Overall SVR
93% (68/73)
84% (210/250)
Outcome for subjects without SVR
On-treatment virologic failure
0% (0/73)
<1% (1/250)
Relapseb
7% (5/73)
14% (34/249)
Treatment-naïve
3% (1/32)
5% (5/105)
Treatment-experienced
10% (4/41)
20% (29/144)
Otherc
0% (0/73)
2% (5/250)
a. Placebo subjects (N=85) were not included as none achieved SVR12. Eleven genotype 3 subjects who received SOVALDI + ribavirin for 12 weeks were not included.
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 17 presents the subgroup analysis by genotype for cirrhosis and prior HCV treatment experience.
Table 17 SVR Rates for Selected Subgroup by Genotype in Study VALENCE
Genotype 2 SOVALDI + RBV 12 weeks
Genotype 3 SOVALDI + RBV 24 weeks
N=73
N=250
Treatment-naïve
97% (31/32)
93% (98/105)
Non-cirrhotic
97% (29/30)
93% (86/92)
Cirrhotic
100% (2/2)
92% (12/13)
Treatment-experienced
90% (37/41)
77% (112/145)
Non-cirrhotic
91% (30/33)
85% (85/100)
Cirrhotic
88% (7/8)
60% (27/45)
Clinical Trials in Subjects Co-infected with HCV and HIV-1
SOVALDI was studied in an open-label clinical trial (Study PHOTON-1) eva luating the safety and efficacy of 12 or 24 weeks of treatment with SOVALDI and ribavirin in subjects with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1. Genotype 2 and 3 subjects were either HCV treatment-naïve or experienced, whereas genotype 1 subjects were all treatment-naïve. Subjects received 400 mg SOVALDI and weight-based ribavirin (1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75kg) daily for 12 or 24 weeks based on genotype and prior treatment history. Subjects were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1 with a CD4+ cell count >200 cells/mm3. Efficacy data 12 weeks post treatment are available for 210 subjects (see Table 18).
Table 18 Response Rates in Study PHOTON-1a
HCV genotype 1
HCV genotype 2
HCV genotype 3
SOVALDI + RBV
24 weeks
TN (N=114)
SOVALDI + RBV
12 weeks
TN (N=26)
SOVALDI + RBV
24 weeks
TE (N=13)
Overall
76% (87/114)
88% (23/26)
92% (12/13)
Outcome for s
