TABLE 4.
Baseline demographics, characteristics and outcomes of patients with clinically significant hepatic events
| HIV-negative
|
HIV-positive
|
|||
|---|---|---|---|---|
| HBsAg−
|
HBsAg+ (N = 1) | HBsAg-(N = 1) | ||
| HBsAg-or untested (N = 12) | Anti-HBs+ (N = 27) | |||
| Cirrhosis, N (%) | 9 (75) | 22 (81) | 1 (100) | 1 (100) |
|
| ||||
| Decompensated cirrhosis, N (%) | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
|
| ||||
| Hepatocellular carcinoma, N (%) | 0 (0) | 1 (4) | 0 (0) | 0 (0) |
|
| ||||
| Alcoholism, N (%) | 1 (8) | 1 (4) | 0 (0) | 0 (0) |
|
| ||||
| Alcohol misuse, N (%)a | 1 (8) | 1 (4) | 0 (0) | 0 (0) |
|
| ||||
| Baseline total bilirubin (mg/dL), median (IQR) | 1.0 (0.8–1.2) | 3.1 (2.3–3.6) | 0.7 (0.7–0.7) | N/A |
|
| ||||
| Baseline ALT (IU/mL), median (IQR) | 89 (54–98) | 77 (45–103) | 62 (62–62) | 90 (90–90) |
|
| ||||
| HCV direct-acting antiviral, N (%) | ||||
|
| ||||
| PrOD | 0 (0) | 1 (4) | 0 (0) | 0 (0) |
|
| ||||
| ELB/GZP | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
|
| ||||
| SOF/DAC | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
|
| ||||
| SOF/LDV | 6 (50) | 13 (48) | 0 (0) | 1 (100) |
|
| ||||
| SOF/RBV | 4 (33) | 5 (19) | 0 (0) | 0 (0) |
|
| ||||
| SOF/SIM | 2 (17) | 8 (30) | 1 (100) | 0 (0) |
|
| ||||
| SOF/VEL | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
|
| ||||
| HCV DAA duration days, median (IQR) | 91 (81–86) | 129 (78–137) | 55 (55–55) | 142 (142–142) |
|
| ||||
| Follow-up to 12 wk post-treatment, N (%) | 12 (100) | 26 (96) | 1 (100) | 1 (100) |
|
| ||||
| SVR12 tested, N (%) | 11 (92) | 23 (85) | 1 (100) | 1 (100) |
|
| ||||
| SVR12 (among tested), N (%) | 6 (55) | 18 (78) | 1 (100) | 1 (100) |
|
| ||||
| Event timing | ||||
|
| ||||
| Significant hepatic events during therapy, N (%)a | 1 (8) | 3 (11) | 1 (100) | 0 (0) |
|
| ||||
| Significant hepatic events after therapy, N (%)a | 11 (92) | 24 (89) | 1 (100) | 1 (100) |
|
| ||||
| Laboratory changes | ||||
|
| ||||
| Maximum ALT (IU/mL) during treatment, median (IQR) | 35 (24–80) | 51 (29–95) | 1495 (1495–1495) | 80 (80–80) |
|
| ||||
| Maximum ALT (IU/mL) during treatment | 1594 | 909 | 1495 | 80 |
|
| ||||
| Maximum total bilirubin (mg/dL) during treatment, median (IQR) | 1.1 (1.0–1.7) | 2.3 (1.5–4.1) | 12.2 (12.2–12.2) | 3.2 (3.2–3.2) |
|
| ||||
| Maximum total Bilirubin (mg/dL) during treatment | 8.1 | 11.8 | 12.2 | 3.2 |
|
| ||||
| Maximum ALT (IU/mL) after treatment, median (IQR) | 255 (207–492) | 247 (162–381) | 132 (132–132) | 1540 (1540–1540) |
|
| ||||
| Maximum ALT (IU/mL) after treatment | 1427 | 2452 | 132 | 1540 |
|
| ||||
| Peak total Bilirubin (mg/dL) after treatment, median (IQR) | 8.7 (3.9–15.1) | 4.3 (3.2–14.2) | 4.1 (4.1–4.1) | 17.3 (17.3–17.3) |
|
| ||||
| Maximum total Bilirubin (mg/dL) after treatment | 21.9 | 28.1 | 4.1 | 17.3 |
|
| ||||
| HBV DNA tested at baseline, N (%) | 0 (0) | 1 (4) | 1 (100) | 0 (0) |
|
| ||||
| HBV DNA tested during event, N (%) | 1 (4) | 1 (4) | 0 (0) | 0 (0) |
|
| ||||
| HBV DNA increase 1-log during therapy, N (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
|
| ||||
| HBV DNA increase 1-log after therapy, N (%) | 0 (0) | 1 (4) | 1 (100) | 1 (100) |
|
| ||||
| HBV DNA increase 4-log after therapy, N (%) | 0 (0) | 0 (0) | 1 (100) | 0 (0) |
|
| ||||
| Related to HBVr | 0 | 1 | 1 | 1 |
|
| ||||
| Not related to HBVr (tested and negative) | 1 | 9 | 0 | 0 |
|
| ||||
| Undetermined cause | 11 | 17 | 0 | 0 |
ALT, alanine aminotransferase; DAA, direct-acting antiviral.
a
Clinically significant hepatic events was defined as ALT >100 IU/L and total bilirubin >2.5 μg/dL.