VALENCE: GT 2 and 3 treatment‑naïve and -experienced adult subjects1

The VALENCE trial evaluated SOVALDI in combination with weight-based RBV for the treatment of genotype 2 or 3 HCV infection in treatment‑naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis. The original trial design was a 4 to 1 randomization to SOVALDI + RBV for 12 weeks or placebo. Based on emerging data, this trial was unblinded and all genotype 2 HCV-infected subjects continued the original planned treatment and received SOVALDI + RBV for 12 weeks, and duration of treatment with SOVALDI + RBV in genotype 3 HCV-infected subjects was extended to 24 weeks. Eleven genotype 3 subjects had already completed SOVALDI + RBV for 12 weeks at the time of the amendment.

STUDY ARMS (AMENDED)

TREATED SUBJECTS

58%
TREATMENT-EXPERIENCED
(65% EXPERIENCED RELAPSE/BREAKTHROUGH TO PRIOR HCV TREATMENT)

STUDY ARMS (AMENDED)

TREATED SUBJECTS

58%
TREATMENT-EXPERIENCED
(65% EXPERIENCED RELAPSE/BREAKTHROUGH TO PRIOR HCV TREATMENT)




Other SOVALDI trials for HCV GT 2 subjects:

FISSION: GT 2 and 3 treatment‑naïve adult subjects1

A trial evaluating 12 weeks of treatment with SOVALDI + RBV compared to 24 weeks of treatment with Peg‑IFN + RBV in treatment‑naïve subjects with GT 2 or 3 HCV. The recommended regimen for GT 3 patients is SOVALDI + RBV for 24 weeks.

STUDY ARMS

STUDY ARMS



FUSION: GT 2 and 3 previously treated adult subjects1

A trial evaluating SOVALDI + RBV for 12 weeks or SOVALDI + RBV for 16 weeks in GT 2 or 3 subjects who did not achieve SVR with prior interferon-based treatment. The recommended regimen for GT 2 patients is SOVALDI + RBV for 12 weeks. The recommended regimen for GT 3 patients is SOVALDI + RBV for 24 weeks.1

STUDY ARMS

STUDY ARMS



POSITRON: IFN-unable GT 2 and 3 adult subjects1

A trial evaluating 12 weeks of treatment with SOVALDI + RBV vs placebo in GT 2 or 3 subjects who were interferon-intolerant, -ineligible, or -unwilling. The recommended regimen for GT 3 patients is SOVALDI + RBV for 24 weeks.1

STUDY ARMS

STUDY ARMS