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P1565 - Real World Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Infection: A Meta-Analysis

Monday, October 28

10:30 AM - 4:15 PM

Location: Exhibit Halls 3 and 4 (Street Level)

Presenting Author(s)

MC

Markus Cornberg, MD

Hannover, Sachsen-Anhalt, Germany

Markus Cornberg, MD¹, Francesco Negro, MD², Pietro Lampertico, MD³, Juan Turnes, MD⁴, Michael P. Curry, MD⁵, Ashley Brown, MD⁶, Heiner Wedemeyer, MD⁷, Jose A. Carrion, MD⁸, Nicole Wick, MD⁹, Andreas Pangerl, MD¹⁰, Lois Larsen, PhD¹⁰, Yao Yu, PhD¹⁰, Marcello Persico, MD¹¹

¹Hannover Medical School, Hannover, Sachsen-Anhalt, Germany; ²University Hospital, Geneva, Geneve, Switzerland; ³Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Lombardia, Italy; ⁴C.H.U. Pontevedra & IIS Galicia Sur, Pontevedra, Galicia, Spain; ⁵Beth Israel Deaconess Medical Center, Boston, MA; ⁶Imperial College Healthcare NHS Trust, London, England, United Kingdom; ⁷University Clinic, Essen, Nordrhein-Westfalen, Germany; ⁸Hospital del Mar Medical Research Institute, Universitat Autonoma de Barcelona, Barcelona, Catalonia, Spain; ⁹Trio Health, La Jolla, CA; ¹⁰AbbVie, Inc., North Chicago, IL; ¹¹University of Salerno, Salerno, Campania, Italy

Introduction: Glecaprevir/pibrentasvir (G/P) is approved for adults infected with hepatitis C virus (HCV) genotypes 1–6. In clinical trials, G/P was associated with high rates of sustained virologic response at post-treatment Week 12 (SVR12) and was well tolerated. Currently, real-world evidence (RWE) regarding G/P use is being collected. A systematic review and meta-analysis of RWE reporting the effectiveness and safety of G/P were undertaken.

Methods: Biosis, Derwent Drug File, Embase®, International Pharmaceutical Abstracts, Medline®, and SciSearch databases were searched using pre-defined terms for “G/P” and “RWE” to identify real-world prospective/retrospective studies (1 January 2017‒15 October 2018) that reported SVR12 and/or safety parameters in HCV-infected adults (N≥20) treated with G/P. Congress presentations up to 12 November 2018 were included. Random effects meta-analysis was used to determine SVR12 and naïve pooling for adverse event (AE) rates. Intention-to-treat (ITT) SVR12 analyses included all patients dosed with G/P; modified ITT (mITT) excluded those who had non-virologic failure.

Results: 10,048 adults treated with G/P in 16 studies were included; ITT SVR12 rates were reported in 14 studies and mITT SVR12 rates in 11 studies. SVR12 rates overall and by subgroups based on ITT and mITT populations are shown (Table). AEs were summarised in 6 studies and reported in 12.7% (724/5685) of patients. Treatment discontinuations due to AEs were summarised in 5 studies and reported in 0.5% (24/4508) of patients. The most frequent AEs were pruritus (4.7%; 126/2698), fatigue (4.4%; 146/3305), and headache (2.7%; 102/3759). SVR12 and safety data will be updated in the final presentation.

Discussion: Consistent with results observed in clinical trials, RWE indicates that G/P is a well-tolerated and highly effective pangenotypic treatment option for a broad range of HCV-infected patients.

Disclosures:

Markus Cornberg: AbbVie – Advisory Committee/Board Member, Speaker's Bureau. Gilead – Advisory Committee/Board Member, Speaker's Bureau. Merck – Advisory Committee/Board Member, Speaker's Bureau. MSD – Advisory Committee/Board Member, Speaker's Bureau.

Francesco Negro: AbbVie – Advisory Committee/Board Member. Gilead – Advisory Committee/Board Member, Grant/Research Support. Merck – Advisory Committee/Board Member.

Pietro Lampertico: AbbVie – Advisory Committee/Board Member, Speaker's Bureau. Alnylam – Advisory Committee/Board Member, Speaker's Bureau. Arrowhead – Advisory Committee/Board Member, Speaker's Bureau. Bristol-Myers Squibb – Advisory Committee/Board Member, Speaker's Bureau. Gilead – Advisory Committee/Board Member, Speaker's Bureau. GlaxoSmithKline – Advisory Committee/Board Member, Speaker's Bureau. Janssen – Advisory Committee/Board Member, Speaker's Bureau. MSD – Advisory Committee/Board Member, Speaker's Bureau. Roche – Advisory Committee/Board Member, Speaker's Bureau.

Juan Turnes: AbbVie – Consultant, Speaker's Bureau. Gilead – Consultant, Speaker's Bureau. Gilead – Grant/Research Support. MSD – Consultant, Speaker's Bureau.

Michael P. Curry: AbbVie – Advisory Committee/Board Member. Bristol-Myers Squibb – Advisory Committee/Board Member. Gilead – Advisory Committee/Board Member, Grant/Research Support. Trio – Consultant.

Ashley Brown: AbbVie – Advisory Committee/Board Member, Consultant, Speaker's Bureau.

Heiner Wedemeyer: Abbott – Grant/Research Support. AbbVie – Grant/Research Support. Bristol-Myers Squibb – Grant/Research Support. Eiger – Grant/Research Support. Falk and Falk – Grant/Research Support. Gilead – Grant/Research Support. Merck – Grant/Research Support. MyrmbH – Advisory Committee/Board Member, Consultant. Novartis – Grant/Research Support. Roche – Grant/Research Support. Transgene – Consultant.

Jose Carrion: AbbVie – Advisory Committee/Board Member, Speaker's Bureau. Gilead – Speaker's Bureau. MSD – Speaker's Bureau.

Nicole Wick: AbbVie – Grant/Research Support. Gilead – Grant/Research Support. Merck – Grant/Research Support. Trio – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Andreas Pangerl: AbbVie – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Lois Larsen: Lois Larsen – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Yao Yu: AbbVie – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Marcello Persico: AbbVie – Consultant. Gilead – Consultant. MSD – Consultant.

Citation: Markus Cornberg, MD; Francesco Negro, MD; Pietro Lampertico, MD; Juan Turnes, MD; Michael P. Curry, MD; Ashley Brown, MD; Heiner Wedemeyer, MD; Jose A. Carrion, MD; Nicole Wick, MD; Andreas Pangerl, MD; Lois Larsen, PhD; Yao Yu, PhD; Marcello Persico, MD. P1565 - REAL WORLD EFFECTIVENESS AND SAFETY OF GLECAPREVIR/PIBRENTASVIR IN ADULTS WITH CHRONIC HEPATITIS C VIRUS INFECTION: A META-ANALYSIS. Program No. P1565. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.