TABLE 2.
Virologic Outcomes at Week 24, Full Analysis Set
| Week 24 | B/F/TAF (n = 328) |
SBR (No Switch) (n = 165) |
B/F/TAF vs SBR |
| Difference in Percentages (95% CI)* | |||
| HIV-1 RNA <50 copies/mL | 316 (96.3%) | 156 (94.5%) | 1.8% (−2.0% to 6.8%) |
| HIV-1 RNA ≥50 copies/mL | 2 (0.6%) | 3 (1.8%) | −1.2% (−4.8% to 0.9%) |
| HIV-1 RNA ≥50 copies/mL | 2 (0.6%) | 3 (1.8%) | |
| Discontinued because of lack of efficacy | 0 | 0 | |
| Discontinued study drug because of AE/death and last available HIV-1 RNA ≥50 copies/mL | 0 | 0 | |
| Discontinued because of other reasons† and last available HIV-1 RNA ≥50 copies/mL | 0 | 0 | |
| No virologic data in the week 24 window | 10 (3.0%) | 6 (3.6%) | |
| Discontinued because of AE/death and last available HIV-1 RNA <50 copies/mL | 6 (1.8%) | 0 | |
| Discontinued because of other reasons† and last available HIV-1 RNA <50 copies/mL | 4 (2.1%) | 1 (0.6%) | |
| Missing data but on study drug | 0 | 5 (3.0%) | |
| HIV-1 RNA <50 copies/mL by per-protocol snapshot analysis‡ | 304/306 (99.3%) | 145/148 (98.0%) | 1.4% (−1.0% to 5.3%) |
| HIV-1 RNA <50 copies/mL by missing = failure§ | 321/328 (97.9%) | 156/165 (94.5%) | 3.3% (−0.2% to 8.2%) |
| HIV-1 RNA <50 copies/mL by missing = excluded§ | 321/323 (99.4%) | 156/159 (98.1%) | 1.3% (−0.8% to 4.9%) |
| HIV-1 RNA <20 copies/mL | 305/328 (93.0%) | 149/165 (90.3%) | 2.7% (−2.4% to 8.7%) |
| Hepatitis B virus DNA <29 IU/mL by missing = excluded‖ | 6/7 (86%) | 1/1 (100%) |
Data are n (%).
Virology outcomes are based on snapshot algorithm unless otherwise specified.
The week 24 window is between days 127 and 210 (inclusive).
Per-protocol analysis excluded patients in full analysis set who were off study drug at week 24 or had low adherence, that is, adherence ≤2.5th percentile among those in study or did not meet the inclusion criteria for baseline ARV medication or met inclusion/exclusion criteria for mutations detected before baseline or after baseline.
The difference in percentages of participants between treatment groups and their 95% CIs were calculated based on exact methods.
Other reasons include participants who discontinued study drug because of investigator's discretion, subject decision, lost to follow-up, noncompliance with study drug, protocol violation, pregnancy, and study terminated by sponsor.
The per-protocol analysis was performed in a similar manner to the primary endpoint but excluded participants with low adherence (below the 2.5th percentile), violation of key entry criteria, or who did not have a plasma HIV-1 RNA value in the week 24 analysis window because of reasons other than lack of efficacy.
Difference in percentages and 95% CI were based on a dichotomized response: HIV-1 RNA <50 copies/mL vs HIV-1 RNA ≥50 copies/mL or missing for missing = failure approach and HIV-1 RNA <50 copies/mL vs HIV-1 RNA ≥50 copies/mL for missing = excluded approach.
At baseline, 18 participants had HBV coinfection: 15 (5%) in the B/F/TAF group and 3 (2%) in the SBR group. At baseline, 13 of 15 in the B/F/TAF group and 2 of 3 in the SBR group had HBV DNA <29 IU per mL. The denominator for percentage is the number of participants in the full analysis set with HIV/HBV coinfection and with nonmissing HBV DNA at week 24.