Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG
IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure
clinical benefit with regard to viral suppression and alanine aminotransferase (ALT)
normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks)
virologic response and ALT normalization will be used. Virologic response will be defined as
a 2 log10 IU/mL reduction from baseline.