Treated subjects (n = 201) had a median age of 56 years (range: 24 to 70); 70% of the subjects were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 19 to 44 kg/m2); 73% had baseline HCV RNA levels greater than 6 log10 IU/mL; 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers. Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Table 11: Response rates in study FUSION

  SOF+RBV

12 weeks

(n = 103)a
 SOF+RBV

16 weeks

(n = 98)a
 
Overall SVR12
 50% (51/103)
 71% (70/98)
 
Genotype 2
 82% (32/39)
 89% (31/35)
 
Genotype 3
 30% (19/64)
 62% (39/63)
 
Outcome for subjects without SVR12
    
On-treatment virologic failure
 0/103
 0/98
 
Relapseb
 48% (49/103)
 29% (28/98)
 
Otherc
 3% (3/103)
 0/98

a. The efficacy analysis includes 6 subjects with recombinant genotype 2/1 HCV infection.

b. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.

c. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).

Table 12 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.

Table 12: SVR12 rates for selected subgroups by genotype in study FUSION

  Genotype 2
 Genotype 3
 
SOF+RBV

12 weeks

(n = 39)
 SOF+RBV

16 weeks

(n = 35)
 SOF+RBV

12 weeks

(n = 64)
 SOF+RBV

16 weeks

(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
 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)

VALENCE was a Phase 3 study that 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 study was designed as a direct comparison of sofosbuvir and ribavirin versus placebo for 12 weeks. However, based on emerging data, the study was unblinded and all HCV genotype 2 subjects continued to receive sofosbuvir and ribavirin for 12 weeks, whilst treatment for HCV genotype 3 subjects was extended to 24 weeks. Eleven HCV genotype 3 subjects had already completed treatment with sofosbuvir and ribavirin for 12 weeks at the time of the amendment.

Treated subjects (n = 419) had a median age of 51 years (range: 19 to