Only 3 patients had had an EVR without end-of-treatment response (EoTR) to the previous http://www.selleckchem.com/products/brefeldin-a.html treatment, whereas the majority of the patients (86%) had had less than 2 log10 reduction of VL within the first 12 weeks of the previous treatment (primary nonresponse, PNR). For one female patient there was no week 12 VL available from the previous treatment, she however showed an EoT nonresponse (EoTNR). Patients in group A were not significantly different from patients in group B in any of the characteristics listed in Table 1, except for VL at baseline (Figure 2A). Figure 2 Effect of pretreatment with SAMe and betaine on HCV viral load. Table 1 Patient Characteristics. Virological and Biochemical Response to SAMe and Betaine To test whether SAMe and betaine have an effect on VL and liver enzyme values that is independent from pegIFN�� and ribavirin, patients in group A were pre-treated for one week with SAMe and betaine only.

There was no significant decrease in VL in response to SAMe and betaine (Figure 2B), and no significant effect on ALAT serum levels (data not shown). The mean reduction of VL for both treatment groups at days 1, 2, 4, and 7 and at weeks 2, 4, 8 and 12 is shown in Figure 2C. Group A (pretreatment with SAMe and betaine) had a slightly more pronounced reduction of VL in the first 48 h of combination treatment (unpaired t-test; p=0.03 for d1; p=0.04 for d2), there was however no statistically significant difference between the two groups (A and B) at later time points, and even the significant results at early time points have to be interpreted with caution, given the fact that baseline VL was higher in group A.

Virological and Biochemical Response to Treatment with PegIFN��2b, Ribavirin, SAMe and Betaine Twelve patients (41%) did not achieve an EVR with the study combination treatment (Figure 3), and therapy was discontinued after 12 weeks. The remaining 17 patients (59%) showed an initial virological response, although 14 formerly had a documented PNR in their previous treatment. Two patients (patients #3 and #14) now showed rapid virological response (RVR) with undetectable HCV-RNA after 4 weeks of the study treatment, and both had SVR in follow-up (Figure 4). Four patients had negative HCV RNA after 12 weeks of study treatment (complete EVR; cEVR), and one of them (#25) completed study treatment with a SVR (Figure 5).

The other 3 patients relapsed either on treatment (#23) or during follow-up (#16, #33). All 4 cEVR patients were cirrhotic, and 3 of them had been previously treated with pegIFN��2 and ribavirin (Figure 5). The remaining eight patients with previous PNR had an EVR at week 12 of study combination therapy (Figure 6). However, only two of them became HCV RNA negative on treatment, and none of them had an SVR. Finally, there were three patients who had achieved an Cilengitide EVR but no EoTR in their previous treatments with (peg)IFN��2 and ribavirin (Figure 7).