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 language | English (US) |
|---|---|
| Pages (from-to) | 834-845 |
| Number of pages | 12 |
| Journal | Annals of Hepatology |
| Volume | 15 |
| Issue number | 6 |
| DOIs | |
| State | Published - Nov 1 2016 |
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Keywords
- Antiviral therapy
- Ethnicity
- Liver disease
- NS5A inhibitor
- Race
ASJC Scopus subject areas
- Hepatology
Cite this
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 journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=84995676814&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84995676814&partnerID=8YFLogxK
U2 - 10.5604/16652681.1222098
DO - 10.5604/16652681.1222098
M3 - Article
C2 - 27740516
AN - SCOPUS:84995676814
VL - 15
SP - 834
EP - 845
JO - Annals of Hepatology
JF - Annals of Hepatology
SN - 1665-2681
IS - 6
ER -