Daclatasvir and peginterferon/ribavirin for black/African-American and latino patients with HCV infection

Maribel Rodriguez-Torres, Eric Lawitz, Bienvenido Yangco, Lennox J Jeffers, Steven Huy Han, Paul J. Thuluvath, Vinod Rustgi, Stephen Harrison, Reem Ghalib, John M. Vierling, Velimir Luketic, Philippe J. Zamor, Natarajan Ravendhran, Timothy R. Morgan, Brian Pearlman, Christopher B O'Brien, Hicham Khallafi, Nikolaos Pyrsopoulos, George Kong, Fiona McPheePhilip D. Yin, Eric Hughes, Michelle Treitel

Research output: Contribution to journalArticle

1 Scopus citations

Abstract

Background. Patient race and ethnicity have historically impacted HCV treatment response. This phase 3 study evaluated daclatasvir with peginterferon-alfa-2a/ribavirin (pegIFN alfa-2a/RBV) in treatment-naive black/African American (AA), Latino, and white non-Latino patients with chronic HCV genotype 1 infection. Material and methods. In this single-arm, open-label study, 246 patients received daclatasvir plus pegIFN alfa-2a and weight-based RBV. Patients with an extended rapid virologic response (eRVR; undetectable HCV-RNA at treatment weeks 4 and 12) received 24 weeks of treatment; those without eRVR received an additional 24 weeks of treatment with pegIFN alfa-2a/RBV. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12; HCV-RNA < 25 IU/mL) compared with the cohort historical rate. Results. Most patients were IL28B non-CC (84.4% black/AA; 77.6% Latino) genotype 1a-infected (72.7%; 81.3%), with HCV-RNA ≥ 800,000 IU/mL (81.3%; 64.5%). SVR12 rates were 50.8% (65/128; 95% confidence interval [CI], 42.1-59.4) for black/AA and 58.9% (63/107; 95% CI, 49.6-68.2) for Latino patients. The majority (55.5%; 58.9%) received 24 weeks treatment; rapid reductions (> 4-log10) in HCV-RNA levels were observed. Only 60.9% (78/128) of black/AA and 63.6% (68/107) of Latino patients completed treatment. On-treatment serious adverse events (SAEs) occurred in 21 patients. Discontinuations due to adverse events (AEs) occurred in 9 black/AA and 6 Latino patients. Conclusion. SVR12 rates for black/AA (50.8%) and Latino (58.9%) cohorts treated with daclatasvir plus pegIFN alfa-2a/RBV and the lower bound of the 95% CIs were higher than the estimated historical control (black/AA, 26% SVR; Latino, 36% SVR) treated with pegIFN alfa-2a/RBV. These data support daclatasvir use in all-oral direct-acting antiviral combinations.

Original languageEnglish (US)
Pages (from-to)834-845
Number of pages12
JournalAnnals of Hepatology
Volume15
Issue number6
DOIs
StatePublished - Nov 1 2016

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Keywords

  • Antiviral therapy
  • Ethnicity
  • Liver disease
  • NS5A inhibitor
  • Race

ASJC Scopus subject areas

  • Hepatology

Cite this

Rodriguez-Torres, M., Lawitz, E., Yangco, B., Jeffers, L. J., Han, S. H., Thuluvath, P. J., Rustgi, V., Harrison, S., Ghalib, R., Vierling, J. M., Luketic, V., Zamor, P. J., Ravendhran, N., Morgan, T. R., Pearlman, B., O'Brien, C. B., Khallafi, H., Pyrsopoulos, N., Kong, G., ... Treitel, M. (2016). Daclatasvir and peginterferon/ribavirin for black/African-American and latino patients with HCV infection. Annals of Hepatology, 15(6), 834-845. https://doi.org/10.5604/16652681.1222098