| Abstract | 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. |
| Authors | Jean-François Rossignol, Asem Elfert, Yehia El-Gohary, Emmet B Keeffe
(Affiliation: The Romark Institute for Medical Research, Tampa, Florida, USA.)
|
| Journal | Gastroenterology
(Gastroenterology)
Vol. 136
Issue 3
Pg. 856-62
(Mar 2009)
ISSN: 1528-0012 [Electronic] United States |
| PMID | 19135998
(Publication Type: Journal Article, Randomized Controlled Trial)
|
| Chemical References |
- Antiparasitic Agents
- Antiviral Agents
- Polyethylene Glycols
- Thiazoles
- peginterferon alfa-2a
- Ribavirin
- nitazoxanide
- Interferon Alfa-2a
|
| Topics |
- Adult
- Antiparasitic Agents
(administration & dosage, adverse effects)
- Antiviral Agents
(administration & dosage, adverse effects)
- Drug Therapy, Combination
- Female
- Genotype
- Hepacivirus
(drug effects, genetics)
- Hepatitis C, Chronic
(drug therapy)
- Humans
- Interferon Alfa-2a
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Polyethylene Glycols
(administration & dosage, adverse effects)
- Ribavirin
(administration & dosage, adverse effects)
- Thiazoles
(administration & dosage, adverse effects)
- Treatment Outcome
- Young Adult
|
