Disclosures: Gregory J. Dore – Board selleckchem Membership: Bristol-Myers Squibb, Roche, Gilead, Merck, Janssen, Abbvie; Grant/Research Support: Janssen, Bristol-Myers Squibb, Vertex, Roche, Gilead, Merck, Abbvie; Speaking and Teaching: Roche, Merck, Janssen Ana Schteinman – Grant/Research Support: UNSW Gail Matthews
– Advisory Committees or Review Panels: gilead; Consulting: Viiv; Grant/Research Support: Gilead Sciences, janssen; Speaking and Teaching: BMS, MSD The following people have nothing to disclose: Marianne Martinello, Maryam Alavi, Richard O. Day, Kenneth Williams Background: Sofosbuvir (SOF) has revolutionized the treatment for chronic hepatitis C virus (HCV) infection. Phase III studies (NEUTRINO, FISSION, VALENCE) demonstrate the efficacy, simplicity, and tolerability of SOF-based regimens in a clinical trial setting. We now report our experience with these regimens in a community setting with the multiethnic population of Hawaii, including patients with factors previously associated with inferior treatment GDC-0199 molecular weight response. Methods: Retrospective chart review was performed on patients (N=100) with HCV genotype (GT) 1-6 being treated with SOF-based regimens at a single referral center. All patients were treated with SOF and ribavirin (RBV), with or without pegylated interferon (PEG) depending on their GTs. GTs 1, 4, 5, and 6 (N=35) received SOF+PEG+RBV for 12 weeks. GT 2 (N=37)
and GT 3 (N=28) received MCE公司 SOF+RBV for 12 and 24 weeks, respectively. The primary endpoint was SVR12. Results: Patient demographics are summarized in Table 1. Patients with factors previously associated with inferior response: age ≥50 yrs (85%), BMI ≥30 (33%), HCV RNA ≥800,000 IU/mL (52%), cirrhosis (28%), non-CC IL28B GT (11/15) and prior treatment (25%). Interim analyses of data are presented. In GTs 1, 4, 5, and 6 that completed treatment (n=26), platelets decreased 65.3±38.5 x 103/mL from baseline while hemoglobin (Hb) decreased 3.1±1.4 g/dL from baseline by end of treatment (EOT). Main side effects: fatigue (56.7%), headache (28.7%), and body aches
(18.9%). In 44% GT2 and 33% GT3, total bilirubin (TB) increased 0.4±0.6 mg/dL within first 2 weeks of treatment, followed by return to baseline. In GT2s that completed treatment (n=9), platelets increased 50.5±33.2 x 103/mL from baseline while Hb decreased 1.8±1.2 g/dL from baseline at EOT. Conclusions: Sofosbuvir-based regimens were well tolerated by our multiethnic cohort that included patients with cirrhosis. Decrease from baseline Hb and early rise in total bilirubin are likely due to RBV-induced hemolysis. The increase in platelet count in GT2 cirrhotics at EOT may suggest improving portal hypertension. SVR12 data and further results on GTs 2 and 3 treatment tolerability will be available by Oct 2014. Disclosures: Marina Roytman – Advisory Committees or Review Panels: Gilead; Speaking and Teaching: Gilead Leena K.