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CompletedNCT02604017Updated Jul 13, 2021Results posted

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection

A Phase 3 interventional study of ABT-493/ABT-530 in Chronic Hepatitis C, Hepatitis C Virus and HCV, sponsored by AbbVie. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-13.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
703
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis

02

Conditions studied

  • Chronic Hepatitis C
  • Hepatitis C Virus
  • HCV

Keywords

  • HCV GT1
  • Non-cirrhotic
  • RBV Free
  • Without cirrhosis
  • Chronic Hepatitis C
  • Hepatitis C Genotype 1 (GT1)
  • IFN free
  • Hepatitis C
  • Ribavirin Free
  • Interferon (IFN) Free
  • HCV
  • Hepatitis C virus
  • DAA
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 703 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female, at least 18 years of age at time of screening.
  • Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.
  • Chronic HCV infection.
  • Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).
  • Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

  • HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA \<1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.

OR

  • On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA \< LLOQ at Screening and at least once during the 12 months prior to Screening.

Exclusion criteria

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
  • Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
  • 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).
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
  • Chronic HIV type 2 (HIV-2) infection.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
703 participants (actual)

Study arms

  • Experimental
    ABT-493/ABT-530 for 12 weeks

    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

    Drug: ABT-493/ABT-530

  • Experimental
    ABT-493/ABT-530 for 8 weeks

    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

    Drug: ABT-493/ABT-530

Interventions

  • DrugABT-493/ABT-530

    Tablet; ABT-493 coformulated with ABT-530

    Also known as: ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm

    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 study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).

    Time frame: 12 weeks after the last actual dose of study drug

  2. Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later

    SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.

    Time frame: 12 weeks after last actual dose of study drug

  3. Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants

    SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.

    Time frame: 12 weeks after the last actual dose of study drug

Secondary outcomes

  1. Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants

    SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.

    Time frame: 12 weeks after last actual dose of study drug

  2. Percentage of Participants With SVR12

    SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.

    Time frame: 12 weeks after last actual dose of study drug

  3. Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants

    SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.

    Time frame: 12 weeks after last actual dose of study drug

  4. Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants

    SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.

    Time frame: 12 weeks after last actual dose of study drug

  5. Percentage of Participants With On-treatment Virologic Failure

    On-treatment virologic failure was defined as confirmed increase of \>1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA \<LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.

    Time frame: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment

  6. Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants

    On-treatment virologic failure was defined as confirmed increase of \>1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA \<LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.

    Time frame: Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment

  7. 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, excluding reinfection.

    Time frame: From the end of treatment through 12 weeks after the last dose of study drug

  8. Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants

    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, excluding reinfection.

    Time frame: From the end of treatment through 12 weeks after the last dose of study drug

07

Results

Posted Sep 14, 2017

Participant flow

Participant flow — Overall Study
MilestoneABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Started352351
Completed346343
Not completed68
Withdrew: Withdrew consent02
Withdrew: Lost to follow-up56
Withdrew: Other10

Outcome measures

PrimaryPercentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm

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 study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).

Time frame:
12 weeks after the last actual dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm
percentage of participantsABT-493/ABT-530 for 12 Weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm99.7
Statistical analysis
  • ABT-493/ABT-530 for 12 Weeks · Percentage of participants: 99.7 · 95% CI 99.1 to 100.0
PrimaryPercentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later

SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.

Time frame:
12 weeks after last actual dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later100.0 (98.9 to 100.0)100 (98.9 to 100.0)
Statistical analysis
  • ABT-493/ABT-530 for 12 Weeks vs ABT-493/ABT-530 for 8 Weeks · Difference in percentage of participants: 0.0 · 95% CI -1.1 to 1.1
PrimaryPercentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants

SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.

Time frame:
12 weeks after the last actual dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants99.7 (99.1 to 100.0)99.1 (98.1 to 100.0)
Statistical analysis
  • ABT-493/ABT-530 for 12 Weeks vs ABT-493/ABT-530 for 8 Weeks · Difference in percentage of participants: -0.6 · 95% CI -1.8 to 0.6
SecondaryPercentage of Participants With SVR12 in Mono-infected HCV GT1 Participants

SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.

Time frame:
12 weeks after last actual dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants99.7 (98.3 to 99.9)99.1 (97.4 to 99.7)
SecondaryPercentage of Participants With SVR12

SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.

Time frame:
12 weeks after last actual dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With SVR12
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With SVR1299.7 (98.4 to 99.9)99.1 (97.5 to 99.7)
SecondaryPercentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants

SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.

Time frame:
12 weeks after last actual dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants100.0 (82.4 to 100.0)100.0 (79.6 to 100.0)
SecondaryPercentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants

SVR12 was defined as plasma HCV RNA level \<LLOQ 12 weeks after the last dose of study drug.

Time frame:
12 weeks after last actual dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants100.0 (34.2 to 100.0)100.0 (20.7 to 100.0)
SecondaryPercentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of \>1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA \<LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.

Time frame:
Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
Reported as:
Number · percentage of particpants
Percentage of Participants With On-treatment Virologic Failure
percentage of particpantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With On-treatment Virologic Failure0.0 (0.0 to 1.1)0.3 (0.1 to 1.6)
SecondaryPercentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants

On-treatment virologic failure was defined as confirmed increase of \>1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA \<LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.

Time frame:
Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment
Reported as:
Number · percentage of participants
Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants0.0 (0.0 to 1.1)0.3 (0.1 to 1.7)
SecondaryPercentage 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, excluding reinfection.

Time frame:
From the end of treatment through 12 weeks after the last dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With Post-treatment Relapse
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With Post-treatment Relapse0.0 (0.0 to 1.1)0.0 (0.0 to 1.1)
SecondaryPercentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants

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, excluding reinfection.

Time frame:
From the end of treatment through 12 weeks after the last dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants
percentage of participantsABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants0.0 (0.0 to 1.1)0.0 (0.0 to 1.1)

Adverse events

Collected over Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ABT-493/ABT-530 for 12 Weeks—4/352 (1.1%)130/352 (36.9%)
ABT-493/ABT-530 for 8 Weeks—5/351 (1.4%)133/351 (37.9%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
ANGINA UNSTABLECardiac disorders0/3521/351
ARTERIAL INJURYInjury, poisoning and procedural complications0/3521/351
RADIUS FRACTUREInjury, poisoning and procedural complications0/3521/351
UTERINE LEIOMYOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)0/3521/351
TRANSIENT ISCHAEMIC ATTACKNervous system disorders0/3521/351
SUICIDE ATTEMPTPsychiatric disorders0/3521/351
ATRIAL FIBRILLATIONCardiac disorders1/3520/351
IRRITABLE BOWEL SYNDROMEGastrointestinal disorders1/3520/351
BRONCHITISInfections and infestations1/3520/351
ALCOHOL POISONINGInjury, poisoning and procedural complications1/3520/351
Most frequent other events
Most frequent other events
EventABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 Weeks
HEADACHENervous system disorders62/35268/351
FATIGUEGeneral disorders43/35231/351
NASOPHARYNGITISInfections and infestations31/35222/351
NAUSEAGastrointestinal disorders29/35219/351
INSOMNIAPsychiatric disorders15/35221/351
PRURITUSSkin and subcutaneous tissue disorders17/35220/351

Baseline characteristics

All participants who received at least 1 dose of study drug (ITT population).

Age, Continuous
Age, Continuous(years)ABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 WeeksTotal
Mean50.27 ± 11.6251.58 ± 11.9050.93 ± 11.77
Sex: Female, Male
Sex: Female, Male(Participants)ABT-493/ABT-530 for 12 WeeksABT-493/ABT-530 for 8 WeeksTotal
Female176184360
Male176167343
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, Asselah T, Bourliere M, Ruane PJ, Wedemeyer H, Pol S, Flisiak R, Poordad F, Chuang WL, Stedman CA, Flamm S, Kwo P, Dore GJ, Sepulveda-Arzola G, Roberts SK, Soto-Malave R, Kaita K, Puoti M, Vierling J, Tam E, Vargas HE, Bruck R, Fuster F, Paik SW, Felizarta F, Kort J, Fu B, Liu R, Ng TI, Pilot-Matias T, Lin CW, Trinh R, Mensa FJ. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018 Jan 25;378(4):354-369. doi: 10.1056/NEJMoa1702417. PubMed 29365309 ↗
  • Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18. PubMed 31568620 ↗
  • 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 ↗
  • Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022. PubMed 30923816 ↗
  • 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 ↗
  • Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10. PubMed 30012435 ↗

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02604017
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 13, 2015
Start date
Oct 2015
Primary completion
Jan 2017
Completion
Jan 2017
Results posted
Sep 14, 2017
Last update
Jul 13, 2021

Study contacts

AbbVie Inc.
study director · AbbVie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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