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 HIV and Hepatitis.com Coverage of the
60
th Annual Meeting of the American Association
for the Study of Liver Diseases
(AASLD 2009)

October 30 - November 3, 2009, Boston, MA

Genotype 1 Chronic Hepatitis C Patients with Low Viral Load Can Achieve Sustained Response with 24 Weeks of Pegylated Interferon plus Ribavirin

SUMMARY: Final results from the PREDICT study showed that genotype 1 chronic hepatitis C patients with low baseline viral load and rapid virological response at week 4 can achieve good outcomes with just 24 weeks of pegylated interferon plus ribavirin, researchers reported at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2009) this month in Boston.

By Liz Highleyman

Standard therapy for chronic hepatitis C virus (HCV) infection consists of pegylated interferon plus ribavirin for 24 weeks in patients with HCV genotypes 2 or 3, and for 48 weeks in patients with hard-to-treat genotype 1. But the shorter treatment duration may be adequate for certain genotype 1 patients with favorable characteristics.

PREDICT was a Phase 4 open-label post-marketing study conducted in Europe to evaluate shortened therapy for treatment-naive genotype 1 patients with low baseline viral load (< 600,000 IU/mL) and rapid virological response (RVR), or undetectable HCV RNA at week 4 of therapy. A majority of participants (62%) were men, most (97%) were white, the mean age was about 38 years, and the mean estimated duration of HCV infection was 13 years.

A total of 187 enrolled participants were treated with 1.5 mcg/kg/week pegylated interferon alfa-2b (PegIntron) plus 800-1200 mg/day weight-based ribavirin. Patients who had undetectable HCV RNA at week 24 were given the option to stop therapy at that point, and were followed for 24 weeks post-treatment.

Results

93% of participant completed the study.
3% were lost to follow-up, 2% discontinued due to adverse events, 2% elected not to continue, and 1% did not meet eligibility requirements.
In an efficacy analysis of 170 patients, the sustained virological response (SVR) rate was 87.6% and the relapse rate was 9.7%.
In a per-protocol analysis of 156 patients, the SVR rate was 90.4% and the relapse rate was 9.6%.
Looking at 153 patients who were deemed adherent to therapy, the corresponding rates were 90.8% and 9.2%, respectively.
14% of participants reported adverse events.
The most common side effect was flu-like symptoms, reported by 3%.

Based on these findings, the PREDICT investigators concluded, "In HCV genotype 1 low viral load treatment-naive subjects who attain RVR, pegylated interferon alfa-2b and weight-based ribavirin for 24 weeks is well-tolerated and results in a high rate of SVR with a low likelihood of relapse."

University of Palermo, Palermo, Italy; Carmel Medical Center Liver Unit, Haifa, Israel; 1st Hospital IKA PENTELI, Gastroenterology , Mellisia, Greece; Russian University of People Friendship, Moscow, Russia; University of Padua, Padova, Italy; University Medical Centre Ljubljana, Department of Infectious Diseases and Febrile Illnesses, Ljubljana, Slovenia; Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Hospital General Valencia, Valencia, Spain; Cardarelli Hospital, Naples, Italy; University Hospital Schleswig Holstein Campus Luebeck , Lubeck, Germany; Schering Plough Research Institute , Kenilworth, NJ.

11/17/09

Reference
A Craxi, E Zuckerman, S Koutsounas, and others. PREDICT Study Final Results: Efficacy and Safety of 24-Wk Regimen of Peginterferon alfa-2b Plus Weight-based Ribavirin in Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 (G1) With Low Viral Load Who Achieve Rapid Viral Response. 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2009). Boston. October 30-November 1, 2009. Abstract 832.



 




 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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