In black adults with hepatitis C virus (HCV) infection, treatment with elbasvir/grazoprevir is highly effective, safe, and well tolerated, according to a recent pooled analysis of clinical trials.
The rate of sustained virologic response (SVR) at 12 weeks was similar for black participants and non-black participants, both overall and specifically for the subgroups of patients with HCV genotypes 1 or 4, say researchers.
The findings, published online on April 26, 2018 in the American Journal of Gastroenterology,1 provide evidence needed to demonstrate that direct acting antiviral (DAA) therapy is highly effective in black adults specifically, particularly since older interferon-based treatments were typically less effective in blacks, according to Philippe J. Zamor, MD, Carolinas HealthCare System, Charlotte, North Carolina, and coinvestigators
“There still exists some evidence that black people with HCV infection remain a difficult population to treat, and that black race may be an independent predictor of treatment failure in people receiving DAA treatments,” wrote Zamor and colleagues in their study report.
“There is also evidence,” they added, “that black participants are underrepresented in recent HCV treatment clinical trials, suggesting that additional data are required in this important population.”
The analysis was based on data from 9 international phase 2/3 clinical trials including 332 black participants, making it one of the largest analyses to date of black participants receiving all-oral DAA treatment.
In one previous analysis2 of similar size, investigators pooled data from phase 3 trials of ledpasvir/sofosbuvir in patients with genotype 1 HCV infection. They found that regimen had similar efficacy in 308 black participants as compared to the overall cohort of 1,949 individuals.
In the current analysis conducted by Zamor et al, participants received elbasvir 50 mg and grazoprevir 100 mg once daily either separately or as a fixed-dose combination tablet. Treatment was given for 12 weeks, or for 16 weeks in combination with ribavirin twice daily.
1. Zamor PJ, Vierling J, Ghalib R, et al. Elbasvir/grazoprevir in black adults with hepatitis C virus infection: a pooled analysis of phase 2/3 clinical trials. Am J Gastroenterol. 2018 Apr 26. doi: 10.1038/s41395-018-0053-4.
2. Wilder JM, Jeffers LJ, Ravendhran N, et al. Safety and efficacy of ledipasvir-sofosbuvir in black patients with hepatitis C virus infection: A retrospective analysis of phase 3 data. Hepatology. 2016;63:437-44. doi: 10.1002/hep.28334.