• Gregory J Dore, Frederick Altice, Alain H Litwin, Olav Dalgard, Edward J Gane, Oren Shibolet, Anne Luetkemeyer, Ronald Nahass, Cheng-Yuan Peng, Brian Conway, Jason Grebely, Anita Y M Howe, Isaias N Gendrano, Erluo Chen, Hsueh-Cheng Huang, Frank J Dutko, David C Nickle, Bach-Yen Nguyen, Janice Wahl, Eliav Barr, Michael N Robertson, Heather L Platt, and C-EDGE CO-STAR Study Group.
• 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.
• Ann. Intern. Med. 2016 Nov 1; 165 (9): 625-634.

BackgroundHepatitis C virus (HCV) infection is common in persons who inject drugs (PWID).ObjectiveTo evaluate elbasvir-grazoprevir in treating HCV infection in PWID.DesignRandomized, placebo-controlled, double-blind trial. (ClinicalTrials.gov: NCT02105688).SettingAustralia, Canada, France, Germany, Israel, the Netherlands, New Zealand, Norway, Spain, Taiwan, the United Kingdom, and the United States.Patients301 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).InterventionThe 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.MeasurementsThe 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.ResultsThe 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.LimitationThese 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.ConclusionPatients 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.Primary Funding SourceMerck & Co.

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