Highlights in Hepatitis C Virus from the 2017 AASLD Liver Meeting

December 2017 Volume 13, Issue 12, Supplement 5 A SPECIAL MEETING REVIEW EDITION Highlights in Hepatitis C Virus From the 2017 AASLD Liver Meeting A Review of Selected Presentations From the 2017 AASLD Liver Meeting • October 20-24, 2017 • Washington, DC Special Reporting on: • Efficacy, Safety, and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis • Hepatitis C Virus Reinfection and Injecting Risk Behavior Following Elbasvir/Grazoprevir Treatment in Participants on Opiate Agonist Therapy: Co-STAR Part B • Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Treatment-Naive Patients With Chronic HCV Genotype 3: An Integrated Phase 2/3 Analysis • SOF/VEL/VOX for 12 Weeks in NS5A-Inhibitor–Experienced HCV-Infected Patients: Results of the Deferred Treatment Group in the Phase 3 POLARIS-1 Study • Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and SVR12 in HCV-Infected Patients: An Integrated Analysis of the Phase 2/3 Clinical Trial Program • The C-BREEZE 1 and 2 Studies: Efficacy and Safety of Ruzasvir Plus Uprifosbuvir for 12 Weeks in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 3, 4, or 6 Infection • 100% SVR With 8 Weeks of Ledipasvir/Sofosbuvir in HIV-Infected Men With Acute HCV Infection: Results From the SWIFT-C Trial (Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1–Infected Individuals) PLUS Meeting Abstract Summaries With Expert Commentary by: Fred Poordad, MD Chief, Hepatology University Transplant Center Clinical Professor of Medicine The University of Texas Health, San Antonio San Antonio, Texas ON THE WEB: gastroenterologyandhepatology.net Indexed through the National Library of Medicine (PubMed/Medline), PubMed Central (PMC), and EMBASE EDITORIAL ADVISORY BOARD Learn more at WWW.MAVYRET.COM EDITOR-IN-CHIEF: Brooks D. Cash, MD Maureen M. Jonas, MD K. Rajender Reddy, MD National Naval Medical Center Children’s Hospital Boston University of Pennsylvania Gary R. Lichtenstein, MD University of Pennsylvania Lin Chang, MD Sunanda V. Kane, MD, MSPH Douglas K. Rex, MD David Geffen School of Medicine Mayo Clinic Indiana University Medical Center SECTION EDITORS: University of California, Los Angeles Philip O. Katz, MD Joel E. Richter, MD, FACP, MACG Todd H. Baron, MD Albert Einstein Medical Center University of South Florida FOR CHRONIC HCV University of North Carolina Russell D. Cohen, MD at Chapel Hill School of Medicine University of Chicago Seymour Katz, MD, FACG, David T. Rubin, MD MACG University of Chicago William D. Chey, MD Scott J. Cotler, MD New York University University of Michigan Medical University of Illinois at Chicago Paul Rutgeerts, MD TREAT ALL GENOTYPES Center Asher Kornbluth, MD Katholieke Universiteit Leuven Douglas Dieterich, MD Mount Sinai Medical Center Robert G. Gish, MD Mount Sinai Medical Center Sammy Saab, MD, MPH Stanford University Joshua Korzenik, MD David Geffen School Adrian M. Di Bisceglie, MD Massachusetts General of Medicine IN AS FEW AS 8 WEEKS Saint Louis University Hospital University of California, Stephen B. Hanauer, MD Los Angeles Northwestern University Feinberg Jack A. Di Palma, MD Brian E. Lacy, MD, PhD THE ONLY 8-WEEK PANGENOTYPIC REGIMEN FOR School of Medicine University of South Alabama Dartmouth-Hitchcock Medical Seymour M. Sabesin, MD Center Rush University Eugene R. Schiff, MD David B. Doman, MD Medical Center TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS University of Miami Miller School George Washington University Jonathan A. Leighton, MD of Medicine School of Medicine Mayo Clinic William J. Sandborn, MD Duration is dependent on treatment history, genotype, or University of California the presence of compensated cirrhosis. Refer to the full Herbert L. DuPont, MD Anthony J. Lembo, MD San Diego Prateek Sharma, MD University of Texas–Houston Beth Israel Deaconess Prescribing Information for further dosing information. University of Kansas School of School of Public Health and Medical Center Ellen J. Scherl, MD Medicine Baylor College of Medicine Weill Medical College Richard MacDermott, MD Cornell University Gary W. Falk, MD Albany Medical Center New York-Presbyterian Hospital University of Pennsylvania 1 1 Willis C. Maddrey, MD Philip S. Schoenfeld, MD, INDICATION CONTRAINDICATIONS Maria T. Abreu, MD Ronnie Fass, MD University of Texas Southwestern MEd, MSc University of Miami MAVYRET™ (glecaprevir and pibrentasvir) tablets MAVYRET is contraindicated: Case Western Reserve University Medical Center University of Michigan School of Medicine are indicated for the treatment of adult patients with • In patients with severe hepatic impairment Brian G. Feagan, MD Uma Mahadevan-Velayos, MD Bo Shen, MD Leonard Baidoo, MD chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, (Child-Pugh C) University of Western Ontario University of California, The Cleveland Clinic Northwestern University or 6 infection without cirrhosis or with compensated San Francisco • With the following drugs: atazanavir or rifampin Feinberg School of Medicine M. Brian Fennerty, MD Mitchell Shiffman, MD cirrhosis (Child-Pugh A). MAVYRET is also indicated Oregon Health & Science Paul Martin, MD Liver Institute of Virginia 1 John Baillie, MB ChB, FRCP for the treatment of adult patients with HCV genotype University University of Miami Bon Secours Health System WARNINGS AND PRECAUTIONS Virginia Commonwealth University 1 infection, who previously have been treated with Risk of Reduced Therapeutic Effect Due to School of Medicine a regimen containing an HCV NS5A inhibitor or an Steven L. Flamm, MD Philip B. Miner Jr., MD Corey A. Siegel, MD Concomitant Use of MAVYRET with Carbamazepine, Northwestern University Oklahoma School of Medicine Dartmouth-Hitchcock Robert N. Baldassano, MD NS3/4A protease inhibitor (PI), but not both. Feinberg School of Medicine Medical Center Efavirenz-containing Regimens, or St. John’s Wort Children’s Hospital of Philadelphia Kevin D. Mullen, MD University of Pennsylvania 1 • Carbamazepine, efavirenz, and St. John’s Wort Basavana Goudra, MD Metrohealth Medical Center Jerome H. Siegel, MD IMPORTANT SAFETY INFORMATION University of Pennsylvania may significantly decrease plasma concentrations Theodore Bayless, MD Beth Israel Medical Center WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION Guy W. Neff, MD, MBA Johns Hopkins Hospital of glecaprevir and pibrentasvir, leading to reduced Tarek Hassanein, MD Tampa General Medical Group Mark Sulkowski, MD IN PATIENTS COINFECTED WITH HCV AND HBV: Test University of California, therapeutic effect of MAVYRET. The use of these Manoop S. Bhutani, MD Johns Hopkins University all patients for evidence of current or prior hepatitis B San Diego Marion G. Peters, MD agents with MAVYRET is not recommended. University of Texas School of Medicine virus (HBV) infection before initiating treatment with University of California, M. D. Anderson Cancer Center Colin W. Howden, MD San Francisco Nicholas J. Talley, MD, PhD MAVYRET. HBV reactivation has been reported in HCV/ 1 University of Tennessee ADVERSE REACTIONS Athos Bousvaros, MD, MPH Mayo Clinic HBV coinfected patients who were undergoing or had Health Science Center Mark Pimentel, MD, FRCP(C) Most common adverse reactions observed with Children’s Hospital Boston completed treatment with HCV direct-acting antivirals Cedars-Sinai Medical Center Michael F. Vaezi, MD, PhD MAVYRET: Ira M. Jacobson, MD and were not receiving HBV antiviral therapy. Some Thomas D. Boyer, MD Vanderbilt University Icahn School of Medicine Paul J. Pockros, MD • >10% of subjects: headache and fatigue University of Arizona Medical Center cases have resulted in fulminant hepatitis, hepatic at Mount Sinai Scripps Clinic failure, and death. Monitor HCV/HBV coinfected • ≥5% of subjects: headache, fatigue, and nausea Joel V. Brill, MD Fernando Velayos, MD David L. Jaffe, MD Fred Poordad, MD patients for hepatitis flare or HBV reactivation during Predictive Health, LLC University of California, University of Pennsylvania The University of Texas Health San Francisco HCV treatment and post-treatment follow-up. Initiate Please see following page for a brief summary of the School of Medicine San Antonio Robert S. Brown, Jr., MD, MPH appropriate patient management for HBV infection as full Prescribing Information. Columbia University Nizar Zein, MD Lennox J. Jeffers, MD Eamonn M. M. Quigley, MD clinically indicated. Reference: 1. MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017. Medical Center Cleveland Clinic Foundation University of Miami Houston Methodist Hospital ©2017 AbbVie Inc. North Chicago, IL 60064 46A-1928484 October 2017 Printed in U.S.A. 14_1944 46A-1928484_MAVYRET_ACG_Print_Ad_A-Size_mm.indd 1 10/18/17 1:48 PM Learn more at WWW.MAVYRET.COM FOR CHRONIC HCV TREAT ALL GENOTYPES IN AS FEW AS 8 WEEKS THE ONLY 8-WEEK PANGENOTYPIC REGIMEN FOR TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS Duration is dependent on treatment history, genotype, or the presence of compensated cirrhosis. Refer to the full Prescribing Information for further dosing information. INDICATION1 CONTRAINDICATIONS1 MAVYRET™ (glecaprevir and pibrentasvir) tablets MAVYRET is contraindicated: are indicated for the treatment of adult patients with • In patients with severe hepatic impairment chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, (Child-Pugh C) or 6 infection without cirrhosis or with compensated • With the following drugs: atazanavir or rifampin cirrhosis (Child-Pugh

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