86, a specificity of 0.61, and an AUROC of 0.82 (Table (Table2).2). In comparison to FS, TE had a similar sensitivity (0.88), but a higher specificity (0.92) and AUROC (0.92, P = 0.11); however, there were only LCL161? 33 Asian patients with available TE. There was no difference in F2-4 prevalence between Asian patients with available TE (25%) and FS (24%). Despite the small cohort, TE results for F2-4 in Asian patients were comparable to those in NAR patients (n = 181, AUROC 0.92 vs 0.87, P = 0.35). Table 2 Performance of FibroSURE and transient elastography in patients from Asia vs non-Asian regions For patients with both noninvasive tests available (Asian, n = 33; NAR, n = 176), agreement between FS and TE for stages F2-4 was higher in Asian than in NAR patients [94% (�� = 0.86) vs 67% (�� = 0.

35); P < 0.001]. The combination of FS and TE improved the accuracy for F2-4 in both Asian (97.0%) and NAR patients (72.7%), with AUROC values of 0.97 and 0.88, respectively (Table (Table22). Most patients from the Asian region with available FS or TE achieved an SVR (85%; n = 216) and thus comparisons with NRs were not feasible. Baseline FS fibrosis scores, however, were higher in Asian than in NAR patients with an SVR (0.45 vs 0.36; P < 0.001), likely reflecting differences in F2-4 prevalence between the two study populations. Changes in FS fibrosis scores at week-12 follow-up were also comparable between Asian and NAR patients with an SVR (�� = -0.04 vs -0.06; P = 0.09). In addition, mean TE measurements were comparable at baseline between Asian and NAR patients with an SVR (8.

8 vs 7.8 kPa; P = 0.56), with no significant differences in changes at week 12 (-0.14 kPa vs -0.25 kPa, P = 0.91) or after therapy (-1.4 kPa vs -1.3 kPa, P = 0.98). DISCUSSION This large prospective cohort study in patients with chronic HCV provides validation of the diagnostic utility of serum markers and TE in relation to biopsy and IFN-based therapy. Few studies have addressed longitudinal changes in either serum markers or TE with therapy and, importantly, the present global study also provides the first evaluation of both noninvasive tests in patients from the Asia-Pacific region with chronic HCV. One limitation of this study was that TE data could only be obtained at 40 non-US study sites, as this device is not yet approved for use in the United States. Despite the limited cohort size for TE (n = 214) compared with FS (n = 2055), in accordance with prior observations, the overall results of this study indicate that both FS and TE have potential utility in the detection of moderate-severe-stage disease. However, the performance characteristics of these noninvasive Anacetrapib tests (particularly TE) may be somewhat better for exclusion of cirrhosis[6,23].