World Congress at ACG2017

Simultaneous Plenary Session 1A: Liver

11 - Integrated Efficacy and Safety of Glecaprevir/Pibrentasvir to Treat HCV Genotype 1-6 Infection in Patients Without Cirrhosis Including HIV Co-Infection

Monday, October 16
4:30 PM - 4:40 PM
Location: Valencia Ballroom A (Level 4)



Category: Liver       

David E. Bernstein, MD, FACG1, Graham Foster, MD, PhD2, Douglas Dylla, PhD3, Stefan Mauss, MD4, David Nelson, MD5, Tarik Asselah, MD6, Steven Flamm, MD7, Curtis Cooper, MD8, Ran Liu, PhD3, Rolando Viani, MD3, Stanley Wang, MD, PhD3, Federico Mensa, MD3, Mark Sulkowski, MD9
1Hofstra Northwell School of Medicine, Manhasset, NY; 2Queen Mary University of London, London, United Kingdom; 3AbbVie, Inc., North Chicago, IL; 4Zentrum für HIV und Hepatogastroenterologie, Düsseldorf, Germany; 5University of Florida, Gainesville, FL; 6Hopital Beaujon, Clichy, France; 7Northwestern University Feinberg School of Medicine, Chicago, IL; 8University of Ottawa, Ottawa, ON, Canada; 9Johns Hopkins University School of Medicine, Baltimore, MD
Introduction: Glecaprevir, an NS3/4A protease inhibitor (developed by AbbVie and Enanta) and pibrentasvir (NS5A inhibitor), collectively G/P, is a once-daily, pangenotypic, direct-acting antiviral (DAA) regimen shown to be efficacious in the treatment of all major genotypes (GT) of hepatitis C virus (HCV). Here, we present an integrated efficacy and safety analysis of 8-, 12-, and 16-week durations of G/P in non-cirrhotic HCV GT 1-6 patients, including those with HIV co-infection.

Methods: Data were pooled from the SURVEYOR-I and –II and ENDURANCE-1, -2, -3, and –4, and EXPEDITION-2 and -4 studies. Patients were either treatment-naïve or treatment-experienced with interferon (IFN), pegIFN ± ribavirin (RBV), or sofosbuvir (SOF) + RBV ± pegIFN. Patients with experience to a DAA other than SOF were excluded. Patients with GT1, 2, 4, 5, and 6 infection received 8 or 12 weeks of G/P regardless of treatment history, whereas treatment-experienced GT3-infected patients received 16 weeks of G/P. Efficacy was evaluated as the rate of sustained virologic response (HCV RNA < lower limit of quantification) at 12 weeks post-treatment (SVR12) using a modified intent-to-treat analysis excluding those not achieving SVR for reasons other than virologic failure. Safety was assessed in all patients.

Results: In total, 2063 chronic HCV patients without cirrhosis were included in the analysis comprised of 55% (1135/2063) males, 79% (1639/2063) white race, 24% (494/2063) treatment experienced, and 8% (170/2063) HIV co-infected. SVR12 rates are shown in Figure 1 according to treatment duration and genotype. In the modified intent-to-treat (mITT) population, overall SVR12 rates were 99.1% for the 8-week (943/952) and 99.6% for the 12-week groups (1060/1064). The SVR12 rate was 95% (21/22) for treatment-experienced GT3 patients receiving 16-weeks of G/P. In patients with HIV co-infection, 100% (169/169) of patients achieved SVR12. Overall, G/P was well-tolerated with 1 ( < 0.1%) DAA-related serious adverse events and 10 (0.5%) adverse events leading to treatment discontinuation.

Discussion: G/P for 8, 12, and 16 weeks in chronic HCV GT1-6 infected patients without cirrhosis was well-tolerated and achieved high SVR12 rates. These data suggest that the majority of patients without cirrhosis can be treated for 8 weeks with G/P.

Supported by Industry Grant: No

Disclosures: Does Disclose

David Bernstein: AbbVie Inc. – Consultant, Grant/Research Support, Speaker. Bristol-Myers Squibb – Consultant, Grant/Research Support, Speaker. Gilead Sciences – Consultant, Grant/Research Support, Speaker. Merck & Co. – Consultant, Grant/Research Support, Speaker.
Graham Foster: AbbVie Inc. – Consultant, Grant/Research Support. Bristol-Myers Squibb – Consultant, Grant/Research Support. Gilead Sciences – Consultant, Grant/Research Support. GlaxoSmithKline – Consultant. Janssen Pharmaceutical – Consultant, Grant/Research Support. Merck & Co. – Consultant, Grant/Research Support. Novartis International – Consultant, Grant/Research Support. Roche/Genetech – Consultant, Grant/Research Support. Vertex Pharmaceuticals – Consultant. Virco Pharmaceuticals Inc. – Consultant.
Douglas Dylla: AbbVie Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Stefan Mauss: AbbVie Inc. – Consultant, Speaker. Bristol-Myers Squibb – Consultant, Speaker. Gilead Sciences – Consultant, Speaker. Hexal AG – Speaker. Janssen Pharmaceutical – Consultant, Speaker. MSD – Consultant, Speaker. ViiV Healthcare – Consultant.
David Nelson: Abbott Labs – Grant/Research Support. Bayer – Grant/Research Support. Boehringer Ingelheim – Grant/Research Support. Bristol-Myers Squibb – Grant/Research Support. Genetech – Grant/Research Support. Gilead Sciences – Grant/Research Support. Idenix Pharmaceuticals, Inc. – Grant/Research Support. Janssen Pharmaceutical – Grant/Research Support. Merck & Co. – Grant/Research Support. Vertex Pharmaceuticals – Grant/Research Support.
Tarik Asselah: AbbVie Inc. – Advisory Committee/Board Member, Speaker and Investigator. Bristol-Myers Squibb – Advisory Committee/Board Member, Speaker and Investigator. Gilead Sciences – Advisory Committee/Board Member, Speaker and Investigator. Janssen Pharmaceutical – Advisory Committee/Board Member, Speaker and Investigator. Merck & Co. – Advisory Committee/Board Member, Speaker and Investigator. Roche – Advisory Committee/Board Member, Speaker and Investigator.
Steven Flamm: AbbVie Inc. – Consultant, Grant/Research Support. Bristol-Myers Squibb – Consultant, Grant/Research Support. Gilead Sciences – Consultant, Grant/Research Support. Merck & Co. – Consultant, Grant/Research Support.
Curtis Cooper: AbbVie Inc. – Advisory Committee/Board Member, Grant/Research Support, Speaker. Gilead Sciences – Advisory Committee/Board Member, Grant/Research Support, Speaker. Merck & Co. – Advisory Committee/Board Member, Grant/Research Support, Speaker.
Ran Liu: AbbVie Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Rolando Viani: AbbVie Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Stanley Wang: AbbVie Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Federico Mensa: AbbVie Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Mark Sulkowski: AbbVie Inc. – Advisory Committee/Board Member, Consultant, Grant/Research Support. Cocrystal Pharma Inc. – Advisory Committee/Board Member, Consultant. Gilead Sciences – Advisory Committee/Board Member, Consultant, Grant/Research Support. Janssen Pharmaceutical – Advisory Committee/Board Member, Consultant. Merck & Co. – Grant/Research Support. Trek Therapeutics – Advisory Committee/Board Member, Consultant.

Figure 1: mITT Analysis of Integrated Efficacy for 8-, 12-, and 16-week G/P treatment

Citation: . INTEGRATED EFFICACY AND SAFETY OF GLECAPREVIR/PIBRENTASVIR TO TREAT HCV GENOTYPE 1-6 INFECTION IN PATIENTS WITHOUT CIRRHOSIS INCLUDING HIV CO-INFECTION. Program No. 11. World Congress of Gastroenterology at ACG2017 Meeting Abstracts. Orlando, FL: American College of Gastroenterology.

David E. Bernstein

Professor of Medicine
Hofstra Northwell School of Medicine
Manhasset, NY, US

David Bernstein, MD, FACG, is the VIce Chair of Medicine for Clinical Trials, Chief of Hepatology and Director of the Sandra Atlas Bass Center for Liver Diseases at Northwell Health. He is Professor of Medicine at the Hofstra Northwell School of Medicine. He graduated from Johns Hopkins University and received his MD from SUNY Stony Brook School of Medicine. He completed his training in Gastroenterology and Hepatology at the University of Miami/Jackson Memorial Hospital in Miami, FL, under the direction of Dr. Eugene Schiff. Dr. Bernstein has participated in more than 200 large clinical and investigator-initiated research trials.

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