meet virologic failure criteria (e.g., lost to follow-up).
Table 15 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
Table 15 SVR Rates for Selected Subgroups by Genotype in Study FUSION
Genotype 2
Genotype 3
SOVALDI + RBV 12 weeks
SOVALDI + RBV 16 weeks
SOVALDI + RBV 12 weeks
SOVALDI + RBV 16 weeks
N=39
N=35
N=64
N=63
Cirrhosis
No
90% (26/29)
92% (24/26)
37% (14/38)
63% (25/40)
Yes
60% (6/10)
78% (7/9)
19% (5/26)
61% (14/23)
Response to prior HCV treatment
Relapser/ breakthrough
86% (25/29)
89% (24/27)
31% (15/49)
65% (30/46)
Nonresponder
70% (7/10)
88% (7/8)
27% (4/15)
53% (9/17)
Treatment-Naïve and Previously Treated Adults ─ VALENCE (Study 133)
The VALENCE trial eva luated sofosbuvir in combination with weight-based ribavirin 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 + ribavirin 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 + ribavirin for 12 weeks, and duration of treatment with SOVALDI + ribavirin in genotype 3 HCV-infected subjects was extended to 24 weeks. Eleven genotype 3 subjects had already completed SOVALDI + ribavirin for 12 weeks at the time of the amendment.
Treated subjects (N=419) had a median age of 51 years (range: 19 to 74); 60% of the subjects were male; mean body mass index was 26 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA level was 6.4 log10 IU per mL; 78% had HCV genotype 3; 58% of the subjects were treatment-experienced and 65% of those subjects experienced relapse/breakthrough to prior HCV treatment.
Table 16 presents the response rates for the treatment groups of SOVALDI + ribavirin for 12 weeks and 24 weeks.
Table 16 Response Rates in Study VALENCEa
Genotype 2 SOVALDI + RBV 12 weeks
Genotype 3 SOVALDI + RBV 24 weeks
N=73
N=250