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Use of Different Pegylated Interferon/Ribavirin Regimens after Rapid Virological Response Does Not Affect Sustained Response Rate

By Liz Highleyman

Several recent studies have shown that rapid virological response (RVR) to hepatitis C treatment with pegylated interferon plus ribavirin - or undetectable HCV RNA after 4 weeks of therapy - is a good predictor of sustained virological response (SVR) 6 months after completion of treatment.

In a study described in the current issue of the Journal of Viral Hepatitis (April 2008), Italian researchers investigated whether different dosages of pegylated interferon plus ribavirin would influence the likelihood of achieving SVR in patients who had already achieved RVR.

The study included 45 previously untreated chronic hepatitis C patients. All started treatment with 1.5 mcg/kg/week pegylated interferon alfa-2b (PegIntron) plus 800-1200 mg/day weight-based ribavirin. At week 4 of therapy, 31 patients (68.9%) attained RVR. In addition, 4 individuals achieved early virological responders (EVR), or undetectable HCV RNA at week 12.

The 31 rapid responders were then randomly assigned to continue on either 1.5 mcg/kg/week (n=17) or 1.0 mcg/kg/week (n=14) PegIntron plus the same dose of ribavirin for the remaining 44 weeks. The 2 groups were well matched for age, sex, baseline alanine aminotransferase (ALT) levels, HCV viral load, and fibrosis scores.

Results

After 6 months of post-treatment follow-up, 16 of 17 RVR patients (94.1%) in the PegIntron 1.5 mcg/kg/week arm had achieved SVR, compared with 13 of 14 (92.8%) in the 1.0 mcg/kg/week (a non-significant difference).

High baseline HCV RNA (P = 0.01) and pre-existing bridging fibrosis or cirrhosis (P = 0.02) were associated with a lower likelihood of achieving RVR.

However, the ability of rapid responders to achieve SVR did not correlate with these baseline characteristics in either PegIntron dose group.

The SVR rate among EVR patients who responded after more than 4 but up to 12 weeks of treatment was significantly lower than that observed for RVR patients (25.0% vs 93.5%; P = 0.0058)

Conclusion

Based on these findings, the researchers concluded that varying the dose of pegylated interferon did not affect the likelihood of achieving sustained virological response.

They attributed the difference in sustained response rates to a higher prevalence of post-treatment relapse among patients with early (12 week) but not rapid (4 week) virological response.

3/18/08

Reference
N Napoli, G Giannelli, A Antonaci, and others. The use of different Peg-interferon alpha-2b regimens plus ribavirin in HCV-1b-infected patients after rapid virological response does not affect the achievement of sustained virological response. Journal of Viral Hepatitis 15(4): 300-304. April 2008.

 

 

 

 

 

 

 

 

 

 

 


FDA-approved Combination Therapies for Chronic HCV Infection

Pegasys + Copegus
PEG-Intron + Rebetol
Intron A + Rebetol
Roferon A + Ribavirin