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VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir)extended-release tablets(三十一)
he components of VIEKIRA XR with or without ribavirin in subjects with chronic hepatitis C (HCV) genotype 1 (GT1) infection. For detailed description of trial design and recommended regimen and duration [see Dosage and Administration (2) and Clinical Studies (14)].
Table 10. Clinical Trials Conducted with the Components of VIEKIRA XR With or Without Ribavirin (RBV) in Subjects with Chronic HCV GT1 Infection
Trial Population Study Arms and Duration
(Number of Subjects Treated)
SAPPHIRE-I
(double-blind) GT1 (a and b)
TNa without cirrhosis
Components of VIEKIRA XR + RBV for 12 weeks (473)
Placebo for 12 weeks (158)
SAPPHIRE-II
(double-blind) GT1 (a and b)
TEb without cirrhosis
Components of VIEKIRA XR + RBV for 12 weeks (297)
Placebo for 12 weeks (97)
PEARL-II
(open-label) GT1b
TE without cirrhosis
Components of VIEKIRA XR + RBV for 12 weeks (88)
Components of VIEKIRA XR for 12 weeks (91)
PEARL-III
(double-blind) GT1b
TN without cirrhosis
Components of VIEKIRA XR + RBV for 12 weeks (210)
Components of VIEKIRA XR for 12 weeks (209)
PEARL-IV
(double-blind) GT1a
TN without cirrhosis
Components of VIEKIRA XR + RBV for 12 weeks (100)
Components of VIEKIRA XR for 12 weeks (205)
TURQUOISE-II
(open-label) GT1 (a and b)
TN & TE with
compensated cirrhosis
Components of VIEKIRA XR + RBV for 12 weeks (208)
Components of VIEKIRA XR + RBV for 24 weeks (172)
TURQUOISE-III
(open-label) GT1b
TN & TE with
compensated cirrhosis
Components of VIEKIRA XR for 12 weeks (60)
TN, treatment-naïve was defined as not having received any prior therapy for HCV infection.
TE, treatment-experienced subjects were defined as having failed to respond to prior treatment with pegIFN/RBV.
The components of VIEKIRA XR with RBV were also eva luated in the following two studies:
HCV GT1-infected liver transplant recipients (CORAL-I) [see Clinical Studies (14.5)].
Subjects with HCV GT1 co-infected with HIV-1 (TURQUOISE-I) [see Clinical Studies (14.6)].
In all clinical trials, the ombitasvir, paritaprevir, ritonavir dose was 25/150/100 mg once daily and the dasabuvir dose was 250 mg twice daily and doses were not adjusted. For subjects who received RBV, the RBV dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg. RBV dose adjustments were performed according to the RBV labeling.
In all clinical trials, sustained virologic response was defined as HCV RNA below the lower limit of quantification (<LLOQ) 12 weeks after the end of treatment (SVR12). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, which has an LLOQ of 25 IU per mL. Outcomes for subjects not achieving an SVR12 were recorded as on-treatment virologic failure (VF), post-treatment virologic relapse through post-treatment Week 12 or failure due to other non-virologic reasons (e.g., premature discontinuation, adverse event, lost to follow-up, consent withdrawn).
14.2 Clinical Trial Results in Adults with Chronic HCV Genotype 1a and 1b Infection without Cirrhosis
Subjects with Chronic HCV GT1a Infection without Cirrhosis
Subjects with HCV GT1a infection without cirrhosis treated with the components of VIEKIRA XR with RBV for 12 weeks in SAPPHIR |
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