[27] The use of RGT
in a telaprevir-containing regimen was studied explicitly in the PS-341 purchase ILLUMINATE trial,[28] which enrolled treatment-naïve (TN) patients with chronic HCV genotype 1 infection. All patients received telaprevir-based triple therapy for 12 weeks. Those who experienced eRVR were then randomized to receive PegIFN/RBV for either 12 or 36 more weeks (those not experiencing eRVR received PegIFN/RBV for 36 more weeks.) Sixty-five percent of participants experienced eRVR. Among those participants who had eRVR, those randomized to receive an additional 12 weeks of PegIFN/RBV achieved SVR rates of 92% and those https://www.selleckchem.com/products/PD-0332991.html randomized to receive an additional 36 weeks of PegIFN/RBV achieved SVR rates of 88%. The results satisfied the criteria for non-inferiority, allowing the investigators to conclude
that the shorter duration of therapy for patients who achieved eRVR was non-inferior to the longer duration. Notably, significantly more participants randomized to the longer duration of therapy discontinued treatment because of adverse events compared with those randomized to the shorter duration (12% vs 1%; P < 0.001).[28] Telaprevir was also studied in previously treated patients in the REALIZE trial.[31] However, the treatment protocol for that trial did not employ RGT. Current guidelines note that the use of boceprevir- or telaprevir-containing therapy, in combination with PegIFN/RBV, is optimal for treatment-naïve patients with genotype 1 HCV.[2] Treatment regimens employing boceprevir should use a 4-week PegIFN/RBV lead-in period prior to initiation of triple therapy.[32] Triple therapy should then be administered for 24 weeks in patients eligible for RGT (i.e. those without cirrhosis and who have undetectable HCV Etofibrate RNA levels at weeks 8 and 24). Patients with cirrhosis should receive triple therapy for 44 weeks. Triple therapy
should be stopped if the HCV RNA level is > 100 IU/mL at treatment week 12 or detectable at treatment week 24.[32] Telaprevir-containing regimens do not require a lead-in period. Triple therapy with telaprevir should be administered for 12 weeks, followed by 12 weeks of PegIFN/RBV in patients eligible for RGT (i.e. those without cirrhosis and who have undetectable HCV RNA levels at weeks 4 and 12). Patients with cirrhosis should continue PegIFN/RBV therapy for a total of 48 weeks. Triple therapy should be stopped at week 12 if HCV RNA levels are > 1000 IU/mL at weeks 4 and 12 of the triple-therapy phase, or at week 24 if HCV RNA is detectable at that time.