0; e-Biometria, Madrid, Spain). Continuous variables are expressed as median (range) and categorical variables are expressed as the number of cases (percentage). For this analysis, the level of 800000 www.selleckchem.com/products/Roscovitine.html IU/mL was chosen as the cut-off point for plasma HCV-RNA concentration. Intraindividual variability in plasma concentrations was assessed by measuring the coefficient of variation (CV=standard deviation/mean��100) of all the available values from each patient throughout the follow-up. Interindividual variability was calculated using the CV for the geometric mean of each subject. Ninety-five percent confidence intervals (CI95) around single proportions were calculated as p��1.96 where p is the proportion and q=1 ? p. The relationships between virological responses and potentially predictive variables were examined using ��2 tests.
To assess the independence of these factors, a logistic regression analysis was used in which all variables with P values below 0.2 in the initial analyses were included. All tests were two-tailed, and the differences were considered significant when P was<0.05. Statistical calculations were performed with the Statistical Product and Service Solutions for Windows (15.0 version, SPSS, Chicago, IL). Results Characteristics of the study population A total of 60 Caucasian HCV/HIV-1-coinfected patients (G2, 2; G3, 58) were included in the study in four infectious disease units in Spain from January 2008 to August 2009. The trial ended after the completed follow-up of the last enrolled patient. The two patients with HCV G2 were excluded from analysis for homogenizing results.
Baseline characteristics are summarized in table 1. Information on liver fibrosis was available for 56 patients (by liver biopsy in 23, by transient elastography in 41, and by both techniques in 16); 21 (36.2%) of these 58 patients had cirrhosis. Baseline HCV-RNA was similar in patients with CC rs129679860 IL28B genotype (5.93 log10 IU/ml; range, 3.02 �C 7.15) and in those carrying the T allele (5.55; range, 3.52 �C 7.13; p=0.4). Table 1 Baseline characteristics of the patients included in the study. Treatment efficacy and safety The study flow diagram and virological responses are shown in figure 1, and table 2, respectively. Fifteen patients (25.8%) prematurely discontinued treatment, 4 (6.8%) due to lack of response and 11 due mainly to AEs. Although 55 patients (94.8%) presented one or more AEs (table Cilengitide 3), especially within the first 12 weeks of therapy, the AEs considered related to the study medication led to discontinuation of treatment in only 4 (6.9%) patients (nausea and vomiting, 2; depression, 1; pneumococcal pneumonia, 1). In 5 additional patients the AEs were considered unrelated to the study medication.