Tolerability and Efficacy of Pegasys/Ribavirin in Black Patients with Hepatitis C

Previous research has shown that black Americans are twice as likely as whites to be infected with hepatitis C virus (HCV), and that individuals of African descent respond less well to interferon-based therapy for chronic hepatitis C.

In the June 2006 Journal of Viral Hepatitis, researchers from the University of Maryland School of Medicine described the safety profile of pegylated interferon alfa-2a (Pegasys) plus ribavirin and the relationship between treatment adherence and sustained virological response (SVR) in 78 black patients infected with genotype 1 HCV. The same research team previously reported that the SVR rate in blacks was 26%, lower than the 39% sustained response rate observed in whites.

Results

• 62 patients (79%) completed 48 weeks of combination treatment with Pegasys plus ribavirin.

• The Pegasys dose was modified due to neutropenia in 36 patients (46%).

• The ribavirin dose was reduced due to anemia in 31 patients (40%).

• The SVR rate was directly related to total medication exposure, based on the percentage of planned doses of Pegasys and ribavirin the patients received.

• The respective SVR rates were 33%, 25%, and 0% in patients who received more than 80%, 61%-80%, and 60% or less of the planned doses of Pegasys.

• SVR rates were 28%, 33%, and 18% in patients who received more than 80%, 61%-80%, and 60% or less of the planned doses of ribavirin.

• The SVR rate was 29% (11 of 38) among patients who received at least 80% of the total planned doses of both Pegasys and ribavirin, compared with 7% (1 of 14) among patients who received 80% or less of both drugs.


• The SVR was 30% among patients who received more than 60% of the planned doses of both drugs, compared with 0% in patients with 60% or less of planned exposure

Conclusion

In conclusion, the researchers wrote, “peginterferon alfa-2a plus ribavirin demonstrated good safety and tolerability profiles in blacks infected with HCV genotype 1.” However, they added that, “Adherence to at least 60% of the planned peginterferon alfa-2a and ribavirin doses for 48 weeks was associated with a greater SVR.”

References

C D Howell, L S Jeffers, W Cassidy, and others. Peginterferon alfa-2a and ribavirin for chronic hepatitis C genotype 1 infections in black patients: safety, tolerability and impact on sustained virologic response. Journal of Viral Hepatitis 13(6): 371-376. June 2006.

L J Jeffers, W Cassidy, C D Howell, and others. Peginterferon alfa-2a (40 kd) and ribavirin for black American patients with chronic HCV genotype 1. Hepatology 39(6): 1702-1708. June 2004.