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

Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals non-black individuals. HCV trials submitted to the Food and Drug Administration (2013-2017) to support approval or to expa...

Full description

Saved in:
Bibliographic Details
Published in:Journal of Virus Eradication Vol. 5; no. 3; pp. 138 - 144
Main Authors: Struble, Kimberly, Chan-Tack, Kirk, Qi, Karen, Valappil, Thamban, Connelly, Sarah, Mishra, Poonam, Price, Dionne, Murray, Jeffrey, Birnkrant, Debra
Format: Journal Article
Language:English
Published: England Mediscript Ltd 18.09.2019
Elsevier
Subjects:
clinical trial
Food and Drug Administration
hepatitis C
Original Research
clinical trial
hepatitis C
Food and Drug Administration
ISSN:2055-6640, 2055-6659
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals non-black individuals. HCV trials submitted to the Food and Drug Administration (2013-2017) to support approval or to expand an indication of 12-week interferon-free DAA regimens with or without ribavirin to treat HCV genotype 1 (GT1) infection were pooled to explore efficacy comparisons by ethnicity. 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% 97.3%). Baseline characteristics did not affect SVR12 for the two groups. Of the 742 subjects with both HCV GT1 and HIV, 243 (32.7%) were black: SVR12 was 89.5%-100% in black individuals and 94.4%-100% in non-black individuals. In pooled analyses for HCV GT1/HIV co-infection, black individuals had a 4% (95% confidence interval -7.7% to 0.3%) lower SVR12 than non-black individuals (93.4% 97.0%). This difference was driven by ION-4 in which study SVR12 was approximately 10% lower for black than for non-black individuals (89.5% 99.1%). Baseline characteristics did not affect SVR12 for the two groups. 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.
Bibliography:SourceType-Scholarly Journals-1
content type line 23
ObjectType-Editorial-2
ObjectType-Commentary-1
Shared first authorship.
ISSN:2055-6640
2055-6659
DOI:10.1016/S2055-6640(20)30043-1