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NCT02738138: EXPEDITION-2

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)

Completed Phase 3 Results posted Last updated 13 July 2021
What this trial tests

Phase 3 trial testing ABT-493 coformulated with ABT-530 in Hepatitis C Virus Infection in 153 participants. Completed in 7 June 2017.

Timeline
17 May 2016
Primary endpoint
15 March 2017
7 June 2017

Quick facts

Lead sponsorAbbVie
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment153
Start date17 May 2016
Primary completion15 March 2017
Estimated completion7 June 2017

Drugs / interventions tested

Conditions studied

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 99, any sex, with Hepatitis C Virus Infection or Human Immunodeficiency Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
ABT-493/ABT-53098.095.8 – 100.0
Percentage of Participants With On-treatment Virologic Failure Secondary · Up to 12 weeks

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.

GroupValue95% CI
ABT-493/ABT-5300.70.1 – 3.6
Percentage of Participants With Post-treatment Relapse Secondary · From the end of treatment through 12 weeks after the last dose of study drug

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.

GroupValue95% CI
ABT-493/ABT-53000.0 – 2.5

Adverse events — posted to ClinicalTrials.gov

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).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ABT-493/ABT-530 for 8 Weeks
Serious: 3/137 (2%)
Deaths: 0/137
ABT-493/ABT-530 for 12 Weeks
Serious: 1/16 (6%)
Deaths: 0/16

Serious adverse events (5 terms)

ReactionSystemABT-493/ABT-530 for 8 WeeksABT-493/ABT-530 for 12 Weeks
UPPER GASTROINTESTINAL HAEMORRHAGEGastrointestinal disorders
CEREBRAL HAEMORRHAGENervous system disorders
CEREBROVASCULAR ACCIDENTNervous system disorders
CALCULUS URINARYRenal and urinary disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASEVascular disorders
Other adverse events (18 terms — click to expand)

ReactionSystemABT-493/ABT-530 for 8 WeeksABT-493/ABT-530 for 12 Weeks
FATIGUEGeneral disorders
NAUSEAGastrointestinal disorders
VIRAL UPPER RESPIRATORY TRACT INFECTIONInfections and infestations
HEADACHENervous system disorders
RASHSkin and subcutaneous tissue disorders
DIZZINESSNervous system disorders
PRURITUSSkin and subcutaneous tissue disorders
ABDOMINAL PAINGastrointestinal disorders
ANXIETYPsychiatric disorders
COUGHRespiratory, thoracic and mediastinal disorders
CONSTIPATIONGastrointestinal disorders
DENTAL CARIESGastrointestinal disorders
GASTROINTESTINAL SOUNDS ABNORMALGastrointestinal disorders
SEASONAL ALLERGYImmune system disorders
CANDIDA INFECTIONInfections and infestations
SINUSITIS BACTERIALInfections and infestations
SINUS CONGESTIONRespiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROMERespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: UPPER GASTROINTESTINAL HAEMORRHAGE, CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT, CALCULUS URINARY, PERIPHERAL ARTERIAL OCCLUSIVE DISEASE.

Data from ClinicalTrials.gov NCT02738138 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: An integrated analysis of HCV genotype 1-6 patients without cirrhosis.
    Puoti M, Foster GR, Wang S, Mutimer D, et al · · 2018 · cited 106× · PMID 29551706 · DOI 10.1016/j.jhep.2018.03.007
  2. Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study.
    Rockstroh JK, Lacombe K, Viani RM, Orkin C, et al · · 2018 · cited 102× · PMID 29566246 · DOI 10.1093/cid/ciy220
  3. Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis.
    Flamm S, Mutimer D, Asatryan A, Wang S, et al · · 2019 · cited 33× · PMID 30421537 · DOI 10.1111/jvh.13038
  4. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis.
    Back D, Belperio P, Bondin M, Negro F, et al · · 2019 · cited 19× · PMID 30977945 · DOI 10.1111/jvh.13110
  5. Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection.
    Naganuma A, Chayama K, Notsumata K, Gane E, et al · · 2019 · cited 13× · PMID 30868245 · DOI 10.1007/s00535-019-01569-7
  6. High Sustained Virologic Response Rates of Glecaprevir/Pibrentasvir in Patients With Dosing Interruption or Suboptimal Adherence.
    Zamor PJ, Brown A, Dylla DE, Dillon JF, et al · · 2021 · cited 11× · PMID 34465693 · DOI 10.14309/ajg.0000000000001332
  7. Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5/6: An integrated analysis of phase 2/3 studies.
    Yao BB, Fredrick LM, Schnell G, Kowdley KV, et al · · 2020 · cited 8× · PMID 32445613 · DOI 10.1111/liv.14535
  8. Safety of Patients with Hepatitis C Virus Treated with Glecaprevir/Pibrentasvir from Clinical Trials and Real-World Cohorts.
    Forns X, Feld JJ, Dylla DE, Pol S, et al · · 2021 · cited 6× · PMID 34021887 · DOI 10.1007/s12325-021-01753-3

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02738138.

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