Table 4.
Frequency of grade 2–4 treatment-emergent hepatic laboratory abnormalities occurring in ≥2% of patients per treatment group by HIV/HBV and/or HIV/HCV coinfection status (N = 1368)a
| Laboratory parameter, n (%) | HIV patients with HBV/HCV coinfection |
HIV patients without HBV/HCV coinfection |
||
|---|---|---|---|---|
| 25 mg of RPV once daily, N = 54 | 600 mg of EFV once daily, N = 66 | 25 mg of RPV once daily, N = 631b | 600 mg of EFV once daily, N = 604b | |
| Increased alkaline phosphatase | ||||
| all grades | 4 (7.4) | 13 (19.7) | 16 (2.5) | 75 (12.4) |
| grade 2–3c | 0 | 2 (3.0) | 1 (0.2) | 6 (1.0) |
| Increased ALT | ||||
| all grades | 27 (50.0) | 28 (42.4) | 114 (18.1) | 161 (26.7) |
| grade 2–4 | 18 (33.3) | 19 (28.8) | 17 (2.7) | 47 (7.8) |
| Increased ASTd | ||||
| all grades | 22 (40.7) | 24 (36.4) | 94 (14.9) | 146 (24.7) |
| grade 2–4 | 11 (20.4) | 12 (18.2) | 22 (3.5) | 48 (7.9) |
| Hyperbilirubinaemia (total)e | ||||
| all grades | 7 (13.0) | 1 (1.5) | 50 (7.9) | 4 (0.7) |
| grade 2–3c | 4 (7.4) | 1 (1.5) | 17 (2.7) | 2 (0.3) |
RPV, rilpivirine; EFV, efavirenz.
aPatient numbers are higher than for the efficacy analyses because the safety analyses were performed using all available data, including beyond week 48; patients who seroconverted for HBV/HCV during the study were also included in the subgroup of HIV/HBV- and/or HIV/HCV-coinfected patients.
bNumber of patients with data.
cNo grade 4 laboratory abnormality observed.
dData available for 603 patients in the efavirenz non-coinfected group.
eThe majority of patients had increased indirect bilirubin above the normal limit.