Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.

This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.

Study Overview

• Status: Completed
• Conditions: Hepatitis C

• Study Type: Observational
• Enrollment (Actual): 2118

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Landeskrankenhaus /ID# 169922
  • Wels, Austria, 4600
    • Klinikum Wels - Grieskirchen /ID# 169916
  • Wien, Austria, 1160
    • Wilhelminenspital der Stadt Wien /ID# 169914
  • Kaernten
    • Klagenfurt Am Woerthersee, Kaernten, Austria, 9020
      • Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931
  • Niederoesterreich
    • St. Pölten, Niederoesterreich, Austria, 3100
      • University Hospital St. Polten /ID# 169918
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4010
      • KH der Elisabethinen Linz GmbH /ID# 169915
  • Steiermark
    • Graz, Steiermark, Austria, 8020
      • Medizinische Universität Graz /ID# 169932
  • Tirol
    • Hall in Tirol, Tirol, Austria, 6060
      • Landeskrankenhaus Hall /ID# 169930
• Belgium
  • Antwerpen, Belgium, 2060
    • Zna /Id# 170927
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre /ID# 170920
  • Brussels, Belgium, 1070
    • Hopital Erasme /ID# 170918
  • Bruxelles, Belgium, 1020
    • CHU Brugmann /ID# 170956
  • Genk, Belgium, 3600
    • Z.O.L - Campus St. Jan /ID# 171058
  • Gent, Belgium, 9000
    • AZ Middelares Gent /ID# 170874
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis /ID# 170958
  • Kortrijk, Belgium, 8500
    • AZ Groeninge /ID# 170931
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 170930
  • Liege, Belgium, 4000
    • CHC Liege /ID# 170926
  • Mons, Belgium, 7000
    • CHU Ambroise Pare /ID# 171107
  • Uccle, Belgium, 1180
    • Clinique Edith Cavell /ID# 170932
  • Yvoir, Belgium, 5530
    • CHU Dinant Godinne /ID# 170929
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Uza /Id# 170960
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • UCL Saint-Luc /ID# 170964
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Algemeen Stedelijk Ziekenhuis /ID# 170876
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 170922
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 170921
  • Wallonne, Region
    • Tournai, Wallonne, Region, Belgium, 7500
      • Centre Hospitalier de Wallonie Picarde /ID# 200822
• France
  • Aix En Provence, France, 13100
    • Cabinet medical /ID# 202794
  • Angers, France, 49933
    • CHU d'Angers /ID# 202500
  • Bordeaux, France, 33082
    • Clinique du Tondu /ID# 207508
  • Bourgoin Jallieu, France, 38300
    • Centre Endo Nord Isere /ID# 204181
  • Brest, France, 29609
    • Hopital de la Cavale Blanche /ID# 202640
  • Clamart, France, 92140
    • Hopital Antoine Beclere /ID# 202676
  • Clermont Ferrand, France, 63100
    • CHU Estaing /ID# 202949
  • Creteil, France, 94010
    • Hopital Henri Mondor /ID# 202806
  • Grenoble, France, 38043
    • Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 202957
  • Hyeres, France, 83407
    • CH d'Hyeres /ID# 202515
  • Le Port, France, 97420
    • Dr. Cuissard, Le Port, FR /ID# 203487
  • Lorient, France, 56322
    • C.H. de Bretagne Sud /ID# 202362
  • Lyon, France, 69004
    • Hopital de la Croix Rousse /ID# 203071
  • Lyon, France, 69437
    • Hopital Edouard Herriot /ID# 203149
  • Marseille, France, 13003
    • Hopital Europeen /ID# 205073
  • Marseille, France, 13008
    • Hopital Saint Joseph /ID# 202519
  • Nanterre, France, 92000
    • Cabinet Medical, Boyer Darrigr /ID# 202050
  • Nice, France, 06202
    • Hopital l'Archet 2 /ID# 205295
  • Nimes Cedex 9, France, 30029
    • CHU Nimes /ID# 208200
  • Paris, France, 75018
    • Hopital Bichat-Claude Bernard /ID# 202513
  • Paris, France, 75651
    • Hopital Pitie Salpetriere /ID# 202364
  • Paris Cedex 12, France, 75571
    • Hopital Saint Antoine /ID# 202565
  • Perpignan, France, 66000
    • Centre Hospitalier PERPIGNAN /ID# 205762
  • Reims, France, 51092
    • Hopital Robert Debre /ID# 202953
  • Saint Laurent Du Var, France, 06721
    • Institut Arnault Tzanck /ID# 202363
  • St Jean de Vedas, France, 34430
    • Gastrodoc /Id# 206290
  • Toulon, France, 83000
    • Cabinet Medical, Dr. Constant, /ID# 202361
  • Toulouse, France, 31082
    • Clinique Amroise Pare /ID# 205064
  • Toulouse, France, 81059
    • Hopital Joseph Ducuing /ID# 205666
  • Tourcoing, France, 59208
    • Ctre Hospitalier de Tourcoing /ID# 202358
  • Tourcoing, France, 59208
    • Ctre Hospitalier de Tourcoing /ID# 202805
  • Villejuif, France, 94800
    • Hopital Paul Brousse /ID# 202623
  • Centre-Val De Loire
    • Orleans CEDEX 2, Centre-Val De Loire, France, 45067
      • CHR Orleans - Hopital de la Source /ID# 202360
  • Deux-Sevres
    • Niort CEDEX, Deux-Sevres, France, 79028
      • CH Georges Renon /ID# 202737
  • Doubs
    • Besancon, Doubs, France, 25000
      • CHU de Besancon - Jean Minjoz /ID# 208502
  • Franche-Comte
    • Limoges CEDEX 1, Franche-Comte, France, 87042
      • CHU Dupuytren /ID# 202514
  • Gironde
    • Pessac CEDEX, Gironde, France, 33604
      • Hopital Haut-Lévêque /ID# 202501
  • Haute-Garonne
    • TOULOUSE Cedex 9, Haute-Garonne, France, 31059
      • Hopital Purpan /ID# 202357
    • TOULOUSE Cedex 9, Haute-Garonne, France, 31059
      • Hopital Purpan /ID# 204201
  • Haute-Savoie
    • Epagny Metz Tessy, Haute-Savoie, France, 74370
      • CH Annecy Genevois Site Annecy /ID# 202804
  • Haute-Vienne
    • Limoges, Haute-Vienne, France, 87000
      • CH Spécialisé Esquirol /ID# 204522
  • Herault
    • Beziers CEDEX, Herault, France, 34525
      • Centre Hospitalier de Béziers /ID# 202948
    • Montpellier CEDEX 5, Herault, France, 34295
      • Hopital Saint Eloi /ID# 202512
  • Ile-de-France
    • Clichy, Ile-de-France, France, 92110
      • Hopital Beaujon /ID# 202675
  • Ille-et-Vilaine
    • St Malo CEDEX, Ille-et-Vilaine, France, 35403
      • Hopital Broussais /ID# 202677
  • Meurthe-et-Moselle
    • Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
      • CHU NANCY - Hopital Brabois Adultes /ID# 202570
  • Provence-Alpes-Cote-d Azur
    • Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385
      • Hopital de la Timone /ID# 202792
  • Seine-Maritime
    • Rouen CEDEX, Seine-Maritime, France, 76031
      • Charles Nicolle CHU Rouen /ID# 203518
  • Val-de-Marne
    • Creteil, Val-de-Marne, France, 94000
      • Centre Hosp Intercommunal de Creteil /ID# 202566
• Greece
  • Alexandroupolis, Greece, 68100
    • Gen Univ Hosp Alexandroupolis /ID# 206416
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206414
  • Pireaus, Greece, 18454
    • General Hospital Nikaias-Piraeus St. Panteleimon /ID# 206420
  • Thessaloniki, Greece, 54622
    • Bioclinic Thessaloniki /ID# 207981
  • Thessaloniki, Greece, 54636
    • University Gen Hosp AHEPA /ID# 209961
  • Thessaloniki, Greece, 57001
    • Interbalkan Medical Center /ID# 206417
  • Attiki
    • Athens, Attiki, Greece, 115 27
      • General Hospital of Athens Laiko /ID# 206421
    • Kifissia, Attiki, Greece, 14564
      • General Oncological Hospital of Kifisia Oi Agioi Anargyroi /ID# 206419
    • Piraeus, Attiki, Greece, 18536
      • Tzaneio general hospital of Piraeus /ID# 208828
  • Thessaloniki
    • Nea Efkarpia, Thessaloniki, Greece, 54603
      • Papageorgiou General Hospital Thessaloniki /ID# 207980
• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center /ID# 169318
  • Be'er Ya'akov, Israel, 70300
    • Assaf Harofeh Medical Center /ID# 169370
  • Gush Dan, Israel, 7565016
    • Maccabi Health Services /ID# 169372
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center /ID# 169368
  • Haifa, Israel, 3109601
    • Rambam Medical Center /ID# 169316
  • Haifa, Israel, 3339419
    • Bnai Zion Medical Center /ID# 169358
  • Haifa, Israel, 34362
    • Carmel Medical Center /ID# 169309
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center /ID# 169329
  • Jerusalem, Israel, 91120
    • Gastroenterology Institute, Division of Medicine /ID# 169360
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center /ID# 169327
  • Nahariya, Israel, 2210001
    • Galilee Medical Center /ID# 169325
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 169320
  • Ramat Gan, Israel, 5239424
    • Sheba Medical Center /ID# 169365
  • Tel Aviv, Israel, 64239
    • Tel Aviv Medical Center /ID# 169313
  • HaDarom
    • Be'er Sheva, HaDarom, Israel, 84101
      • Soroka Medical Center /ID# 169321
• Italy
  • Bari, Italy, 70120
    • Azienda Universitaria Ospedali /ID# 168129
  • Cagliari, Italy, 09042
    • AOU di Cagliari - Presidio di /ID# 168132
  • Ferrara, Italy, 44124
    • A.O.U Sant'Anna di Ferrara /ID# 168714
  • Foggia, Italy, 71121
    • AOU Riuniti di Foggia /ID# 168143
  • Latina, Italy, 04100
    • Ospedale SM Goretti /ID# 169257
  • Messina, Italy, 98125
    • A.O.U. Policlinico G. Martino /ID# 168139
  • Milan, Italy, 20153
    • Ospedale S. Carlo Borromeo /ID# 168144
  • Milan, Italy, 20157
    • Azienda Ospedaliera Luigi Sacc /ID# 168136
  • Milan, Italy, 20157
    • Azienda Ospedaliera Luigi Sacc /ID# 168140
  • Naples, Italy, 80131
    • Azienda Ospedaliera di Rilievo /ID# 168141
  • Napoli, Italy, 80131
    • AO Domenico Cutugno /ID# 168133
  • Napoli, Italy, 80138
    • Universita degli Studi della /ID# 168135
  • Novara, Italy, 28100
    • Azienda Ospedaliera Maggiore d /ID# 168710
  • Padua, Italy, 35128
    • Azienda Ospedaliera di Padova /ID# 168125
  • Padua, Italy, 35128
    • Azienda Ospedaliera di Padova /ID# 168126
  • Pisa, Italy, 56125
    • Azienda Ospedaliero - Universi /ID# 168130
  • Rome, Italy, 00149
    • IRCCS Lazzaro Spallanzani /ID# 169234
  • Salerno, Italy, 84131
    • AOU OO. RR. San Giovanni di Di /ID# 168715
  • Campania
    • Naples, Campania, Italy, 80131
      • AOU Federico II /ID# 168131
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Ospedale Sant Orsola Malpighi /ID# 168127
    • Modena, Emilia-Romagna, Italy, 41124
      • Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 168711
  • Lombardia
    • Milan, Lombardia, Italy, 20122
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 168137
    • Milano, Lombardia, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda /ID# 168138
    • Milano, Lombardia, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda /ID# 168712
  • Milano
    • Rozzano, Milano, Italy, 20089
      • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 169353
  • Piemonte
    • Turin, Piemonte, Italy, 10126
      • AOU Citta della Salute Scienza /ID# 168142
  • Roma
    • Rome, Roma, Italy, 00133
      • Fondazione PTV Policlinico Tor Vergata /ID# 168709
    • Rome, Roma, Italy, 00168
      • Università Cattolica Sacro Cuore /ID# 168781
  • Sicilia
    • Palermo, Sicilia, Italy, 90127
      • Policlinico Paolo Giaccone /Id# 168134
• Poland
  • Bydgoszcz, Poland, 85-030
    • Wojewodzki Szpital Obserwacyjn /ID# 209345
  • Kielce, Poland, 25-736
    • Wojewódzki Szpital Zespolony w Kielcach /ID# 210569
  • Lodz, Poland, 91-347
    • Wojewodzki Szpit Bieganskiego /ID# 208445
  • Lodz, Poland, 91-347
    • Wojewodzki Szpit Bieganskiego /ID# 209608
  • Warsaw, Poland, 53-522
    • MED-FIX Centrum Medyczne Sp. z /ID# 208453
  • Dolnoslaskie
    • Walbrzych, Dolnoslaskie, Poland, 58-300
      • Specjalistyczny Szpital im. dra Alfreda Sokolowskiego /ID# 208862
    • Zielona Gora, Dolnoslaskie, Poland, 65-191
      • NZOZ - Lubuska Specjalistyczna Poradnia Chorób Wątroby Sp. z o.o. /ID# 208449
  • Lodzkie
    • Zychlin, Lodzkie, Poland, 31-956
      • NZOZ Przychodnia Specjalistycz /ID# 208334
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-202
      • Krakowski Szpital Specjalistyczny im. Jana Pawla II /ID# 208451
  • Opolskie
    • Opole, Opolskie, Poland, 46-020
      • Szpital Wojewodzki w Opolu /ID# 208444
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-276
      • Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 208604
  • Slaskie
    • Chorzow, Slaskie, Poland, 41-500
      • Szpital Specjalistyczny W Chorzowie /Id# 209129
    • Katowice, Slaskie, Poland, 40-659
      • NZOZ All-Medicus /ID# 208452
    • Myslowice, Slaskie, Poland, 41-406
      • ID Clinic /ID# 208332
• Portugal
  • Lisboa, Portugal, 1069-166
    • Centro Hospitalar Universitário Lisboa Central, EPE - Hospital Curry Cabral /ID# 208463
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 207910
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto EPE /ID# 207733
  • Lisboa
    • Barreiro, Lisboa, Portugal, 2834-003
      • Centro Hospitalar Barreiro Montijo, EPE /ID# 211267
  • Porto
    • Vila Nova De Gaia, Porto, Portugal, 4434-502
      • Centro Hospitalar Vila Nova Gaia/Espinho, EPE /ID# 208195
  • Setubal
    • Almada, Setubal, Portugal, 2805-267
      • Hospital Garcia de Orta, E.P.E /ID# 207717
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitaetsklinik /ID# 201022
  • Lugano, Switzerland, 6900
    • Fondazione Epatocentro Ticino /ID# 201024
  • Neuchatel, Switzerland, CH-2000
    • Hopital Neuchatelois /ID# 201026
  • Zurich, Switzerland, 8091
    • Universitaetsspital Zuerich /ID# 201023
  • Geneve
    • Genève, Geneve, Switzerland, 1205
      • Hopitaux Universitaires de Geneve /ID# 203435
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 201025

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving GLE/PIB who have started the treatment combination recommended in the current local label for their disease characteristics.

Description

Inclusion Criteria:

• Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.
• Participants may be enrolled up to 4 weeks after treatment initiation
• Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria:

None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HCV Genotypes 1, 2, 3, 4, 5, or 6 participants; Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)	SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir	12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Taking Concomitant Medications	The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir.	Up to approximately 28 weeks
Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed	The percentage of GLE/PIB doses taken by participant in relation to the prescribed target dose (number of pills taken out of the number of pills that should have been taken).	Up to approximately 16 weeks
Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)	Among participants with renal impairment, changes from baseline during treatment in estimated glomerular filtration rate (eGFR determined by Modification of Diet in Renal Disease [MDRD] equation).	Up to 16 weeks
Number of Healthcare Resource Utilization (HCRU)	Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call) with an Health Care Provider (HCP) or designee in relation to their HCV infection during the study.	Up to approximately 28 weeks
Percentage of Participants Using Each Treatment Regimen	Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks)	Up to 16 weeks
Percentage of Participants with Co-morbidities	The percentage of participants with co-morbidities at baseline.	Baseline (Day 1)

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Aghemo A, Horsmans Y, Bourgeois S, Bondin M, Gschwantler M, Hofer H, Semmo N, Negro F, Zhang Z, Marcinak J, Veitsman E, Hazzan R, Mimidis K, Goulis I, Marques N, Flisiak R, Mazur W, Roncero C, Marra F, Pageaux GP, Asselah T, Lampertico P. Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir. Infect Dis Ther. 2021 Dec;10(4):2203-2222. doi: 10.1007/s40121-021-00455-1. Epub 2021 Jun 14. Erratum In: Infect Dis Ther. 2021 Sep 16;:
• Mullhaupt B, Semela D, Ruckstuhl L, Magenta L, Clerc O, Torgler R, Negro F, Semmo N. Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland. Swiss Med Wkly. 2021 Jan 19;151:w20399. doi: 10.4414/smw.2021.20399. eCollection 2021 Jan 18.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Hepatitis C; Chronic Hepatitis C genotype 1; Chronic Hepatitis C genotype 4; Sustained Virological Response; Chronic Hepatitis C genotype 2; Chronic Hepatitis C genotype 3; Chronic Hepatitis C genotype 5; Chronic Hepatitis C genotype 6
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic
• Other Study ID Numbers: P17-094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No