Table 1. Characteristics of the study population.
IFN-free, all-DAA regimens | Telaprevir and pegIFN | P-valuea | |||||
---|---|---|---|---|---|---|---|
Paritaprevir, ombitasvir and dasabuvir | Daclatasvir and asunaprevir | Daclatasvir and sofosbuvir | Sofosbuvir and simeprevir | ||||
Patients, N | 32 | 9 | 5 | 35 | 30 | ||
HCV genotype, N(%) | 1a | 8 (25.0) | 0 (0.0) | 2 (40.0) | 20 (57.1) | 13 (43.3) | 0.545 |
1b | 24 (75.0) | 9 (100) | 3 (60.0) | 15 (42.9) | 17 (56.7) | ||
Males, N(%) | 23 (71.9) | 6 (66.7) | 4 (80.0) | 24 (68.6) | 22 (73.3) | 0.760 | |
Age (years), Median (IQR) | 58 (53–65) | 65 (56–68) | 53 (50–54) | 56 (51–64) | 55 (51–63) | 0.300 | |
Stiffness at baseline (Kpa), Median (IQR)b | 26.7 (17.3–33.8) | 28.4 (16–31) | 22.8 (12.1–72) | 20.4 (16.6–27.7) | 21 (19–26) | 0.367 | |
Naive patients, N(%) | 6 (18.8) | 1 (11.1) | 1 (20.0) | 8 (22.9) | 7 (23.3) | 0.793 | |
Treatment experience, N(%) | Non responder | 17 (53.1) | 6 (66.7) | 2 (40.0) | 17 (48.6) | 15 (50) | 1.000 |
Relapser | 7 (21.9) | 2 (22.2) | 2 (40.0) | 5 (14.3) | 8 (26.7) | 0.445 | |
Breakthrough | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (5.7) | 0 (0.0) | 1.000 | |
Other | 2 (6.3) | 0 (0.0) | 0 (0.0) | 3 (8.6) | 0 (0.0) | 0.321 | |
PI experienced, N(%) | 2 (6.3) | 0 (0.0) | 1 (20.0) | 5 (14.3) | 0 (0.0) | 0.074 | |
RBV administration, N(%) | 32 (100) | 0 (0.0) | 3 (60.0) | 21 (60.0) | 30 (100) | 0.001 | |
Baseline HCV-RNA (logIU/ml), Median (IQR) | 5.5 (5.1–6) | 5.8 (5.4–6.1) | 5.5 (5.3–6.3) | 5.8 (5.2–6.2) | 6.0 (5.7–6.7) | 0.006 | |
Baseline ALT (IU/ml), Median (IQR) | 74 (60–127) | 118 (70–155) | 111 (102–139) | 96 (77–166) | 95 (65–144) | 0.963 | |
Baseline AST (IU/ml), Median (IQR) | 85 (63–125) | 133 (91–170) | 128 (122–134) | 96 (72–129) | 72 (51–100) | 0.015 | |
SVR12, N (%) | 32 (100) | 8 (88.9) | 4 (80.0) | 32 (91.4) | 20 (66.7) | <0.001 |
a P-values were calculated by Fisher exact test for categorical variables and by Mann-Whitney test for continuous variables. The comparison was performed for telaprevir and pegIFN patients vs. all DAA-treated patients.
b Baseline stiffness value was available for 30 paritaprevir, ombitasvir and dasabuvir treated patients, 9 daclatasvir and asunaprevir patients, 3 daclatasvir and sofosbuvir patients, 29 sofosbuvir and simeprevir patients, and 21 telaprevir and pegIFN treated patients.
ALT, alanine transaminase; AST, aspartate aminotransferase; DAAs, Direct Acting Antivirals; HCV, hepatitis C virus; IFN, interferon; IQR, interquartile range; PI, protease inhibitor; RBV, ribavirin; SVR12, sustained virological response after 12 weeks of follow-up.