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Editorial
. 2019 Sep 18;5(3):138-144.
doi: 10.1016/S2055-6640(20)30043-1.

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

Kimberly Struble  1 , Kirk Chan-Tack  1 , Karen Qi  2 , Thamban Valappil  2 , Sarah Connelly  1 , Poonam Mishra  1 , Dionne Price  2 , Jeffrey Murray  1 , Debra Birnkrant  1
Affiliations
Editorial

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

Kimberly Struble et al. J Virus Erad. .

Abstract

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.

Keywords: Food and Drug Administration; clinical trial; hepatitis C.

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Figures

Figure 1.
Figure 1.
Difference in SVR12 rate between black and non-black subjects for those with HCV GT1 alone and those with both HCV GT1 and HIV for 12-week regimens. CI: confidence interval; GT1: genotype 1; HCV: hepatitis C virus; SVR12: sustained virological response assessed 12 weeks following cessation of treatment; TE: treatment experienced; TN: treatment naive
Figure 2.
Figure 2.
Difference in SVR12 rates between black and non-black subjects by subgroups for those with HCV GT1 alone in 12-week regimens. *: Including non-cirrhotic subjects and subjects with missing cirrhosis status; **: including GT1b subjects and subjects with other or undetermined subtype; ***: excluding subjects with missing IL-28B status. BMI: body mass index; CI: confidence interval; HCV: hepatitis C virus; SVR12: sustained virological response assessed 12 weeks following cessation of treatment; TE: treatment experienced; TN: treatment naive
Figure 3.
Figure 3.
Difference in SVR12 rates between black and non-black subjects by subgroups for those with both HCV GT1 and HIV in 12-week regimens. *: Including non-cirrhotic subjects and subjects with missing cirrhosis status; **: including GT1b subjects and subjects with other or undetermined subtype. BMI: body mass index; CI: confidence interval; HCV: hepatitis C virus; SVR12: sustained virological response assessed 12 weeks following cessation of treatment; TE: treatment experienced; TN: treatment naïve
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References

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