| |
Retreatment Of Chronic Hepatitis C- Genotype 1-Infected Relapsers To Peginterferon/Ribavirin With Consensus Interferon/Ribavirin Or With Extended Duration Therapy Peginterferon/Ribavirin
|
| |
| |
Infergen Patient Assistance Program:
Aspire SM Program - INFERGEN
Make the most of your treatment with help from the INFERGEN Aspire Program. .... INFERGEN is a registered trademark of Amgen, Inc., and Three Rivers ...
www.infergen.com/5-Aspire/1-About_Aspire.html
Reported by Jules Levin
AASLD Nov 2009
Pearlman, Brian1-4 and Ehleben, Carole2
1. Center For Hepatitis C, Atlanta, Georgia 2. Atlanta Medical Center, Atlanta, Georgia
3. Medical College of Georgia, Augusta, Georgia 4. Emory School of Medicine, Atlanta, Georgia
Disclosures: Dr. Pearlman is on the SpeakersŐ Bureaus for Schering-Plough and Three Rivers Pharmaceuticals
OBJECTIVE
Relapse is an unfortunate outcome of interferon-based therapy for chronic hepatitis C virus (HCV) infection, and an optimal retreatment strategy remains uncertain. Up to 31% of genotype 1-infected patients will suffer relapse after 48 weeks of peginterferon alfa-2a and ribavirin.1 Relapsers to peginterferon/ribavirin with genotype one infection achieve an SVR rate of merely 23% with 48 weeks of peginterferon alfa-2b/ribavirin therapy.2 The use of consensus interferon/ribavirin3 or the extension of treatment duration with peginterferon/ribavirin in the retreatment of relapsers may improve response rates.
METHODS
Genotype 1-infected patients who had relapsed to 48 weeks of peginterferon alfa-2a (180 mcg weekly) and ribavirin (800 to 1,400 mg daily), despite 80/80/80 adherence, were randomized in a 1:2:2 ratio to: peginterferon alfa-2b (1.5 mcg/kg weekly) for 48 weeks (PEG-48), consensus interferon (15 mcg daily) for 48 weeks (CIFN-48) or to peginterferon alfa-2b (1.5 mcg/kg weekly) for 72 weeks (PEG-72); all groups received weight-based ribavirin (800-1,400 mg daily) for the therapy duration. Serum RNA was measured by PCR, Taqman, Roche; detection limit 10 IU/ml. Growth factors were prohibited.
RESULTS
Complete data for 76 patients are currently available (n=14,30,32). Patients analyzed had statistically similar baseline characteristics (Table). Dose reductions and treatment discontinuations for adverse events or lab abnormalities were similar between the 48 treatment groups, but were higher in the 72 week arm (Figure 1). SVR rates were 29% in PEG-48, significantly different from the rates of 47% and 50% in CIFN-48 and PEG-72, respectively (p=NS between the latter two groups). Relapse rates were 35% in PEG-48, but 20% in CIFN-48 and 22% in PEG-72 (Figure 2). Interestingly, all obese patients (BMI >30) that completed therapy in both peg arms achieved SVR (n=12 in PEG-72; n=7 in PEG-48).
CONCLUSIONS
Approximately half of genotype 1-infected relapsers to peginterferon alfa-2a/ribavirin benefited from retreatment with consensus interferon/ribavirin or with extended duration therapy peginterferon alfa-2b/ribavirin. However, the extended
therapy arm patients experienced higher rates of treatment discontinuations relative to those of the standard duration arms. The study is ongoing.
REFERENCES
1. Hadziannis SJ, et al. Ann Intern Med. 2004;140:346-355.
2. Poynard T, et al. Gastroenterology. 2009;136:1618-1628.
3. Kaiser S, et al. AASLD 2007. Abstract 1310.
|
|
| |
| |
|
|
|
