Table 2. Recent studies in recurrent HCV.
Treatment | Study name/author | Study type | Number of enrolled patients | Genotype | Fibrosis severity (METAVIR or equivalent fibrosis stage) | SVR 12 | Adverse effects |
---|---|---|---|---|---|---|---|
Boceprevir/telaprevir + RBV + PEG-IFN | Coily et al., 201470 | Prospective | 37 | Genotype 1 1a (28%) 1b (72%) |
F2 (38%) F3 (46%) F4 (16%) |
20% (telaprevir) 71% (boceprevir) |
Anemia (92%) Blood transfusion requirement (35%) Infection (27%) |
Daclatasvir + sofosbuvir +/− RBV | Pellicelli et al., 201494 | Prospective | 12 | Genotype 1 (92%) 1a (58%) 1b (8%) Genotype 4 (8%) |
F4 (75%) | 75% | N/A |
Boceprevir/telaprevir + RBV + PEG-IFN | Burton et al., 201469 | Retrospective | 81 | Genotype 1 (100%) 1a (56%) 1b (41%) Unknown (4%) |
F0-2 (47%) F3-4 (53%) |
63% | Blood transfusion requirement (57%) Creatinine increase ≥0.5 mg/dL (38%) Hemoglobin <8 g/dL (21%) |
Ombiasvir + paritaprevir + dasabuvir + ritonavir + RBV | Kwo et al., 2014 CORAL-1101 | Prospective | 34 | Genotype 1 1a (85%) |
F0 (18%) F1 (38%) F2 (44%) |
97% | Fatigue (50%) Headache (44%) Cough (32%) Anemia (29%) |
Sofosbuvir + RBV +/− PEG-IFN | Forns et al., 201483 | Prospective | 104 | Genotype 1 (82%) 1a (35%) 1b (47%) Genotype 2 (1%) Genotype 3 (7%) Genotype 4 (7%) |
N/A | 59% | Hepatic decompensation on treatment (18%) Infections (16%) Anemia (10%) |
Ledipasvir + sofosbuvir + RBV | SOLAR-1 (preliminary results 2014)100 | Prospective | 223 | Genotype 1 1a (71%) 1b (28%) Genotype 4 (<1%) |
F0-3 (50%) F4 (50%) |
96% (non-cirrhotic) 96% (cirrhotic) 81% (decompensated) |
N/A |
Sofosbuvir + RBV | Charlton et al., 201584 | Prospective | 40 | Genotype 1 (83%) 1a (55%) 1b (28%) Genotype 3 (15%) Genotype 4 (3%) |
F0 (3%) F1-2 (35%) F3 (23%) F4 (40%) |
70% | Fatigue (30%) Diarrhea (28%) Headache (25%) Anemia (20%) |
Boceprevir/telaprevir + RBV + PEG-IFN | Verna et al., 201572 | Retrospective | 45 | Genotype 1 1a (57%) |
F1 (2%) F2 (11%) F3 (54%) F4 (33%) |
51% in advanced fibrosis 44% in FCH |
Blood transfusion requirement (56%) Creatinine increase ≥0.5 mg/dL (37%) Hemoglobin <8 g/dL (26%) Hepatic decompensation on treatment (24%) |
Simeprevir + sofosbuvir +/− RBV | Pungpapong et al., 201591 | Prospective | 123 | Genotype 1 1a (60%) 1b (35%) Unable to subtype (5%) |
F0-2 (70%) F3-4 (30%) |
90% | Anemia (72% in RBV group, 5% in non-RBV group) Fatigue (13%) Skin complaints (6%) Headache (5%) GI complaints (5%) |
Abbreviations: RBV, ribavirin; PEG-IFN, pegylated interferon; FCH, fibrosing cholestatic hepatitis; GI, gastrointestinal; N/A, not available.