Pegylated interferon plus ribavirin improves fibrosis in non-responders to standard interferon therapy

Approximately 60% of the patients who are treated with Rebetron (standard interferon + ribavirin) fail to respond to that therapy. The re-treatment of this population, with a more effective regimen, for example pegylated interferon plus Rebetol (ribavirin), is primarily for the possibility of viral eradication, but even if that goal is not attained, secondary benefits may include biochemical or histological improvement.

In a study presented at Digestive Disease Week 2003, 193 patients who were virologic non-responders to Rebetron therapy were treated with PEG-Intron (pegylated interferon alpha-2b) plus Rebetol and evaluated regarding histologic improvement with that therapy. Of the enrolled patients, 160 were HCV genotype 1. After enrolment, the patients were randomised to receive either PEG-Intron 1.5 mcg/kg/week plus Ribavirin 800 mg/day or PEG-Intron 1.0 mcg/kg/week plus Ribavirin 1000-1200 mg/day for 48 weeks.

The investigators found that of 49 patients with paired liver biopsies after finishing 48 weeks of treatment, 17 (35%) were HCV RNA negative and 32 (65%) were HCV RNA positive. In these patients, the overall Histological Activity Index (HAI) improved after treatment from 5.91 to 4.47 and the fibrosis score improved from 2.65 to 2.22.

As shown in the table below, while the HAI significantly improved in both virologic responders and nonresponders, histologic improvement in fibrosis was significant only in patients who achieved an undetectable HCV RNA by the end of treatment.

The authors conclude: “Significant histologic improvement was only seen in patients who achieved viral clearance by week 48. Patients that were PCR positive at week 48 achieved significant improvement in hepatic inflammation but not in fibrosis. Combination of Peg-Intron and Ribavirin is very effective in improving histologic activity in patients who failed to clear HCV RNA.”

K Selim et al. Histological improvement in patients with pegylated interferon alpha-2b plus ribavirin who were previously non-responders to Rebetron. Abstract 217 (oral). Abstracts of Digestive Disease Week 2003. May 17-22, 2003. Orlando, FL, USA.

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	HCV RNA Negative at Wk 48			HCV RNA Positive at Wk 48
	Pre-Treatment	Post-Treatment	p value	Pre-Treatment	Post-Treatment	p value
HAI	5.29 ± 2.1	3.35 ± 1.9	0.0008	6.25 ± 2.3	4.97 ± 2.4	0.019
Fibrosis	2.65 ± 1.2	2.12 ± 1.36	0.029	2.66 ± 1.1	2.28 ± 1.4	0.064