Hepatitis C Virus InfectionPhase 3EXPEDITION-2NCT02738138

A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)

A Phase 3 study testing ABT-493 coformulated with ABT-530 in people with Hepatitis C Virus Infection and Human Immunodeficiency Virus Infection, run by AbbVie.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C
What is being tested?: ABT-493 coformulated with ABT-530
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: No sites listed yet
Study dates: 17 May 2016to 7 Jun 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, at least 18 years of age at time of Screening.
Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit.
Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening.
Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have
CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than or equal to 14%) at Screening; and
Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and at least once during the 12 months prior to Screening.

Who cannot join

Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg).
Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.

About this study

Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)

The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.

Conditions: Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
Being tested: ABT-493 coformulated with ABT-530
Keywords: HCV Genotype 3, Non-cirrhotic, HCV Genotype 1, HCV Genotype 6, Human Immunodeficiency Virus (HIV) Infection, HCV Genotype 5, HCV Treatment Naive, HCV Genotype 4, HCV Treatment Experienced, HCV Genotype 2, Hepatitis C Virus (HCV) Infection, Compensated Cirrhosis
Medical subject headings: Hepatitis C, Acquired Immunodeficiency Syndrome, Hepatitis C, Chronic, Infections

What participants receive

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

ABT-493 coformulated with ABT-530Drug
Also called ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET
Tablet

Study groups in NCT02738138
Study group	Role	What they receive
ABT-493/ABT-530 for 8 weeks	Experimental	HCV Genotype (GT)1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks Receives: Drug: ABT-493 coformulated with ABT-530
ABT-493/ABT-530 for 12 weeks	Experimental	HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks Receives: Drug: ABT-493 coformulated with ABT-530

What is being measured

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

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug.
Measured: 12 weeks after last dose of study drug

Secondary outcomes (2)

Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Measured: Up to 12 weeks
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Measured: From the end of treatment through 12 weeks after the last dose of study drug

Timeline

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

17 May 20167 Jun 2017

First posted14 Apr 2016 (estimated)
Study start17 May 2016
Primary completion15 Mar 2017
Study completion7 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02738138
Sponsor's protocol ID: M14-730
Other IDs: 2015-005577-20, 2015
Acronym: EXPEDITION-2
Status last verified: Jul 2021
First submitted: 11 Apr 2016
Last updated: 13 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Rockstroh JK, Lacombe K, Viani RM, Orkin C, Wyles D, Luetkemeyer AF, Soto-Malave R, Flisiak R, Bhagani S, Sherman KE, Shimonova T, Ruane P, Sasadeusz J, Slim J, Zhang Z, Samanta S, Ng TI, Gulati A, Kosloski MP, Shulman NS, Trinh R, Sulkowski M. Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study. Clin Infect Dis. 2018 Sep 14;67(7):1010-1017. doi: 10.1093/cid/ciy220.
PubMed 29566246
Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.
PubMed 30977945
Naganuma A, Chayama K, Notsumata K, Gane E, Foster GR, Wyles D, Kwo P, Crown E, Bhagat A, Mensa FJ, Otani T, Larsen L, Burroughs M, Kumada H. Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection. J Gastroenterol. 2019 Aug;54(8):752-761. doi: 10.1007/s00535-019-01569-7. Epub 2019 Mar 13.
PubMed 30868245
Foster GR, Dore GJ, Wang S, Grebely J, Sherman KE, Baumgarten A, Conway B, Jackson D, Asselah T, Gschwantler M, Tomasiewicz K, Aguilar H, Asatryan A, Hu Y, Mensa FJ. Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. Drug Alcohol Depend. 2019 Jan 1;194:487-494. doi: 10.1016/j.drugalcdep.2018.11.007. Epub 2018 Nov 24.
PubMed 30529905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)
ClinicalTrials.gov ID: NCT02738138
Acronym / sponsor ID: EXPEDITION-2 / M14-730
Conditions: Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
Keywords: HCV Genotype 3, Non-cirrhotic, HCV Genotype 1, HCV Genotype 6, Human Immunodeficiency Virus (HIV) Infection, HCV Genotype 5, HCV Treatment Naive, HCV Genotype 4
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 17 May 2016 (actual)
Primary completion: 15 Mar 2017 (actual)
Study completion: 7 Jun 2017 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Posted 9 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ABT-493/ABT-530 for 8 weeks	Experimental	Drug: ABT-493 coformulated with ABT-530HCV Genotype (GT)1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
ABT-493/ABT-530 for 12 weeks	Experimental	Drug: ABT-493 coformulated with ABT-530HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female, at least 18 years of age at time of Screening.
Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit.
Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening.
Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have

Key exclusion criteria (5 listed)

Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg).
Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-493 coformulated with ABT-530Also: ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRETTablet	Drug	ABT-493/ABT-530 for 12 weeks, ABT-493/ABT-530 for 8 weeks

Primary outcome

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks after last dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug.

2 secondary outcomes

Percentage of Participants With On-treatment Virologic Failure
Time frame: Up to 12 weeks
Percentage of Participants With Post-treatment Relapse
Time frame: From the end of treatment through 12 weeks after the last dose of study drug

Results and safety

Results posted to the registry on 9 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABT-493/ABT-530 for 8 Weeks	137	134
ABT-493/ABT-530 for 12 Weeks	16	15

Primary outcome: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Time frame: 12 weeks after last dose of study drug. Number (95% Confidence Interval). Unit: percentage of participants

Measure	ABT-493/ABT-530 n = 153
Value	98.0 (95.8 to 100.0)

Population analysed: Per protocol, all efficacy analyses were performed using the intention-to-treat (ITT) population (all enrolled participants who received at least 1 dose of study drug); in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABT-493/ABT-530 for 8 Weeks	3 of 137 (2.2%)	50 of 137 (36.5%)	0 of 137
ABT-493/ABT-530 for 12 Weeks	1 of 16 (6.3%)	7 of 16 (43.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29566246Rockstroh JK, Lacombe K, Viani RM, Orkin C, Wyles D, Luetkemeyer AF, Soto-Malave R, Flisiak R, Bhagani S, Sherman KE, Shimonova T, Ruane P, Sasadeusz J, Slim J, Zhang Z, Samanta S, Ng TI, Gulati A, Kosloski MP, Shulman NS, Trinh R, Sulkowski M. Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study. Clin Infect Dis. 2018 Sep 14;67(7):1010-1017. doi: 10.1093/cid/ciy220.
Derived from this study: PubMed 30977945Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.
Derived from this study: PubMed 30868245Naganuma A, Chayama K, Notsumata K, Gane E, Foster GR, Wyles D, Kwo P, Crown E, Bhagat A, Mensa FJ, Otani T, Larsen L, Burroughs M, Kumada H. Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection. J Gastroenterol. 2019 Aug;54(8):752-761. doi: 10.1007/s00535-019-01569-7. Epub 2019 Mar 13.
Derived from this study: PubMed 30529905Foster GR, Dore GJ, Wang S, Grebely J, Sherman KE, Baumgarten A, Conway B, Jackson D, Asselah T, Gschwantler M, Tomasiewicz K, Aguilar H, Asatryan A, Hu Y, Mensa FJ. Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. Drug Alcohol Depend. 2019 Jan 1;194:487-494. doi: 10.1016/j.drugalcdep.2018.11.007. Epub 2018 Nov 24.
Related InfoLink provided by the sponsor.

Related trials for Hepatitis C Virus Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-493 coformulated with ABT-530 in people with Hepatitis C Virus Infection and Human Immunodeficiency Virus Infection, run by AbbVie.

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 7 inclusion and 5 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after last dose of study drug). 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 NCT02738138, which also lists 4 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 13 Jul 2021.