Table 4.
Treatment regimen (treatment duration) study | Type of study | Treatment duration (weeks) | HCV GT | Sample size | SVR rate (ITT) | SAE rate (%) | Treatment discontinuation rate (%) | Comments |
---|---|---|---|---|---|---|---|---|
Sofosbuvir/ribavirin | ||||||||
Charlton et al. [99] | CT | 24 | GT1,3,4 | 40 | 70% (28/40) | 15% (6/40) | 5% (2/40) | |
Daclatasvir/asunaprevir | ||||||||
Ikegami et al. [85] | RW | 24 | GT 1b | 74 | 80.3% | 18% | ||
Sofosbuvir/ledipasvir/RBV | ||||||||
SOLAR-1 Charlton et al. [38] |
CT | 12–24 | GT1, (4) | 223 | CH or CP-A: 96–98% CP-B: 85–88% CP-C: 60–75% |
11 to 75% | 0–12% | |
SOLAR-2 Manns et al. [101] |
CT | 12–24 | GT1, 4 | 227 | CH/CP-A: 93–100% (GT1) CP-B: 95–100% (GT1) CP-C: 50–80% |
9 to 67% | 3.5% (8/227) | |
Sofosbuvir/ledipasvir | ||||||||
Ueda et al. [102] | RW | 12 | GT1 | 54 | 98 (53/54) | 13% (7/54) | 2% (1/54) | |
Sofosbuvir/daclatasvir/RBV | ||||||||
ALLY-1 Poordad et al. [103] |
CT | 12 | GT1,3,6 | 53 | 94 (50/53) | 9% (5/53) | 2% (1/53) | |
PTV/RTV/OBV/DSV + RBV | Concentration of CI should be carefully monitored due to interactions with RTV | |||||||
CORAL-2 Kwo et al. [39] |
CT | 24 | GT1 | 34 | 96% (33/34) | 6% (2/34) | 3% (1/34) | |
SMV/sofosbuvir ± RBV | ||||||||
Pungpapong et al. [105] | RW | 12 | GT1 | 123 | 90% (94/105) | 2% (3/123) | 2% (3/123) | |
Brown et al. [106] | RW | 12–24 | GT1 | 151 | 88% (133/151) | 12% (18/151) |
CT clinical trials, RW real-world data, IFN interferon, DAAs direct-acting antivirals, HCV hepatitis C virus, GT genotype, SVR sustained viral response, SAE serious adverse event, CP Child–Pugh classification (classes A through C), ITT intention to treat, CH chronic hepatitis, RBV ribavirin, SMV simeprevir, RTV ritonavir, CI calcineurin inhibitor