Improved virologic response in chronic hepatitis C genotype 4 treated with nitazoxanide, peginterferon, and ribavirin

JF Rossignol, A Elfert, Y El–Gohary, EB Keeffe - Gastroenterology, 2009 - Elsevier
JF Rossignol, A Elfert, Y El–Gohary, EB Keeffe
Gastroenterology, 2009Elsevier
BACKGROUND & AIMS: Sustained virologic response (SVR) rates of 50%–60% have been
achieved in patients with chronic hepatitis C (genotype 4) treated with peginterferon plus
ribavirin. The safety and efficacy of nitazoxanide plus peginterferon alfa-2a, with or without
ribavirin, were evaluated in a randomized controlled trial at 2 centers in Egypt. METHODS:
Previously untreated patients with chronic hepatitis C and genotype 4 infection were
assigned randomly to groups that were given standard of care (peginterferon alfa-2a and …
BACKGROUND & AIMS
Sustained virologic response (SVR) rates of 50%–60% have been achieved in patients with chronic hepatitis C (genotype 4) treated with peginterferon plus ribavirin. The safety and efficacy of nitazoxanide plus peginterferon alfa-2a, with or without ribavirin, were evaluated in a randomized controlled trial at 2 centers in Egypt.
METHODS
Previously untreated patients with chronic hepatitis C and genotype 4 infection were assigned randomly to groups that were given standard of care (peginterferon alfa-2a and ribavirin for 48 weeks, n = 40), nitazoxanide monotherapy for 12 weeks followed by nitazoxanide plus peginterferon alfa-2a for 36 weeks (n = 28), or nitazoxanide monotherapy for 12 weeks followed by nitazoxanide plus peginterferon alfa-2a and ribavirin for 36 weeks (n = 28). Therapeutics included nitazoxanide (500 mg) twice daily, peginterferon alfa-2a (180 μg) once weekly, and weight-based ribavirin (1000–1200 mg/day).
RESULTS
The percentages of rapid virologic response (RVR), defined as undetectable HCV RNA at week 4 of combination therapy, and SVR were significantly higher in patients given the triple therapy compared with the standard of care (64% vs 38%, P = .048; and 79% vs 50%, P = .023; respectively). Patients given nitazoxanide plus peginterferon alfa-2a had intermediate rates of RVR (54%) and SVR (61%). Adverse events were similar across treatment groups except for a higher rate of anemia in the groups receiving ribavirin.
CONCLUSIONS
The combination of nitazoxanide, peginterferon alfa-2a, and ribavirin increased the percentages of patients with RVR and SVR, compared with patients given peginterferon plus ribavirin, without an increase in adverse events.
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