
| HIV-RNA <50 copies/mL | 41 (91.1%) | 44 (97.8%) |
| VF at week 48 | ||
| HIV-RNA ≥50 copies/mL | 1 (2.2%) | 0 |
| discontinued study drug due to lack of efficacy | 2 (4.4%) | 0 |
| discontinued study drug due to other reasons and last available HIV-RNA ≥50 copies/mL | 0 | 0 |
| No virological data in week 48 window | ||
| discontinued study drug due to adverse events | 1 (2.2%) | 0 |
| discontinued study drug due to other reasons and last available HIV-RNA <50 copies/mL | 0 | 1 (2.2%) |
| missing data during window, but on study drug | 0 | 0 |
| . | Experimental, n = 45 . | Control, n = 45 . |
|---|---|---|
| Virological success at week 48 | ||
| HIV-RNA <50 copies/mL | 41 (91.1%) | 44 (97.8%) |
| VF at week 48 | ||
| HIV-RNA ≥50 copies/mL | 1 (2.2%) | 0 |
| discontinued study drug due to lack of efficacy | 2 (4.4%) | 0 |
| discontinued study drug due to other reasons and last available HIV-RNA ≥50 copies/mL | 0 | 0 |
| No virological data in week 48 window | ||
| discontinued study drug due to adverse events | 1 (2.2%) | 0 |
| discontinued study drug due to other reasons and last available HIV-RNA <50 copies/mL | 0 | 1 (2.2%) |
| missing data during window, but on study drug | 0 | 0 |
Outcomes (US FDA snapshot algorithm) for plasma HIV-1 RNA of <50 copies/mL at week 48 (ITT-exposed population)
| . | Experimental, n = 45 . | Control, n = 45 . |
|---|---|---|
| Virological success at week 48 | ||
| HIV-RNA <50 copies/mL | 41 (91.1%) | 44 (97.8%) |
| VF at week 48 | ||
| HIV-RNA ≥50 copies/mL | 1 (2.2%) | 0 |
| discontinued study drug due to lack of efficacy | 2 (4.4%) | 0 |
| discontinued study drug due to other reasons and last available HIV-RNA ≥50 copies/mL | 0 | 0 |
| No virological data in week 48 window | ||
| discontinued study drug due to adverse events | 1 (2.2%) | 0 |
| discontinued study drug due to other reasons and last available HIV-RNA <50 copies/mL | 0 | 1 (2.2%) |
| missing data during window, but on study drug | 0 | 0 |
| . | Experimental, n = 45 . | Control, n = 45 . |
|---|---|---|
| Virological success at week 48 | ||
| HIV-RNA <50 copies/mL | 41 (91.1%) | 44 (97.8%) |
| VF at week 48 | ||
| HIV-RNA ≥50 copies/mL | 1 (2.2%) | 0 |
| discontinued study drug due to lack of efficacy | 2 (4.4%) | 0 |
| discontinued study drug due to other reasons and last available HIV-RNA ≥50 copies/mL | 0 | 0 |
| No virological data in week 48 window | ||
| discontinued study drug due to adverse events | 1 (2.2%) | 0 |
| discontinued study drug due to other reasons and last available HIV-RNA <50 copies/mL | 0 | 1 (2.2%) |
| missing data during window, but on study drug | 0 | 0 |
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