Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P

NCT02634008 | Completed Phase 3 DMC

• 1 other identifier: VHCRP1502
• Study Type: interventional
• Target: 83
• Locations: 3 countries
• Sites: 11

Brief Summary

An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.

Conditions

Hepatitis C, Acute

Keywords

Pangenotypic; Treatment

Outcome Measures

Primary Outcomes (1)

• Proportion of treated subjects (intention-to-treat (ITT) population) demonstrating undetectable hepatitis C virus (HCV) RNA at 12 weeks following treatment (SVR 12).

  12 weeks post treatment

Secondary Outcomes (10)

• The proportion of treated subjects overall with ETR, SVR4 and SVR24 defined as undetectable HCV RNA at end of therapy, 4 weeks and 24 weeks post therapy, respectively.

  End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 24 weeks post treatment

• Comparison of ETR, SVR4, SVR12 and SVR24 between those receiving 8 weeks treatment and those receiving 6 weeks treatment.

  End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 12 weeks post treatment; 24 weeks post treatment

• Comparison of adherence between those receiving 8 weeks treatment and those receiving 6 weeks treatment

  Baseline to week 6 or week 8 treatment duration

• Proportion with early treatment discontinuation

  Baseline through to 6 or 8 weeks depending on the study arm

• Proportion with adverse events (including serious adverse events)

  Baseline to week 6 or week 8 treatment duration

Study Arms (3)

Cohort 1

EXPERIMENTAL

Paritaprevir/ritonavir/ombitasvir (75mg/50mg/12.5mg) and dasabuvir (250mg) with or without ribavirin (1000-1200mg) daily taken orally for 8 weeks.

Drug: Paritaprevir/ritonavir/ombitasvir; Drug: Dasabuvir; Drug: Ribavirin

Cohort 2

EXPERIMENTAL

Three tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 6 weeks

Drug: Glecaprevir/pibrentasvir

Cohort 3

EXPERIMENTAL

Three tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 4 weeks

Drug: Glecaprevir/pibrentasvir

Interventions

Paritaprevir/ritonavir/ombitasvir DRUG

Also known as: Viekira Pak

Cohort 1

Dasabuvir DRUG

Also known as: Viekira Pak

Cohort 1

Ribavirin DRUG

Cohort 1

Glecaprevir/pibrentasvir DRUG

Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent;
• Male and female patients aged 18 years and over;
• For Cohort One: willing to use two effective methods of contraception during the treatment period and 24 weeks post;
• For Cohort Two and Three: If female and of childbearing potential, willing to use at least one effective method of contraception during the treatment period and 4 weeks post; women not of childbearing potential include those who are postmenopausal or permanently surgically sterile (no contraception is required for male participants);
• For Cohort One, Two and Three: Females of child-bearing potential must have a negative pregnancy test at screening and immediately prior to first dose of study drugs;
• HCV genotype 1 infection at screening (Cohort 1 only);
• Detectable HCV RNA at screening (\>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance;
• Absence of cirrhosis, as defined by one of the following:
• Liver biopsy within 24 months prior to or during screening demonstrating absence of cirrhosis (eg, METAVIR fibrosis score ≤ 3, Ishak fibrosis score ≤ 4); or
• FibroScan score \< 12.5 kPa within ≤ 6 months of screening or during screening period; or
• Medically stable on the basis of physical examination, medical history and vital signs;
• Adequate English to provide reliable responses to the study questionnaires;
• Recently acquired HCV infection (estimated duration of infection ≤12 months) as defined by\*:
• i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV Ab negative within the 18 months prior to anti-HCV antibody positive result
• i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Acute clinical hepatitis (jaundice or ALT\> 10 X ULN) within the previous 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable

You may not qualify if:

• Pregnancy/lactation
• Infection or co-infection with an HCV genotype other than 1 (Cohort 1 only)
• Subject has current or past clinical evidence of decompensated liver disease, such as ascites, hepatic encephalopathy, oesophageal varices, and/or any of the following screening laboratory results;
• International Normalized Ration (INR) \> 1.5;
• Patients with a known inherited blood disorder and INR \> 1.5 may be enrolled after discussion with the Principal Investigator
• Serum albumin \<3.3 g/dL;
• Serum total bilirubin \>1.8 x upper limit of normal (ULN), unless isolated in subjects with Gilbert's syndrome;
• Subject shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis (NASH), or primary biliary cirrhosis;
• Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma);
• History of chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study;
• Poorly controlled diabetes mellitus as evidenced by haemoglobin A1c (HbA1c) ≥8.5%;
• Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug
• Prior treatment failure with an HCV protease inhibitor;
• Any investigational drug ≤6 weeks prior to the first dose of study drug;
• Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab or HBsAg;

Sponsors & Collaborators

• Kirby Institute: lead
• AbbVie: collaborator

Study Sites (11)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Auckland City Hospital

Auckland, Grafton, 1023, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Barts and London

London, EC1A 7BE, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Guy's and St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Pennine Acute Hospital

Manchester, M8 5RB, United Kingdom

Location

Related Publications (1)

• Martinello M, Bhagani S, Shaw D, Orkin C, Cooke G, Gane E, Iser D, Ustianowski A, Kulasegaram R, Stedman C, Tu E, Grebely J, Dore GJ, Nelson M, Matthews GV. Glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection: The TARGET3D study. JHEP Rep. 2023 Jul 27;5(10):100867. doi: 10.1016/j.jhepr.2023.100867. eCollection 2023 Oct.

  PMID: 37771545 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

paritaprevir; Viekira Pak; dasabuvir; Ribavirin; glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Gail Matthews, MBBS PhD

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 17, 2015
• Study Start: June 1, 2016
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); GB (6); NZ (2)