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VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir)extended-release tablets(三十三)
er treatment-naïve or did not achieve SVR with prior treatment with pegIFN/RBV. Subjects were randomized to receive the components of VIEKIRA XR with RBV for either 12 or 24 weeks of treatment.
Treated subjects had a median age of 58 years (range: 21 to 71); 70% of the subjects were male; 95% were White; 3% were Black/African American; 12% were Hispanic or Latino; 28% had a body mass index of at least 30 kg per m2; 43% of patients were enrolled in US sites; 82% had IL28B (rs12979860) non‑CC genotype; 86% had baseline HCV RNA levels of at least 800,000 IU per mL; 69% had HCV GT1a infection, 31% had HCV GT1b infection; 42% were treatment-naïve, 36% were prior pegIFN/RBV null responders; 8% were prior pegIFN/RBV partial responders, 14% were prior pegIFN/RBV relapsers; 15% had platelet counts of less than 90 x 109 per L; 50% had albumin less than 4.0 mg per dL.
TURQUOISE-III was an open-label trial that enrolled 60 HCV GT1b-infected subjects with cirrhosis and mild hepatic impairment (Child-Pugh A) who were either treatment-naïve or did not achieve SVR with prior treatment with pegIFN/RBV. Subjects received the components of VIEKIRA XR without RBV for 12 weeks. Treated subjects had a median age of 61 years (range: 26 to 78); including 45% treatment-naïve and 55% pegIFN/RBV treatment-experienced; 25% were ≥65 years; 62% were male; 12% were Black; 5% were Hispanic or Latino; 28% had a body mass index of at least 30 kg per m2; 40% of patients were enrolled in US sites; 22% had platelet counts of less than 90 x 109 per L; 17% had albumin less than 35 g/L; 92% had baseline HCV RNA levels of at least 800,000 IU per mL; 83% had IL28B (rs12979860) non‑CC genotype.
TABLE 12 presents treatment outcomes for GT1a- and GT1b-infected treatment-naïve and treatment-experienced subjects.
In GT1a infected subjects, the overall SVR12 rate difference between 24 and 12 weeks of treatment with the components of VIEKIRA XR with RBV was +6% with 95% confidence interval (-0.1% to +13% with differences varying by pretreatment history).
Table 12. TURQUOISE-II: SVR12 for Chronic HCV Genotype 1-Infected Subjects with Cirrhosis Who Were Treatment-Naïve or Previously Treated with pegIFN/RBV
GT1a
(TURQUOISE-II) GT1b
(TURQUOISE-III)
Components of VIEKIRA XR
+ RBV for
24 Weeks
% (n/N) Components of VIEKIRA XR
+ RBV for
12 Weeks
% (n/N) Components of VIEKIRA XR
without RBV for
12 Weeks
% (n/N)
SVR12 95% (115/121) 89% (124/140) 100% (60/60)
Outcome for subjects without SVR12
On-treatment VF 2% (3/121) <1% (1/140) 0
Relapse 1% (1/116) 8% (11/135) 0
Other 2% (2/121) 3% (4/140) 0
SVR12 for Naïve 95% (53/56) 92% (59/64) 100% (27/27)
SVR12 by Prior pegIFN Experience 100% (33/33)
Null Responder 93% (39/42) 80% (40/50) 100% (7/7)
Partial Responder 100% (10/10) 100% (11/11) 100% (5/5)
Relapser 100% (13/13) 93% (14/15) 100% (3/3)
14.4 Effect of Ribavirin Dose Reductions on SVR12
Seven percent of subjects (101/1551) treated with the components of VIEKIRA XR with RBV had a RBV dose adjustment due to a decrease in hemoglobin lev |
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