Table 2.
Phase II and III study treatment regimens and SVR in treatment-naïve patients with HCV genotype 1 (modified according to [44])
| Study | Dosing | SVR |
|---|---|---|
| Simeprevir/sofosbuvir COSMOS [27] (N = 167 (40 naïve)) | 400 mg SOF + 150 mg SMV ± 1,000-1,200 mg RBV 12-24 weeks | 92%; RBV: 91%, no RBV 95%; naïve PP: 95% |
| Daclatasvir/sofosbuvir | ||
| AI444040 Study Group [21] (N = 126 naïve) | 400 mg SOF + 60 mg DCV ± 1,000-1,200 mg RBV 12-24 weeks | 95-100% |
| Ledipasvir/sofosbuvir | ||
| ION-1 [29] (N = 865) | 400/90 mg SOF/LDV 12 weeks; | no cirrhosis: 100%, cirrhosis: 97%; |
| 400/90 mg SOF/LDV + 1,000-1,200 mg RBV 12 weeks; | no cirrhosis: 100%, cirrhosis: 100%; | |
| 400/90 mg SOF/LDV 24 weeks | no cirrhosis: 99.5%, cirrhosis: 96.9%; | |
| 400/90 mg SOF/LDV + 1,000-1,200 mg RBV 24 weeks | no cirrhosis: 100%, cirrhosis: 100% | |
| ION-3 [31] (N = 647; no cirrhosis) | 400/90 mg SOF/LDV 8 weeks; | 94%; |
| 400/90 mg SOF/LDV + 1,000-1,200 mg RBV 8 weeks; | 93%; | |
| 400/90 mg SOF/LDV 12 weeks | 95% | |
| Paritaprevir/ombitasvir/dasabuvir | ||
| SAPPHIRE I [33] (N = 473) | 150/100 mg PTV/r + 25 mg OBV + 250 DSV BID + 1,000-1,200 mg RBV 12 weeks | 96%, G1a: 95% (96%a), G1b: 98% |
| PEARL III [34] (N = 419 genotype 1b without cirrhosis) | 150/100 mg PTV/r + 25 mg OBV + 250 DSV BID + 12 weeks; | 99% (100%a); |
| 150/100 mg PTV/r + 25 mg OBV + 250 DSV BID + 1,000-1,200 mg RBV 12 weeks | 99.5% | |
| PEARL IV [34] (N = 305 genotype 1a without cirrhosis) | 150/100 mg PTV/r + 25 mg OBV + 250 DSV BID + 12 weeks; | 90% |
| 150/100 mg PTV/r + 25 mg OBV + 250 DSV BID + 1,000-1,200 mg RBV 12 weeks | 97% | |
| TURQUOISE II [35] (N = 160 (treatment-naïve with cirrhosis)) | 150/100 mg PTV/r + 25 mg OBV + 250 DSV BID + 1,000-1,200 mg RBV 12 weeks; 150/100 mg PTV/r + 25 mg OBV + 250 DSV BID + 1,000-1,200 mg RBV 24 weeks | 94%, G1a: 92%, G1b: 100%; |
| 95% (96%a), G1a: 93% (95%a), G1b: 100% | ||
a
Final data given in the EMA summary and product characteristics.
SVR = Sustained virological response; PTV/r = paritaprevir/ritonavir; OBV = ombitasvir; DSV = dasabuvir; RBV = ribavirin; SOF = sofosbuvir; LDV = ledipasvir; DCV = daclatasvir.