Sustained virological response rates with direct-acting antivirals in black subjects with HCV genotype 1 infection: systematic analysis of clinical trials.

Food and Drug Administration clinical trial hepatitis C

Journal

Journal of virus eradication
ISSN: 2055-6640
Titre abrégé: J Virus Erad
Pays: England
ID NLM: 101654142

Informations de publication

Date de publication:
18 Sep 2019
Historique:
entrez: 9 11 2019
pubmed: 9 11 2019
medline: 9 11 2019
Statut: epublish

Résumé

Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals Twenty-six trials were pooled and included 2869 individuals with HCV GT1 alone and 742 individuals with both HCV GT1 and HIV. Of the 2869 HCV GT1-mono-infected subjects, 408 (14.2%) were black. Sustained virological response assessed 12 weeks following cessation of treatment (SVR12) was 92%-100% in black individuals and 87.5%-100.0% in non-black individuals. In pooled analyses, SVR12 was numerically similar between black and non-black subjects (97.1% No notable SVR12 differences were seen in between black and non-black individuals with HCV GT1 alone. Although a numerical difference was observed between black and non-black individuals with both HCV GT1 and HIV, this finding was driven by results from a single trial and may be due to reasons other than ethnicity: 19 subgroup analyses showed baseline characteristics did not affect SVR12 for black and non-black individuals with both HCV GT1 and HIV.

Identifiants

pubmed: 31700657
pmc: PMC6816118

Types de publication

Editorial

Langues

eng

Pagination

138-144

Informations de copyright

© 2019 The Authors. Journal of Virus Eradication published by Mediscript Ltd.

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Auteurs

Kimberly Struble (K)

Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Kirk Chan-Tack (K)

Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Karen Qi (K)

Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Thamban Valappil (T)

Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Sarah Connelly (S)

Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Poonam Mishra (P)

Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Dionne Price (D)

Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Jeffrey Murray (J)

Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Debra Birnkrant (D)

Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Classifications MeSH