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

Kimberly Struble; Kirk Chan-Tack; Karen Qi; Thamban Valappil; Sarah Connelly; Poonam Mishra; Dionne Price; Jeffrey Murray; Debra Birnkrant

Journal of Virus Eradication (Jul 2019)

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

Kimberly Struble,
Kirk Chan-Tack,
Karen Qi,
Thamban Valappil,
Sarah Connelly,
Poonam Mishra,
Dionne Price,
Jeffrey Murray,
Debra Birnkrant

Affiliations

Kimberly Struble: Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; Corresponding author: Kimberly Struble Division of Antiviral Products, US Food and Drug Administration, Building 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
Kirk Chan-Tack: Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Karen Qi: Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Thamban Valappil: Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Sarah Connelly: Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Poonam Mishra: Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Dionne Price: Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Jeffrey Murray: Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Debra Birnkrant: Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

Journal volume & issue: Vol. 5, no. 3
pp. 138 – 144

Abstract

Read online

Objectives: Under representation of black subjects in trials of hepatitis C virus (HCV) direct-acting antivirals (DAAs) complicates assessment of differential outcomes for black individuals vs 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. Methods: Twenty-six trials were pooled and included 2869 individuals with HCV GT1 alone and 742 individuals with both HCV GT1 and HIV. Results: 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% vs 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% vs 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% vs 99.1%). Baseline characteristics did not affect SVR12 for the two groups. Conclusion: 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.

Published in Journal of Virus Eradication

ISSN: 2055-6640 (Print); 2055-6659 (Online)
Publisher: Elsevier
Country of publisher: United Kingdom
LCC subjects: Science: Microbiology; Medicine: Public aspects of medicine
Website: https://www.journals.elsevier.com/journal-of-virus-eradication

About the journal

Abstract

Keywords