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

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 microg) 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 higher rates 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.

Nitazoxanide in the treatment of amoebiasis.

Amoebiasis is a significant cause of morbidity worldwide and is the third leading cause of death from parasitic diseases. This study evaluated nitazoxanide, a thiazolide anti-infective, in the treatment of intestinal and hepatic amoebiasis. Prospective, randomised, double-blind, placebo-controlled studies were conducted in outpatients with intestinal amoebiasis from the Nile Delta of Egypt. Nitazoxanide was administered twice daily for 3 days at doses of 500mg (age > or =12 years), 200mg (age 4-11 years) or 100mg (age 1-3 years). Seventeen adults hospitalised with hepatic amoebiasis were treated with 500mg nitazoxanide twice daily for 10 days. Four days after completion of therapy, 32 (94%) of 34 nitazoxanide-treated patients with intestinal amoebiasis resolved symptoms compared with 15 (50%) of 30 patients who received placebo (P<0.001). Thirty-two (94%) of 34 nitazoxanide-treated patients were free of Entamoeba histolytica in two post-treatment stool specimens compared with only 13 (43%) of 30 patients receiving placebo (P<0.0001). All patients with hepatic amoebiasis responded to nitazoxanide therapy. Nitazoxanide is effective in treating invasive intestinal amoebiasis and in eliminating E. histolytica colonisation of the intestinal tract. Further studies are warranted in patients with hepatic amoebiasis.

Effect of nitazoxanide in diarrhea and enteritis caused by Cryptosporidium species.

BACKGROUND & AIMS: The aim of this study was to evaluate the efficacy of nitazoxanide for the treatment of diarrhea and enteritis caused by Cryptosporidium species in patients 12 years of age and older. METHODS: A multicenter, randomized, double-blind, placebo-controlled study was conducted in 90 outpatients 12 years of age and older from the Nile Delta region of Egypt. Patients were randomized to receive either one 500 mg tablet or one matching placebo tablet, or 25 mL of nitazoxanide oral suspension (500 mg nitazoxanide), each given twice daily for 3 days. Clinical and microbiologic response rates were evaluated 4 days after completion of treatment. RESULTS: Twenty-seven (96%) of the 28 patients receiving nitazoxanide tablets responded clinically compared with 11 (41%) of 27 patients who received placebo (P < .0001). Twenty-six (93%) of the 28 patients who received nitazoxanide were free of Cryptosporidium oocysts in each of 2 posttreatment stool samples compared with only 10 (37%) of 27 patients who received placebo (P < .0001). Response rates in patients receiving the tablets and the suspension were comparable (clinical response rate for suspension, 27 of 31 [87%]; microbiologic response rate for suspension, 28 of 31 [90%]). CONCLUSIONS: These findings show that a 3-day course of nitazoxanide is effective in treating diarrhea and enteritis caused by Cryptosporidium in nonimmunodeficient patients 12 years of age and older.