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Sovaldi 400 mg film coated tablets (十九)
2014-05-08 12:27:01 来源: 作者: 【 】 浏览:11209次 评论:0
POSITRON)
 SOF+RBV 12 weeks
 Overall
 93% (101/109)
 
No cirrhosis
 92% (85/92)
 
Cirrhosis
 94% (16/17)
 
Treatment-experienced

(FUSION)
 SOF+RBV 12 weeks
 Overall
 82% (32/39)
 
No cirrhosis
 90% (26/29)
 
Cirrhosis
 60% (6/10)
 
Treatment-naïve

(VALENCE)
 SOF+RBV 12 weeks
 Overall
 97% (31/32)
 
No cirrhosis
 97% (29/30)
 
Cirrhosis
 100% (2/2)
 
Treatment-experienced

(VALENCE)
 SOF+RBV 12 weeks
 Overall
 90% (37/41)
 
No cirrhosis
 91% (30/33)
 
Cirrhosis
 88% (7/8)
 
Treatment-experienced

(FUSION)
 SOF+RBV 16 weeks
 Overall
 89% (31/35)
 
No cirrhosis
 92% (24/26)
 
Cirrhosis
 78% (7/9)
 
Treatment-naïve co-infected with HIV

(PHOTON-1)
 SOF+RBV 12 weeks
 Overall
 88% (23/26)
 
No cirrhosis
 88% (22/25)
 
Cirrhosis
 100% (1/1)
 
Treatment-experienced co-infected with HIV

(PHOTON-1)
 SOF+RBV 24 weeks
 Overalla
 93% (14/15)
 
No cirrhosisa
 92% (12/13)
 
Cirrhosisa
 100% (2/2)
 
Treatment-naïve

(ELECTRONb and PROTONb)
 SOF+PEG+RBV 12 weeks
 Overallc
 96% (25/26)
 
Treatment-experienced

(LONESTAR-2b)
 SOF+PEG+RBV 12 weeks
 Overall
 96% (22/23)
 
No cirrhosis
 100% (9/9)
 
Cirrhosis
 93% (13/14)
 
n = number of subjects with SVR12 response; N = total number of subjects per group.

a. These data are preliminary.

b. These are exploratory or Phase 2 studies. The outcomes should be interpreted with caution, as subject numbers are small and SVR rates may be impacted by the selection of patients. In the ELECTRON study (N = 11), the duration of peginterferon alfa ranged from 4-12 weeks in combination with sofosbuvir + ribavirin.
c. All patients were non-cirrhotic in these two studies.

Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection

Patient population

(Study number/name)
 Regimen/Duration
 Subgroup
 SVR12 rate % (n/N)
 
Treatment-naïve

(FISSION)
 SOF+RBV 12 weeks
 Overall
 56% (102/183)
 
No cirrhosis
 61% (89/145)
 
Cirrhosis
 34% (13/38)
 
Interferon intolerant, ineligible or unwilling

(POSITRON)
 SOF+RBV 12 weeks
 Overall
 61% (60/98)
 
No cirrhosis
 68% (57/84)
 
Cirrhosis
 21% (3/14)
 
Treatment-experienced

(FUSION)
 SOF+RBV 12 weeks
 Overall
 30% (19/64)
 
No cirrhosis
 37% (14/38)
 
Cirrhosis
 19% (5/26)
 
Treatment-experienced

(FUSION)
 SOF+RBV 16 weeks
 Overall
 62% (39/63)
 
No cirrhosis
 63% (25/40)
&

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