High-dose Induction Therapy with Interferon Alfa-2b (PegIntron) Plus Ribavirin for Treatment of Relapsers or Nonresponders

The aim of the current study was to evaluate daily high-dose induction therapy with interferon-alfa-2b (PegIntron; IFN-alfa-2b) in combination with ribavirin for the treatment of patients who failed with interferon monotherapy and had a relapse, based on the assumption that the viral burden would decline faster, thus increasing the likelihood of higher response rates in this difficult-to-treat patient group.

Seventy patients were enrolled in this study. Treatment was started with 10 MU IFN-alfa-2b daily for 3 wk, followed by IFN-alfa-2b 5 MU/TIW in combination with ribavirin (1 000-1 200 mg/d) for 21 wk. In case of a negative HCV RNA PCR, treatment was continued until wk 48 (IFN-alfa-2b 3 MU/TIW+1 000-1 200 mg ribavirin/daily).

Results

· The dose of IFN-alfa-2b or ribavirin was reduced in 16% of patients because of hematologic side effects, and treatment was discontinued in 7% of patients;

· An early viral response (EVR) was achieved in 60% of patients;

· Fifty percent of all patients achieved an end-of-treatment response (EOT) and 40% obtained a sustained viral response (SVR);

·  Patients with no response had a significantly lower response rate than those with a former relapse (SVR 30% vs 53%; P = 0.049);

· Furthermore, lower response rates were observed in patients infected with genotype 1a/b than in patients with non-1-genotype (SVR 28% vs 74%; P = 0.001);

· A rapid initial decline of HCV RNA was identified as a significant predictive factor for a sustained response;

· No patients achieving a negative HCV-RNA PCR at wk 18 or later eventually eliminated the virus.

In conclusion, the authors write, “Daily high-dose induction therapy with interferon-alfa-2b is well tolerated and effective for the treatment of non-responders and relapsers, when interferon monotherapy fails.”

“A fast decline of viral load during the first 12 wk is strongly associated with a sustained viral response.”

Department of Gastroenterology and Hepatology, University of Tuebingen, Tubingen, Germany.

09/19/05

Reference
H G Hass and others. High-dose interferon-alpha2b induction therapy in combination with ribavirin for treatment of chronic hepatitis C in patients with non-response or relapse after interferon-alpha monotherapy. World Journal of Gastroenterology 11(34):5342-5346. September 14, 2005.

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