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Sovaldi (sofosbuvir) tablets(九)
2014-05-08 11:53:34 来源: 作者: 【 】 浏览:5174次 评论:0
meet virologic failure criteria (e.g., lost to follow-up).

Table 15 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.

Table 15         SVR Rates for Selected Subgroups by Genotype in Study FUSION
 
 Genotype 2
 Genotype 3
 
 
 SOVALDI + RBV                                12 weeks
 SOVALDI + RBV                              16 weeks
 SOVALDI + RBV                              12 weeks
 SOVALDI + RBV                             16 weeks
 
 N=39
 N=35
 N=64
 N=63
 
Cirrhosis
 
No
 90% (26/29)
 92% (24/26)
 37% (14/38)
 63% (25/40)
 
Yes
 60% (6/10)
 78% (7/9)
 19% (5/26)
 61% (14/23)
 
Response to prior HCV treatment
 
Relapser/  breakthrough
 86% (25/29)
 89% (24/27)
 31% (15/49)
 65% (30/46)
 
Nonresponder
 70% (7/10)
 88% (7/8)
 27% (4/15)
 53% (9/17)
Treatment-Naïve and Previously Treated Adults ─ VALENCE (Study 133)

The VALENCE trial eva luated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis. The original trial design was a 4 to 1 randomization to SOVALDI + ribavirin for 12 weeks or placebo. Based on emerging data, this trial was unblinded and all genotype 2 HCV-infected subjects continued the original planned treatment and received SOVALDI + ribavirin for 12 weeks, and duration of treatment with SOVALDI + ribavirin in genotype 3 HCV-infected subjects was extended to 24 weeks. Eleven genotype 3 subjects had already completed SOVALDI + ribavirin for 12 weeks at the time of the amendment.

Treated subjects (N=419) had a median age of 51 years (range: 19 to 74); 60% of the subjects were male; mean body mass index was 26 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA level was 6.4 log10 IU per mL; 78% had HCV genotype 3; 58% of the subjects were treatment-experienced and 65% of those subjects experienced relapse/breakthrough to prior HCV treatment.

Table 16 presents the response rates for the treatment groups of SOVALDI + ribavirin for 12 weeks and 24 weeks.

Table 16         Response Rates in Study VALENCEa
 
 Genotype 2 SOVALDI + RBV  12 weeks
 Genotype 3 SOVALDI + RBV 24 weeks
 
 N=73
 N=250

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