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)

NCT02738138 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M14-7302015-005577-20
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief 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.

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; HCV Treatment Experienced; HCV Genotype 2; Hepatitis C Virus (HCV) Infection; Compensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after last dose of study drug

Secondary Outcomes (2)

• Percentage of Participants With On-treatment Virologic Failure

  Up to 12 weeks

• Percentage of Participants With Post-treatment Relapse

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

Study Arms (2)

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

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

Drug: ABT-493 coformulated with ABT-530

Interventions

ABT-493 coformulated with ABT-530 DRUG

Tablet

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

ABT-493/ABT-530 for 12 weeks; ABT-493/ABT-530 for 8 weeks

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (4)

• 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.

  PMID: 29566246 BACKGROUND

• 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.

  PMID: 30977945 DERIVED

• 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.

  PMID: 30868245 DERIVED

• 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.

  PMID: 30529905 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome; Hepatitis C, Chronic; Infections

Interventions

pibrentasvir; glecaprevir; glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: May 17, 2016
• Primary Completion: March 15, 2017
• Study Completion: June 7, 2017
• Last Updated: July 13, 2021
• Results First Posted: May 9, 2018

Record last verified: 2021-07