Source: HIVANDHEPATITIS.COM 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
ReferenceA 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.
