You have reached the HIVandHepatitis.com legacy site. Please visit our new site at hivandhepatitis.com

HIV and Hepatitis.com Coverage of the
45th Annual Meeting of the European
Association for the Study of the Liver (EASL 2010)

April 14 - 18, 2010, Vienna, Austria
Closely Individualized Treatment with Pegylated Interferon plus Ribavirin Is Possible Based on Baseline Viral Load and Early Response

SUMMARY: Closely tailoring the duration of chronic hepatitis C treatment with pegylated interferon plus ribavirin on the basis of pre-treatment HCV viral load and when an individual first achieves undetectable HCV RNA can produce outcomes equaling those of standard duration therapy, according to an oral presentation last week at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) in Vienna. The researchers also indicated that these findings may help tailor duration of pegylated interferon when used with new directly targeted oral anti-HCV agents.

By Liz Highleyman

Pegylated interferon plus ribavirin is an effective therapy for many people with chronic hepatitis C, but many others do not achieve a cure, and the treatment can cause difficult side effects. Researchers, therefore, have looked for ways to reduce the duration as much as possible, and to discontinue treatment early if it appears unlikely to produce a sustained response.

A 24 week course of pegylated interferon/ribavirin is standard therapy for chronic hepatitis C patients with HCV genotypes 2 or 3, but those with hard-to-treat genotype 1 are usually treated for 48 weeks. In Europe, however, shortening treatment to 24 weeks is approved for people with low baseline viral load and rapid virological response (RVR), or undetectable HCV viral load 4 weeks after starting therapy.

Christoph Sarrazin and fellow investigators with the INDIV-2 Study assessed whether more closely individualized treatment durations according to baseline viral load and initial viral decline is a feasible strategy.

This multicenter trial included more than 600 treatment-naive genotype 1 patients in Germany. Participants were randomly assigned to either undergo standard 48-week therapy or to receive pegylated interferon-alfa-2b (PegIntron) plus ribavirin for individualized treatment durations.

In the latter group, patients were treated for 24, 30, 36, 42, 48, 60, or 72 weeks, depending on whether they had high or low baseline viral load (HCV RNA > or < 800,000 IU/mL) and undetectable HCV RNA at week 4, 6, 8,12, or 24 using a highly sensitive TMA viral load assay.

Results

Overall rates of sustained virological response (SVR) -- or continued undetectable HCV RNA 24 weeks after treatment completion -- were similar in the individualized and standard treatment duration groups (53% vs 48%).
SVR rates were statistically similar between participants with individualized treatment durations and patients who had undetectable HCV RNA after the same durations but continued therapy through week 48.
Patients in the individualized therapy group who achieved RVR at week 4:
  Treated for 24 weeks if low viral load: SVR 88% vs 93% in standard duration control group;
Treated for 30 weeks if high viral load: SVR 86% vs 100% in standard therapy group.
Patients with first undetectable HCV RNA at week 6:
  Treated for 30 weeks if low viral load: SVR 91% vs 77% in standard therapy group;
Treated for 36 weeks if high viral load: SVR 85% vs 78% in standard therapy group
" Patients with first undetectable HCV RNA at week 8:
  Treated for 42 weeks if low viral load: SVR 72% vs 100% in standard therapy group;
Treated for 48 weeks if high viral load: SVR 82% vs 88% in standard therapy group.
" Patients with first undetectable HCV RNA at week 12 (complete early virological response, or EVR):
Patients with first undetectable HCV RNA at week 24 and high viral load, as well as those who first became undetectable at week 30 and had low viral load, were treated for 72 weeks: SVR 50%.

Based on these results, the researchers concluded, "For treatment of patients with chronic hepatitis C genotype 1 infection with pegylated interferon [alfa-]2b and ribavirin complete individualization and optimization of treatment duration is possible according to baseline viral load and first time HCV RNA negativity at week 4, 6, 8, 12, and 24."

They also suggested that "Complete individualized treatment durations may also be useful for STAT-C triple treatment schedules," referring to directly targeted agents such as HCV protease and polymerase inhibitors that may shorten the required duration of pegylated/interferon.

Medizinische Klinik 1, J. W. Goethe-University Hospital, Frankfurt/Main, Germany; University Hospital Munich, Munich, Germany; Leberzentrum Checkpoint, Berlin, Germany; University Hospital Ulm, Ulm, Germany; Institut für Interdisziplinäre Medizin, Hamburg, Germany; Johanna Etienne Krankenhaus, Neuss, Germany; Imterdisziplinäres Facharztzentrum, Frankfurt/Main, Germany; University Hospital Cologne, Cologne, Germany; University Hospital Freiburg, Freiburg im Breisgau, Germany; University Hospital Würzburg, Würzburg,Germany; University Hospital Mainz, Mainz, Germany; Klinikum Freising, Freising, Germany; Essex Pharma, Munich, Germany; University Hospital Leipzig, Leipzig, Germany.

4/23/10

Reference

C Sarrazin, S Schwendy, B. Möller, and others.completely individualized treatment durations (24, 30, 36, 42, 48, 60 or 72 weeks) with peginterferon-alfa-2b and ribavirin in HCV genotype 1-infected patients (INDIV-2 Study). 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010). Vienna, Austria. April 14-18, 2010. (Abstract).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



EASL 2010 MAIN PAGE