Studies continue to explore the various factors that influence the outcome of hepatitis C treatment. This study analyzed “real world” data from six clinics (two each in the United States, Germany, and Italy), looking at predictors of sustained virological response (SVR) in chronic hepatitis C patients receiving pegylated interferon.

Data were collected from 824 treatment-naive individuals with chronic HCV infection; 506 had genotype 1 HCV, 147 had genotype 2, and 171 had genotype 3. Participants in clinical trials, people treated prior to 2001, those coinfected with HIV or HBV, and those with decompensated liver disease were excluded. Patients at the six clinics received either weight-based peginterferon alfa-2b (Peg-Intron) or fixed dose peginterferon alfa-2a (Pegasys), both with ribavirin.

The researchers assessed the influence of a variety of disease-related and demographic factors including age, sex, race, body weight, HCV genotype, and baseline alanine aminotransferase (ALT).

Results

Overall, genotype 1 patients treated with Peg-Intron were more likely to achieve sustained virological response 24 weeks after completing therapy than those receiving Pegasys (49% vs. 36%; OR 1.62, 95% CI 1.10-2.39; P = 0.017). The difference in SVR rates between the two types of peginterferon was not significant among patients with genotype 2 or 3.

The mean baseline body weight for genotype 1 patients was slightly higher among patients receiving Pegasys compared with Peg-Intron (78.4 kg/BMI 26.7 vs 75.5 kg/BMI 26.6, respectively). Among genotype 1 patients, higher baseline weight was a significant negative predictor of SVR (P = 0.012). Further, there was a larger difference between the SVR rates produced by the two types of peginterferon as body weight increased. This effect was not significant among patients with genotype 2 or 3.

In this analysis, age, sex, and race were not statistically significant predictors of treatment response, in contrast to past studies showing that younger patients, women, and Caucasians are more likely to achieve sustained response than older patients, men, and African-Americans. Baseline ALT also did not predict treatment response.

Conclusion

The researchers concluded that treatment with Peg-Intron “has an advantage relative to” Pegasys in achieving SVR in treatment-naive patients with genotype 1 HCV. Higher baseline weight was a “significant negative prognostic factor” for SVR.

5/30/06

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