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HIV and Hepatitis.com Coverage of
Digestive Disease Week 2006 (DDW 2006)
 May 20 - 25, 2006, Los Angeles, California
Retreatment with Peginterferon Alfa-2a (Pegasys) Plus Ribavirin of Nonresponders to Peginterferon Alfa-2b (PegIntron) Plus Ribavirin

The REPEAT trial is assessing the efficacy/safety of peginterferon alfa-2a (Peg-IFNα-2a) [Pegasys] + ribavirin (RBV) in prior non-responders to peginterferon alfa-2b (Peg-IFNα-2b [PegIntron] /ribavirin. At Digestive Disease Week (DDW) 2006 in Los Angeles (May 20-25, 2006), Dr. N Gitlin reported outcomes in patients (pts) with cirrhosis/advanced fibrosis according to geographic region from a protocol-planned interim efficacy/safety analysis after 12 weeks (wks) of retreatment in the REPEAT trial.

Prior non-responders to ≥12wks of Peg-IFNα-2b/ribavirin who were HCV RNA positive throughout treatment were eligible.

950 pts were randomized to 1 of 4 groups: Peg-IFNα-2a 360μg/wk for 12wks then 180μg/wk for 60 or 36 wks (Arms A or B); Peg-IFNα-2a 180μg/wk for 72 or 48 wks (C or D).

All 942 pts treated received RBV 1000/1200mg/d. HCV RNA was measured by quantitative (≥600 IU/mL) or qualitative (≥50 IU/mL) PCR at baseline and after 12 wks' retreatment. Data from Arms A+B (Peg-IFNα-2a induction dose), and C+D (Peg-IFNα-2a standard dose) were combined.

Outcomes were assessed in pts with a local baseline histological diagnosis of cirrhosis/advanced fibrosis.

Results (Table)

  • Cirrhosis/advanced fibrosis was present in 133/469 pts (28.4%) receiving Peg-IFNα-2a 180μg/wk and 119/473 pts (25.2%) receiving Peg-IFNα-2a  360μg/wk.
  • Baseline characteristics were generally similar in the 2 groups. At wk 12, more pts with cirrhosis/advanced fibrosis receiving induction-dose Peg-IFNα-2a achieved an early virological response (EVR; HCV RNA undetectable, unquantifiable or ≥2-log10 drop), vs standard-dose Peg-IFNα-2a.
  • Virological response rates in pts with cirrhosis/advanced fibrosis were similar in US/Canadian and European/Brazilian pts across both treatment groups.

In conclusion, the authors write, “Induction-dose (360μg/wk) Peg-IFNα-2a  (Pegasys) + RBV (Copegus) is more effective than standard-dose (180μg/wk) Peg-IFNα-2a (Pegasys) + RBV over the first 12 wks of retreatment in pts with cirrhosis/advanced fibrosis who have previously failed to respond to Peg-IFNα-2b /ribavirin.”

“Outcomes in these pts do not appear to differ according to geographic region.”

Table

 

Peg-IFNα-2a (40KD) dose during wks 1−12 (+RBV 1000/1200mg/d)

 

180µg/wk (C+D; n=133)

360µg/wk (A+B; n=119)

Baseline characteristics

No. of patients (%)

Male

102 (77)

80 (67)

Mean age±SD, yrs

51.1±8.0

51.7±9.1

Caucasian

119 (89)

110 (92)

Genotype 1

121 (91)

108 (91)

Mean HCV RNA±SD, x106 IU/mL

5.2±5.6

4.5±5.5

EVR‡ at wk 12

All patients

50 (38)

60 (50)

USA/Canada

21/55 (38)

21/45 (47)

Europe/Brazil

29/78 (37)

39/74 (53)

‡HCV RNA ≥2-log10 drop or unquantifiable or undetectable
05/23/06

Reference                                                                                                                                      N. Gitlin, A. Di Bisceglie, P. Marcellin, and others.Peginterferon Alfa-2a (40KD) (PEGASYS®) Plus Ribavirin (RBV) (COPEGUS®) in Pegylated Interferon Alfa-2b (12KD)/Ribavirin Non-Responders with Cirrhosis/Advanced Fibrosis: Interim Analysis of the REPEAT Study. Abstract T1808.



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