Clinical Trial Results:
A phase II, open-label, single arm, multicentre, international trial of sofosbuvir and GS-5816 for people with chronic hepatitis C virus infection and recent injection drug use
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Summary
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EudraCT number |
2015-000178-36 |
Trial protocol |
GB |
Global end of trial date |
28 Nov 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Dec 2019
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First version publication date |
18 Dec 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
VHCRP1309
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02336139 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of New South Wales, The Kirby Institute
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Sponsor organisation address |
UNSW Sydney, Sydney, Australia, 2052
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Public contact |
Philippa Marks, University of New South Wales, 61 02 93850886, pmarks@kirby.unsw.edu.au
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Scientific contact |
Gregory Dore, University of New South Wales, 61 02 93850898, gdore@kirby.unsw.edu.au
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Apr 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Nov 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective is to evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following SOF/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug.
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Protection of trial subjects |
Subjects were seen by a health practitioner at each study visit to assess safety and adherence.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Jan 2016
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
3 Years | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Norway: 5
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Country: Number of subjects enrolled |
United Kingdom: 5
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Country: Number of subjects enrolled |
Australia: 36
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Country: Number of subjects enrolled |
New Zealand: 7
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Country: Number of subjects enrolled |
Switzerland: 10
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Country: Number of subjects enrolled |
United States: 5
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Country: Number of subjects enrolled |
Canada: 35
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Worldwide total number of subjects |
103
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
102
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from 19 sites, in Australia (seven sites), Canada (six sites), New Zealand (one site), Norway (one site), Switzerland (two sites), the UK (one site), and the USA (one site). Subjects were recruited from people from three drug treatment clinics, 12 hospital clinics, a private practice, and three community clinics. | ||||||||||||||||
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Pre-assignment
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Screening details |
Participants were 18 years or older, had chronic HCV genotypes 1–6 (confirmed ≥6 months), were naive to NS5A-based HCV therapy, and had recently injected drugs (self-reported injection drug use within 6 months of enrolment). Participants with HIV infection or decompensated liver disease, or both, were excluded. | ||||||||||||||||
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Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||
Blinding implementation details |
Not applicable, the study was open-label.
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Arms
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Arm title
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Single arm - open-label | ||||||||||||||||
Arm description |
The study was open-label. Subjects enrolled in the study received 12 weeks of SOF/GS-5816 in an oral once-daily fixed dose combination. Therapy was administered in weekly electronic blister packs for monitoring of adherence | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Sofosbuvir/Velpatasvir
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Investigational medicinal product code |
SOF/VEL
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Other name |
Epclusa
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Patients received a fixed-dose combination tablet that contained 400 mg of sofosbuvir and 100 mg of velpatasvir, administered orally once daily for 12 weeks.
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Period 2
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Period 2 title |
Primary endpoint SVR12
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Is this the baseline period? |
No | ||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||
Blinding implementation details |
Not applicable, the study was open-label.
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Arms
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Arm title
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Single arm - open-label | ||||||||||||||||
Arm description |
The study was open-label. Subjects enrolled in the study received 12 weeks of SOF/GS-5816 in an oral once-daily fixed dose combination. Therapy was administered in weekly electronic blister packs for monitoring of adherence | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Sofosbuvir/Velpatasvir
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Investigational medicinal product code |
SOF/VEL
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Other name |
Epclusa
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Patients received a fixed-dose combination tablet that contained 400 mg of sofosbuvir and 100 mg of velpatasvir, administered orally once daily for 12 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Single arm - open-label
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Reporting group description |
The study was open-label. Subjects enrolled in the study received 12 weeks of SOF/GS-5816 in an oral once-daily fixed dose combination. Therapy was administered in weekly electronic blister packs for monitoring of adherence | ||
Reporting group title |
Single arm - open-label
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Reporting group description |
The study was open-label. Subjects enrolled in the study received 12 weeks of SOF/GS-5816 in an oral once-daily fixed dose combination. Therapy was administered in weekly electronic blister packs for monitoring of adherence | ||
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End point title |
SVR12 | |||||||||
End point description |
The primary efficacy endpoint was the proportion of participants with SVR12, which was defined as a HCV RNA load below the limit of quantification 12 weeks after the end of treatment in all participants who received at least one dose of sofosbuvir and velpatasvir.
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End point type |
Primary
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End point timeframe |
12 weeks post-treatment
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Statistical analysis title |
Intention to treat | |||||||||
Comparison groups |
Single arm - open-label v Single arm - open-label
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Number of subjects included in analysis |
206
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.05 | |||||||||
Method |
t-test, 2-sided | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
90
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Confidence interval |
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95% | |||||||||
sides |
2-sided
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lower limit |
88 | |||||||||
upper limit |
95 | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Treatment emergent adverse events up to 28 days after last dose of study treatment
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Single arm - open-label
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Reporting group description |
The study was open-label. Subjects enrolled in the study received 12 weeks of SOF/GS-5816 in an oral once-daily fixed dose combination. Therapy was administered in weekly electronic blister packs for monitoring of adherence | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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31 Mar 2015 |
Inclusion criteria: Clarification about patients with cirrhosis was added.
Disallowed agents: Clarification about Amiodarone was added. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Subjects were recruited from hospital-based HCV clinics and community health centres, 10% of participants who were assessed for eligibility were not enrolled. HIV-positive people were excluded because of the absence of data at the start of the study. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/29310928 |
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