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An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1

10. mars 2017 oppdatert av: Hoffmann-La Roche

Non-Interventional, Prospective Cohort Study of the Effectiveness, Safety and Utilization of Two Approved Pegylated Interferon-Based Direct Acting Antiviral Triple Therapies in the Management of Genotype 1 Chronic Hepatitis C in Routine Clinical Practice in the USA

This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.

Studieoversikt

Status

Fullført

Forhold

Hepatitt C, kronisk

Studietype

Observasjonsmessig

Registrering (Faktiske)

672

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater, 35233
    - Cooper Green Hospital
  - Birmingham, Alabama, Forente stater, 35233
    - Univ. of Alabama at Birmingham; The Kirklin Clinic
- Arkansas
  - Little Rock, Arkansas, Forente stater, 72205
    - Liver Wellness Center
- California
  - Loma Linda, California, Forente stater, 92354
    - Loma Linda University Medical Center and Liver Center
  - Pasadena, California, Forente stater, 91105
    - HMRI Liver Center
  - San Diego, California, Forente stater, 92161
    - VA San Diego Healthcare System
  - San Diego, California, Forente stater, 92154
    - Kaiser Permanente San Diego; Hepatology Research
  - Torrance, California, Forente stater, 90505
    - South Bay Gastroenterology Medical Group
- Colorado
  - Aurora, Colorado, Forente stater, 80045
    - University of Colorado Denver
- Connecticut
  - Torrington, Connecticut, Forente stater, 06790
    - Litchfield County Gastroenterology Associates
- Florida
  - Daytona Beach, Florida, Forente stater, 32117
    - Consultive Medicine
  - Largo, Florida, Forente stater, 33777
    - Florida Center for Gastroenterology
  - Maitland, Florida, Forente stater, 32751
    - Center For Advanced Gastroenterology
  - Orlando, Florida, Forente stater, 32806
    - Internal Medicine Specialists
  - Orlando, Florida, Forente stater, 32806
    - Orlando Infectious Disease Center, Pa
  - Tampa, Florida, Forente stater, 33606
    - Tampa General Hospital; Tampa General Medical Group
- Georgia
  - Decatur, Georgia, Forente stater, 30033
    - Atlanta Center for Gastroenterology, PC
  - Decatur, Georgia, Forente stater, 30033
    - Dekalb Gastroenterology Associates
  - Macon, Georgia, Forente stater, 31201
    - Gastroenterology Associates of Central Georgia
- Illinois
  - Chicago, Illinois, Forente stater, 60637
    - University of Chicago
- Indiana
  - Indianapolis, Indiana, Forente stater, 46237
    - Indianapolis Gastroenterology
- Kentucky
  - Crestview Hills, Kentucky, Forente stater, 41017
    - Tristate Gastroenerology Associates
- Louisiana
  - Baton Rouge, Louisiana, Forente stater, 70809
    - Ochsner Clinic Foundation
  - Metairie, Louisiana, Forente stater, 70006
    - New Orleans Research Institute.
  - New Orleans, Louisiana, Forente stater, 70112-2699
    - Tulane Uni Health Sciences Center
- Maryland
  - Baltimore, Maryland, Forente stater, 21202
    - Mercy Medical Center; Institute For Digestive Health And Liver Disease
- Massachusetts
  - Brockton, Massachusetts, Forente stater, 02302
    - Commonwealth Clinical Studies
  - Springfield, Massachusetts, Forente stater, 01199
    - Baystate Infectious Diseases Clinical Research
  - Worcester, Massachusetts, Forente stater, 01068
    - Partners in Internal Medicine
- Michigan
  - Detroit, Michigan, Forente stater, 48201
    - Harper University Hospital/Wayne State
  - Wyoming, Michigan, Forente stater, 49519
    - Gastroenterology Associates of Western Michigan
- Minnesota
  - Rochester, Minnesota, Forente stater, 55905
    - Mayo Clinic Rochester
- Missouri
  - Kansas City, Missouri, Forente stater, 64111
    - St. Luke's Hospital
  - Kansas City, Missouri, Forente stater, 64128
    - Midwest Biomedical Research Foundation
  - St. Louis, Missouri, Forente stater, 63104
    - Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
- New Hampshire
  - Lebanon, New Hampshire, Forente stater, 03756
    - Dartmouth Hitchcock Med Center
- New Jersey
  - Haddon Heights, New Jersey, Forente stater, 08035
    - Lourdes Medical Associates; Southern New Jersey Center for LIver Disease
  - Morristown, New Jersey, Forente stater, 07960
    - Atlantic Research Affiliates
  - Twp, New Jersey, Forente stater, 08234
    - AGA Clinical Research Associates, LLC
- New York
  - Bronx, New York, Forente stater, 10467
    - Montefiore Medical Center
  - Brooklyn, New York, Forente stater, 11215
    - New York Methodist Hospital
  - Catskill, New York, Forente stater, 12414
    - Mountainview Medical Practice
  - Flushing, New York, Forente stater, 11355
    - New Discovery, LLC
  - Manhasset, New York, Forente stater, 11030
    - North Shore University Hospital
  - New York, New York, Forente stater, 10016
    - Concorde Medical Group
  - Rochester, New York, Forente stater, 14642
    - University of Rochester Medical Center
- North Carolina
  - Asheville, North Carolina, Forente stater, 28801
    - Asheville Gastroenterology Associates, P.A.
  - Durham, North Carolina, Forente stater, 27710
    - Duke Univ Medical Center
  - Rocky Mount, North Carolina, Forente stater, 27804
    - Boice-Willis Clinic
- Oklahoma
  - Oklahoma City, Oklahoma, Forente stater, 73112
    - Integris Baptist Medical Center
- Oregon
  - Bend, Oregon, Forente stater, 97701
    - Bend Memorial Clinic
- Pennsylvania
  - DuBois, Pennsylvania, Forente stater, 15801
    - Dubois Regional Medical Center
  - Philadelphia, Pennsylvania, Forente stater, 19107
    - Thomas Jefferson University
  - Philadelphia, Pennsylvania, Forente stater, 19140
    - Temple University Hospital
  - Philadelphia, Pennsylvania, Forente stater, 19141
    - Albert Einstein Medical Center; Division of Hepatology
- Tennessee
  - Memphis, Tennessee, Forente stater, 38104
    - Methodist Heathcare University Hospital
- Texas
  - Austin, Texas, Forente stater, 78758
    - Imtiaz Alam MD, P.A. - Private Practice
  - Dallas, Texas, Forente stater, 75203
    - Methodist Transplant Physicians
  - Galveston, Texas, Forente stater, 77555
    - Univ of Texas Medical Branch
  - Houston, Texas, Forente stater, 77005
    - Kelsey Research Foundation
  - Houston, Texas, Forente stater, 77030
    - Liver Associates of Texas
  - Houston, Texas, Forente stater, 77090
    - Digestive And Liver Disease Consultants, PA
- Vermont
  - Burlington, Vermont, Forente stater, 5401
    - University of Vermont
- Virginia
  - Charlottesville, Virginia, Forente stater, 22908
    - University of Virginia Health System: Gastroenterology at UVA
  - Fairfax, Virginia, Forente stater, 22031
    - Metropolitan Research
Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Fundacion De Investigacion de Diego

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Patients with chronic hepatitis C genotype 1 receiving pegylated interferon-based direct acting antiviral triple therapies in the US

Beskrivelse

Inclusion Criteria:

Adult patients, >/= 18 years of age
Chronic hepatitis C, genotype 1
Receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and US labeling

Exclusion Criteria:

Contraindications per US labels

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Kohort

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Time to Premature Treatment Discontinuation Due to Any Reason Tidsramme: Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)	Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason - first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.	Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)
Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period Tidsramme: 12 weeks or later post-completion of the treatment period	SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period	12 weeks or later post-completion of the treatment period

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Number of Participants With Virologic Response (VR) Tidsramme: Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period	VR was defined as undetectable HCV RNA (i.e.,HCV RNA less than 50 IU/mL)	Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above Tidsramme: Weeks 2, 4, 8, and 12	VRVR was defined as HCV RNA < 50 IU/mL at treatment Week 2; RVR as HCV RNA < 50 IU/mL by treatment Week 4, but no HCV RNA < 50 IU/mL at Week 2; Week 8 VR as HCV RNA < 50 IU/mL by study Week 8 but no HCV RNA < 50 IU/mL at Weeks 2 to 4; cEVR as HCV RNA < 50 IU/mL by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 8; and pEVR as at least a 2 log10 decrease in HCV RNA by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 12.	Weeks 2, 4, 8, and 12
Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder Tidsramme: Up to Week 48	The extended VR is defined as initial HCV RNA < 50 IU/mL during Weeks 2 to 24 and remaining HCV RNA < 50 IU/mL at all subsequent assessments; virologic breakthrough/rebound is defined as detectable HCV RNA during the treatment period in participants with prior non-detectable HCV RNA or increase of HCV RNA by >=1 log10 above nadir for direct-acting antiviral (DAA) tripe therapies (PegIFN + RBV + TEL or PegIFN + RBV + BOC); virologic relapse is defined as detectable HCV RNA during the treatment-free follow-up period in participants with HCV RNA < 50 IU/mL at EoT; non-responder is defined as participants who never achieved undetectable HCV-RNA during the 48 weeks of treatment.	Up to Week 48
Predictors of Sustained Virologic Response by Week Tidsramme: Weeks 2, 4, 6, 8, and 12	SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period. The predictors defined as participants with virological response (HCV RNA < 50 IU/mL at any visit), or with virological response at Week 12 (HCV-RNA < 50 IU/mL or unquantifiable or HCV-RNA >=2 log10 drop from baseline). Positive predictive value is the probability that participants with a positive screening test truly have the disease. Negative predictive value is the probability that participants with a negative screening test truly don't have the disease.	Weeks 2, 4, 6, 8, and 12
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Tidsramme: Week 12	Participants for VR to prior therapy (PegIFN + RBV) were categorized as: relapse (who completed the previous treatment with HCV RNA undetectable, but relapsed with detectable HCV RNA once treatment was discontinued), breakthrough (HCV RNA undetectable, followed by detectable HCV RNA during on-treatment period), null responder (completed at least 12 weeks of treatment with HCV RNA decrease < 2 log10 at Week 12), partial responder (HCV RNA decrease > 2 log10 by Week 12 of treatment and HCV RNA remained detectable), unknown response (completed previous treatment, but treatment response based on HCV RNA determinations was not available), and prior intolerant (treated previously, but discontinued due to adverse event or participant's choice prior to completion of therapy). Participants categorized into 3 genotypes (CC, CT and TT) based on single nucleotide polymorphism in the Interleukin 28B (IL28B) gene.	Week 12
Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment Tidsramme: Up to Week 48	The undetectable HCV RNA means HCV RNA values less than 50 IU/mL. This outcome measure was calculated as the duration of participant's first date of undetectable HCV RNA and the date of the participant's last dose.	Up to Week 48
Time to Premature Treatment Discontinuation Due to Lack of Efficacy Tidsramme: Up to Week 48	The participants discontinued the study treatment due to lack of efficacy of study treatment. Time to premature treatment discontinuation due to lack of efficacy (weeks) = (date of treatment discontinuation due to lack of efficacy - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.	Up to Week 48
Time to Premature Treatment Discontinuation Due to Intolerance Tidsramme: Up to Week 48	The participants discontinued the study treatment due to intolerance of the study treatment. Time to premature treatment discontinuation due to intolerance (weeks) = (date of treatment discontinuation due to lack of intolerance - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.	Up to Week 48
Treatment Duration, as Measure of Extent of Exposure to Study Medication Tidsramme: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir is calculated as the number of weeks between the start and end of treatment.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication Tidsramme: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. The mean cumulative doses of PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir were presented.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication Tidsramme: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. Degree of dose reduction was calculated as actual exposure/target exposure × 100%. Target exposure was defined as the actual received treatment duration multiplied by the initial assigned dose. Actual exposure was defined as cumulative dose during the treatment period.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Compliance of Study Treatment Tidsramme: Weeks 4, 8, 12, and 24	Compliance was assessed based on the number of participants who received the planned study treatment (PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir) during the treatment period.	Weeks 4, 8, 12, and 24
Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label Tidsramme: Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)	As per the U.S. labeling, participants with treatment-naive, prior relapse (TN-PR) and prior partial or null responder (PP/NR) received PegIFN + RBV + TEL (triple therapy) for 12 weeks; followed additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label Tidsramme: Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)	As per the U.S. labeling, participants with cirrhosis (C); non-cirrhotic/treatment-naïve (NC/TN); and non-cirrhotic/previous partial responders or relapsers (NC/PPR or R) received first 4 weeks of dual therapy, followed by additional 28 or 36 weeks of PegIFN + RBV + BOC (triple therapy) and/or then completed dual therapy through Week 48 depending on viral response and prior response status.	Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)
Number of Participants With Safety-related Dose Reductions Tidsramme: Up to 48 weeks	The dose reduction was done because of safety-related reasons (AEs) including alanine aminotransferase disorder, anemia, neutropenia, thrombocytopenia, and rash.	Up to 48 weeks
Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs) Tidsramme: Up to 48 weeks	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	Up to 48 weeks
Number of Participants With Any AEs and Serious Adverse Events (SAEs) Tidsramme: Up to 12 weeks post-treatment	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.	Up to 12 weeks post-treatment
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Tidsramme: Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment	WPAI-AS is a 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Each sub-scores was scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.	Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. januar 2012

Primær fullføring (Faktiske)

31. mars 2014

Studiet fullført (Faktiske)

31. mars 2014

Datoer for studieregistrering

Først innsendt

9. januar 2012

Først innsendt som oppfylte QC-kriteriene