Treatment of Chronic Hepatitis C with Pegasys Plus Ribavirin in Hemophiliac Patients Shows High Rate of Sustained Virologic Response

Hemophiliac patients who received clotting factors before the mid to late 1980s were almost universally infected with hepatitis C. Since liver biopsy is associated with a high risk of bleeding in this population, in this prospective study, Turkish researchers aimed to evaluate the success of a biopsy-independent treatment protocol.

In this open-label study, 37 hemophiliac patients (35 male, 2 female) with chronic hepatitis C infection were enrolled. All patients were over 18 years of age and had positive HCV RNA and elevated ALT levels at baseline. Patients with HIV and HBV infection or other hepatic diseases were excluded.

Liver biopsy was not performed due to the potential risks involved in hemophiliacs. The patients received pegylated interferon alfa-2a (Pegasys), 180μg weekly and ribavirin 800mg daily for 48 weeks and were followed for at least 24 weeks after the end of treatment. Genotypes were determined when possible. Treatment was adjusted as necessitated by side effects.

Results

Two patients withdrew after 2 weeks due to severe flu-like symptoms. One patient died of a cerebrovascular accident on week 18 of treatment, considered to be unrelated to therapy. Two patients refused to stay on therapy after PCR turned negative at week 24 of treatment.

Only 16 patients were genotyped. Genotypes 1a, 1b, 2b, and 3a were detected in 6, 2, 1, and 5 patients respectively and two patients were non-typable.

In the remaining patients, HCV RNA became negative in all but one patient at the end of 48 weeks of treatment 96.9% (31/32). At 24 weeks after end of treatment, four more patients became viremic.

The per-protocol and intention-to-treat rates for sustaind virologic response was 84.4% (27/32) and 73.0% (27/37) respectively.

Dose reduction was necessary in 6 cases, 1 due to aggressive behavior, 3 due to neutropenia (neutrophil count < 750 /mm3), and 2 due to anemia (Hb < 10 g/dL).

The authors conclude, “A biopsy-independent protocol of combination therapy with pegylated interferon alfa-2a and ribavirin for 48 weeks in hemophiliac patients with chronic hepatitis C resulted in a very high rate of sustained virologic response. No life-threatening adverse effects were observed.”

05/19/04

Reference
R Malekzadeh and others. Treatment of Chronic Hepatitis C with Pegylated Interferon Alfa-2a plus Ribavirin in Hemophiliac Patients. Abstract 1131 (poster). Digestive Disease Week. May 15-20, 2004. New Orleans, LA.