Is Shorter Treatment with Peginterferon Alfa-2a (Pegasys) Plus Ribavirin Possible in HCV Genotype 1 ‘Super Responders’?

Peter Ferenci, MD, and colleagues at the Medical University of Vienna in Vienna, Austria designed a prospective, randomized multicentre trial to determine if response rates in genotype 1 patients could be improved by individualizing therapy based on viral kinetic responses at wk 4 and 12 to treatment with peginterferon alfa-2a  (Pegasys) plus ribavirin (Copegus).

In the current report, presented at the 56^th AASLD in San Francisco (November 11-15, 2005) the Austrian researchers offer preliminary results of a prospective, randomized clinical trial of patients with undetectable HCV RNA at wk 4, the most responsive subgroup.

Interferon-naïve adults with quantifiable HCV RNA genotype 1 were enrolled. All received Pegasys (peginterferon alfa-2a) 180 μg/wk plus ribavirin 1000/1200 mg/d prior to allocation to one of 4 treatments based on HCV RNA testing at wks 4 and 12.

At wk 4, ‘super-responders’ (HCV RNA <50 IU/mL) were assigned to group D and received a further 20 wks of therapy. At wk 12, remaining patients who with HCV RNA <50IU/mL received a further 36 wks therapy (group C). Patients with detectable HCV RNA at wk 12 but a >/= 2-log drop over baseline were randomized to group A (48wk) or B (72wk).

Results

• Data are now available from group D.
  
  
• Of 366 patients, 79 (22%) ‘super-responders’ were assigned to 24 wks therapy.
  
  
• To date, 48 patients have completed the study.
  
  
• An SVR [HCV RNA <50 IU/mL after 24 weeks’ of untreated follow-up] was recorded in 32 of these patients (67% ITT analysis).
  
  
• Group D had a very low drop-out rate (6%).

Conclusions

Based on these findings, the study authors conclude, “Analyses now indicate that treatment duration in genotype 1 patients might be best individualized based on HCV RNA levels at wk 4.”

“In this study, initial data indicate that shorter treatment (24 wks) with peginterferon alfa-2a (40KD) (Pegasys) plus ribavirin (Copegus) provide substantial benefit in genotype 1 ‘super-responders’, with an SVR rate of 66%.”

11/14/05

Reference
P Ferenci and others. Is shorter treatment with peginterferon alfa-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®) possible in HCV genotype 1 ‘super-responders’? Preliminary results of a prospective randomized clinical trial. Abstract  64296. 56^th annual meeting of the American Association for the Study of Liver Diseases (56^th AASLD). November 11-15, 2005. San Francisco, CA.