SMV + SOF With/Without RBV for IFN-II Patients With CHC
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Prior trials have shown that many G1 CHC patients are ineligible or intolerant to pegylated
(PEG)-based regimens due to prior severe side effects, worsening of cytopenias, exacerbation
of underlying psychiatric disorders, or autoimmune disorders. These patients will not be
candidates for treatment with the approvals of SMV and SOF in early 2014 due to the
combination with PEG-regimens. Results of the COSMOS study suggest that these patients are
likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy,
and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed
in order to confirm this hypothesis.