PMID- 27740516 OWN - NLM STAT- MEDLINE DCOM- 20170227 LR - 20221207 IS - 1665-2681 (Print) IS - 1665-2681 (Linking) VI - 15 IP - 6 DP - 2016 Nov-Dec 2016 TI - Daclatasvir and Peginterferon/Ribavirin for Black/African-American and Latino Patients with HCV infection. PG - 834-845 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. FAU - Rodriguez-Torres, Maribel AU - Rodriguez-Torres M AD - Fundacion de Investigacion, San Juan, Puerto Rico. FAU - Lawitz, Eric AU - Lawitz E AD - Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas, USA. FAU - Yangco, Bienvenido AU - Yangco B AD - Infectious Disease Research Institute, Inc, Tampa, Florida, USA. FAU - Jeffers, Lennox AU - Jeffers L AD - Miami VA Medical Center, Miami, Florida, USA. FAU - Han, Steven-Huy AU - Han SH AD - Pfleger Liver Institute, Los Angeles, California, USA. FAU - Thuluvath, Paul J AU - Thuluvath PJ AD - Mercy Medical Center, Baltimore, Maryland, USA. FAU - Rustgi, Vinod AU - Rustgi V AD - Thomas Starzl Transplant Institute UPMC, Pittsburgh, Pennsylvania, USA. FAU - Harrison, Stephen AU - Harrison S AD - Brooke Army Medical Center, San Antonio, Texas, USA. FAU - Ghalib, Reem AU - Ghalib R AD - North Texas Research Institute, Arlington, Texas, USA. FAU - Vierling, John M AU - Vierling JM AD - Baylor College of Medicine, Houston, Texas, USA. FAU - Luketic, Velimir AU - Luketic V AD - Virginia Commonwealth University School of Medicine and McGuire Research Institute, Richmond, Virginia, USA. FAU - Zamor, Philippe J AU - Zamor PJ AD - Carolinas Medical Center, Charlotte, North Carolina, USA. FAU - Ravendhran, Natarajan AU - Ravendhran N AD - Digestive Disease Associates, Catonsville, Maryland, USA. FAU - Morgan, Timothy R AU - Morgan TR AD - VA Long Beach Healthcare System, Long Beach, California, USA. FAU - Pearlman, Brian AU - Pearlman B AD - Atlanta Medical Center, Atlanta, Georgia, USA. FAU - O'Brien, Christopher AU - O'Brien C AD - University of Miami Schiff Center for Liver Diseases, Miami, Florida, USA. FAU - Khallafi, Hicham AU - Khallafi H AD - Florida Hospital Transplant Center, Orlando, Florida, USA. FAU - Pyrsopoulos, Nikolaos AU - Pyrsopoulos N AD - Rutgers-New Jersey Medical School, Newark, New Jersey, USA. FAU - Kong, George AU - Kong G AD - Bristol-Myers Squibb Research and Development, Wallingford, Connecticut, USA. FAU - McPhee, Fiona AU - McPhee F AD - Bristol-Myers Squibb Research and Development, Wallingford, Connecticut, USA. FAU - Yin, Philip D AU - Yin PD AD - Bristol-Myers Squibb Research and Development, Wallingford, Connecticut, USA. FAU - Hughes, Eric AU - Hughes E AD - Bristol-Myers Squibb Research and Development, Princeton, New Jersey, USA. FAU - Treitel, Michelle AU - Treitel M AD - Bristol-Myers Squibb Research and Development, Princeton, New Jersey, USA. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PL - Mexico TA - Ann Hepatol JT - Annals of hepatology JID - 101155885 RN - 0 (Antiviral Agents) RN - 0 (Biomarkers) RN - 0 (Carbamates) RN - 0 (Imidazoles) RN - 0 (Interferon-alpha) RN - 0 (Pyrrolidines) RN - 0 (RNA, Viral) RN - 0 (Recombinant Proteins) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 49717AWG6K (Ribavirin) RN - HG18B9YRS7 (Valine) RN - LI2427F9CI (daclatasvir) RN - Q46947FE7K (peginterferon alfa-2a) SB - IM MH - Administration, Oral MH - Adult MH - *Black or African American MH - Aged MH - Antiviral Agents/adverse effects/*therapeutic use MH - Biomarkers/blood MH - Carbamates MH - Drug Therapy, Combination MH - Female MH - Genotype MH - Hepacivirus/*drug effects/genetics/pathogenicity MH - Hepatitis C, Chronic/diagnosis/*drug therapy/ethnology/virology MH - *Hispanic or Latino MH - Humans MH - Imidazoles/adverse effects/*therapeutic use MH - Interferon-alpha/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Polyethylene Glycols/adverse effects/*therapeutic use MH - Puerto Rico MH - Pyrrolidines MH - RNA, Viral/blood MH - Recombinant Proteins/adverse effects/therapeutic use MH - Ribavirin/adverse effects/*therapeutic use MH - Time Factors MH - Treatment Outcome MH - United States/epidemiology MH - Valine/analogs & derivatives MH - Viral Load MH - Young Adult EDAT- 2016/10/16 06:00 MHDA- 2017/02/28 06:00 CRDT- 2016/10/15 06:00 PHST- 2016/10/15 06:00 [entrez] PHST- 2016/10/16 06:00 [pubmed] PHST- 2017/02/28 06:00 [medline] AID - 1222098 [pii] AID - 10.5604/16652681.1222098 [doi] PST - ppublish SO - Ann Hepatol. 2016 Nov-Dec 2016;15(6):834-845. doi: 10.5604/16652681.1222098.