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.
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.