Treatment of hepatitis C virus (HCV) with pegylated interferon + ribavirin has been widely studied, but there is scant data on combination treatment of patients with HCV and end-stage renal disease (ESRD). This pilot study was designed to determine the initial and sustained viral response (SVR) of combination treatment of these patients.

This was a non-randomized, prospective observational study of combination therapy with low dose Pegasys and ribavarin. 20 patients who met the criteria for inclusion (age over 18yrs, viremic for HCV, any genotype, on dialysis) were enrolled.

Exclusion criteria were decompensated liver disease, immunosuppressive therapy, hepatocellular cancer, and use of antiviral therapy in the last 6 months.
After undergoing liver biopsies, patients began Pepasys at 135 microgram/week, and 4 weeks later ribavirin was started at 200 mg weekly, increasing gradually to three times a week for a total of 48 weeks.

Results

• 20 patients: M:F 18:2; mean age 52.4 yrs; African American 15, Caucasian 3, Hispanic 2; genotype 1: 18, non-1: 2.
• All patients underwent liver biopsy (stage I: 4; stage II: 9; stage III 7).
• Of the 20 patients, 4 withdrew from the study prior to starting treatment.
• 2 patients discontinued before three months of treatment (1 for moderate fatigue and 1 patient moved out of state).
• 11 patients have reached the three-month time point to determine initial viral response, while 3 have not.
• Of the 11, 5 patients have had initial viral response, defined as at least a two log drop in their HCV viral count (45%).
• Of the 3 patients that have not reached 3 months on treatment 1 has had a viral response.
• Side effects included 2 cases of anemia (Hgb less than 9.5g/dl) requiring temporary withholding of ribavirin, and one patient with headaches not requiring stopping treatment.

Based on these results, the authors conclude, “Low-dose pegylated interferon and ribavirin therapy of patients with HCV and ESRD in this study has not been associated with any serious adverse effects.”

“The response rate in individuals taking three months of treatment is comparable to studies in non-ESRD patients.”

“These results demonstrate that combination therapy with low dose pegylated interferon α-2a [Pegasys] and ribavirin is a safe therapeutic option in the ESRD population with HCV infection.”

“Conclusive results will be obtained once all patients complete the treatment and the follow-up period for determining a sustained response.”

This study was supported by Roche Pharmaceuticals.

05/23/06

Reference