Table 5.
Summary of the patient characteristics of the hepatitis B virus (HBV) reactivation cases notified to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and published in the literature.
| Isolated increased HBV DNA |
Mild hepatitis | Moderate-severe hepatitis | Severe hepatitis with jaundice |
Fulminant hepatic failure | ||
|---|---|---|---|---|---|---|
| n=15 | n=4 | n=2 | n=2 | n=3 | ||
| Age, years (Median, IQR) | 58.0 (54.0–69.0) | 59.0 (45.8–71.3) | 48.5 (46.3–50.8) | 56.0 (54.5–57.5) | 59.0 (58.0–66.0) | |
| Male (n, %) | 7 (46.7%) | 2 (50.0%) | 1 (50.0%) | 2 (100.0%) | 0 (0.0%) | |
| HCV genotype (n, %) | 1 | 4 (26.7%) | 1 (25.0%) | - | - | - |
| 1a | 3 (20.0%) | - | - | 1 (50.0%) | 1 (33.3%) | |
| 1b | 3 (20.0%) | 1 (25.0%) | - | 1 (50.0%) | - | |
| 3a | 1 (6.7%) | - | - | - | - | |
| 4d | - | - | 1 (50.0%) | - | - | |
| Unknown | 4 (26.7%) | 2 (50.0%) | 1 (50.0%) | - | 2 (66.7%) | |
| Fibrosis stage | Cirrhosis | 5 (33.3%) | 1 (25.0%) | 1 (50.0%) | - | 1 (33.3%) |
| Bridging fibrosis | 2 (13.3%) | - | - | - | - | |
| F0–2 METAVIR stage | 3 (20.0%) | 1 (25.0%) | 1 (50.0%) | 1 (50.0%) | 2 (66.7%) | |
| Unknown | 5 (33.3%) | 2 (50.0%) | - | 1 (50.0%) | - | |
| Past HCV treatment (n, %) | Naïve | 1 (6.7%) | - | - | - | 1 (33.3%) |
| IFN monotherapy | 0 (0.0%) | - | 1 (50.0%) | - | - | |
| IFN + RBV | 5 (33.3%) | - | 1 (50.0%) | 1 (50.0%) | 1 (33.3%) | |
| Unknown | 9 (60.0%) | 4 (100.0%) | - | 1 (50.0%) | 1 (33.3%) | |
| DAA regimen (n, %) | IFN + RBV + SMV | 1 (6.7%) | - | - | - | - |
| SOF + RBV | 2 (13.3%) | - | - | - | - | |
| SOF/LDV | 2 (13.3%) | 2 (50.0%) | 2 (100.0%) | 1 (50.0%) | - | |
| SOF + SMV | 2 (13.3%) | - | - | - | - | |
| SOF + SMV + RBV | - | - | - | - | 1 (33.3%) | |
| SOF + DCV + RBV | 1 (6.7%) | - | - | - | - | |
| DCV + ASV | 7 (46.7%) | 2 (50.0%) | - | - | 2 (66.7%) | |
| PrO + D + RBV | - | - | - | 1 (50.0%) | - | |
| HBsAg positive at baseline (n, %) | Yes | 14 (93.3%) | 2 (50.0%) | 1 (50.0%) | 2 (100.0%) | 2 (66.7%) |
| No | - | 1 (25.0%) | 1 (50.0%) | - | 1 (33.3%) | |
| Unknown | 1 (6.7%) | 1 (25.0%) | - | - | - | |
| HBeAg positive at baseline (n, %) | Yes | 0 (0.0%) | - | - | - | - |
| No | 10 (66.7%) | 3 (75.0%) | 1 (50.0%) | 1 (50.0%) | 2 (66.7%) | |
| Unknown | 5 (33.3%) | 1 (25.0%) | 1 (50.0%) | 1 (50.0%) | 1 (33.3%) | |
| Isolated anti-HBc (n, %) | Yes | 0 (0.0%) | 1 (25.0%) | 1 (50.0%) | - | 1 (33.3%) |
| No | 15 (100.0%) | 3 (75.0%) | 1 (50.0%) | 2 (100.0%) | 2 (66.7%) | |
| Unknown | - | - | - | - | - | |
| Baseline HBV DNA (IU/mL) | 22.5 (18.4–206.0) | 39.5 (21.9–64.7) | 355 (178–533) | 1,350 (675–2025) | 0 (0–709) | |
| Timing HBV reactivation, weeks (median, IQR) | 6.0 (4.0–8.5) | 7.0 (5.0–8.3) | 7.5 (6.8–8.3) | 9.0 (7.5–10.5) | 8.0 (7.5–9.5) | |
| Peak ALT (IU/mL) | 57.0 (44.5–60.5) | 309.0 (193.0–416.5) | 1221.5 (123.8–1319.3) | 1,521.5 (1,150.3–1892.8) | 2,263.0 (2,188.5–2,362.0) | |
| Peak HBV DNA level (IU/mL) | 3,563 (330–14,556) | 1406 (435–225,430) | 160,207,878 (151,026,103–169,389,653) | 42,150,000 (21,925,000–62,375,000) | 29,000,000 (27,059,432–140,094,322) |
*
= This regimen includes interferon and ribavirin
†
= Significant outcome from HBV reactivation
IFN = Interferon
RBV = Ribavirin
SMV = Simeprevir
SOF = Sofosbuvir
LDV = Ledipasvir
ASV = Asunaprevir
DCV = Daclatasvir
PrO + D = Paritaprevir/ritonavir/Ombitasvir + Dasabuvir
ALT = Alanine aminotransferase
IU = International units
IQR = Interquartile range