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Table 2 Adverse events

From: Ombitasvir/paritaprevir/ritonavir & dasabuvir ± ribavirin following protease inhibitors failure - a prospective multi-centre trial

No. (%)Entire cohort (n = 39)GT1b without cirrhosis (no RBV) (n = 27)GT1b with cirrhosis/ GT1a (with RBV) (n = 12)P value
Patients with at least one AE15 (38.5%)7 (25.9%)8 (66.7%)0.031
Total number of AEs251312
Patients with any serious AE7 (17.9%)4 (14.8%)3 (25.0%)0.654
Patients with any common AE12 (30.8)6 (22.2)6 (50.0)0.133
Early termination due to AE2 (5.1%)1 (3.7%)1 (8.3%)0.526
Serious AE
 Psychiatric admission3 (7.7%)1 (3.7%)2 (16.7%)0.219
 Pneumonia (admission)1 (2.6%)0 (0.0%)1 (8.3%)0.308
 Ankle fracture1 (2.6%)1 (3.7%)0 (0.0%)1.000
 Palpitations2 (5.1%)2 (7.4%)0 (0.0%)1.000
Common AE
 Weakness8 (20.5%)4 (14.8%)4 (33.3%)0.221
 Leg oedema2 (5.1%)1 (3.7%)1 (8.3%)0.526
 Rash2 (5.1%)1 (3.7%)1 (8.3%)0.526
 Diarrhoea1 (2.6%)1 (3.7%)0 (0.0%)1.000
 Anaemia2 (5.1%)2 (16.7%)0 (0.0%)0.089
  1. AE Adverse event; GT Genotype; RBV Ribavirin