Rapid
Virological Response Predicts Sustained Response and Can Help Optimize HCV Treatment Rapid
virological response (RVR), defined as undetectable HCV viral load with qualitative
PCR after 4 weeks of treatment, has gained increasing acceptance on as a predictor
of sustained virological response (SVR) to treatment with pegylated interferon
plus ribavirin. Among
patients who achieve RVR, the standard duration of therapy of 48 weeks for patients
with HCV genotypes 1/4, and 24 weeks for those with genotypes 2/3, may be "too
much" treatment, and shortening the duration of therapy in these individuals
may provide better care and significantly improve their quality of life. The
Association of German Independent Gastroenterologists (BNG), together with Roche
Pharmaceuticals, is conducting a nationwide observational study to determine the
quality of treatment for chronic hepatitis C in routine clinical practice. Data
from 4377 patients in different phases of treatment with pegylated interferon
alfa-2a (Pegasys) and ribavirin, collected through May 2006, were reported at
the 42nd Annual Meeting of the European Association for the Study of the Liver
last week in Barcelona, Spain. Results
Although there was no recommendation to measure HCV viral load at Week 4, this
value was checked in 1207 of 4377 patients (27.6%).
However, only 609 (50.5%)
received the more sensitive qualitative HCV RNA test.
Of 379 patients with
genotype 1 or 4, 25.1% achieved RVR, compared with 63.0% of patients with genotype
2 or 3.
SVR data were available
for 330 patients with known RVR results.
In this group, at baseline,
56.1% were men, the mean age was 42 years (those with RVR were 4 years younger),
BMI was 24.9 kg/m², and the mean duration of HCV infection Was 11.3 years
(with a 2-year advantage in those with RVR).
197 patients were
infected with genotype 1 or 4, and 133 with genotype 2 or 3.
16 patients (4.9%)
had liver cirrhosis (15 Child A, 1 Child B); 4 of these achieved RVR.
Active controlled shortening
or prolongation of standard treatment duration was not reported.
Overall, 205 of these
330 patients (62.1%) achieved SVR.
SVR data according
to genotype and RVR are shown in the table.
TABLE
Conclusion
Based
on these results, RVR appears to have a high positive predictive value for SVR.
However, the researchers emphasized that especially in genotype 1/4 patients,
"a careful examination of other predictive values in combination with use
of a very sensitive PCR" and strict adherence to medication is necessary
"if treatment optimization is attempted through shortening the duration of
therapy." Center
Of Gastroenterology, Dortmund, Germany; Center Of Gastroenterology and Hepatology,
Duesseldorf, Germany; Center Of Gastroenterology An Livercenter, Berlin, Germany;
Center Of Infectiology And Center Of Gastroenterology, Frankfurt, Germany; Center
Of Gastroenterolgy, Bad Schwalbach, Germany; Center Of Gastroeneterology, Krefeld,
Germany; Centar Of Gastroenterology, Hannvover, Germany; Center Of Gastroenterology,
Paderborn, Germany; Center Of Gastroenterology, Herne, Germany; Roche Pharma AG,
Grenzach-Wyhlen, Germany.
04/17/07
Reference
E Zehnter, S Mauss, K Boeker, and others. Potential Relevance of Rapid
Viral Response for SVR and Optimization of the Treatment of Hepatitis C (CHC)
with Peginterferon Alfa-2a and Ribavirin (RBV). 42nd Annual Meeting of the European
Association for the Study of the Liver. April
11 - 15, 2007, Barcelona,
Spain.
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