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 McPhee & 3 others Philip D. Yin, Eric Hughes, Michelle Treitel

Research output: Contribution to journalArticle

1 Citation (Scopus)

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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Ribavirin
Hispanic Americans
African Americans
Infection
RNA
Therapeutics
BMS-790052
Antiviral Agents
Genotype
Weights and Measures

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., ... 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

Daclatasvir and peginterferon/ribavirin for black/African-American and latino patients with HCV infection. / Rodriguez-Torres, Maribel; Lawitz, Eric; Yangco, Bienvenido; Jeffers, Lennox J; Han, Steven Huy; Thuluvath, Paul J.; Rustgi, Vinod; Harrison, Stephen; Ghalib, Reem; Vierling, John M.; Luketic, Velimir; Zamor, Philippe J.; Ravendhran, Natarajan; Morgan, Timothy R.; Pearlman, Brian; O'Brien, Christopher B; Khallafi, Hicham; Pyrsopoulos, Nikolaos; Kong, George; McPhee, Fiona; Yin, Philip D.; Hughes, Eric; Treitel, Michelle.

In: Annals of Hepatology, Vol. 15, No. 6, 01.11.2016, p. 834-845.

Research output: Contribution to journalArticle

Rodriguez-Torres, M, Lawitz, E, Yangco, B, Jeffers, LJ, Han, SH, Thuluvath, PJ, Rustgi, V, Harrison, S, Ghalib, R, Vierling, JM, Luketic, V, Zamor, PJ, Ravendhran, N, Morgan, TR, Pearlman, B, O'Brien, CB, Khallafi, H, Pyrsopoulos, N, Kong, G, McPhee, F, Yin, PD, Hughes, E & Treitel, M 2016, 'Daclatasvir and peginterferon/ribavirin for black/African-American and latino patients with HCV infection', Annals of Hepatology, vol. 15, no. 6, pp. 834-845. https://doi.org/10.5604/16652681.1222098
Rodriguez-Torres M, Lawitz E, Yangco B, Jeffers LJ, Han SH, Thuluvath PJ et al. Daclatasvir and peginterferon/ribavirin for black/African-American and latino patients with HCV infection. Annals of Hepatology. 2016 Nov 1;15(6):834-845. https://doi.org/10.5604/16652681.1222098
Rodriguez-Torres, Maribel ; Lawitz, Eric ; Yangco, Bienvenido ; Jeffers, Lennox J ; Han, Steven Huy ; Thuluvath, Paul J. ; Rustgi, Vinod ; Harrison, Stephen ; Ghalib, Reem ; Vierling, John M. ; Luketic, Velimir ; Zamor, Philippe J. ; Ravendhran, Natarajan ; Morgan, Timothy R. ; Pearlman, Brian ; O'Brien, Christopher B ; Khallafi, Hicham ; Pyrsopoulos, Nikolaos ; Kong, George ; McPhee, Fiona ; Yin, Philip D. ; Hughes, Eric ; Treitel, Michelle. / Daclatasvir and peginterferon/ribavirin for black/African-American and latino patients with HCV infection. In: Annals of Hepatology. 2016 ; Vol. 15, No. 6. pp. 834-845.
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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.",
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author = "Maribel Rodriguez-Torres and Eric Lawitz and Bienvenido Yangco and Jeffers, {Lennox J} and Han, {Steven Huy} and Thuluvath, {Paul J.} and Vinod Rustgi and Stephen Harrison and Reem Ghalib and Vierling, {John M.} and Velimir Luketic and Zamor, {Philippe J.} and Natarajan Ravendhran and Morgan, {Timothy R.} and Brian Pearlman and O'Brien, {Christopher B} and Hicham Khallafi and Nikolaos Pyrsopoulos and George Kong and Fiona McPhee and Yin, {Philip D.} and Eric Hughes and Michelle Treitel",
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TY - JOUR

T1 - Daclatasvir and peginterferon/ribavirin for black/African-American and latino patients with HCV infection

AU - Rodriguez-Torres, Maribel

AU - Lawitz, Eric

AU - Yangco, Bienvenido

AU - Jeffers, Lennox J

AU - Han, Steven Huy

AU - Thuluvath, Paul J.

AU - Rustgi, Vinod

AU - Harrison, Stephen

AU - Ghalib, Reem

AU - Vierling, John M.

AU - Luketic, Velimir

AU - Zamor, Philippe J.

AU - Ravendhran, Natarajan

AU - Morgan, Timothy R.

AU - Pearlman, Brian

AU - O'Brien, Christopher B

AU - Khallafi, Hicham

AU - Pyrsopoulos, Nikolaos

AU - Kong, George

AU - McPhee, Fiona

AU - Yin, Philip D.

AU - Hughes, Eric

AU - Treitel, Michelle

PY - 2016/11/1

Y1 - 2016/11/1

N2 - 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.

AB - 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.

KW - Antiviral therapy

KW - Ethnicity

KW - Liver disease

KW - NS5A inhibitor

KW - Race

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DO - 10.5604/16652681.1222098

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JO - Annals of Hepatology

JF - Annals of Hepatology

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