TABLE 1.
E/C/F/TAF vs ATV + RTV plus FTC/TDF |
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E/C/F/TAF (n = 159) | ATV+RTV plus FTC/TDF (n = 53) | P | Difference in Percentages (95% CI)† | |
HIV-1 RNA <50 copies/mL† | 150 (94%) | 46 (87%) | 0.13 | 7.5% (21.2% to 19.4%) |
HIV-1 RNA ≥50 copies/mL | 3 (2%) | 2 (4%) | ||
HIV-1 RNA ≥50 copies/mL | 2 (1%) | 2 (4%) | ||
Discontinued because of the lack of efficacy | 0 | 0 | ||
Discontinued because of other reasons and the last available HIV-1 RNA ≥50 copies/ mL* | 1 (1%) | 0 | ||
Added new ARV | 0 | 0 | ||
No virologic data | 6 (4%) | 5 (9%) | ||
Discontinued because of AE/death | 1 (1%) | 1 (2%) | ||
Discontinued because of other reasons* and the last available HIV-1 RNA <50 copies/ mL | 4 (3%) | 3 (6%) | ||
Missing data but on study drug | 1 (1%) | 1 (2%) | ||
HIV-1 RNA <50 copies/mL by missing = failure‡ | 150 (94%) | 47 (89%) | 0.21 | 5.7% (22.5% to 17.2%) |
HIV-1 RNA <50 copies/mL by missing = excluded‡ | 150/153 (98%) | 47/49 (96%) | 0.60 | 2.1% (22.9% to 11.4%) |
Data are n (%).
Other reasons include subjects who discontinued study drug because of investigator’s discretion, withdrawal of consent, lost to follow-up, noncompliance with study drug, protocol violation, and pregnancy.
P values were from the Fisher exact test. Difference in percentages of virologic success and its 95% CI were calculated based on exact method. The exact CI was estimated based on an unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.
P value, difference in percentages, and 95% CI were based on a dichotomized response: success (HIV-1 RNA <50 copies/mL) or failure (HIV-1 RNA ≥50 copies/mL or missing) for missing = failure approach or missing = excluded approach. Difference in percentage of virologic success and its 95% CI were calculated based on an unconditional exact method using 2 inverted one-sided tests with the standardized statistic.