PMID- 29695828 OWN - NLM STAT- MEDLINE DCOM- 20190806 LR - 20221207 IS - 1572-0241 (Electronic) IS - 0002-9270 (Linking) VI - 113 IP - 6 DP - 2018 Jun TI - Elbasvir/grazoprevir in black adults with hepatitis C virus infection: a pooled analysis of phase 2/3 clinical trials. PG - 863-871 LID - 10.1038/s41395-018-0053-4 [doi] AB - OBJECTIVES: Although direct-acting antiviral regimens have dramatically improved the treatment of hepatitis C virus (HCV) infection, there is some evidence that black race may be an independent predictor of treatment failure. We report a retrospective analysis of black participants receiving elbasvir/grazoprevir (EBR/GZR) in nine phase 2/3 clinical trials. METHODS: Black participants with chronic HCV genotype 1 or 4 (GT1 or GT4) infection who received EBR 50 mg/GZR 100 mg once daily for 12 weeks, or in combination with ribavirin for 16 weeks, were included. The primary end point was sustained virologic response 12 weeks after completion of therapy (SVR12, HCV RNA < 15 IU/mL). RESULTS: Compared with nonblack participants (n = 1310), black participants (n = 332) were more likely to have chronic kidney disease stage 4/5 (9.2% vs. 31.0%, respectively), while other comorbidities were similar between the groups. In black and nonblack participants receiving EBR/GZR for 12 weeks, SVR12 rates were 93.7% (282/301) and 94.2% (1072/1138) in those with GT1 infection, and 93.8% (15/16) and 94.6% (88/93) in those with GT4 infection. SVR12 was 100.0% (15/15) in black participants and 97.5% (77/79) in nonblack participants with GT1 infection receiving EBR/GZR plus ribavirin for 16 weeks. Rates of drug-related adverse events (AEs) were 30% vs. 36.6%, and serious AEs were 7.6% vs. 3.4% in black and nonblack participants, respectively. CONCLUSION: EBR/GZR showed high efficacy in black participants with HCV GT1 or GT4 infection and was generally well tolerated, with a safety profile similar to that reported overall in phase 2/3 clinical trials. FAU - Zamor, Philippe J AU - Zamor PJ AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Vierling, John AU - Vierling J AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Ghalib, Reem AU - Ghalib R AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Luketic, Velimir AU - Luketic V AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Ravendhran, Natarajan AU - Ravendhran N AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Balart, Luis AU - Balart L AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Robertson, Michael AU - Robertson M AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Hwang, Peggy AU - Hwang P AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Hanna, George J AU - Hanna GJ AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Nguyen, Bach-Yen AU - Nguyen BY AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Barr, Eliav AU - Barr E AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Talwani, Rohit AU - Talwani R AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. FAU - Pearlman, Brian AU - Pearlman B AD - Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA. LA - eng PT - Evaluation Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180426 PL - United States TA - Am J Gastroenterol JT - The American journal of gastroenterology JID - 0421030 RN - 0 (Antiviral Agents) RN - 0 (Benzofurans) RN - 0 (Drug Combinations) RN - 0 (Imidazoles) RN - 0 (Quinoxalines) RN - 0 (RNA, Viral) RN - 0 (elbasvir-grazoprevir drug combination) RN - 49717AWG6K (Ribavirin) MH - Adult MH - Black or African American/*statistics & numerical data MH - Aged MH - Aged, 80 and over MH - Antiviral Agents/*therapeutic use MH - Benzofurans/*therapeutic use MH - Clinical Trials, Phase II as Topic MH - Clinical Trials, Phase III as Topic MH - Drug Combinations MH - Drug Therapy, Combination MH - Female MH - Genotype MH - Hepacivirus/genetics/isolation & purification MH - Hepatitis C, Chronic/*drug therapy/virology MH - Humans MH - Imidazoles/*therapeutic use MH - Male MH - Middle Aged MH - Quinoxalines/*therapeutic use MH - RNA, Viral/isolation & purification MH - Retrospective Studies MH - Ribavirin/*therapeutic use MH - Sustained Virologic Response MH - Treatment Failure MH - Young Adult EDAT- 2018/04/27 06:00 MHDA- 2019/08/07 06:00 CRDT- 2018/04/27 06:00 PHST- 2017/09/14 00:00 [received] PHST- 2018/02/20 00:00 [accepted] PHST- 2018/04/27 06:00 [pubmed] PHST- 2019/08/07 06:00 [medline] PHST- 2018/04/27 06:00 [entrez] AID - 10.1038/s41395-018-0053-4 [doi] PST - ppublish SO - Am J Gastroenterol. 2018 Jun;113(6):863-871. doi: 10.1038/s41395-018-0053-4. Epub 2018 Apr 26.