Background
Material and methods
Study population
Parameter | Boceprevir-experienced | Telaprevir-experienced |
---|---|---|
Number of patients, n (%) | 127 (38%) | 208 (62%) |
Gender: females/males, n (%) | 63 (49.6%)/65 (50.4%) | 95 (45.7%)/ 113 (54.3%) |
Age (years) mean ± SD; min-max | 55.4 ± 10.9; 23–74 | 60.3 ± 10.7; 27–78 |
BMI mean ± SD; min-max | 27.4 ± 4.99; 19–38 | 27.6 ± 4.11; 19–44 |
HCV Genotype: n (%) | ||
1b | 120 (94.5%) | 191 (91.8%) |
1a | 5 (3.9%) | 9 (4.3%) |
1 | 2 (1.6%) | 8 (3.9%) |
Fibrosis, n (%) | ||
F4 | 78 (61.4%) | 134 (64.4%) |
F3 | 36 (28.4%) | 39 (18.8%) |
F2 | 9 (7.1%) | 19 (9.1%) |
F1 | 4 (3.1%) | 16 (7.7%) |
Child-Turcotte-Pugh, n (%) | ||
A | 123 (96.9%) | 201 (96.6%) |
B | 4 (3.1%) | 5 (2.4%) |
C | 0 (0%) | 2 (1%) |
Response to previous treatment with PI+PegIFN+RBV, n (%) | ||
Non-response | 45 (35.4%) | 83 (39.9%) |
Relapse | 48 (37.8%) | 66 (31.7%) |
Discontinuation | 17 (13.4%) | 37 (17.8%) |
Unknown | 17 (13.4%) | 22 (10.6%) |
History of hepatic decompensation, n (%) | 9 (7.1%) | 11 (5.3%) |
Ascites | 9 (7.1%) | 9 (4.3%) |
Encephalopathy | 0 (0%) | 2 (1%) |
Documented oesophageal varices, n (%) | 21 (16.5%) | 47 (22.6%) |
History of hepatocellular carcinoma, n (%) | 1 (0.8%) | 4 (1.9%) |
HBV coinfection, n (%) | ||
HBsAg positive | 4 (3.1%) | 0 (0%) |
HBV DNA positive | 0 (0%) | 0 (0%) |
Anti-HBc positive | 11 (8.7%) | 17 (8.2%) |
HIV coinfection, n (%) | 0 (0%) | 0 (0%) |
History of liver transplantation, n (%) | 1 (0.8%) | 5 (2.4%) |
Comorbidities, n (%) | ||
Any comorbidity | 87 (68.5%) | 142 (68.3%) |
Hypertension | 48 (37.8%) | 82 (39.4%) |
Diabetes | 17 (13.4%) | 34 (16.3%) |
Renal insufficiency | 1 (0.8%) | 2 (1%) |
Autoimmune diseases | 2 (1.6%) | 2 (1%) |
Non-HCC tumours | 1 (0.8%) | 0 (0%) |
Other | 21 (16.5%) | 46 (22.1%) |
Concomitant medications, n (%) | 81 (63.8%) | 141 (67.8%) |
Statistical analysis
Results
Treatment regimen | Boceprevir-experienced | Telaprevir-experienced |
---|---|---|
LDV/SOF, n (%) | n = 63 | n = 105 |
LDV/SOF 12 weeks | 11 (8.7%) | 26 (12.5%) |
LDV/SOF 24 weeks | 6 (4.7%) | 9 (4.3%) |
LDV/SOF + RBV 12 weeks | 41 (32.3%) | 63 (30.3%) |
LDV/SOF + RBV 24 weeks | 5 (3.9%) | 7 (3.4%) |
PrOD, n (%) | n = 64 | n = 103 |
PrOD 12 weeks | 29 (22.8%) | 42 (20.2%) |
PrOD+RBV 12 weeks | 33 (26%) | 56 (26.9%) |
PrOD+RBV 24 weeks | 2 (1.6%) | 5 (2.4%) |
Treatment efficacy
Treatment safety
Parameter | Boceprevir-experienced | Telaprevir-experienced | ||
---|---|---|---|---|
LDV/SOF (n = 63) | PrOD (n = 64) | LDV/SOF (n = 105) | PrOD (n = 103) | |
Patients with at least one AE, n (%) | 24 (38.1%) | 28 (43,8%) | 44 (41.9%) | 45 (43.7%) |
RBV-containing regimen | 18 (28.6%) | 19 (29.7%) | 31 (29.5%) | 33 (32%) |
Most common AEs (> 5%), n (%) | ||||
Fatigue | 15 (23.8%) | 17 (26.6%) | 27 (25.7%) | 30 (29.1%) |
Anaemia | 9 (14.3%) | 13 (20.3%) | 15 (14.3%) | 22 (21.4%) |
Headache | 8 (12.7%) | 11 (17.2%) | 10 (9.5%) | 12 (11.7%) |
Nausea | 4 (6.3%) | 4 (6.3%) | 7 (6.7%) | 8 (7.8%) |
Serious AEs, n (%) | 1 (1.6%) | 1 (1.6%) | 2 (1.9%) | 1 (1%) |
Deaths | 1 (1.6%) | 0 (0%) | 2 (1.9%) | 0 (0%) |