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VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir)extended-release tablets(三十二)
E-I and -II and in PEARL-IV [see Clinical Studies (14.1)] had a median age of 53 years (range: 18 to 70); 63% of the subjects were male; 90% were White; 7% were Black/African American; 8% were Hispanic or Latino; 19% had a body mass index of at least 30 kg per m2; 55% of patients were enrolled in US sites; 72% had IL28B (rs12979860) non-CC genotype; 85% had baseline HCV RNA levels of at least 800,000 IU per mL.
TABLE 11 presents treatment outcomes for HCV GT1a treatment-naïve and treatment-experienced subjects treated with the components of VIEKIRA XR with RBV for 12 weeks in SAPPHIRE-I, PEARL-IV and SAPPHIRE-II.
Treatment-naïve, HCV GT1a-infected subjects without cirrhosis treated with the components of VIEKIRA XR with RBV for 12 weeks in PEARL-IV had a significantly higher SVR12 rate than subjects treated with the components of VIEKIRA XR without RBV (97% and 90% respectively; difference +7% with 95% confidence interval, +1% to +12%). The components of VIEKIRA XR without RBV were not studied in treatment-experienced subjects with GT1a infection.
In SAPPHIRE-I and SAPPHIRE-II, no placebo subject achieved a HCV RNA <25 IU/mL during treatment.
Table 11. SVR12 for HCV Genotype 1a-Infected Subjects without Cirrhosis Who Were Treatment-Naïve or Previously Treated with PegIFN/RBV
Components of
VIEKIRA XR + RBV
for 12 Weeks
% (n/N)
GT1a treatment-naïve
SAPPHIRE-I SVR12 96% (308/322)
Outcome for subjects without SVR12
On-treatment VF <1% (1/322)
Relapse 2% (6/314)
Other 2% (7/322)
PEARL-IV SVR12 97% (97/100)
Outcome for subjects without SVR12
On-treatment VF 1% (1/100)
Relapse 1% (1/98)
Other 1% (1/100)
GT1a treatment-experienced
SAPPHIRE-II SVR12 96% (166/173)
Outcome for subjects without SVR12
On-treatment VF 0% (0/173)
Relapse 3% (5/172)
Other 1% (2/173)
SVR12 by Prior pegIFN Experience
Null Responder 95% (83/87)
Partial Responder 100% (36/36)
Relapser 94% (47/50)
Subjects with Chronic HCV GT1b Infection without Cirrhosis
Subjects with HCV GT1b infection without cirrhosis were treated with the components of VIEKIRA XR with or without RBV for 12 weeks in PEARL-II and -III [see Clinical Studies (14.1)]. Subjects had a median age of 52 years (range: 22 to 70); 47% of the subjects were male; 93% were White; 5% were Black/African American; 2% were Hispanic or Latino; 21% had a body mass index of at least 30 kg per m2; 21% of patients were enrolled in US sites; 83% had IL28B (rs12979860) non-CC genotype; 77% had baseline HCV RNA levels of at least 800,000 IU per mL.
The SVR rate for HCV GT1b-infected subjects without cirrhosis treated with the components of VIEKIRA XR without RBV for 12 weeks in PEARL-II (treatment-experienced: null responder, n=32; partial responder, n=26; relapser, n=33) and PEARL-III (treatment-naïve, n=209) was 100%.
14.3 Clinical Trial Results in Adults with Chronic HCV Genotype 1a and 1b Infection and Compensated Cirrhosis
The components of VIEKIRA XR with and without ribavirin were eva luated in two clinical trials in patients with compensated cirrhosis.
TURQUOISE-II was an open-label trial that enrolled 380 HCV GT1 subjects with cirrhosis and mild hepatic impairment (Child-Pugh A) who were eith |
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