Development and Regulatory status
Evidence based evaluations
SarasarHepatitis D infection - in combination with ritonavir
Development and Regulatory status
Dec 18: Granted PRIME status in EU .
Dec 18: Granted breakthrough therapy status in US .
Feb 18: Eiger BioPharmaceuticals plans to conduct End of Phase II meeting with the US FDA for hepatitis D virus infections in February 2018.
Apr 15. The FDA has granted Fast Track designation to lonafarnib, for use in combination with ritonavir for the treatment of hepatitis delta virus infection. 
Dec 14: Eiger Bio receives orphan designation from the US FDA and EMA for lonafarnib as investigational treatment for Hepatitis Delta Virus (HDV) Infection .
Trial or other data
Jan 19: PIII study has a primary completion date of April 2021.
Dec 18: Eiger are recruiting to PIII study (NCT03719313) D-LIVR (Delta Liver Improvement and Virologic Response in HDV) to evaluate an all-oral arm of lonafarib (LNF) boosted with ritonavir (RTV) and a combination arm of LNF boosted with RTV combined with pegylated interferon-alfa (PEG IFN-alfa) vs placebo, in HDV-infected patients. A combined primary endpoint of ≥ 2 log10 decline in HDV RNA and ALT normalization at end of 48 weeks of treatment will be used to assess activity .
Jan 17: Jan 17: PII NCT02430194 (LOWR-2) is still recruiting patients; the estimated completion date is now Feb 17. PII NCT02430181 (LOWR-1) completed Nov 15, NCT02527707 (LOWR-4) completed Aug 16. Estimated primary completion date of PIIb NCT02968641 [LOWR-5] is December 2018 .
Jan 17: Eiger BioPharmaceuticals plan to initiate PIIb LOWR HDV-5 trial to assess the efficacy, safety, pharmacokinetics and pharmacodynamics of lonafarnib with or without ritonavir in patients with chronic HDV infections (EIG-LNF-004; NCT02960360). The open-label, parallel, randomised trial will enrol approximately 60 patients in Mongolia and the US .
Nov 16: Eiger BioPharmaceuticals present interim efficacy, adverse events, pharmacodynamics data from the phase II LOWR HDV-2, LOWR HDV-3 and pooled analysis of the LOWR HDV programme in Hepatitis D (Combination therapy) at the American Association for the Study of Liver Diseases Meeting (AASLD-2016). An all-oral optimal combination of lonafarnib and ritonavir that reatined antiviral efficacy and was well-tolerated was identified and the company intends to explore the dose in future trials for longer durations .
Jan 16: Eiger are currently recruiting to 3 PIII studies NCT02430181 (LOWR-1), NCT02430194 (LOWR-2) and NCT02527707 (LOWR-4) in combination with ritonavir. Studies should all be complete by Q1 2017 .
Dec 14: Eiger are currently recruiting into a PII randomised, double-blind, interventional, pharmacokinetics study (NCT01495585) to test the safety and effectiveness of lonafarnib as a treatment for chronic hepatitis D. Adult pts with HBsAg and HDV RNA in serum, elevated aminotransferases, or moderate-to-severe chronic hepatitis and HDV antigen on liver biopsy will receive either lonafarnib or placebo twice a day for 28 days after which they will stop taking the drug or placebo. They will have regular follow-up visits for up to 6 months after stopping treatment. The primary endpoint will be an improvement in quantitative serum HDV RNA levels after 28 days of lonafarnib therapy. Several secondary endpoints will be measured, including side effects, ALT levels, and symptoms. The study aims to complete during the second quarter of 2016 .