Table 5.
Interferon-free regimens for HCV genotype 2 treatment-naïve and treatment-experienced patients
| Study | Sponsor | Trial Phase | N= | Study population | Treatment regimen | SVR12 | SVR12 in special populations |
|---|---|---|---|---|---|---|---|
| HCV genotype 2 treatment-naïve patients | |||||||
| FISSION38 | Gilead | III | 70 | 20% F4 | 12 w SOF + RBV | 97% (68/70) | |
| VALENCE39 | Gilead | III | 32 | 20% F4 | 12 w SOF + RBV | 97% (31/32) | F0–3: 97% (29/30) F4: 100% (2/2) |
| AI44404020 | BMS | II | 18 | 7%–15% F4 | SOF 7 days + SOF + DCV 23 w | 88% (14/16) | |
| 24 w SOF + DCV | 100% (14/14) | ||||||
| 24 w SOF + DCV + RBV | 93% (13/14) | ||||||
| SOF + GS-581649 | Gilead | II | 21 | F0–3 only | 12 w SOF + GS-5816 25 mg | 91% (10/11) | |
| 12 w SOF + GS-5816 100 mg | 100% (10/10) | ||||||
| SOF + GS-581658 | Gilead | II | 103 | F0–3 only | 12 w SOF + GS-5816 25 mg | 77% (20/26) | |
| 12 w SOF + GS-5816 25 mg + RBV | 88% (22/25) | ||||||
| 12 w SOF + GS-5816 100 mg | 88% (23/26) | ||||||
| 12 w SOF + GS-5816 100 mg + RBV | 88% (23/26) | ||||||
| HCV genotype 2 treatment-experienced patients | |||||||
| FUSION40 | Gilead | III | 68 | 34% F4 | 12 w SOF + RBV | 86% (31/36) | F0–3: 96% (12 w) vs 100% (16 w) |
| 25% prior NR | 16 w SOF + RBV | 94% (30/32) | Cirrhosis: 60% (12 w) vs 78% (16 w) | ||||
| VALENCE39 | Gilead | III | 41 | 22% F4 | 12 w SOF + RBV | 90% (37/41) | F0–3: 94% (30/32) F4: 78% (7/9) |
Abbreviations: HCV, hepatitis C virus; SVR, sustained virological response; w, weeks; SOF, sofosbuvir; RBV, ribavirin; BMS, Bristol–Myers Squibb; DCV, daclatasvir; NR, null responder; N, number of patients included in the study population; F, METAVIR fibrosis stage.