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C-EDGE CO-STAR: efficacy of grazoprevir / elbasvir Fixed Dose Combination for 12 Weeks in HCV-infected Persons Who Inject Drugs on Opioid Agonist Therapy
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Reported by Jules Levin
AASLD 2015 Nov 13-17 San Francisco, CA
from Jules: CO-STAR is a large Phase 3, randomized, parallel-group, placebo-controlled, double-blind trial in treatment naïve, GT1, 4, and 6, for genotypes of 1, 4, and 6, for patients on opiate agonist therapy (OAT) for at least 3 months, and consistently kept at least 80% of scheduled appointments while on OAT. About 75% were men median age of 47, about 80% were white, 12% African-American, 7% Asian, 76% were genotype 1a, 15% genotype 1b, 6% genotype 4, and 20% had cirrhosis (F4), 7% HIV coinfected.Of note 57% tested urine positive for a drug screen besides the opiate agonist therapy they were taking. The SVR Rate was 96% for genotypes !a & 1b, and 11/11 100% for GT4. 5 patients were reinfected, see data below. The about 59% testing positive for drugs were positive for at least 1 of these: 8 drug classes: amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, phencyclidine, propoxyphene; 25% for opiates, 10% cocaine. Adhere was very high with 96-100% 95% adherent, see details below. Fatigue (17%), headache (13%), nausea (10%), and diarrhea (9%) were reported. The authors summarized and I agree: grazoprevir / elbasvir Fixed Dose Combination for 12 Weeks demonstrated high efficacy and high medication adherence. These data demonstrate support for treating HCV among subjects receiving Opiate Agonist Therapy. And I would add this demonstratessupport for treating IDUs.
Dore GJ1, Altice F2, Litwin AH3, Dalgard O4, Gane E5, Shibolet O6, Luetkemeyer A7, Nahass R8, Peng CY9, Conway B10, Grebely J1, Howe A11, Nguyen BY11, Wahl J11, Barr E11, Robertson M11, Platt HL11
1The Kirby Institute, UNSW Australia, 2Yale School of Medicine, 3Montefiore Medical Center and Albert Einstein College of Medicine, 4Institute of Clinical Medicine, 5Auckland Clinical Studies, 6Tel-Aviv Medical Center, 7University of California, San Francisco, 8ID Care, 9China Medical University Hospital, 10Vancouver Infectious Diseases Centre, 11Merck & Co., Inc.
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