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

NCT02336139 | Completed Phase 2 DMC

• 1 other identifier: VHCRP1309
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (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.

  Week 24

Secondary Outcomes (12)

• Treatment adherence

  Baseline to Week 12

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

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

• Factors associated with on-treatment adherence

  Baseline to Week 12

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

  Week 12

• Safety and tolerability (number and type of adverse events and serious adverse events)

  Baseline to Week 24

Study Arms (1)

Sofosbuvir (SOF)/GS-5816

EXPERIMENTAL

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

Drug: Sofosbuvir (SOF)/GS-5816

Interventions

Sofosbuvir (SOF)/GS-5816 DRUG

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

Also known as: SOF/GS-5816

Sofosbuvir (SOF)/GS-5816

Eligibility Criteria

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

You may qualify if:

• Participants have voluntarily signed the informed consent form.
• 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).
• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (1)

The Kirby Institute

Sydney, New South Wales, 2052, Australia

Location

Related Publications (3)

• 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.

  PMID: 32166305 DERIVED

• 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.

  PMID: 31300820 DERIVED

• 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.

  PMID: 29310928 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir

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)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Greg Dore, MBBS PhD

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2015
• First Posted: January 12, 2015
• Study Start: March 16, 2016
• Primary Completion: April 17, 2017
• Study Completion: November 28, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

AU (1)