a.         The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.
b.         Other includes subjects who did not achieve SVR and did not meet virologic failure criteria (e.g., lost to follow-up).

Table 13 presents the subgroup analysis by genotype for cirrhosis and interferon classification.

Table 13         SVR Rates for Selected Subgroups by Genotype in POSITRON

 SOVALDI + RBV 12 weeks
 
Genotype 2
 Genotype 3
 
 N=109
 N=98
 
Cirrhosis
 
No
 92% (85/92)
 68% (57/84)
 
Yes
 94% (16/17)
 21% (3/14)
 
Interferon Classification
 
Ineligible
 88% (36/41)
 70% (33/47)
 
Intolerant
 100% (9/9)
 50% (4/8)
 
Unwilling
 95% (56/59)
 53% (23/43)

Previously Treated Adults - FUSION (Study 108)

FUSION was a randomized, double-blinded trial that eva luated 12 or 16 weeks of treatment with SOVALDI and ribavirin in subjects who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders). Subjects were randomized in a 1:1 ratio and stratified by cirrhosis (presence vs. absence) and HCV genotype (2 vs. 3).

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 6log10 IU per mL; 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers. Table 14 presents the response rates for the treatment groups of SOVALDI + ribavirin for 12 weeks and 16 weeks.

Table 14         Response Rates in Study FUSION

 SOVALDI +  RBV
12 weeks              
 SOVALDI + RBV
 16 weeks          
 
 
 N= 103a
 N=98a
 
Overall SVR
 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 SVR
 
On-treatment virologic failure
 0/103
 0/98
 
Relapseb
 48% (49/103)
 29% (28/98)
 
  Genotype 2
 18% (7/39)
 11% (4/35)
 
  Genotype 3
 66% (42/64)
 38% (24/63)
 
Otherc
 3% (3/103)
 0/98
a.         Including six 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 SVR and did not