Table 2.
Efficacy parameters at week 48a | HIV patients with HBV/HCV coinfection |
HIV patients without HBV/HCV coinfection |
||
---|---|---|---|---|
25 mg of RPV once daily, N = 49 | 600 mg of EFV once daily, N = 63 | 25 mg of RPV once daily, N = 621 | 600 mg of EFV once daily, N = 602 | |
Patients with viral load <50 copies/mL (ITT-TLOVR), % (95% CI) | 73.5 (61–86) | 79.4 (69–90) | 85.0 (82–88) | 82.6 (80–86) |
Virological failures, n (%) | 5 (10.2) | 3 (4.8) | 55 (8.9) | 30 (5.0) |
Discontinuation due to AE/death, n (%) | 2 (4.1) | 6 (9.5) | 13 (2.1) | 40 (6.6) |
Discontinuation due to reason other than AEb, n (%) | 6 (12.2) | 4 (6.3) | 25 (4.0) | 35 (5.8) |
Change in CD4 count (NC = Fc) from baseline (cells/mm3), mean (95% CI)d | +137 (100–175) | +192 (147–238) | +197 (186–209) | +173 (161–185) |
RPV, rilpivirine; EFV, efavirenz.
aPatients included in efficacy analysis were those with baseline HBV/HCV assessments.
bLost to follow-up, non-compliance, withdrew consent, ineligible to continue, sponsor's decision.
cNC = F, non-completer = failure: missing values after discontinuation imputed with change = 0; last observation carried forward otherwise.
dN′ = 48 for rilpivirine for HBV- and/or HCV-coinfected patients.