Table 2.
Associations between DAA treatment and mortality in HCV-infected patients with HCC
| Patients | Deaths | Person-years | Mortality rate (per 100 person years) | Crude rate ratio | Adjusted HR* | Sample size in adjusted HR | |
|---|---|---|---|---|---|---|---|
| DAA treatment as time-varying exposure† | |||||||
| Overall | |||||||
| Untreated | 414 | 103 | 526.63 | 19.56 (16.05, 23.62) | 401 | ||
| DAA-treated | 383 | 43 | 941.01 | 4.57 (3.35, 6.09) | 0.23 (0.16, 0.33) | 0.54 (0.33, 0.90) | 339 |
| Within Milan | |||||||
| Untreated | 332 | 83 | 427.95 | 19.35 (15.55, 23.91) | 323 | ||
| DAA-treated | 313 | 38 | 777.54 | 4.89 (3.51, 6.63) | 0.25 (0.17, 0.37) | 0.56 (0.32, 0.98) | 280 |
| Beyond Milan | |||||||
| Untreated | 79 | 18 | 96.22 | 18.71 (11.48, 28.93) | 78 | ||
| DAA-treated | 66 | 5 | 155.00 | 3.23 (1.22, 7.07) | 0.17 (0.06, 0.46) | 0.53 (0.21, 1.39) | 59 |
| Surgical resection | |||||||
| Untreated | 33 | 9 | 58.91 | 15.28 (7.55, 27.89) | 30 | ||
| DAA-treated | 81 | 5 | 235.89 | 2.12 (0.80, 4.65) | 0.14 (0.05, 0.41) | 0.21 (0.06, 0.76) | 73 |
| Local ablation | |||||||
| Untreated | 130 | 42 | 174.59 | 24.06 (17.58, 32.19) | 123 | ||
| DAA-treated | 138 | 13 | 326.02 | 3.99 (2.23, 6.63) | 0.17 (0.09, 0.31) | 0.26 (0.13, 0.51) | 116 |
| TACE | |||||||
| Untreated | 222 | 43 | 264.59 | 16.25 (11.92, 21.67) | 220 | ||
| DAA-treated | 136 | 23 | 312.42 | 7.36 (4.79, 10.86) | 0.45 (0.27, 0.75) | 0.99 (0.47, 2.08) | 129 |
| Child Pugh A | |||||||
| Untreated | 199 | 45 | 301.80 | 14.91 (11.02, 19.76) | 191 | ||
| DAA-treated | 235 | 17 | 600.47 | 2.83 (1.71, 4.43) | 0.19 (0.11, 0.33) | 0.25 (0.14, 0.48) | 206 |
| Child Pugh B | |||||||
| Untreated | 160 | 44 | 182.43 | 24.12 (17.76, 32.07) | 155 | ||
| DAA-treated | 127 | 18 | 303.71 | 5.93 (3.64, 9.17) | 0.25 (0.14, 0.43) | 0.43 (0.24, 0.79) | 116 |
| Child Pugh C | |||||||
| Untreated | 55 | 14 | 42.40 | 33.02 (18.91, 53.92) | 55 | ||
| DAA-treated | 44 | 11 | 36.83 | 3.62 (1.92, 6.27) | 0.90 (0.41, 1.99) | 1.92 (0.56, 6.51) | 17 |
| Recurrence | |||||||
| Untreated | 205 | 62 | 326.40 | 19.00 (14.70, 24.18) | 196 | ||
| DAA-treated | 209 | 39 | 535.88 | 7.28 (5.25, 9.84) | 0.38 (0.26, 0.57) | 0.86 (0.49, 1.52) | 184 |
| No recurrence | |||||||
| Untreated | 199 | 40 | 197.62 | 20.24 (14.67, 27.27) | 195 | ||
| DAA-treated | 174 | 4 | 405.13 | 0.99 (0.33, 2.35) | 0.05 (0.02, 0.14) | 0.09 (0.02, 0.29) | 155 |
| No prior recurrence | |||||||
| Untreated | 400 | 95 | 508.91 | 18.67 (15.19, 22.71) | 387 | ||
| DAA-treated | 372 | 43 | 917.13 | 4.69 (3.44, 6.25) | 0.25 (0.18, 0.36) | 0.57 (0.34, 0.94) | 329 |
| Using 180-day landmark‡ | |||||||
| Overall | |||||||
| Untreated | 423 | 73 | 714.16 | 10.22 (8.07, 12.78) | 394 | ||
| DAA-treated | 133 | 11 | 204.14 | 5.39 (2.86, 9.33) | 0.53 (0.28, 0.99) | 0.57 (0.30, 1.09) | 115 |
*
Adjusted for age, sex, Child Pugh class, HCC tumor stage, AFP level, and type of HCC treatment
†
Exposure to DAAs modeled as a time-dependent covariate
‡
DAA group includes patients who initiated DAA therapy within 180 days from HCC complete response. Patients who died, developed recurrence, received liver transplantation, or had their last clinic visit within 180 days were excluded.
DAA – direct acting antiviral; HCC – hepatocellular carcinoma; SVR – sustained virological response; TACE – transarterial chemoembolization