PegIntron
plus Ribavirin in HCV Genotype 1 Patients with Slow Virological Response: Analysis
of Early Enrollers in the SUCCESS Study
Many
individuals with chronic hepatitis C have a slow virological response to therapy
with interferon alfa plus ribavirin. The objective of the "SUCCESS"
study was to assess the efficacy of 72 vs 48 weeks of treatment with pegylated
interferon alfa-2b (PegIntron) plus ribavirin in genotype
1, treatment-naive chronic hepatitis C patients with have slow virological
response.
In
this open-label study, patients receive PegIntron 1.5 mcg/kg/week + weight-based
ribavirin (800-1400mg/day) for 12 weeks. HCV RNA levels at weeks 12 and 24 were
used to determine whether patients discontinued therapy or were assigned to continue
for a total of 48 or 72 weeks of treatment.
Rapid
virological response (RVR) was defined as undetectable HCV RNA at week 4.
Early virologic response (EVR) was defined as >2 log decrease in HCV
RNA or undetectable HCV RNA at week 12. The primary endpoint was sustained virological
response (SVR) 24 weeks after therapy. HCV RNA levels were measured using the
TaqMan assay at screening, baseline, weeks 4, 12, 24, 48, 72, and follow-up.
Results
At the time of the report, 1932 patients had been screened and 1324 patients were
enrolled at 133 sites in Europe, Canada, and Israel.
Of these, 1129 patients had been treated until week 4, 934 until week 12, and
511 until week 24.
Most subjects (62%) were men, almost all were white (97%), the mean age was 43
years and the mean body weight was 76kg.
RVR was observed in 17% of patients and EVR in 78%.
17% of subjects were classified as "slow responders," defined as >
2 log decrease in baseline HCV RNA levels at week 12 and undetectable HCV RNA
at week 24. Conclusion In conclusion, the authors noted the following:
"Early enroller analyses from the SUCCESS study are encouraging, with 78%
of G1 patients achieving EVR."
"Our data indicate that 17% of genotype 1 patients are likely to be slow
responders."
"Given the high prevalence of genotype 1 HCV infections, this observation
suggests there is a large population of genotype 1 'slow-responders' who could
benefit from longer duration therapy with [PegIntron] plus weight-based ribavirin."
"This
analysis emphasizes the importance of establishing the optimal treatment duration
for genotype 1 'slow-responders.'"
Hospital General
Universitario, Barcelona, Spain; Department of Gastroenterology and Hepatology,
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Institute of Biomedical Chemistry,
Russian Academy of Medical Sciences, Moscow, Russian Federation; Johann-Wolfgang
Goethe-Universitat, Frankfurt, Germany; L. Rydygier Medical Center University
Floriana, Bydgoszcz, Poland; Clinic of Gastroenterology Kaunas University of Medicine,
Kaunas, Lithuania; Department of Infectious Diseases of Kiev, National Medical
Center, Kiev, Ukraine; Toronto General Hospital, Toronto, ON, Canada; Global Medical
Affairs, Schering-Plough Corporation, Kenilworth, NJ; Department of Hepatology,
Hospital Valle Hebron, Barcelona, Spain.
11/07/06
Reference M
Buti, Y Lurie, N Blokhina, and others. Pegylated Interferon alfa-2b plus Ribavirin
in Patients with Genotype 1 Chronic Hepatitis C with a Slow Virologic Response:
An Early Enrollers Analysis of the SUCCESS Study. 57th AASLD. October 27-31, 2006.
Boston, MA. Abstract 404.
At the time of the report, 1932 patients had been screened and 1324 patients were
enrolled at 133 sites in Europe, Canada, and Israel. 
