Table 1.
Characteristics of Reports Extracted from VigiBase on DAAs for HCV Treatment.
| Active Ingredient | Total, n (%) | P | ||||
|---|---|---|---|---|---|---|
| SOF/RBV, n (%) | DCV/SOF, n (%) | SOF/LDV, n (%) | OBV/PTV/r, n (%) | |||
| Gender | ||||||
| Female | 69 (10.28) | 1202 (59.04) | 14 (27.5) | 78 (44.97) | 1363 (46.6) | < 0.001a |
| Male | 176 (26.23) | 643 (31.83) | 29 (56.9) | 81 (46.03) | 929 (31.76) | < 0.001a |
| Unknown | 426 (63.49) | 187 (9.23) | 8 (15.7) | 12 (8.99) | 633 (21.64) | < 0.001a |
| Age group (year) | ||||||
| 2–11 years | 0 (0) | 0 (0) | 14 (27.5) | 0 (0) | 14 (0.48) | < 0.001b |
| 12–17 years | 0 (0) | 0 (0) | 4 (7.8) | 0 (0) | 4 (0.14) | < 0.001b |
| 18–44 years | 33 (4.92) | 553 (27.16) | 4 (7.8) | 27 (15.9) | 617 (21.09) | < 0.001b |
| 45–64 years | 167 (24.89) | 1102 (54.22) | 12 (23.5) | 104 (57.7) | 1385 (47.35) | < 0.001a |
| 65–74 years | 17 (2.53) | 196 (9.63) | 3 (5.9) | 30 (16.4) | 246 (8.41) | < 0.001b |
| ≥ 75 years | 1 (0.15) | 15 (0.74) | 0 (0) | 7 (3.7) | 23 (0.79) | < 0.001b |
| Unknown | 453 (67.51) | 166 (8.25) | 14 (27.45) | 3 (6.3) | 636 (21.74) | < 0.001b |
| ADR category | ||||||
| Serious | 575 (85.69) | 526 (25.9) | 18 (35.3) | 12 (9.5) | 1131 (38.67) | < 0.001a |
| Non serious | 95 (14.16) | 1495 (73.6) | 33 (64.7) | 156 (88.9) | 1779 (60.82) | < 0.001a |
| Unknown | 1 (0.15) | 11 (0.5) | 0 (0) | 3 (1.6) | 15 (0.51) | 0.07b |
| Death | 8 (1.19) | 18 (0.88) | 1 (2) | 0 (0) | 27 (0.92) | 0.43b |
| Life threatening | 18 (2.68) | 16 (0.79) | 1 (2) | 1 (0.5) | 36 (1.23) | < 0.01b |
| Caused/Prolonged hosp. | 27 (4.02) | 16 (0.79) | 5 (9.8) | 1 (1.6) | 49 (1.68) | < 0.001b |
| Permanent disability | 0 (0) | 0 (0) | 1 (2) | 0 (0) | 1 (0.03) | < 0.001b |
| Disabling/incapacitating | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | – |
| Other medically important condition | 529 (78.84) | 490 (24.1) | 16 (31.4) | 10 (8.5) | 1045 (35.73) | < 0.001a |
| ADR severity | ||||||
| Mild | 49 (7.3) | 1294 (63.68) | 11 (21.57) | 96 (50.79) | 1450 (49.57) | < 0.001a |
| Moderate | 440 (65.57) | 304 (14.96) | 5 (9.8) | 15 (7.94) | 764 (26.12) | < 0.001a |
| Severe | 27 (4.02) | 34 (1.67) | 2 (3.92) | 1 (0.53) | 64 (2.19) | < 0.01b |
| Unknown (No data) | 155 (23.1) | 400 (19.69) | 33 (64.71) | 59 (31.22) | 647 (22.12) | < 0.001a |
| System Organ Class | ||||||
| Nervous system disorders | 42 (6.26) | 714 (35.14) | 8 (15.69) | 37 (21.64) | 801 (27.38) | < 0.001a |
| Blood and lymphatic system disorders | 399 (59.46) | 306 (15.06) | 7 (13.73) | 34 (19.88) | 746 (25.5) | < 0.001a |
| General disorders and administration site conditions | 114 (16.99) | 553 (27.21) | 8 (15.69) | 70 (40.94) | 745 (25.47) | < 0.001a |
| Infections and infestations | 118 (17.59) | 343 (16.88) | 7 (13.73) | 2 (1.17) | 470 (16.07) | < 0.001b |
| Skin and subcutaneous tissue disorders | 18 (2.68) | 144 (7.09) | 3 (9.8) | 40 (23.39) | 205 (7.01) | < 0.001b |
| Preferred term | ||||||
| Anaemia | 385 (57.38) | 202 (9.94) | 5 (9.8) | 32 (18.71) | 624 (21.33) | < 0.001a |
| Hepatitis C relapse | 109 (16.24) | 308 (15.16) | 6 (11.7) | 2 (1.17) | 425 (14.53) | < 0.001b |
| Headache | 17 (2.53) | 375 (18.45) | 3 (5.88) | 15 (8.77) | 410 (14.02) | < 0.001b |
| Fatigue | 34 (5.07) | 309 (15.21) | 3 (5.88) | 34 (19.88) | 380 (12.99) | < 0.001b |
| Dizziness | 7 (1.04) | 335 (16.49) | 1 (3.92) | 15 (8.77) | 358 (12.24) | < 0.001b |
| Pruritus | 6 (0.89) | 99 (4.87) | 2 (3.92) | 35 (20.47) | 142 (4.85) | < 0.001b |
| ADR causality | ||||||
| Certain | 8 (0.96) | 1 (0.03) | 0 (0) | 0 (0) | 9 (0.18) | < 0.001b |
| Probable | 8 (0.96) | 20 (0.53) | 0 (0) | 7 (1.9) | 35 (0.69) | 0.01b |
| Possible | 804 (96.06) | 3717 (98.28) | 83 (93.26) | 328 (89.13) | 4932 (97.16) | < 0.001a |
| Unlikely | 13 (1.55) | 28 (0.74) | 5 (5.62) | 31 (8.42) | 77 (1.52) | < 0.001a |
| Conditional | 0 (0) | 4 (0.11) | 1 (1.12) | 2 (0.54) | 7 (0.14) | < 0.01b |
| Unassessable | 4 (0.48) | 12 (0.32) | 0 (0) | 0 (0) | 16 (0.32) | 0.54b |
DAA direct-acting antiretrovirals, HCV hepatitis C virus, ADR adverse drug reaction, SOF sofosbuvir, DCV daclatasvir, LDV ledipasvir, OBV/PTV/r ombitasvir/paritaprevir/ritonavir, RBV ribavirin.
aChi-Squared Test.
bFisher’s Exact Test.