If ANC decreased below 500, PEG IFN was held for 2 weeks and resumed at 90 μg if ANC PLX4032 in vitro increased to greater than 1,000. Patients would be discontinued from the study if ANC remained below 500. We assumed an SVR of approximately 40% for the 24-week and 80% for the 48-week treatment group based on results of our previous retrospective study and other studies with HCV genotype 6.16 With such expected SVR rates and a 2-sided alpha of 0.05, the power is 80% for a total sample size of 60 patients and approximately 30 patients in each arm. Continuous variables
were compared using Student’s t test if tests normality is observed, whereas nonparametric methods such as the rank sum test was used for all others. Chi-square statistics were used to compare categorical variables. Univariate and multivariate logistic regression was used to estimate adjusted odd ratios relating potential treatment predictors to SVR. Primary analysis of SVR was done by intention-to-treat. Statistical significance was defined as a two-sided P value of 0.05 or less. All statistical analysis was performed using Stata v. 9.0 (Stata Corp., College Station, TX). The study flow diagram is shown in Fig. 1. Of the 75 patients screened, 60 patients were included selleck chemicals in the trial from five clinical sites.
Twenty-seven patients were randomly assigned to 24 weeks of treatment and 33 patients were assigned to 48 weeks of treatment. All selleckchem except one patient were of Asian descent and 93% of patients were Vietnamese or Chinese Vietnamese immigrants. The one non-Asian patient was a Hispanic woman in the 24-week group. As shown in Table 1, baseline characteristics were similar in both groups. As included in the randomization process, the
proportion of patients with advanced fibrosis stage 3-4 and HCV RNA levels ≥800,000 IU/mL were similar in the 24- and 48-week groups: 26% and 27% for advanced fibrosis and 74% and 64% for high HCV RNA levels, respectively. Steatosis was noted in 33% versus 52% (P = 0.36) and excess iron was found in 28% versus 24% (P = 0.35) in the 24-week and 48-week groups, respectively. Average baseline viral loads in both groups was over 6.2 ± 1.0 log IU/mL. Seventy-eight percent of patients in the 24-week group and 82% of patients in the 48-week group adhered to the assigned duration of therapy (P = 0.70). RVR, complete EVR, and SVR results are shown in Fig. 2. Of the subgroup of 39 patients who had HCV RNA PCR testing at week 4 of therapy, 17 of 20 (85%) in the 24-week treatment group and 12 of 19 (63%) achieved RVR but this difference (22%, 95% confidence interval [CI]: −05% to 49%) was not statistically significant (P = 0.12). RVR was a significant predictor of SVR in the 48-week group and trending towards significance in the 24-week group: 14 of 17 (82%) and 10 of 12 (83%) of those with RVR achieved SVR compared to 1 of 3 (33%) and 2 of 7 (29%) for the 24-week and 48-week groups, respectively (P = 0.