HIV and Hepatitis.com Coverage of the
42nd EASL Conference
April 11 - 15, 2007, Barcelona, Spain
THE EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER

Treatment Duration and Response in Patients with Genotype 2 or 3 HCV Infection  

By Liz Highleyman

At the 42nd Annual Meeting of the European Association for the Study of the Liver last month in Barcelona, various research teams presented data from studies looking at tailoring interferon-based therapy for chronic hepatitis patients with genotypes 2 or 3.

As previously reported, O. Dalgard and colleagues* found that among 428 genotype 2 or 3 patients treated with pegylated interferon alpha-2b (PegIntron) plus ribavirin who achieved rapid virological response (RVR) by Week 4, those treated for a total of 14 weeks were as likely to achieve sustained virological response (SVR) as those treated for the standard 24 weeks (91% vs 95%).

How Much is Too Much?

In a related report, E. Zehnter and colleagues conducted a nationwide observational study in Germany to assess treatment for chronic hepatitis C in routine clinical practice. The analysis included data from more than 4000 patients treated with pegylated interferon alpha-2a (Pegasys) plus ribavirin. SVR data were available for 330 patients with known RVR results (197 with genotype 1 or 4; 133 with genotype 2 or 3). As shown in the table, the researchers found that nearly 90% of genotype 2 or 3 patients and about 70% of genotype 1 or 4 patients with Week 4 RVR went on to achieve SVR.

“RVR seems to be a good positive predictive value for SVR,” they concluded, especially among patients with easier-to-treat genotypes 2 or 3.

They suggested that the standard 24-week (for genotype 2 or 3) or 48-week (for genotype 1 or 4) course of therapy may be excessive for many rapid responders. However, they urged caution -- including ensuring optimal adherence and evaluating other factors that predict good response -- when attempting shorten the duration of therapy.

Center of Gastroenterology, Dortmund, Germany; Center of Gastroenterology and Hepatology, Duesseldorf, Germany; Center of Gastroenterology and Liver Center, Berlin, Germany; Center of Infectiology and Center of Gastroenterology, Frankfurt, Germany; Center of Gastroenterolgy, Bad Schwalbach, Germany; Center of Gastroeneterology, Krefeld, Germany; Center of Gastroenterology, Hannover, Germany; Center of Gastroenterology, Paderborn, Germany; Center of Gastroenterology, Herne, Germany; Roche Pharma AG, Grenzach-Wyhlen, Germany.

What about Slow Responders?

B. Willems and colleagues analyzed patients with genotype 2 or 3 who did not achieve RVR.

As background, they noted that in the recent ACCELERATE study, administration of Pegasys plus ribavirin for 24 weeks was shown to be superior to 16 weeks for genotype 2 or 3 patients overall. The two-thirds who achieved RVR had a greater than 80% probability of achieving SVR using only 16 weeks of therapy. However, those who did not achieve RVR had only a 49% probability of achieving SVR, suggesting that they might benefit from more intensive treatment.

To determine whether an intensified regimen is beneficial, the researchers performed a retrospective analysis of data from 2 large clinical trials, looking at SVR and relapse rates following treatment in genotype 2 or 3 patients without RVR. In study NV15942, subjects were randomly assigned to receive Pegasys plus either 800 mg or 1000-1200 mg ribavirin for either 24 or 48 weeks. In NV15801, patients received Pegasys plus 1000-1200 mg ribavirin for 48 weeks.

A majority of genotype 2 or 3 patients achieved RVR in both studies. However, among patients without RVR, the SVR rate was higher for those receiving 48-week treatment using the higher dose of ribavirin compared with 24-week treatment using the lower dose.



The researchers concluded that, “Genotype 2/3 patients without an RVR could receive added benefit if treated for 48 weeks with a higher dose of ribavirin (1000-1200 mg/day).” However, they added that, “These results need to be confirmed in a prospective controlled study.”

Hopital Saint-Luc Et Centre Hospitalier de L’Universite de Montreal, Montreal, QC, Canada; Department of Medicine and Hepatology, Henry Dunant Hospital, Athens, Greece; Department of Gastroenterology-11, VA Medical Center, Long Beach, CA; Hospital General, Valencia, Spain; Hopital Beaujon, Clichy, France; North Shore University Hospital, Manhasset, NY; Division of Gastroenterology and Hepatology, Scripps Clinic, La Jolla, CA; Virginia Commonwealth University Medical Center, Richmond, VA; Department of Internal Medicine, Saarland University Hospital, Homburg-Saar, Germany; Roche, Nutley, NJ.

05/01/07

References

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 (PEG) and ribavirin (RBV). 42nd Annual Meeting of the European Association for the Study of the Liver (42nd EASL). April 11-15, 2007. Barcelona, Spain.

B Willems, SJ Hadziyannis, TR Morgan, and others. Should treatment with peginterferon plus ribavirin be intensified in patients with HCV genotype 2/3 without a rapid virological response? 42nd EASL.

*O Dalgard, K Bjøro, H Ring-Larsen, and H Verbaan. Peginterferon alfa-2b and ribavirin for 14 or 24 weeks in patients with HCV genotype 2 or 3 and rapid virological response: the North-C Trial. 42nd EASL.

 

 

 





























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