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Hepatitis CPhase 2SIMPLIFYNCT02336139

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

A Phase 2 study testing Sofosbuvir (SOF)/GS-5816 in people with Hepatitis C, run by Kirby Institute at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Sofosbuvir (SOF)/GS-5816
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteAustralia
Study dates
16 Mar 2016to 28 Nov 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants have voluntarily signed the informed consent form.
  • 18 years of age or older.
  • Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
  • HCV RNA plasma ≥ 1000 IU/ml at Screening.
  • HCV genotypes 1-6.
  • Recent injecting drug use (previous 6 months).
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  • Compensated liver disease.
  • 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.
  • Negative pregnancy test at baseline (females of childbearing potential only).
  • All fertile males and females must be using effective contraception during treatment and during the 30 days after treatment end.

Who cannot join

  • History of any of the following:
  • 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.
  • Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage)
  • Solid organ transplant
  • 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.
  • Significant drug allergy (such as anaphylaxis or hepatotoxicity).
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  • Screening ECG with clinically significant abnormalities
  • Any of the following lab parameters at screening:
  • ALT > 10 x ULN
  • AST > 10 x ULN
  • Direct bilirubin > 1.5 x ULN
  • Platelets < 50,0000/μL
  • HbA1c > 8.5%
  • Creatinine clearance (CLcr) < 60 mL/min
  • Haemoglobin < 11 g/dL for females ; < 12 g/dL for males
  • Albumin < 30g/L
  • INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
  • Pregnant or nursing female.
  • HIV infection or HBV infection (HBcAb and HBsAg positive)
  • Use of prohibited concomitant medications as described in section 5.2
  • Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day)
  • Known hypersensitivity to GS-5816, sofosbuvir (SOF) or formulation excipients.
  • 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.
  • Any investigational drug ≤6 weeks prior to the first dose of study drug.
  • Previous therapy with sofosbuvir (SOF) or an NS5A inhibitor prior to the first dose of study drug.
  • Ongoing severe psychiatric disease as judged by the treating physician.
  • Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Kirby Institute

    Sydney, New South Wales, 2052

Other trials in Australia

About this study

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

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.

Conditions
Hepatitis C
Being tested
Sofosbuvir (SOF)/GS-5816
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sofosbuvir (SOF)/GS-5816Drug

    Also called SOF/GS-5816

    12 weeks of Sofosbuvir (SOF)/GS-5816 (400mg/100mg) in an oral once-daily fixed dose

Study groups in NCT02336139
Study groupRoleWhat they receive
Sofosbuvir (SOF)/GS-5816Experimental12 weeks of Sofosbuvir (SOF)/GS-5816 (400mg/100mg) in an oral once-daily fixed dose combination
Receives: Drug: Sofosbuvir (SOF)/GS-5816

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained Virological Response (SVR12)

    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.

    Measured: Week 24

Secondary outcomes (12)

  1. Treatment adherence

    To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

    Measured: Baseline to Week 12

  2. Impact of adherence on therapy (association between adherence and response to treatment )

    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.

    Measured: early (0-3 weeks), mid (4-7 weeks) and late (8-11 weeks) during therapy

  3. Factors associated with on-treatment adherence

    To evaluate factors associated with on-treatment adherence >90% and treatment discontinuation. Demographic and behavioural factors will be examined.

    Measured: Baseline to Week 12

  4. End of Treatment Response (ETR) (proportion of participants with undetectable HCV RNA at the end of treatment (ETR)

    To evaluate the proportion of participants with undetectable HCV RNA at the end of treatment (ETR)

    Measured: Week 12

  5. Safety and tolerability (number and type of adverse events and serious adverse events)

    To evaluate the number and type of adverse events and serious adverse events on treament and for 12 weeks post end of treatment

    Measured: Baseline to Week 24

  6. Change in drug use

    To evaluate the change in drug use during treatment

    Measured: Baseline to Week 12

  7. Change in mental health

    To evaluate the change in mental health during treatment

    Measured: Basleine to Week 12

  8. Change in health related quality of life

    To evaluate the change in health-related quality of life during treatment

    Measured: Baseline to Week 12

  9. Impact of mixed infection on treatment response

    To evaluate the rate of mixed HCV infection at baseline and among those with treatment non-response

    Measured: Baseline to Week 24

  10. Reinfection Rate

    To evaluate the rate of HCV reinfection during and up to two years following treatment

    Measured: Week 108

  11. Immunovirological factors associated with treatment clearance

    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

    Measured: Week 24

  12. Utility of Dried Blood Spot (DBS) (method for monitoring HCV including treatment response)

    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)

    Measured: Week 108

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2015 (estimated)
  2. Study start16 Mar 2016
  3. Primary completion17 Apr 2017
  4. Study completion28 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02336139
Sponsor's protocol ID
VHCRP1309
Acronym
SIMPLIFY
Status last verified
Feb 2019
First submitted
4 Jan 2015
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Cunningham EB, Hajarizadeh B, Amin J, Hellard M, Bruneau J, Feld JJ, Cooper C, Powis J, Litwin AH, Marks P, Dalgard O, Conway B, Moriggia A, Stedman C, Read P, Bruggmann P, Lacombe K, Dunlop A, Applegate TL, Matthews GV, Fraser C, Dore GJ, Grebely J. Reinfection Following Successful Direct-acting Antiviral Therapy for Hepatitis C Virus Infection Among People Who Inject Drugs. Clin Infect Dis. 2021 Apr 26;72(8):1392-1400. doi: 10.1093/cid/ciaa253.

    PubMed 32166305

  • Artenie AA, Cunningham EB, Dore GJ, Conway B, Dalgard O, Powis J, Bruggmann P, Hellard M, Cooper C, Read P, Feld JJ, Hajarizadeh B, Amin J, Lacombe K, Stedman C, Litwin AH, Marks P, Matthews GV, Quiene S, Erratt A, Bruneau J, Grebely J. Patterns of Drug and Alcohol Use and Injection Equipment Sharing Among People With Recent Injecting Drug Use or Receiving Opioid Agonist Treatment During and Following Hepatitis C Virus Treatment With Direct-acting Antiviral Therapies: An International Study. Clin Infect Dis. 2020 May 23;70(11):2369-2376. doi: 10.1093/cid/ciz633.

    PubMed 31300820

  • Grebely J, Dalgard O, Conway B, Cunningham EB, Bruggmann P, Hajarizadeh B, Amin J, Bruneau J, Hellard M, Litwin AH, Marks P, Quiene S, Siriragavan S, Applegate TL, Swan T, Byrne J, Lacalamita M, Dunlop A, Matthews GV, Powis J, Shaw D, Thurnheer MC, Weltman M, Kronborg I, Cooper C, Feld JJ, Fraser C, Dillon JF, Read P, Gane E, Dore GJ; SIMPLIFY Study Group. Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial. Lancet Gastroenterol Hepatol. 2018 Mar;3(3):153-161. doi: 10.1016/S2468-1253(17)30404-1. Epub 2018 Jan 6.

    PubMed 29310928

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sofosbuvir (SOF)/GS-5816 in people with Hepatitis C, run by Kirby Institute at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Virological Response (SVR12) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02336139, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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