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HIV Clin Trials. 2013 Nov-Dec;14(6):274-83. doi: 10.1310/hct1406-274.

Addition of nitazoxanide to PEG-IFN and ribavirin to improve HCV treatment response in HIV-1 and HCV genotype 1 coinfected persons naïve to HCV therapy: results of the ACTG A5269 trial.

Author information

1
Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
2
University of California at San Francisco, San Francisco, California.
3
Harvard School of Public Health, Boston, Massachusetts.
4
Birmingham Veterans Affairs Medical Center, Birmingham, Alabama University of Alabama School of Medicine, Birmingham, Alabama.
5
Vanderbilt School of Medicine, Nashville, Tennessee.
6
ACTG Operations Center, Silver Spring, Maryland.
7
Romark Laboratories LC, Tampa, Florida.
8
Harvard Medical School, Boston, Massachsetts.
9
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
10
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.

Abstract

BACKGROUND:

We hypothesized that nitazoxanide (NTZ) added to pegylated interferon alfa-2a (PEG-IFN) and weight-based ribavirin (WBR) would improve hepatitis C virus (HCV) virologic responses in HCV treatment-naïve HIV-1/HCV genotype 1 coinfected persons.

METHODS:

Prospective, single-arm study in which subjects received 4-week lead-in (NTZ 500 mg twice daily) followed by 48 weeks of NTZ, PEG-IFN, and WBR. We compared the HCV virologic responses of these subjects to historical controls from the completed ACTG study A5178 who received PEG-IFN and WBR and had similar subject characteristics. Primary endpoints were early virologic response and complete early virologic response (EVR and cEVR).

RESULTS:

Among 67 subjects (78% male; 48% Black; median age, 50 years), EVR was achieved in 65.7% (90% CI, 55.0%-75.3%), cEVR in 38.8% (28.8%-49.6%). and SVR in 32.8% (23.4%-43.5%). EVR was higher with NTZ (51.4% in A5178; P = .03), but the sustained virologic response (SVR) proportion was similar (27.3% in A5178; P = .24). In contrast to A5178, SVR was similar across IL28B genotypes. Overall, NTZ was safe and well-tolerated.

CONCLUSION:

Whereas EVR proportion improved significantly in this pilot study, the addition of NTZ to PEG-IFN/WBR did not significantly improve SVR compared to historical controls. NTZ may be associated with an attenuation of the effect of IL28B on HCV treatment response.

KEYWORDS:

HIV; genotype 1; hepatitis C; nitazoxanide; pegylated interferon; ribavirin

PMID:
24334180
PMCID:
PMC4113390
DOI:
10.1310/hct1406-274
[Indexed for MEDLINE]
Free PMC Article

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