8% of patients
treated with TVR twice daily and 72.8% of patients treated with TVR every 8 hours (see Supplementary Results). Relapse rates were similar between those treated with TVR twice daily (7.7%) and every 8 hours (6.5%). Virological response by IL28B genotype showed that the efficacy of TVR twice daily versus every 8 hours was similar regardless of IL28B genotype ( Figure 1B). SVR12 was higher in patients with CC versus non-CC Panobinostat chemical structure genotypes (90% vs 67%, respectively; P < .0001). In a post hoc analysis, IL28B genotype was strongly associated with SVR12 after adjustment for other baseline factors, including fibrosis stage (odds ratio, 5.00; 95% CI, 3.01–8.30; P < .0001). Virological response rates for TVR dosing twice daily and every 8 hours were also generally comparable across fibrosis stage subgroups ( Figure 1C). In patients without cirrhosis, SVR12 rates were 78% (245/315) and 77% (246/321) for TVR twice daily and every 8 hours, respectively; in patients with cirrhosis, SVR12 rates were 54% (29/54) and 49% (24/49), respectively. Overall, SVR12 was lower in patients with cirrhosis versus those without (51% vs 77%, respectively; P = .0001). When IL28B genotype and fibrosis stage were considered together, the highest SVR12 rate (90%; 95% CI, 84%–94%) was observed in patients with CC genotype with F0 to F2 fibrosis stage and the lowest SVR12 rate (47%; 95% CI, 39%–55%) was observed in patients with non-CC genotype with
advanced fibrosis or http://www.selleckchem.com/products/bmn-673.html tuclazepam cirrhosis (F3–F4). Both IL28B genotype and fibrosis stage correlated strongly with SVR12 (P < .0001). Subgroup analyses for baseline characteristics, including sex, region, body mass index, insulin resistance (as measured by homeostasis model assessment of insulin resistance), HCV RNA level, and HCV genotype (1a and 1b), showed
similar SVR12 outcomes for TVR twice daily and every 8 hours (Figure 2). The low numbers of patients older than 65 years and who were Asian, black, or “other” race meant no reliable conclusions could be drawn on differences in SVR12 rate between the 2 TVR dosing regimens in these subgroups. The total treatment duration was determined by RVR rates, which were similar with TVR twice daily (69.4%) and every 8 hours (67.4%). For patients who achieved RVR and were eligible for 24 weeks of treatment (68.4%), SVR rates were 86.3% and 85.2% for TVR twice daily and every 8 hours, respectively. In patients with cirrhosis who achieved RVR, SVR rates after 24 weeks of treatment were 67.9% for TVR twice daily and 58.6% for TVR every 8 hours. The SVR12 rate for the minority of patients who did not achieve RVR was 47% for both dosing regimens. Overall, the extended RVR rates (<25 IU/mL, target not detectable at weeks 4 and 12) were 66.1% and 63.1% for TVR twice daily and every 8 hours, respectively. The proportion of patients with extended RVR rates who achieved SVR12 was 89.3% for both groups. On-treatment virological failure was observed in 38 (10.3%) and 36 (9.