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.

Amorosa VK, Luetkemeyer A, Kang M, Johnson VA, Umbleja T, Haas DW, Yesmin S, Bardin MC, Chung RT, Alston-Smith B, Tebas P, Peters MG
HIV Clin Trials. 2013 14 (6): 274-83

PMID: 24334180 · PMCID: PMC4113390 · DOI:10.1310/hct1406-274

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.

MeSH Terms (18)

Adult Animals Antiviral Agents Drug Therapy, Combination Female Hepacivirus Hepatitis C HIV-1 HIV Infections Humans Interferon-alpha Male Middle Aged Pilot Projects Polyethylene Glycols Recombinant Proteins Ribavirin Thiazoles

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