Week 48 (24 Weeks Post-Treatment) Results Presented
23% of Patients BLOQ or Undetectable HDV RNA at Week 48
55% of Patients Improved in Histology Activity Index (HAI) at Week 48
#EIGR "today announced a late-breaker oral presentation of Phase 2 LIFT (Lambda InterFeron combo-Therapy) results at The Liver Meeting Digital Experience™ 2020. Week 48 (24 weeks post-treatment) end of study results were presented. Peginterferon lambda (Lambda) is a first-in-class type III interferon in development for hepatitis delta virus (HDV) infection, the most severe form of human viral hepatitis.
The LIFT study was conducted within the National Institutes of Health (NIH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and was led by Christopher Koh, MD, Principal Investigator at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
LIFT is a Phase 2, open-label study of 26 adult patients with chronic HDV treated with Lambda 180 mcg once weekly in combination with Lonafarnib 50 mg boosted with ritonavir 100 mg twice daily for 24 weeks followed by 24 weeks of post-treatment follow-up. Primary efficacy endpoint was > 2 log decline in HDV RNA at Week 24 (end of treatment). Secondary endpoints included histology (> 2 point improvement in histological activity index or HAI) at Week 48 (end of follow-up). Liver biopsies were obtained in all 26 patients at baseline (pretreatment) and in 20 patients at Week 48 (24 weeks post-treatment, end of study). Median baseline evaluations included: ALT (64 IU/mL), AST (47 IU/mL), Ishak Fibrosis (3), modified HAI inflammation (9), HBV DNA (< 20 IU/mL) and log HDV RNA (4.74 IU/mL).
Twenty-two of 26 patients completed 24 weeks of treatment. At Week 24 (end of treatment), by per-protocol analysis, 17 of 22 patients (77%) achieved the primary endpoint of > 2 log decline in HDV RNA, 11 of 22 patients (50%) were either HDV RNA below limit of quantitation (BLOQ) or HDV RNA undetectable, and median HDV RNA decline was 3.2 log IU/mL (CI: 2.50-3.93, p<0.0001). At Week 48 (24 weeks post-treatment), 5 of 22 patients (23%) maintained HDV RNA BLOQ or were HDV RNA undetectable, 11 of 20 patients (55%) demonstrated improvement in Histology Activity Index (HAI), and 6 of 20 patients (30%) achieved the secondary endpoint of > 2 point improvement in HAI.
Adverse events were mostly mild to moderate and included GI-related side effects, weight loss, hyperbilirubinemia, and anemia. Per-protocol dose reductions occurred in 3 patients and discontinued in 4 patients, and were mostly due to known side effects related to peginterferon lambda" (see press release HERE).
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