Evidence map›Paper›PMID 27098247›Full record

ReviewDrug safety2016

Pharmacokinetics, Efficacy, and Safety of Hepatitis C Virus Drugs in Patients with Liver and/or Renal Impairment.

Elise J Smolders, Clara T M M de Kanter, Bart van Hoek, Joop E Arends, Joost P H Drenth, David M Burger

Open access · hybridAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
7.9field-weighted citation impact, top 2% 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

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
  5. Review
  6. Protein Abundance of Drug Metabolizing Enzymes in Human Hepatitis C Livers.International journal of molecular sciences · 2023
    Article
  7. Review
  8. Nucleotide and nucleoside-based drugs: past, present, and future.Saudi journal of biological sciences · 2022
    Review
  9. Review
  10. Observational
  11. Article
  12. Article
  13. Benzothiazoles as potential antiviral agents.The Journal of pharmacy and pharmacology · 2020
    Review
  14. Article
  15. Article
  16. Review
  17. Observational
  18. Review
  19. Article
  20. 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

6 authors at 4 institutions in 1 country.

Elise J SmoldersDepartment of Pharmacy, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Clara T M M de KanterDepartment of Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.
Bart van HoekDepartment of Gastroenterology and Hepatology, Leids University Medical Center, Leiden, The Netherlands.
Joop E ArendsDepartment of Internal Medicine and Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands.
Joost P H DrenthDepartment Gastroenterology and Hepatology, Radboud university medical center, Nijmegen, The Netherlands.
David M BurgerDepartment of Pharmacy, Radboud university medical center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands. david.burger@radboudumc.nl.
Radboud University Medical Center · NLUniversity Medical Center Utrecht · NLLeiden University Medical Center · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hepatitis C virus (HCV)-infected patients often suffer from liver cirrhosis, which can be complicated by renal impairment. Therefore, in this review we describe the treatment possibilities in HCV patients with hepatic and renal impairment. Cirrhosis alters the structure of the liver, which affects drug-metabolizing enzymes and drug transporters. These modifications influence the plasma concentration of substrates of drugs metabolized/transported by these enzymes. The direct-acting antivirals (DAAs) are substrates of, for example, cytochrome P450 enzymes in the liver. Most DAAs are not studied in HCV-infected individuals with decompensated cirrhosis, and therefore awareness is needed when these patients are treated. Most DAAs are contraindicated in cirrhotic patients; however, patients with a Child-Pugh score of B or C can be treated safely with a normal dose sofosbuvir plus ledipasvir or daclatasvir, in combination with ribavirin. Patients with renal impairment (glomerular filtration rate [GFR] <90 mL/min) or who are dependent on dialysis often tolerate ribavirin treatment poorly, even after dose adjustments. However, most DAAs can be used at the normal dose because DAAs are not renally excreted. To date, grazoprevir plus elbasvir is the preferred DAA regimen in patients with renal impairment as data are pending for sofosbuvir patients with GFR <30 mL/min (as for ledipasvir and velpatasvir). However, sofosbuvir has been used in a small number of patients with severe renal impairment and, based on these trials, we recommend sofosbuvir 400 mg every day when no other DAA regimen is available. Ledipasvir and velpatasvir are not recommended in patients with severe renal impairment.

Indexed as

Antiviral AgentsHepatitis C, ChronicHumansKidney Failure, ChronicLiver CirrhosisAntiviral Agents

Identifiers

PMID27098247
PMCPMC4912979
OpenAlexW2337799375

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.