A Phase 1b Dose-Ranging Study of 4 Weeks of PEG-Interferon (IFN) Lambda (PEG-rIL-29) in Combination with Ribavirin (RBV)

A Phase 1b Dose-Ranging Study of 4 Weeks of PEG-Interferon (IFN) Lambda (PEG-rIL-29) in Combination with Ribavirin (RBV) in Patients with Chronic Genotype 1 Hepatitis C Virus (HCV) I- see attached full poster report



Reported by Jules Levin

20th Conference of the APASL, China National Convention Center, 25 – 28 March 2010, Beijing, China

Andrew J. Muir1, Mitchell L. Shiffman2, Atif Zaman3, Boris Yoffe4, Juan Carlos Lopez-Talavera5, Sherri Souza6, Diana F. Hausman6, Naomi N Hunder6, Todd Gray6, David Fontana6, Eric Lawitz7

1Duke University, Durham, NC, USA; 2McGuire Research Institute, McGuire VA Medical Center, Richmond, VA, USA; 3Oregon Health Sciences University, Portland, OR, USA; 4Baylor College of Medicine, Houston, TX, USA; 5Bristol-Myers Squibb, Research and Development, Princeton, NJ, USA; 6ZymoGenetics Inc, Seattle, WA, USA; 7Alamo Medical Research, San Antonio, TX, USA.



AUTHOR CONCLUSIONS

PEG-IFN-λ was associated with robust antiviral activity at all dose levels tested in both IFN-α relapse and treatment-naïve HCV patients

-- Majority of patients achieved >2 log reduction in HCV RNA during the 4-week treatment period; anti-viral activity appears to be dose-dependent

Treatment was generally safe and well-tolerated

-- Minimal constitutional symptoms or myelosuppressive hematologic effects were observed

-- Dose-limiting toxicities of elevations in ALT or AST with or without increased bilirubin were reversible upon treatment cessation

PK data suggest that PEG-IFN-λ exposure is dose dependent and support once-weekly dosing and exploration of fixed dosing

These results support the initiation of dose-ranging Phase 2 studies in treatment-naïve HCV patients which are currently ongoing