Table 2.
Currently available therapies for genotype 1 with US Food and Drug Administration (FDA) approved indications.
| Name of regimen | Trial name | Group* | Regimen | Duration of treatment (weeks) | Dosing considerations | Potential for cure | FDA approval date |
|---|---|---|---|---|---|---|---|
| LDV/SOF | ION-3 | TN without cirrhosis HCV RNA < 6 million iu | HAR | 8 | Adding RBV did not confer any significant benefit. | 97% | 10 October 2014 |
| ION-1, 3 | TN with or without cirrhosis | HAR | 12 | 96–99% | |||
| ION-2 | TE without cirrhosis | HAR | 12 | This is the only regimen indicated for PI failures | 95% | ||
| ION-2 | TE with cirrhosis | HAR | 24 | Adding RBV did not confer any significant benefit | 100% | ||
| SIM + SOF | COSMOS OPTIMIST-1$ |
TN and TE without cirrhosis | OLY + SOV | 12 | Adding RBV did not confer any significant benefit | 95% | 6 November 2014 |
| COSMOS OPTIMIST-2$ |
TN and TE with cirrhosis | OLY + SOV | 24 | 100% | |||
| OBV/PTV/r + DSV‡ | SAPPHIRE-I, II PEARL-IV | GT1a§, TN and TE without cirrhosis | VIE + RBV | 12 | 96–97% | 19 December 2014 | |
| TURQUOISE-II | GT1a§, TN and TE with cirrhosis | VIE + RBV | 24¶ | See comments below¶ | TN: 95% Rel: 100% Part: 100% NR: 93% |
||
| SAPPHIRE-I, II PEARL-II, III |
GT1b, TN and TE without cirrhosis | VIE | 12 | 96.7–100% | |||
| TURQUOISE-II | GT1b, TN and TE with cirrhosis | VIE + RBV | 12 | 100% |
No patients with decompensated cirrhosis were enrolled in these trials. Direct comparison across studies should not be made due to differing study designs.
At the time of publication, results from the phase III OPTIMIST trials of SIM + SOF are yet to be publicly released.
Dosing for patients coinfected with HIV/HCV is the same as for patients only infected with HCV. Twenty-four weeks of VIE + RBV is indicated for certain liver transplant recipients.
For mixed genotype 1 or unknown genotype 1 subtype, follow dosing recommendations for genotype 1a.
VIE + RBV for 12 weeks may be considered for some patients based on prior treatment history (see text or VIE package insert section 14.3).
GT, genotype; HAR, Harvoni; HCV, hepatitis C virus; LDV, ledipasvir; NR, prior null response; OLY, Olysio; OBV/PTV/r + DSV, ombitasvir/paritaprevir/ritonavir + dasabuvir; Part, prior partial response; PI failures, previous non-SVR with pegylated interferon; RBV, ribavirin; Rel, prior relapse; SIM, simeprevir; SOF, sofosbuvir; TE, treatment experienced; TN, treatment naïve; VIE, Viekira Pak.