Evidence map›Paper›PMID 27389403›Full record

ArticleClinical pharmacokinetics2017

Pharmacokinetics and Tolerability of Anti-Hepatitis C Virus Treatment with Ombitasvir, Paritaprevir, Ritonavir, with or Without Dasabuvir, in Subjects with Renal Impairment.

Amit Khatri, Sandeep Dutta, Thomas C Marbury, Richard A Preston, Lino Rodrigues, Haoyu Wang, Walid M Awni, Rajeev M Menon

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.6field-weighted citation impact, top 9% 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

8 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Clinical Pharmacokinetics of Dasabuvir.Clinical pharmacokinetics · 2017
    Review
  5. Clinical Pharmacokinetics of Ombitasvir.Clinical pharmacokinetics · 2017
    Review
  6. Clinical Pharmacokinetics of Paritaprevir.Clinical pharmacokinetics · 2017
    Review
  7. Anti-hepatitis C virus drugs and kidney.World journal of hepatology · 2016
    Review
  8. Review
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

8 authors at 4 institutions in 1 country.

Amit KhatriClinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP-31-3, 1 North Waukegan Rd, North Chicago, IL, 60064, USA. amit.khatri@abbvie.com.
Sandeep DuttaClinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP-31-3, 1 North Waukegan Rd, North Chicago, IL, 60064, USA.
Thomas C MarburyClinical Research, Orlando Clinical Research Center, Orlando, FL, USA.
Richard A PrestonDivision of Clinical Pharmacology, Department of Medicine, Miller School of Medicine, University of Miami, Miami, FL, USA.
Lino RodriguesAntiviral Global Project Team, AbbVie Inc., North Chicago, IL, USA.
Haoyu WangBiometrics, AbbVie Inc., North Chicago, IL, USA.
Walid M AwniClinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP-31-3, 1 North Waukegan Rd, North Chicago, IL, 60064, USA.
Rajeev M MenonClinical Pharmacology and Pharmacometrics, AbbVie Inc., Dept. R4PK, Bldg. AP-31-3, 1 North Waukegan Rd, North Chicago, IL, 60064, USA.
AbbVie (United States) · USOrlando Clinical Research Center · USUniversity of Miami · USZimmer Biomet (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe direct-acting antiviral agent (DAA) combination of ombitasvir and paritaprevir (administered with ritonavir) with (3D regimen) or without (2D regimen) dasabuvir has shown very high efficacy rates in the treatment of chronic hepatitis C virus (HCV) infection. Renal impairment, a common comorbidity in patients with chronic HCV infection, can influence the pharmacokinetics of antiviral agents and hence their efficacy and safety profiles.

objectiveThe aim of this study was to evaluate the influence of renal impairment on the pharmacokinetics and tolerability of the 3D and 2D regimens.

methodsOverall, 24 subjects, six in each of four renal function groups (normal, mild, moderate, and severe), received a single dose of the 3D and 2D regimens in separate dosing periods. Plasma and urine were analyzed to assess the effect of renal impairment on drug exposure.

resultsDAA exposures changed by up to 21, 37, and 50 % in subjects with mild, moderate, and severe renal impairment, respectively, versus subjects with normal renal function. Ritonavir exposure increased with the degree of renal impairment (maximum 114 %). The half-lives of DAAs and ritonavir in subjects with renal impairment were generally comparable with those in healthy subjects. No safety or tolerability concerns arose in this study.

conclusionThe 3D and 2D regimens do not require dose adjustment for patients with HCV infection and concomitant renal impairment.

Indexed as

2-NaphthylamineAgedAnilidesAntiviral AgentsCarbamatesCyclopropanesDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansKidney DiseasesLactams, MacrocyclicMacrocyclic CompoundsMaleMiddle Aged2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesdasabuvirLactams, MacrocyclicMacrocyclic CompoundsombitasvirparitaprevirProlineRitonavirSulfonamidesUracilValine

Identifiers

PMID27389403
OpenAlexW2468371940

What OpenQuestion holds

Textmetadata
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.