Further definition of
the influence of multiple, concomitant negative baseline host and viral factors is needed. Methods: Retrospective analysis of data from phase 2 and 3 studies of sofosbuvir-based regimens for patients with HCV GT-1 to 3 infections. Univariate logistic-regression analysis performed as a first step in all patients achieving SVR or experiencing relapse. Variables identified as significantly associated with relapse in the multivariate model were used to calculate SVR rates in patients with 0–6 of these factors. Results: Multivariate regression analysis identified male gender, body weight ≥75 kg, IL28B non-CC genotype, cirrhosis, baseline HCV RNA ≥800,000 IU/mL, and prior treatment failure were significantly associated with relapse. SVR rates were above 90% in all genotypes when patients had ≤3 negative predictors. Epigenetics Compound Library Reduction in SVR rates were observed in the presence of 5 or more negative predictors. Conclusion: Current SOF regimens are highly efficacious, even
Alectinib nmr in patients with combination of multiple negative factors. SVR rates are comparatively lower in patients who have 5–6 negative predictors. Further strategies focused on addressing these hardest to cure populations are now required. Key Word(s): 1. hepatitis C; 2. sofosbuvir; 3. SVR; 4. genotypes; 5. negative predictive factors Presenting Author: ALAIN CHAN Additional Authors: WENDY CHENG, STEPHEN SHAFRAN, KIMBERLY BEAVERS, HONGMEI MO, JOHN MCNALLY, DIANA BRAINARD, WILLIAM SYMONDS, ALAIN
CHAN, MARIO CHOJKIER, ALESSANDRA MANGIA, CHRISTIAN SCHWABE Corresponding Author: ALAIN CHAN Affiliations: Royal Perth Hospital, University of Alberta, Asheville click here Gastronenterology Associates, Gilead Sciences, Gilead Sciences, Gilead Sciences, Gilead Sciences, Gilead Sciences, University of California, San Diego, Casa Sollievo della Sofferanza Hospital, Auckland Clinical Studies Objective: To assess the durability of SVR 24, persistence of resistance-associated variants in patients who did not achieve SVR 24 and clinical outcomes in patients who completed the sofosbuvir phase 3 studies: FISSION, POSITRON, FUSION and NEUTRINO. Methods: Patients in the SOF Phase 3 studies who achieved SVR were offered enrollment in a SVR Registry and those who did not achieve SVR were offered enrollment in the Sequence Registry. Periodic laboratory evaluations and clinical assessment of liver disease were performed for up to 3 years. Results: 480 out of 991 eligible patients from the phase 3 studies enrolled into the SVR Registry with a median (range) follow-up of 170 days (1–377 days). 116 eligible patients have enrolled in the Sequence Registry with median (range) follow-up of 204 days (1–369) days. All patients in the SVR registry have maintained SVR through follow up.
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