Table 8.
Safety of DAA-Based Therapy.
| Parameter | All Patients n = 963 |
Non-Cirrhotics n = 756 |
Cirrhotics n = 207 |
p Value |
|---|---|---|---|---|
| Treatment course, n (%) | ||||
| according to schedule | 937 (97.3) | 745 (98.6) | 192 (92.8) | <0.0001 |
| therapy modification | 15 (1.6) 1 | 7 (0.9) 6 | 8 (3.9) 9 | |
| therapy discontinuation | 11 (1.1) 2 | 4 (0.5) 7 | 7 (3.4) 10 | |
| Patients with at least one AE, n (%) | 152 (15.8) | 75 (9.9) | 77 (37.2) | <0.0001 |
| Serious adverse events, n (%) | 26 (2.7) 3 | 9 (1.2) 8 | 17 (8.2) 11 | <0.0001 |
| AEs leading to treatment discontinuation, n (%) |
3 (0.3) 4 | 0 | 3 (1.4) 12 | 0.01 |
| Most common AEs (≥2%), n (%) | ||||
| weakness/fatigue | 54 (5.6) | 30 (4) | 24 (11.6) | <0.0001 |
| anemia | 33 (3.4) | 8 (1.1) | 25 (12.1) | <0.0001 |
| AEs of particular interest, n (%) | ||||
| Ascites | 8 (0.8) | NA | 8 (3.9) | <0.0001 |
| hepatic encephalopathy | 6 0.6) | NA | 6 (2.9) | <0.0001 |
| gastrointestinal bleeding | 1 (0.1) | NA | 1 (0.5) | 0.215 |
| Death, n (%) | 8 (0.8) 5 | 0 | 8 (3.9) | <0.0001 |
As shown: 1 13 × RBV dosage modification, 2 × nonadherence (temporary treatment interruptions); 2 3 × AEs, 3 × death, 4 × patient’s decision, 1 unknown reason; 3 encephalopathy, fracture of lower extremity, dysplastic nodules in the liver, hepatocellular carcinoma, balance disorders, diarrhea, interstitial lung disease, 2 liver impairment, acute hepatitis, ALT elevation, gastrointestinal bleeding, severe thrombocytopenia, progression of hepatocellular carcinoma, ptosis of the left eyelid, liver transplantation, lung cancer, 4 cerebral stroke, clostridium difficile infection, arterial hypertension, head injury, COVID-19, 1 × (myocardial infarction, pulmonary embolism); 4 acute hepatitis, vomits, cerebral stroke; 5 2 × liver impairment, 2 × hepatocellular carcinoma, cerebral stroke, COVID-19, cardiac arrest; 6 5 × RBV dosing, 2 × no adherence; 7 4 × non-adherence; 8 balance disorders, diarrhea, ALT elevation, ptosis of the left eyelid, lung cancer, 2 cerebral stroke, 1 × myocardial infarction with pulmonary embolism; 9 8 × RBV dosing; 10 3 × AEs, 3 × death, 1 unknown reason; 11 encephalopathy, fracture of lower extremity, dysplastic nodules in the liver, hepatocellular carcinoma, interstitial lung disease, 2 liver impairment, acute hepatitis, gastrointestinal bleeding, severe thrombocytopenia, progression of hepatocellular carcinoma, liver transplantation, 2 cerebral stroke, clostridium difficile infection, head injury, COVID-19; 12 acute hepatitis, vomits, and cerebral stroke. DAA: direct-acting antivirals; AE: adverse event; NA: not available.