Table 3.
Harvoni (LDV/SOF) | Viekira Pak (OBV/PTV/r + DSV ± RBV) | ||||||
---|---|---|---|---|---|---|---|
Trial Name | ION I | ION II | ION III | SAPPHIRE I | PEARL III | PEARL IV | TURQUOISE II |
Study population | Treatment-naïve | GT 1 null-responders | Treatment-naïve with no cirrhosis | Treatment-naïve with no cirrhosis | GT 1b treatment-naïve with no cirrhosis | GT 1a treatment-naïve with no cirrhosis | Compensated cirrhosis |
Treatment regimen | LDV/SOF ± RBV | LDV/SOF ± RBV | LDV/SOF ± RBV | OBV/PTV/r + DSV + RBV | OBV/PTV/r + DSV ± RBV | OBV/PTV/r + DSV ± RBV | OBV/PTV/r + DSV + RBV |
Number of patients enrolled | 865 | 440 | 647 | 631 | 419 | 305 | 380 |
Treatment duration | 12 or 24 weeks | 12 or 24 weeks | 8 or 12 weeks | 12 weeks | 12 weeks | 12 weeks | 12 or 24 weeks |
SVR12 | 97%–99% | 94%–99% | 93%–95% | 96.2% | 99.5%–99.0% | 90.2%–97% | 91.8%–95.9% |
Relapse | 2 | 11 | 23 | 7 | 1 | 11 | 13 |
Breakthrough | 0 | 1 | 0 | 1 | 0 | 7 | 4 |
Discontinuation due to adverse events | 0 | 0 | 3 | 4 | 0 | 2 | 8 |
DSV = dasabuvir; GT = genotype; LDV = ledipasvir; OBV = ombitasvir; PTV = paritaprevir; r = ritonavir; RBV = ribavirin; SOF = sofosbuvir; SVR12 = sustained virological response 12 weeks after treatment