Evidence map›Paper›PMID 30775622›Full record

ArticleKidney international reports2019

Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir in Patients With Hepatitis C Virus Genotype 1 or 4 Infection and Advanced Kidney Disease.

Eric Lawitz, Edward Gane, Eric Cohen, John Vierling, Kosh Agarwal, Tarek Hassanein, Parvez S Mantry, Paul J Pockros, Michael Bennett, Nyingi Kemmer and 6 more

Open access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Interventions for dialysis patients with hepatitis C virus (HCV) infection.The Cochrane database of systematic reviews · 2023
    Review
  5. Review
  6. Article
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Article
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

16 authors at 11 institutions in 3 countries.

Eric LawitzThe Texas Liver Institute, University of Texas Health, San Antonio, Texas, USA.
Edward GaneAuckland City Hospital, Auckland, New Zealand.
Eric CohenAbbVie Inc., North Chicago, Illinois, USA.
John VierlingBaylor College of Medicine, Houston, Texas, USA.
Kosh AgarwalInstitute of Liver Studies, Kings College Hospital NHS Foundation Trust, London, UK.
Tarek HassaneinSouthern California GI and Liver Centers and Southern California Research Center, Coronado, California, USA.
Parvez S MantryThe Liver Institute at Methodist Dallas, Dallas, Texas, USA.
Paul J PockrosScripps Clinic, La Jolla, California, USA.
Michael BennettMedical Associates Research Group, San Diego, California, USA.
Nyingi KemmerTampa General Medical Group, Tampa, Florida, USA.
Giuseppe MorelliUniversity of Florida Health Science Center, Gainesville, Florida, USA.
Jiuhong ZhaAbbVie Inc., North Chicago, Illinois, USA.
Deli WangAbbVie Inc., North Chicago, Illinois, USA.
Nancy S ShulmanAbbVie Inc., North Chicago, Illinois, USA.
Daniel E CohenAbbVie Inc., North Chicago, Illinois, USA.
K Rajender ReddyUniversity of Pennsylvania, Philadelphia, Pennsylvania, USA.
AbbVie (United States) · USAuckland City Hospital · NZBaylor College of Medicine · USKing's College Hospital NHS Foundation Trust · GBMedical Research Associates · USScripps Clinic · USSouthern California Reproductive Center · USTampa General Hospital · USThe University of Texas Health Science Center at San Antonio · USUniversity of Florida Health Science Center · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHepatitis C virus (HCV) infection is common in patients with end-stage renal disease. We investigated the safety and efficacy of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) ± dasabuvir (DSV) ± ribavirin (RBV) in 2 phase 3, open-label, multicenter studies in patients with stage 4 or 5 chronic kidney disease (CKD).

methodsRUBY-I, Cohort 2 enrolled treatment-naïve or -experienced patients with HCV genotype (GT) 1a or 1b infection, with or without cirrhosis. Patients received 12 weeks (24 weeks for GT1a patients with cirrhosis) of OBV/PTV/r + DSV; all GT1a patients received RBV. RUBY-II enrolled treatment-naïve patients with GT1a or GT4 infection without cirrhosis. All patients received 12 weeks of RBV-free treatment: OBV/PTV/r + DSV for GT1a-infected patients; OBV/PTV/r for GT4-infected patients. The primary endpoint was sustained virologic response at posttreatment week 12 (SVR12).

resultsRUBY-I, Cohort 2 and RUBY-II enrolled 66 patients, including 50 (76%) on dialysis; 15 (23%) had compensated cirrhosis. Overall, the SVR12 rate was 95% (63/66); 1 patient had virologic failure. There were 3 discontinuations due to adverse events. Seventy-three percent (27/37) of patients receiving RBV had adverse events leading to RBV dose modification. The RBV-free RUBY-II study had no hemoglobin-associated adverse events.

conclusionTreatment with OBV/PTV/r ± DSV ± RBV was well tolerated and patients with HCV GT1 or 4 infection and stage 4 or 5 CKD had high SVR12 rates, including patients with compensated cirrhosis and/or prior treatment experience.

Indexed as

chronic kidney diseaseNS3/4A protease inhibitorNS5A inhibitorrenal diseaseRUBY

Identifiers

PMID30775622
PMCPMC6365406
OpenAlexW2896996128

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.