Evidence map›Paper›PMID 29566246›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018

Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study.

Jürgen K Rockstroh, Karine Lacombe, Rolando M Viani, Chloe Orkin, David Wyles, Anne F Luetkemeyer, Ruth Soto-Malave, Robert Flisiak, Sanjay Bhagani, Kenneth E Sherman and 12 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02738138 (A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus), which is not on this map. Cited by 66 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02738138 phase3completednot on this map

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)

TypeinterventionalSponsorAbbVieRan2016 to 2017Enrolled153ConditionsHepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhoticsArmsABT-493 coformulated with ABT-530
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5/6: An integrated analysis of phase 2/3 studies.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  17. Review
  18. Article
  19. Review
  20. Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Jürgen K RockstrohDepartment of Medicine, Universitätsklinikum Bonn, Germany.
Karine LacombeInfectious Diseases Unit, Inserm UMR-S1136, Université Pierre et Marie Curie, Hôpital Saint-Antoine, Assistance Publique - Hôpitaux de Paris, Paris, France.
Rolando M VianiInfectious Disease Development, AbbVie Inc, Chicago, Illinois.
Chloe OrkinInfection and immunology Barts Health, Royal London Hospital, United Kingdom.
David WylesDivision of Infectious Diseases, Denver Health Medical Center, Colorado.
Anne F LuetkemeyerDivision of HIV, Infectious Diseases and Global Medicine, Zuckerberg San Francisco General, University of California.
Ruth Soto-MalaveInnovative Care P.S.C., Bayamon, Puerto Rico.
Robert FlisiakDepartment of Infectious Diseases and Hepatology, Klinika Chorób Zakaznych i Hepatologii UM w Bialymstoku, Bialystok, Poland.
Sanjay BhaganiDepartment of Infectious Diseases/HIV Medicine, Royal Free London Foundation Trust, United Kingdom.
Kenneth E ShermanDivision of Digestive Diseases, University of Cincinnati, Ohio.
Tatiana ShimonovaState Budgetary Healthcare Institution of Moscow, Infectious Clinical Hospital #2 of Moscow City Healthcare Department, Russia.
Peter RuaneRuane Medical & Liver Health Institute, Los Angeles, California.
Joseph SasadeuszVictorian Infectious Disease Service, Royal Melbourne Hospital, Parkville, Victoria, Australia.
Jihad SlimInfectious Disease Division, Department of Internal Medicine, St. Michael's Medical Center, Newark, New Jersey.
Zhenzhen ZhangData and Statistical Sciences, AbbVie Inc, Chicago, Illinois.
Suvajit SamantaData and Statistical Sciences, AbbVie Inc, Chicago, Illinois.
Teresa I NgHCV Clinical Virology, AbbVie Inc, Chicago, Illinois.
Abhishek GulatiClinical Pharmacology and Pharmacometrics, AbbVie Inc, Chicago, Illinois.
Matthew P KosloskiClinical Pharmacology and Pharmacometrics, AbbVie Inc, Chicago, Illinois.
Nancy S ShulmanInfectious Disease Development, AbbVie Inc, Chicago, Illinois.
Roger TrinhInfectious Disease Development, AbbVie Inc, Chicago, Illinois.
Mark SulkowskiDivisions of Infectious Diseases and Gastroenterology/Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Funding

Stem Cell/Organoid and Genome Editing CoreP30DK078392 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI Alexander Miethke · 2007 to 2026
$24.4M
NIDDK NIH HHS P30 DK078392
6 · The paper itself

Abstract

Background: Once-daily glecaprevir coformulated with pibrentasvir (glecaprevir/pibrentasvir) demonstrated high rates of sustained virologic response 12 weeks after treatment (SVR12) in patients with hepatitis C virus (HCV) genotype 1-6 infection. This phase 3 study evaluated the efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV genotype 1-6 and human immunodeficiency virus type 1 (HIV-1) coinfection, including patients with compensated cirrhosis. Methods: EXPEDITION-2 was a phase 3, multicenter, open-label study evaluating glecaprevir/pibrentasvir (300 mg/120 mg) in HCV genotype 1-6/HIV-1-coinfected adults without and with compensated cirrhosis for 8 and 12 weeks, respectively. Patients were either HCV treatment-naive or experienced with sofosbuvir, ribavirin, or interferon, and antiretroviral therapy (ART) naive or on a stable ART regimen. Treatment-experienced genotype 3-infected patients were excluded. The primary endpoint was the SVR12 rate. Results: In total, 153 patients were enrolled, including 16 (10%) with cirrhosis. The SVR12 rate was 98% (n = 150/153; 95% confidence interval, 95.8-100), with no virologic failures in 137 patients treated for 8 weeks. One genotype 3-infected patient with cirrhosis had on-treatment virologic failure. Most adverse events were mild in severity; 4 patients (2.6%) had serious adverse events, all deemed unrelated to glecaprevir/pibrentasvir. Treatment discontinuation was rare (<1%). All patients treated with ART maintained HIV-1 suppression (<200 copies/mL) during treatment. Conclusions: Glecaprevir/pibrentasvir for 8 weeks in noncirrhotic and 12 weeks in cirrhotic patients is a highly efficacious and well-tolerated treatment for HCV/HIV-1 coinfection, regardless of baseline HCV load or prior treatment with interferon or sofosbuvir. Clinical trial registration: NCT02738138.

Indexed as

AdultAnimalsAntiviral AgentsBenzimidazolesCoinfectionDrug CombinationsFemaleHepatitis CHIV-1HIV InfectionsHumansLiver CirrhosisMalePyrrolidinesQuinoxalinesSulfonamidesAntiviral AgentsBenzimidazolesDrug Combinationsglecaprevir and pibrentasvirPyrrolidinesQuinoxalinesSulfonamides

Identifiers

PMID29566246
PMCPMC6137115

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.