Selected Patients with Genotype 1 HCV May Attain SVR by Extending Treatment Duration to 72 Weeks 

The current standard of care for chronic hepatitis C patients with genotype 1 is pegylated interferon plus ribavirin 1000-1200 mg/day for 48 weeks. However, just under half of patients on this regimen do not experience sustained virological response (SVR), defined as undetectable HCV viral load (< 10 IU/L) 24 weeks after the end of treatment. Some studies have suggested that it may be possible to increase SVR rates by extending the duration of treatment beyond 48 weeks.

In a retrospective analysis of data from 3 multi-center studies conducted in Spain, Austria, and Germany (n = 1338), researchers investigated the relationship between virological response after 4 and 12 weeks of treatment and SVR rates in patients treated for 72 vs 48 weeks. The objective was to identify which patients would be most likely to benefit from extended treatment duration.

All studies compared 48 vs 72 weeks of treatment with pegylated interferon alfa-2a (Pegasys) plus ribavirin (800 mg/day or 1000-1200 mg/day). Overall, 95% of participants had genotype 1 HCV infection.

Rapid virological response (RVR) was defined as HCV RNA < 50 IU/mL after 4 weeks of treatment. Early virological response (EVR) was defined as no RVR but HCV RNA < 50 IU/mL after 12 weeks of treatment and at least a 2 log₁₀ drop in HCV viral load from baseline. Sustained virological response (SVR) was defined as undetectable HCV RNA 24 weeks after the end of treatment.

Results 

• In patients with RVR, SVR rates were relatively high after 48 weeks of treatment.
• In these patients, extending treatment to 72 weeks provided only limited additional benefit.
• However, among patients who did not achieve RVR but experienced EVR (> 2 log₁₀ HCV RNA decrease), sustained response rates were higher after 72 vs 48 weeks of therapy.

Conclusion

In conclusion, the authors wrote, “These exploratory data indicate that genotype 1 patients with an EVR (> 2 log¹⁰ drop) receive benefit from extension of combination therapy to 72 weeks.”

They added, “Treatment optimization in these patients requires confirmation in large prospective studies using the currently recommended doses of ribavirin (1000-1200 mg/day).”

Hospital Clinic Institut Investigations Biomediques August Pi I Sunyer, Barcelona, Spain; Medical University Of Vienna, Vienna, Austria; Hospital General, Valencia, Spain; Hospital Universitario De Valme, Sevilla, Spain; Saarland University Hospital, Homburg-Saar, Germany; Universitatsklinikum Charite, Campus Virchow-Klinikum, Universitatsmedizin Berlin, Berlin, Germany.

04/24/07

Reference 

J M Sanchez-Tapias, P Ferenci, M Diago, and others. How Can We Identify HCV Genotype 1 Patients Who May Benefit from an Extended Treatment Duration with Peginterferon Alfa-2a (40KD) plus RBV? 42nd Annual Meeting of the European Association for the Study of the Liver. April 11-15, 2007. Barcelona, Spain.

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