Evidence map›Paper›PMID 31143073›Full record

Trial reportWorld journal of gastroenterology2019

Ombitasvir/paritaprevir/ritonavir + dasabuvir +/- ribavirin in real world hepatitis C patients.

Nicole Loo, Eric Lawitz, Naim Alkhouri, Jennifer Wells, Carmen Landaverde, Angie Coste, Rossalynn Salcido, Michael Scott, Fred Poordad

Open access · hybridAbstract readClinical Trial, Phase IV
In one paragraph

Trial report in World journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 23% 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

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Observational
  3. The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022
    Article
  4. Review
  5. Article
  6. Article
  7. Observational
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

9 authors at 1 institution in 1 country.

Nicole LooAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States.
Eric LawitzAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States.
Naim AlkhouriAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States.
Jennifer WellsAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States.
Carmen LandaverdeAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States.
Angie CosteAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States.
Rossalynn SalcidoAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States.
Michael ScottAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States.
Fred PoordadAcademic and Clinical Affairs, Texas Liver Institute, 607 Camden Street, San Antonio, TX 78215, United States. poordad@txliver.com.
Texas Liver Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe hepatitis C virus (HCV) NS5A inhibitor ABT-267 (ombitasvir, OBV), the HCV NS4/4A protease inhibitor ABT-450 (paritaprevir, PTV), the CYP3A inhibitor ritonavir (r) and the non-nucleoside NS5B polymerase inhibitor ABT-333 (dasabuvir, DSV) (OBV/PTV/r + DSV) with or without ribavirin (RBV) is a direct-acting antiviral regimen approved in the United States and other major countries for the treatment of HCV in genotype 1 (GT1) infected patients. Patients with HCV who are considered "hard-to-cure" have generally been excluded from registration trials due to rigorous study inclusion criteria, presence of comorbidities and previous treatment failures.

aimTo investigate the efficacy of this regimen in HCV G1-infected patients historically excluded from clinical trials.

methodsPatients were ≥ 18 years old and chronically infected with HCV GT1 (GT1a, GT1b or GT1a/1b). Patients were treatment-naïve or previously failed a regimen including pegylated interferon/RBV +/- telaprevir, boceprevir, or simeprevir. One hundred patients were treated with the study drug regimen, which was administered for 12 or 24 wk +/- RBV according to GT1 subtype and presence/absence of cirrhosis. Patients were evaluated every 4 wk from treatment day 1 and at 4 and 12 wk after end-of-treatment.

resultsMany of the patients studied had comorbidities (44.2% hypertensive, 33.7% obese, 20.2% cirrhotic) and 16% previously failed HCV treatment. Ninety-six patients completed study follow-up and 99% achieved 12-wk sustained virologic response. The majority (88.4%) of patients had undetectable HCV RNA by week 4. The most common adverse events were fatigue (12%), headache (10%), insomnia (9%) and diarrhea (8%); none led to treatment discontinuation. Physical and mental patient reported outcomes scores significantly improved after treatment. Almost all (98%) patients were treatment compliant.

conclusionIn an all-comers HCV GT1 population, 12 or 24-wk of OBV/PTV/r + DSV +/- RBV is highly effective and tolerable and results in better mental and physical health following treatment.

Indexed as

Sustained Virologic ResponseAdultAgedAntiviral AgentsDrug Resistance, ViralDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansMaleMiddle AgedQuality of LifeAntiviral AgentsDasabuvirGenotype 1Hepatitis COmbitasvirParitaprevirRitonavir

Identifiers

PMID31143073
PMCPMC6526152
OpenAlexW2945285279

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.