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Improved virologic response in chronic hepatitis C genotype 4 treated with nitazoxanide, peginterferon, and ribavirin.
Gastroenterology. 2009 Mar; 136(3):856-62.G

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+Show Affiliations

The Romark Institute for Medical Research, Tampa, Florida, USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19135998

Citation

Rossignol, Jean-François, et al. "Improved Virologic Response in Chronic Hepatitis C Genotype 4 Treated With Nitazoxanide, Peginterferon, and Ribavirin." Gastroenterology, vol. 136, no. 3, 2009, pp. 856-62.
Rossignol JF, Elfert A, El-Gohary Y, et al. Improved virologic response in chronic hepatitis C genotype 4 treated with nitazoxanide, peginterferon, and ribavirin. Gastroenterology. 2009;136(3):856-62.
Rossignol, J. F., Elfert, A., El-Gohary, Y., & Keeffe, E. B. (2009). Improved virologic response in chronic hepatitis C genotype 4 treated with nitazoxanide, peginterferon, and ribavirin. Gastroenterology, 136(3), 856-62. https://doi.org/10.1053/j.gastro.2008.11.037
Rossignol JF, et al. Improved Virologic Response in Chronic Hepatitis C Genotype 4 Treated With Nitazoxanide, Peginterferon, and Ribavirin. Gastroenterology. 2009;136(3):856-62. PubMed PMID: 19135998.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved virologic response in chronic hepatitis C genotype 4 treated with nitazoxanide, peginterferon, and ribavirin. AU - Rossignol,Jean-François, AU - Elfert,Asem, AU - El-Gohary,Yehia, AU - Keeffe,Emmet B, Y1 - 2008/11/19/ PY - 2008/08/29/received PY - 2008/11/07/revised PY - 2008/11/13/accepted PY - 2009/1/13/entrez PY - 2009/1/13/pubmed PY - 2009/4/8/medline SP - 856 EP - 62 JF - Gastroenterology JO - Gastroenterology VL - 136 IS - 3 N2 - 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. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/19135998/Improved_virologic_response_in_chronic_hepatitis_C_genotype_4_treated_with_nitazoxanide_peginterferon_and_ribavirin_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(08)02051-9 DB - PRIME DP - Unbound Medicine ER -