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. Author manuscript; available in PMC: 2019 Jun 1.
Published in final edited form as: J Acquir Immune Defic Syndr. 2018 Jun 1;78(2):209–213. doi: 10.1097/QAI.0000000000001663

TABLE 1.

Virologic Outcomes at Week 48

E/C/F/TAF vs ATV + RTV plus FTC/TDF
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.