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.
journal_name
HIV Clin Trialsjournal_title
HIV clinical trialsauthors
Amorosa VK,Luetkemeyer A,Kang M,Johnson VA,Umbleja T,Haas DW,Yesmin S,Bardin MC,Chung RT,Alston-Smith B,Tebas P,Peters MGdoi
10.1310/hct1406-274subject
Has Abstractpub_date
2013-11-01 00:00:00pages
274-83issue
6eissn
1528-4336issn
1945-5771pii
28W6UNK270037691journal_volume
14pub_type
临床试验,杂志文章abstract:PURPOSE:The outdated rules of older HIV genotypic resistance algorithms can affect virologic responses. This study was designed to determine how often these incorrect resistance interpretations affect analyses of long-term clinical trials, antiretroviral (ARV) choices, and HIV disease progression rates. METHOD:Baselin...
journal_title:HIV clinical trials
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
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journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究
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journal_title:HIV clinical trials
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journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:HIV clinical trials
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journal_title:HIV clinical trials
pub_type: 杂志文章,评审
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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journal_title:HIV clinical trials
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journal_title:HIV clinical trials
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