title: Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial.
abstract: Hepatitis C virus (HCV) infection is common in persons who inject drugs (PWID).
  
  
  
  To evaluate elbasvir-grazoprevir in treating HCV infection in PWID.
  
  
  
  Randomized, placebo-controlled, double-blind trial. (ClinicalTrials.gov: NCT02105688).
  
  
  
  Australia, Canada, France, Germany, Israel, the Netherlands, New Zealand, Norway, Spain, Taiwan, the United Kingdom, and the United States.
  
  
  
  301 treatment-naive patients with chronic HCV genotype 1, 4, or 6 infection who were at least 80% adherent to visits for opioid agonist therapy (OAT).
  
  
  
  The immediate-treatment group (ITG) received elbasvir-grazoprevir for 12 weeks; the deferred-treatment group (DTG) received placebo for 12 weeks, no treatment for 4 weeks, then open-label elbasvir-grazoprevir for 12 weeks.
  
  
  
  The primary outcome was sustained virologic response at 12 weeks (SVR12), evaluated separately in the ITG and DTG. Other outcomes included SVR24, viral recurrence or reinfection, and adverse events.
  
  
  
  The SVR12 was 91.5% (95% CI, 86.8% to 95.0%) in the ITG and 89.5% (95% CI, 81.5% to 94.8%) in the active phase of the DTG. Drug use at baseline and during treatment did not affect SVR12 or adherence to HCV therapy. Among 18 patients with posttreatment viral recurrence through 24-week follow-up, 6 had probable reinfection. If the probable reinfections were assumed to be responses, SVR12 was 94.0% (CI, 89.8% to 96.9%) in the ITG. One patient in the ITG (1 of 201) and 1 in the placebo-phase DTG (1 of 100) discontinued treatment because of an adverse event.
  
  
  
  These findings may not be generalizable to PWID who are not receiving OAT, nor do they apply to persons with genotype 3 infection, a common strain in PWID.
  
  
  
  Patients with HCV infection who were receiving OAT and treated with elbasvir-grazoprevir had high rates of SVR12, regardless of ongoing drug use. These results support the removal of drug use as a barrier to interferon-free HCV treatment for patients receiving OAT.
  
  
  
  Merck & Co.
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Dore
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Frederick
authors.initials: F
authors.lastname: Altice
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Alain H
authors.initials: AH
authors.lastname: Litwin
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Olav
authors.initials: O
authors.lastname: Dalgard
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Gane
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Oren
authors.initials: O
authors.lastname: Shibolet
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Anne
authors.initials: A
authors.lastname: Luetkemeyer
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Ronald
authors.initials: R
authors.lastname: Nahass
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Cheng-Yuan
authors.initials: CY
authors.lastname: Peng
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Brian
authors.initials: B
authors.lastname: Conway
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Jason
authors.initials: J
authors.lastname: Grebely
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Anita Y M
authors.initials: AY
authors.lastname: Howe
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Isaias N
authors.initials: IN
authors.lastname: Gendrano
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Erluo
authors.initials: E
authors.lastname: Chen
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Hsueh-Cheng
authors.initials: HC
authors.lastname: Huang
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Dutko
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: David C
authors.initials: DC
authors.lastname: Nickle
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Bach-Yen
authors.initials: BY
authors.lastname: Nguyen
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Janice
authors.initials: J
authors.lastname: Wahl
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Eliav
authors.initials: E
authors.lastname: Barr
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Michael N
authors.initials: MN
authors.lastname: Robertson
authors.affiliation: From The Kirby Institute, UNSW Australia, Sydney, Australia; Yale School of Medicine, New Haven, Connecticut; Montefiore Medical Center, Bronx, New York; Akershus University Hospital, Lorenskog, Norway; Auckland Clinical Studies, Auckland, New Zealand; Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; University of California, San Francisco, San Francisco, California; ID Care, Hillsborough, New Jersey; China Medical University, Taichung, Taiwan; Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada; and Merck & Co., Kenilworth, New Jersey.
authors.forename: Heather L
authors.initials: HL
authors.lastname: Platt
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001572:Benzofurans / Q000009:adverse effects / Q000627:therapeutic use*; D002047:Buprenorphine / Q000627:therapeutic use; D000069479:Buprenorphine, Naloxone Drug Combination / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D024882:Drug Resistance, Viral; D005260:Female; D005838:Genotype; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000235:genetics; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence; D008691:Methadone / Q000627:therapeutic use; D008875:Middle Aged; D058850:Opiate Substitution Treatment; D009293:Opioid-Related Disorders / Q000150:complications / Q000188:drug therapy*; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D015819:Substance Abuse, Intravenous / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D001572:Benzofurans; D000069479:Buprenorphine, Naloxone Drug Combination; D004338:Drug Combinations; D007093:Imidazoles; D011810:Quinoxalines; C000611265:elbasvir-grazoprevir drug combination; D002047:Buprenorphine; D008691:Methadone