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A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use (SIMPLIFY)

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ClinicalTrials.gov Identifier: NCT02336139
Recruitment Status : Completed
First Posted : January 12, 2015
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Sofosbuvir (SOF)/GS-5816 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Single Arm, Multicentre, International Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use
Actual Study Start Date : March 16, 2016
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Sofosbuvir (SOF)/GS-5816
12 weeks of Sofosbuvir (SOF)/GS-5816 (400mg/100mg) in an oral once-daily fixed dose combination
Drug: Sofosbuvir (SOF)/GS-5816
12 weeks of Sofosbuvir (SOF)/GS-5816 (400mg/100mg) in an oral once-daily fixed dose
Other Name: SOF/GS-5816




Primary Outcome Measures :
  1. Sustained Virological Response (SVR12) [ Time Frame: Week 24 ]
    To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir (SOF)/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.


Secondary Outcome Measures :
  1. Treatment adherence [ Time Frame: Baseline to Week 12 ]
    To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

  2. Impact of adherence on therapy (association between adherence and response to treatment ) [ Time Frame: early (0-3 weeks), mid (4-7 weeks) and late (8-11 weeks) during therapy ]
    To evaluate the association between adherence and response to treatment [including an evaluation of the impact of early (0-3 weeks), mid (4-7 weeks) and late (8-11 weeks) missed doses on response to therapy]; Adehernce will be measure via a self report quesitonanire and pill counts via return of the weeekly blister packs. The impact of the number and timing of missed pills will be evaluated.

  3. Factors associated with on-treatment adherence [ Time Frame: Baseline to Week 12 ]
    To evaluate factors associated with on-treatment adherence >90% and treatment discontinuation. Demographic and behavioural factors will be examined.

  4. End of Treatment Response (ETR) (proportion of participants with undetectable HCV RNA at the end of treatment (ETR) [ Time Frame: Week 12 ]
    To evaluate the proportion of participants with undetectable HCV RNA at the end of treatment (ETR)

  5. Safety and tolerability (number and type of adverse events and serious adverse events) [ Time Frame: Baseline to Week 24 ]
    To evaluate the number and type of adverse events and serious adverse events on treament and for 12 weeks post end of treatment

  6. Change in drug use [ Time Frame: Baseline to Week 12 ]
    To evaluate the change in drug use during treatment

  7. Change in mental health [ Time Frame: Basleine to Week 12 ]
    To evaluate the change in mental health during treatment

  8. Change in health related quality of life [ Time Frame: Baseline to Week 12 ]
    To evaluate the change in health-related quality of life during treatment

  9. Impact of mixed infection on treatment response [ Time Frame: Baseline to Week 24 ]
    To evaluate the rate of mixed HCV infection at baseline and among those with treatment non-response

  10. Reinfection Rate [ Time Frame: Week 108 ]
    To evaluate the rate of HCV reinfection during and up to two years following treatment

  11. Immunovirological factors associated with treatment clearance [ Time Frame: Week 24 ]
    To evaluate immunovirological factors associated with treatment clearance. We will evaluate cytokines and chemokines (e.g. interferon inducible protein 10), T-cell responses, viral evolution and genetic markers (e.g. inteferon lambda 4) that are potentially associated with treatment induced clearance

  12. Utility of Dried Blood Spot (DBS) (method for monitoring HCV including treatment response) [ Time Frame: Week 108 ]
    To evaluate the utility of dried blood spot (DBS) as a simple method for monitoring HCV including treatment response. HCV RNA will be measured from DBS samples and then compared to HCV RNA levels measured using standard methods (EDTA Plasma samples and Roche Taqman)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants have voluntarily signed the informed consent form.
  2. 18 years of age or older.
  3. Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
  4. HCV RNA plasma ≥ 1000 IU/ml at Screening.
  5. HCV genotypes 1-6.
  6. Recent injecting drug use (previous 6 months).
  7. Compensated liver disease.
  8. Participants with Fibroscan >12 KPa or AFP >50 ng/mL must have an abdominal ultrasound or CT scan without evidence of hepatocellular carcinoma within 2 months prior to screening.
  9. Negative pregnancy test at baseline (females of childbearing potential only).
  10. All fertile males and females must be using effective contraception during treatment and during the 30 days after treatment end.

Exclusion Criteria:

  1. History of any of the following:

    1. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
    2. Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage)
    3. Solid organ transplant
    4. Malignancy within 5 years prior to screening, with exception of specific cancers that may have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are also excluded.
    5. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
  2. Screening ECG with clinically significant abnormalities
  3. Any of the following lab parameters at screening:

    1. ALT > 10 x ULN
    2. AST > 10 x ULN
    3. Direct bilirubin > 1.5 x ULN
    4. Platelets < 50,0000/μL
    5. HbA1c > 8.5%
    6. Creatinine clearance (CLcr) < 60 mL/min
    7. Haemoglobin < 11 g/dL for females ; < 12 g/dL for males
    8. Albumin < 30g/L
    9. INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
  4. Pregnant or nursing female.
  5. HIV infection or HBV infection (HBcAb and HBsAg positive)
  6. Use of prohibited concomitant medications as described in section 5.2
  7. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day)
  8. Known hypersensitivity to GS-5816, sofosbuvir (SOF) or formulation excipients.
  9. Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug.
  10. Any investigational drug ≤6 weeks prior to the first dose of study drug.
  11. Previous therapy with sofosbuvir (SOF) or an NS5A inhibitor prior to the first dose of study drug.
  12. Ongoing severe psychiatric disease as judged by the treating physician.
  13. Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
  14. Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336139


Locations
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Australia, New South Wales
The Kirby Institute
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
Kirby Institute
Investigators
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Principal Investigator: Greg Dore, MBBS PhD Kirby Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02336139     History of Changes
Other Study ID Numbers: VHCRP1309
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Velpatasvir
Antiviral Agents
Anti-Infective Agents