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.
