Table 4.
Association between increase in FIB-4 score from <3.25 before SVR to ≥3.25 after SVR and increased HCC risk
| FIB-4 Score Pre-treatment | FIB-4 Score Post-treatment | Number of patients | Patient-years | Number who developed HCC (%) | HCC per 100 patient-years | Crude hazard ratio (95% CI) | Adjusted* hazard ratio (95%CI) | |
|---|---|---|---|---|---|---|---|---|
| CIRRHOSIS | ||||||||
| INCREASE in FIB-4 post-treatment ascertained within 1 year of SVR† | ||||||||
| IFN-based REGIMENS | <3.25 | <3.25 | 957(86.8) | 7,397 | 38(4.0) | 0.51 | 1 | 1 |
| <3.25 | ≥3.25 | 146(13.2) | 1,040 | 14(9.6) | 1.35 | 2.57 (1.39–4.75) | 3.20 (1.49–6.88) | |
| DAA-only REGIMENS | <3.25 | <3.25 | 2,070(90.6) | 6,360 | 65(3.1) | 1.02 | 1 | 1 |
| <3.25 | ≥3.25 | 216(9.4) | 609 | 14(6.5) | 2.3 | 2.26 (1.27–4.02) | 2.21 (1.18–4.17) | |
| INCREASE in FIB-4 post-treatment ascertained at any time after SVR as a time-dependent covariate†† | ||||||||
| IFN-based REGIMENS | <3.25 | <3.25 | N/A | 7,545 | 28 | 0.37 | 1 | 1 |
| <3.25 | ≥3.25 | N/A | 1,683 | 31 | 1.84 | 5.27(3.09–9.00) | 7.36 (3.81–14.24) | |
| DAA-only REGIMENS | <3.25 | <3.25 | N/A | 6,689 | 62 | 0.93 | 1 | 1 |
| <3.25 | ≥3.25 | N/A | 909 | 25 | 2.75 | 3.19(1.98–5.13) | 3.16 (1.86–5.36) | |
| NO CIRRHOSIS | ||||||||
| INCREASE in FIB-4 post-treatment ascertained within 1 year of SVR† | ||||||||
| IFN-based REGIMENS | <3.25 | <3.25 |
12,321(94.6) |
118,075 | 157(1.3) | 0.13 | 1 | 1 |
| <3.25 | ≥3.25 | 703(5.4) | 5,967 | 21(3.0) | 0.35 | 2.69 (1.70–4.24) | 2.08 (1.20–3.59) | |
| DAA-only REGIMENS | <3.25 | <3.25 |
13,395(95.7) |
40,178 | 98(0.7) | 0.24 | 1 | 1 |
| <3.25 | ≥3.25 | 596(4.3) | 1,699 | 8(1.3) | 0.47 | 1.92 (0.93–3.94) | 1.65 (0.76–3.61) | |
| INCREASE in FIB-4 post-treatment ascertained at any time after SVR as a time-dependent covariate†† | ||||||||
| IFN-based REGIMENS | <3.25 | <3.25 | N/A | 128,183 | 117 | 0.09 | 1 | 1 |
| <3.25 | ≥3.25 | N/A | 14,656 | 80 | 0.55 | 5.66 (4.22–7.58) | 4.85 (3.43–6.84) | |
| DAA-only REGIMENS | <3.25 | <3.25 | N/A | 45,574 | 85 | 0.19 | 1 | 1 |
| <3.25 | ≥3.25 | N/A | 2,772 | 25 | 0.9 | 4.18 2.66–6.59) | 4.10 (2.54–6.62) | |
Adjusted for antiviral regimen, sex, race/ethnicity, body mass index, HCV genotype, HCV viral load, HIV co-infection, HBV co-infection, type 2 diabetes mellitus, alcohol use disorders, AUDIT-C score, substance use disorder, cirrhosis complications, serum bilirubin, serum creatinine, serum albumin, blood INR and blood hemoglobin levels. The laboratory tests were categorized into quartiles and modeled as dummy categorical variables.
This means at least one post-treatment FIB4 ≥3.25 within one year after treatment
In this analysis, a patient whose FIB-4 rises from <3.25 before SVR to ≥3.25 at time t after SVR is analyzed under the <3.25 category from time 0 until time t and under the ≥3.25 category after time t.