A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Chronic Hepatitis C Virus (HCV) Infection Genotype 1 Clinical Trial

— TOPAZ-I  

Official title:

An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219490
• Other study ID #: M14-423
• Secondary ID: 2014-001022-14
• Status: Completed
• Phase: Phase 3
• Start date: October 30, 2014
• Est. completion date: May 13, 2021

Study information

• Verified date: June 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

Description:

This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT 02167945) conducted in the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1596
• Est. completion date: May 13, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Males and females at least 18 years old at screening

2. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control

3. Chronic hepatitis C, genotype 1 infection

4. Males must be surgically sterile or agree to practice acceptable forms of birth control

5. Screening laboratory result indicating HCV genotype 1 infection

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing

2. Abnormal laboratory tests

3. Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation

4. Confirmed presence of hepatocellular carcinoma

5. History of solid organ transplant

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus (HCV) Infection Genotype 1
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infections

Intervention

Drug:
• ABT-450/r/ABT-267
Tablet for oral use
• ABT-333
Tablet for oral use
• Ribavirin (RBV)
Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing = 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.

Locations

Country	Name	City	State
Algeria	CHU Bab El Oued /ID# 145420	Algiers
Algeria	CHU Bologhine Hospital /ID# 145421	Algiers
Algeria	CHU Mustapha Bacha /ID# 132130	Algiers
Australia	Royal Adelaide Hospital /ID# 131002	Adelaide	South Australia
Australia	St Vincent's Hospital Sydney /ID# 131001	Darlinghurst	New South Wales
Australia	St Vincent's Hospital Melbourne /ID# 131000	Fitzroy Melbourne	Victoria
Australia	Greenslopes Private Hospital /ID# 131003	Greenslopes	Queensland
Australia	Royal Brisbane and Women's Hospital /ID# 131004	Herston	Queensland
Australia	Nepean Hospital /ID# 130999	Kingswood	New South Wales
Australia	The Royal Melbourne Hospital /ID# 130998	Parkville	Victoria
Australia	Westmead Hospital /ID# 130997	Westmead	New South Wales
Austria	Medizinische Universitaet Graz /ID# 131018	Graz	Steiermark
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 131017	Linz	Oberoesterreich
Austria	Medizinische Universitaet Wien /ID# 131015	Vienna	Wien
Belgium	Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020	Brussels	Bruxelles-Capitale
Belgium	Universitair Ziekenhuis Leuven /ID# 131021	Leuven	Vlaams-Brabant
Belgium	UCL Saint-Luc /ID# 131019	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bulgaria	Diagnostic Consultative Center /ID# 131027	Sofia
Bulgaria	Tokuda Hospital Sofia /ID# 131022	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 131026	Sofia
Bulgaria	Univ Hosp for Active Treat /ID# 131023	Sofia
Bulgaria	UMHAT Sveta Marina /ID# 131025	Varna
Canada	University of Calgary /ID# 134370	Calgary	Alberta
Canada	GI Research & Associates /ID# 132169	Edmonton	Alberta
Canada	Clinique Medicale L'Actuel /ID# 132167	Montreal	Quebec
Canada	Jewish General Hospital /ID# 132165	Montreal	Quebec
Canada	Royal Victoria Hospital / McGill University Health Centre /ID# 132166	Montreal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 132170	Ottawa	Ontario
Canada	CHU de Quebec-Université Laval hôpital CHUL /ID# 132132	Québec	Quebec
Canada	Saint John Regional Hospital /ID# 131210	Saint John	New Brunswick
Canada	Toronto General Hospital /ID# 132134	Toronto	Ontario
Canada	Toronto Liver Centre /ID# 132168	Toronto	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 132171	Vancouver	British Columbia
Canada	LAIR Centre /ID# 130970	Vancouver	British Columbia
Canada	Vancouver Infectious Diseases Centre /ID# 134369	Vancouver	British Columbia
Canada	Toronto Digestive Disease Asso /ID# 130968	Vaughan	Ontario
Canada	University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969	Winnipeg	Manitoba
Denmark	Aarhus Univ Hospital, Skejby /ID# 131030	Aarhus
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031	Hvidovre	Hovedstaden
Denmark	Odense University Hospital /ID# 131029	Odense C	Syddanmark
Finland	Helsinki University Hospital /ID# 131034	Helsinki	Uusimaa
Finland	Turku University Hospital /ID# 131032	Turku
France	Hopital Jean Verdier /ID# 135877	Bondy
France	CHU Grenoble - Hopital Michallon /ID# 131041	La Tronche
France	CHU Limoges - Dupuytren 1 /ID# 131038	Limoges CEDEX 1	Franche-Comte
France	HCL - Hopital de la Croix-Rousse /ID# 131042	Lyon
France	Hopital Saint Joseph /ID# 132177	Marseille	Bouches-du-Rhone
France	Hopital Saint Eloi /ID# 131037	Montpellier CEDEX 5	Herault
France	CHU de Nantes, Hotel Dieu -HME /ID# 132179	Nantes	Pays-de-la-Loire
France	Duplicate_Hopital lArchet 2 /ID# 131040	Nice
France	Hopital Haut-Lévêque /ID# 131036	Pessac CEDEX	Gironde
France	CHRU Pontchaillou /ID# 132173	Rennes
France	CHU Strasbourg - Hopital Civil /ID# 132174	Strasbourg cedex
France	Hopital Universitaire Purpan Hopital Rangueil /ID# 131035	Toulouse
Germany	Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053	Berlin
Germany	Zentru fur HIV und Heaptogastroenterologie /ID# 131052	Düsseldorf	Nordrhein-Westfalen
Germany	Universitaetsklinikum Essen /ID# 131048	Essen
Germany	Universitaetsklinikum Frankfurt /ID# 131055	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Freiburg /ID# 131044	Freiburg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051	Hamburg
Germany	Medizinische Hochschule Hannover /ID# 131054	Hannover
Germany	Universitaetsklinik Heidelberg /ID# 134371	Heidelberg	Baden-Wuerttemberg
Germany	Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050	Herne	Nordrhein-Westfalen
Germany	Centrum für interdisziplinaere Medizin /ID# 131046	Muenster
Germany	LMU Klinikum der Universitat Muchen /ID# 131049	Munich	Bayern
Germany	Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045	Tubingen	Baden-Wuerttemberg
Greece	General University Hospital of Alexandroupolis /ID# 131056	Alexandroupolis
Greece	General Hospital of Athens Ippokratio /ID# 131057	Athens	Attiki
Greece	General Hospital of Athens Laiko /ID# 131088	Athens	Attiki
Ireland	Beaumont Hospital /ID# 131089	Beaumont	Dublin
Ireland	St James Hospital /ID# 132180	Dublin 8	Dublin
Ireland	St Vincent's University Hospital /ID# 132181	Elm Park	Dublin
Israel	Rambam Health Care Campus /ID# 131090	Haifa
Israel	The Lady Davis Carmel Medical Center /ID# 131091	Haifa
Israel	The Chaim Sheba Medical Center /ID# 131092	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 132182	Tel Aviv-Yafo	Tel-Aviv
Italy	Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188	Bergamo
Italy	Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102	Cona	Ferrara
Italy	Azienda Ospedaliero Universitaria Careggi /ID# 132197	Florence
Italy	Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195	Foggia
Italy	A.O.U. Policlinico G. Martino /ID# 132193	Messina
Italy	ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198	Milan
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097	Milan
Italy	Ospedale S Giuseppe /ID# 132194	Milan
Italy	Ospedale San Raffaele IRCCS /ID# 131093	Milan	Lombardia
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372	Milano
Italy	Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104	Milano
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 131096	Napoli
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 132191	Napoli
Italy	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184	Palermo
Italy	Azienda Ospedaliero-Universitaria di Parma /ID# 132183	Parma
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 132185	Rome	Roma
Italy	Policlinico Agostino Gemelli /ID# 131098	Rome	Lazio
Italy	Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 132192	Salerno
Italy	Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190	San Giovanni Rotondo	Foggia
Italy	A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100	Turin
Italy	Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196	Udine
Mexico	ITESM campus Ciudad de Mexico /ID# 132383	Ciudad de Mexico
Mexico	Instituto Metropolitano de Inv /ID# 132201	Delegacion Tlalpan
Mexico	Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975	Distrito Federal
Mexico	Cife /Id# 130974	Guadalajara	Jalisco
Mexico	CIF-BIOTEC/Medica Sur /ID# 134971	Mexico City
Mexico	Hospital General de Tijuana /ID# 130972	Tijuana	Baja California
Netherlands	Academisch Medisch Centrum /ID# 132205	Amsterdam
Netherlands	Leids Universitair Medisch Centrum /ID# 132204	Leiden
Netherlands	Erasmus Medisch Centrum /ID# 132206	Rotterdam	Zuid-Holland
Norway	Akershus Universitetssykehus_MAIN /ID# 132212	Lorenskog	Akershus
Norway	Stavanger University Hospital /ID# 132211	Stavanger
Norway	St. Olavs Hospital HF /ID# 132213	Trondheim	Sor-Trondelag
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108	Bialystok	Podlaskie
Poland	Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106	Bydgoszcz	Kujawsko-pomorskie
Poland	Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107	Lodz	Lodzkie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115	Lublin	Lubelskie
Poland	ID Clinic /ID# 131111	Myslowice	Slaskie
Poland	Wojewodzki Szpital Zakazny /ID# 131112	Warsaw	Mazowieckie
Portugal	Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119	Coimbra
Portugal	Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118	Lisboa
Portugal	Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116	Lisboa
Portugal	Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117	Porto
Romania	Institutul Nat. de Boli Infectioase /ID# 131124	Bucuresti
Romania	SC Gastromedica SRL /ID# 131127	Iasi
Romania	Duplicate_Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120	Sector 2	Bucuresti
Romania	Institutul Clinic Fundeni /ID# 131121	Sector 2	Bucuresti
Romania	Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie Dr. Victor Babes /Id# 131126	Timisoara	Timis
Russian Federation	South-Ural State Med. Academy /ID# 132274	Chelyabinsk
Russian Federation	Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270	Kazan	Tatarstan, Respublika
Russian Federation	Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269	Kemerovo
Russian Federation	Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278	Krasnoyarsk
Russian Federation	Central Clinical Hospital of Russian Academy of Science /ID# 132289	Moscow
Russian Federation	City Clinical Hospital #24 /ID# 132268	Moscow
Russian Federation	I. M. Sechenov First Moscow State Medical University /ID# 132275	Moscow
Russian Federation	Moscow Clinical Scientific Center n.a. Loginov /ID# 132266	Moscow
Russian Federation	Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288	Moscow
Russian Federation	Clinical Infectious Diseases Hospital #1 /ID# 132272	Novosibirsk
Russian Federation	Medical Company Hepatolog /ID# 132277	Samara	Samarskaya Oblast
Russian Federation	Samara State Medical University /ID# 136913	Samara
Russian Federation	Stavropol State Medical University /ID# 132279	Stavropol
Russian Federation	Tolyatti City Clinical Hospital #1 /ID# 132273	Tolyatti
Russian Federation	Multidisciplinary Consultative and Diagnostic Center /ID# 131130	Tyumen
Russian Federation	Sverdlovsk Regional Clinical Hospital #1 /ID# 132267	Yekaterinburg
Saudi Arabia	King Abdulaziz Medical City /ID# 145129	Jeddah
Saudi Arabia	King Khalid University Hospita /ID# 132291	Riyadh
Saudi Arabia	Ministry Nat Guard Hosp Health /ID# 145126	Riyadh
Spain	Hospital Universitario A Coruna - CHUAC /ID# 131137	A Coruna
Spain	Hospital Universitario Germans Trias i Pujol /ID# 132293	Badalona	Barcelona
Spain	OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143	Barakaldo	Vizcaya
Spain	Hospital General Universitario Santa Lucia /ID# 131139	Cartagena	Murcia
Spain	Hospital Universitario Reina Sofia /ID# 131135	Cordoba
Spain	Hospital Donostia /ID# 131144	Donostia	Guipuzcoa
Spain	Hospital Universitario 12 de Octubre /ID# 131133	Madrid
Spain	Hospital Universitario de la Princesa /ID# 131131	Madrid
Spain	Hospital Universitario La Paz /ID# 131132	Madrid
Spain	Hospital Universitario Virgen de la Victoria /ID# 131136	Malaga
Spain	Hospital Universitario Central de Asturias /ID# 131138	Oviedo	Asturias
Spain	Hospital Universitari Son Espases /ID# 131140	Palma de Mallorca	Illes Balears
Spain	Hospital Unversitario Marques de Valdecilla /ID# 131141	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio /ID# 131134	Sevilla
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 132292	Zaragoza
Sweden	Sahlgrenska University Hospital /ID# 131147	Gothenburg	Vastra Gotalands Lan
Sweden	Skane University hospital /ID# 131146	Malmo	Skane Lan
Sweden	Karolinska University Hospital Solna /ID# 131145	Solna	Stockholms Lan
Switzerland	Inselspital, Universitätsspital Bern /ID# 132294	Bern
Switzerland	Kantonsspital St. Gallen /ID# 131148	St. Gallen	Sankt Gallen
Switzerland	Universitätsspital Zürich /ID# 134881	Zürich	Zuerich
Turkey	Ankara Univ Medical Faculty /ID# 131151	Ankara
Turkey	Hacettepe University Faculty of Medicine /ID# 131150	Ankara
Turkey	Uludag University Medical Faculty /ID# 132297	Bursa
Turkey	Istanbul University Istanbul Medical Faculty /ID# 131153	Istanbul
Turkey	Ege University Medical Faculty /ID# 132298	Izmir
Turkey	Izmir Tepecik Training and Research Hospital /ID# 134968	Konak	Izmir
Turkey	Karadeniz University /ID# 131152	Trabzon
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 131154	Birmingham
United Kingdom	Duplicate_NHS Tayside /ID# 132300	Dundee
United Kingdom	NHS Lothian /ID# 134368	Edinburgh
United Kingdom	NHS Greater Glasgow and Clyde /ID# 131162	Glasgow	Scotland
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 132305	Leeds
United Kingdom	Barts Health NHS Trust /ID# 132302	London	London, City Of
United Kingdom	King's College Hospital NHS Foundation Trusts /ID# 131157	London
United Kingdom	The Royal Free London NHS Foundation Trust /ID# 131159	London	London, City Of
United Kingdom	Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155	Nottingham	Nottinghamshire
United Kingdom	University Hospital Plymouth NHS Trust /ID# 131160	Plymouth
United Kingdom	Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306	Poole	Dorset
United Kingdom	Portsmouth Hospitals University NHS Trust /ID# 131158	Portsmouth
United Kingdom	Northern Care Alliance NHS Group /ID# 131156	Salford
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 131161	Southampton	Hampshire
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 132301	Tooting

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Algeria,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Denmark,  Finland,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Death: Time to Event	Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary	Liver-Related Death: Time to Event	Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary	Liver Decompensation: Time to Event	Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary	Liver Transplantation: Time to Event	Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary	Hepatocellular Carcinoma: Time to Event	Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Primary	All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event	Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.	At Post-Treatment Weeks 52, 104, 156, 208, and 260
Secondary	Change From Baseline in FibroScan Score by SVR12 Status	The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.	At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260
Secondary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.	12 weeks after the last actual dose of study drug