Clinical trial NCT03303599: Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6
Official title: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C
Sustained Virological Response
Chronic Hepatitis C genotype 1
Chronic Hepatitis C genotype 2
Chronic Hepatitis C genotype 3
Chronic Hepatitis C genotype 4
Chronic Hepatitis C genotype 5
Chronic Hepatitis C genotype 6
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-10-06
Enrollment: 2118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
timeFrame: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir
Secondary outcomes:
measure: Percentage of Participants Taking Concomitant Medications
timeFrame: Up to approximately 28 weeks
measure: Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed
timeFrame: Up to approximately 16 weeks
measure: Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Up to 16 weeks
measure: Number of Healthcare Resource Utilization (HCRU)
timeFrame: Up to approximately 28 weeks
measure: Percentage of Participants Using Each Treatment Regimen
timeFrame: Up to 16 weeks
measure: Percentage of Participants with Co-morbidities
timeFrame: Baseline (Day 1)
Other outcomes:
Locations:
city: Klagenfurt Am Woerthersee
country: Austria
facility: Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931
state: Kaernten
city: St. Pölten
country: Austria
facility: University Hospital St. Polten /ID# 169918
state: Niederoesterreich
city: Linz
country: Austria
facility: KH der Elisabethinen Linz GmbH /ID# 169915
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz /ID# 169932
state: Steiermark
city: Hall in Tirol
country: Austria
facility: Landeskrankenhaus Hall /ID# 169930
state: Tirol
city: Innsbruck
country: Austria
facility: Landeskrankenhaus /ID# 169922
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen /ID# 169916
city: Wien
country: Austria
facility: Wilhelminenspital der Stadt Wien /ID# 169914
city: Edegem
country: Belgium
facility: Uza /Id# 170960
state: Antwerpen
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 170964
state: Bruxelles-Capitale
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis /ID# 170876
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent /ID# 170922
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 170921
state: Vlaams-Brabant
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie Picarde /ID# 200822
state: Wallonne, Region
city: Antwerpen
country: Belgium
facility: Zna /Id# 170927
city: Brussels
country: Belgium
facility: CHU Saint-Pierre /ID# 170920
city: Brussels
country: Belgium
facility: Hopital Erasme /ID# 170918
city: Bruxelles
country: Belgium
facility: CHU Brugmann /ID# 170956
city: Genk
country: Belgium
facility: Z.O.L - Campus St. Jan /ID# 171058
city: Gent
country: Belgium
facility: AZ Middelares Gent /ID# 170874
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis /ID# 170958
city: Kortrijk
country: Belgium
facility: AZ Groeninge /ID# 170931
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 170930
city: Liege
country: Belgium
facility: CHC Liege /ID# 170926
city: Mons
country: Belgium
facility: CHU Ambroise Pare /ID# 171107
city: Uccle
country: Belgium
facility: Clinique Edith Cavell /ID# 170932
city: Yvoir
country: Belgium
facility: CHU Dinant Godinne /ID# 170929
city: Orleans CEDEX 2
country: France
facility: CHR Orleans - Hopital de la Source /ID# 202360
state: Centre-Val De Loire
city: Niort CEDEX
country: France
facility: CH Georges Renon /ID# 202737
state: Deux-Sevres
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 208502
state: Doubs
city: Limoges CEDEX 1
country: France
facility: CHU Dupuytren /ID# 202514
state: Franche-Comte
city: Pessac CEDEX
country: France
facility: Hopital Haut-Lévêque /ID# 202501
state: Gironde
city: TOULOUSE Cedex 9
country: France
facility: Hopital Purpan /ID# 202357
state: Haute-Garonne
city: TOULOUSE Cedex 9
country: France
facility: Hopital Purpan /ID# 204201
state: Haute-Garonne
city: Epagny Metz Tessy
country: France
facility: CH Annecy Genevois Site Annecy /ID# 202804
state: Haute-Savoie
city: Limoges
country: France
facility: CH Spécialisé Esquirol /ID# 204522
state: Haute-Vienne
city: Beziers CEDEX
country: France
facility: Centre Hospitalier de Béziers /ID# 202948
state: Herault
city: Montpellier CEDEX 5
country: France
facility: Hopital Saint Eloi /ID# 202512
state: Herault
city: Clichy
country: France
facility: Hopital Beaujon /ID# 202675
state: Ile-de-France
city: St Malo CEDEX
country: France
facility: Hopital Broussais /ID# 202677
state: Ille-et-Vilaine
city: Vandoeuvre les Nancy CEDEX
country: France
facility: CHU NANCY - Hopital Brabois Adultes /ID# 202570
state: Meurthe-et-Moselle
city: Marseille CEDEX 05
country: France
facility: Hopital de la Timone /ID# 202792
state: Provence-Alpes-Cote-d Azur
city: Rouen CEDEX
country: France
facility: Charles Nicolle CHU Rouen /ID# 203518
state: Seine-Maritime
city: Creteil
country: France
facility: Centre Hosp Intercommunal de Creteil /ID# 202566
state: Val-de-Marne
city: Aix En Provence
country: France
facility: Cabinet medical /ID# 202794
city: Angers
country: France
facility: CHU d'Angers /ID# 202500
city: Bordeaux
country: France
facility: Clinique du Tondu /ID# 207508
city: Bourgoin Jallieu
country: France
facility: Centre Endo Nord Isere /ID# 204181
city: Brest
country: France
facility: Hopital de la Cavale Blanche /ID# 202640
city: Clamart
country: France
facility: Hopital Antoine Beclere /ID# 202676
city: Clermont Ferrand
country: France
facility: CHU Estaing /ID# 202949
city: Creteil
country: France
facility: Hopital Henri Mondor /ID# 202806
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 202957
city: Hyeres
country: France
facility: CH d'Hyeres /ID# 202515
city: Le Port
country: France
facility: Dr. Cuissard, Le Port, FR /ID# 203487
city: Lorient
country: France
facility: C.H. de Bretagne Sud /ID# 202362
city: Lyon
country: France
facility: Hopital de la Croix Rousse /ID# 203071
city: Lyon
country: France
facility: Hopital Edouard Herriot /ID# 203149
city: Marseille
country: France
facility: Hopital Europeen /ID# 205073
city: Marseille
country: France
facility: Hopital Saint Joseph /ID# 202519
city: Nanterre
country: France
facility: Cabinet Medical, Boyer Darrigr /ID# 202050
city: Nice
country: France
facility: Hopital l'Archet 2 /ID# 205295
city: Nimes Cedex 9
country: France
facility: CHU Nimes /ID# 208200
city: Paris Cedex 12
country: France
facility: Hopital Saint Antoine /ID# 202565
city: Paris
country: France
facility: Hopital Bichat-Claude Bernard /ID# 202513
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 202364
city: Perpignan
country: France
facility: Centre Hospitalier PERPIGNAN /ID# 205762
city: Reims
country: France
facility: Hopital Robert Debre /ID# 202953
city: Saint Laurent Du Var
country: France
facility: Institut Arnault Tzanck /ID# 202363
city: St Jean de Vedas
country: France
facility: Gastrodoc /Id# 206290
city: Toulon
country: France
facility: Cabinet Medical, Dr. Constant, /ID# 202361
city: Toulouse
country: France
facility: Clinique Amroise Pare /ID# 205064
city: Toulouse
country: France
facility: Hopital Joseph Ducuing /ID# 205666
city: Tourcoing
country: France
facility: Ctre Hospitalier de Tourcoing /ID# 202358
city: Tourcoing
country: France
facility: Ctre Hospitalier de Tourcoing /ID# 202805
city: Villejuif
country: France
facility: Hopital Paul Brousse /ID# 202623
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 206421
state: Attiki
city: Kifissia
country: Greece
facility: General Oncological Hospital of Kifisia Oi Agioi Anargyroi /ID# 206419
state: Attiki
city: Piraeus
country: Greece
facility: Tzaneio general hospital of Piraeus /ID# 208828
state: Attiki
city: Nea Efkarpia
country: Greece
facility: Papageorgiou General Hospital Thessaloniki /ID# 207980
state: Thessaloniki
city: Alexandroupolis
country: Greece
facility: Gen Univ Hosp Alexandroupolis /ID# 206416
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206414
city: Pireaus
country: Greece
facility: General Hospital Nikaias-Piraeus St. Panteleimon /ID# 206420
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki /ID# 207981
city: Thessaloniki
country: Greece
facility: University Gen Hosp AHEPA /ID# 209961
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center /ID# 206417
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center /ID# 169321
state: HaDarom
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 169318
city: Be'er Ya'akov
country: Israel
facility: Assaf Harofeh Medical Center /ID# 169370
city: Gush Dan
country: Israel
facility: Maccabi Health Services /ID# 169372
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center /ID# 169368
city: Haifa
country: Israel
facility: Rambam Medical Center /ID# 169316
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 169358
city: Haifa
country: Israel
facility: Carmel Medical Center /ID# 169309
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 169329
city: Jerusalem
country: Israel
facility: Gastroenterology Institute, Division of Medicine /ID# 169360
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 169327
city: Nahariya
country: Israel
facility: Galilee Medical Center /ID# 169325
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 169320
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 169365
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center /ID# 169313
city: Naples
country: Italy
facility: AOU Federico II /ID# 168131
state: Campania
city: Bologna
country: Italy
facility: Ospedale Sant Orsola Malpighi /ID# 168127
state: Emilia-Romagna
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 168711
state: Emilia-Romagna
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 168138
state: Lombardia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 168712
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 168137
state: Lombardia
city: Rozzano
country: Italy
facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 169353
state: Milano
city: Turin
country: Italy
facility: AOU Citta della Salute Scienza /ID# 168142
state: Piemonte
city: Rome
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata /ID# 168709
state: Roma
city: Rome
country: Italy
facility: Università Cattolica Sacro Cuore /ID# 168781
state: Roma
city: Palermo
country: Italy
facility: Policlinico Paolo Giaccone /Id# 168134
state: Sicilia
city: Bari
country: Italy
facility: Azienda Universitaria Ospedali /ID# 168129
city: Cagliari
country: Italy
facility: AOU di Cagliari - Presidio di /ID# 168132
city: Ferrara
country: Italy
facility: A.O.U Sant'Anna di Ferrara /ID# 168714
city: Foggia
country: Italy
facility: AOU Riuniti di Foggia /ID# 168143
city: Latina
country: Italy
facility: Ospedale SM Goretti /ID# 169257
city: Messina
country: Italy
facility: A.O.U. Policlinico G. Martino /ID# 168139
city: Milan
country: Italy
facility: Ospedale S. Carlo Borromeo /ID# 168144
city: Milan
country: Italy
facility: Azienda Ospedaliera Luigi Sacc /ID# 168136
city: Milan
country: Italy
facility: Azienda Ospedaliera Luigi Sacc /ID# 168140
city: Naples
country: Italy
facility: Azienda Ospedaliera di Rilievo /ID# 168141
city: Napoli
country: Italy
facility: AO Domenico Cutugno /ID# 168133
city: Napoli
country: Italy
facility: Universita degli Studi della /ID# 168135
city: Novara
country: Italy
facility: Azienda Ospedaliera Maggiore d /ID# 168710
city: Padua
country: Italy
facility: Azienda Ospedaliera di Padova /ID# 168125
city: Padua
country: Italy
facility: Azienda Ospedaliera di Padova /ID# 168126
city: Pisa
country: Italy
facility: Azienda Ospedaliero - Universi /ID# 168130
city: Rome
country: Italy
facility: IRCCS Lazzaro Spallanzani /ID# 169234
city: Salerno
country: Italy
facility: AOU OO. RR. San Giovanni di Di /ID# 168715
city: Walbrzych
country: Poland
facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego /ID# 208862
state: Dolnoslaskie
city: Zielona Gora
country: Poland
facility: NZOZ - Lubuska Specjalistyczna Poradnia Chorób Wątroby Sp. z o.o. /ID# 208449
state: Dolnoslaskie
city: Zychlin
country: Poland
facility: NZOZ Przychodnia Specjalistycz /ID# 208334
state: Lodzkie
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II /ID# 208451
state: Malopolskie
city: Opole
country: Poland
facility: Szpital Wojewodzki w Opolu /ID# 208444
state: Opolskie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 208604
state: Podlaskie
city: Chorzow
country: Poland
facility: Szpital Specjalistyczny W Chorzowie /Id# 209129
state: Slaskie
city: Katowice
country: Poland
facility: NZOZ All-Medicus /ID# 208452
state: Slaskie
city: Myslowice
country: Poland
facility: ID Clinic /ID# 208332
state: Slaskie
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Obserwacyjn /ID# 209345
city: Kielce
country: Poland
facility: Wojewódzki Szpital Zespolony w Kielcach /ID# 210569
city: Lodz
country: Poland
facility: Wojewodzki Szpit Bieganskiego /ID# 208445
city: Lodz
country: Poland
facility: Wojewodzki Szpit Bieganskiego /ID# 209608
city: Warsaw
country: Poland
facility: MED-FIX Centrum Medyczne Sp. z /ID# 208453
city: Barreiro
country: Portugal
facility: Centro Hospitalar Barreiro Montijo, EPE /ID# 211267
state: Lisboa
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova Gaia/Espinho, EPE /ID# 208195
state: Porto
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, E.P.E /ID# 207717
state: Setubal
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Central, EPE - Hospital Curry Cabral /ID# 208463
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 207910
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto EPE /ID# 207733
city: Genève
country: Switzerland
facility: Hopitaux Universitaires de Geneve /ID# 203435
state: Geneve
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 201025
state: Sankt Gallen
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsklinik /ID# 201022
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino /ID# 201024
city: Neuchatel
country: Switzerland
facility: Hopital Neuchatelois /ID# 201026
city: Zurich
country: Switzerland
facility: Universitaetsspital Zuerich /ID# 201023
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.