Response rates for subjects with cirrhosis at baseline are presented in Table 11 by genotype.

Table 11         SVR Rates by Cirrhosis and Genotype in Study FISSION

 Genotype 2
 Genotype 3
 
 
 SOVALDI + RBV                                12 weeks
  Peg-IFN alfa      + RBV                           24 weeks
 SOVALDI + RBV                                12 weeks
  Peg-IFN alfa      + RBV                              24 weeks
 
 N=73
 N=67
 N=183
 N=176
 
Cirrhosis
 
No
 97% (59/61)
 81% (44/54)
 61% (89/145)
 71% (99/139)
 
Yes
 83% (10/12)
 62% (8/13)
 34% (13/38)
 30% (11/37)

Interferon Intolerant, Ineligible or Unwilling Adults ─ POSITRON (Study 107)

POSITRON was a randomized, double-blinded, placebo-controlled trial that eva luated 12 weeks of treatment with SOVALDI and ribavirin (N=207) compared to placebo (N=71) in subjects who are interferon intolerant, ineligible or unwilling. Subjects were randomized in 3:1 ratio and stratified by cirrhosis (presence vs. absence).

Treated subjects (N=278) had a median age of 54 years (range: 21 to 75); 54% of the subjects were male; 91% were White, 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU per mL; 16% had cirrhosis; 49% had HCV genotype 3. The proportions of subjects who were interferon intolerant, ineligible, or unwilling were 9%, 44%, and 47%, respectively. Most subjects had no prior HCV treatment (81%). Table 12 presents the response rates for the treatment groups of SOVALDI + ribavirin and placebo.

Table 12         Response Rates in Study POSITRON
 
 SOVALDI + RBV 12 weeks
 Placebo 12 weeks
 
 N=207
 N=71
 
Overall SVR
 78% (161/207)
 0/71
 
 Genotype 2
 93% (101/109)
 0/34
 
 Genotype 3
 61% (60/98)
 0/37
 
Outcome for subjects without SVR
 
On-treatment virologic failure
 0/207
 97% (69/71)
 
Relapsea
 20% (42/205)
 0/0
 
  Genotype 2
 5% (5/107)
 0/0
 
  Genotype 3
 38% (37/98)
 0/0
 
Otherb