DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)

NCT01743521 | Completed Phase 4 Results DMC

• 2 other identifiers: VHCRP1102VX-950HCP4010
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C; Individualised therapy; Response-guided therapy; Telaprevir; PEG-IFN; Ribavirin; Hepatitis

Outcome Measures

Primary Outcomes (1)

• SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)

  Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)

  12 weeks post-treatment

Secondary Outcomes (14)

• SVR24

  24 weeks post-treatment

• Undetectable HCV RNA (ETR)

  Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

• Undetectable HCV RNA (Week 1)

  Week 1 of therapy

• Undectectable HCV RNA (Week 2)

  Week 2 of therapy

• Undetectable HCV RNA (Week 3)

  Week 3 of therapy

Study Arms (3)

Group A - 8 weeks total therapy

EXPERIMENTAL

8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy

Drug: TPV/PEG-IFN/RBV

Group B - 12 weeks total therapy

EXPERIMENTAL

12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy

Drug: TPV/PEG-IFN/RBV

Group C - 24 weeks total therapy

EXPERIMENTAL

24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy

Drug: TPV/PEG-IFN/RBV

Interventions

TPV/PEG-IFN/RBV DRUG

Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly.

Also known as: Telaprevir brand name: INCIVO, Ribavirin brand name: COPEGUS, PEG-IFN brand name: PEGASYS

Group A - 8 weeks total therapy; Group B - 12 weeks total therapy; Group C - 24 weeks total therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of written, informed consent.
• HCV genotype 1 infection
• Quantifiable HCV RNA at screening and baseline (\>10,000 IU/ml)
• Recent hepatitis C infection with an estimated duration of Infection \>6 months and ≤ 18 months defined as A) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result OR B) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT\> 10 X ULN) within the 12 months prior to first positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable
• Compensated liver disease (Child-Pugh A)
• Negative pregnancy test at screening and 24 hours prior to the first dose of study drugs.
• If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after RBV therapy has ended. Note: Hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. Therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. As of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control.
• Subject is judged to be medically stable on the basis of physical examination, medical history and vital signs.
• Adequate English to provide written, informed consent and to provide reliable responses to the study interview
• Confirmed HIV infection \> 6 months duration
• CD4 \> 200 cells/mm3 and HIV \< 50 c/ml on stable antiretroviral therapy (ART) at least 3 months prior to treatment
• CD4 \>= 500 cells/mm3 and HIV viral load (VL) \< 100,000 not on ART
• If on ART must be taking a regimen containing an accepted\* combination of the following drugs: tenofovir ( TDF), lamivudine ( 3TC), emtricitabine (FTC), efavirenz (EFV), abacavir (ABC), raltegravir (RAL), etravirine (ETV), rilpivirine (RIL), ritonavir boosted atazanavir (r/ATZ) \* Combination must be supported by current HIV treatment guidelines

You may not qualify if:

• Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
• Current injecting drug use (any injecting within previous 4 weeks)

Sponsors & Collaborators

• Kirby Institute: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (2)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

• Martinello M, Hellard M, Shaw D, Petoumenos K, Applegate T, Grebely J, Yeung B, Maire L, Iser D, Lloyd A, Thompson A, Sasadeusz J, Haber P, Dore GJ, Matthews GV. Short duration response-guided treatment is effective for most individuals with recent hepatitis C infection: the ATAHC II and DARE-C I studies. Antivir Ther. 2016;21(5):425-34. doi: 10.3851/IMP3035. Epub 2016 Feb 11.

  PMID: 26867206 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Hepatitis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: A/Prof Gail Matthews
• Organization: Kirby Institute

gmatthews@kirby.unsw.edu.au

+61 (0)2 9385 0900

Study Officials

• Gail Matthews, MbChB, PhD

  Kirby Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 6, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 29, 2017
• Results First Posted: October 20, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)