Evidence map›Paper›PMID 29909549›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2019

Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.

Jiuhong Zha, Bifeng Ding, Haoyu Wang, Weihan Zhao, Chen Yu, Katia Alves, Niloufar Mobashery, Yan Luo, Rajeev M Menon

3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 49% 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.

NCT02517515 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled650ConditionsHepatitis C Virus (HCV)Armsombitasvir/paritaprevir/ritonavir and dasabuvir, Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
NCT02517528 phase3completednot on this map

An Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

TypeinterventionalSponsorAbbVieRan2015 to 2017Enrolled104ConditionsChronic Hepatitis C Virus (HCV)ArmsABT-450/r/ABT-267, ABT-333, ribavirin
NCT02534870 phase1completednot on this map

Multiple-Dose Pharmacokinetics, Safety and Tolerability of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects

TypeinterventionalSponsorAbbVieRan2015 to 2015Enrolled18ConditionsHealthy VolunteerArmsABT-450/r/ABT-267, ABT-333
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

9 authors at 2 institutions in 2 countries.

Jiuhong ZhaClinical Pharmacology and Pharmacometrics, AbbVie Inc, 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA. jiuhong.zha@abbvie.com.
Bifeng DingData and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.
Haoyu WangData and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.
Weihan ZhaoData and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.
Chen YuPhase I Clinical Research Center, Shanghai Xuhui Central Hospital, Shanghai, China.
Katia AlvesClinical Development, AbbVie Inc., North Chicago, IL, USA.
Niloufar MobasheryClinical Development, AbbVie Inc., North Chicago, IL, USA.
Yan LuoClinical Development, AbbVie Inc., North Chicago, IL, USA.
Rajeev M MenonClinical Pharmacology and Pharmacometrics, AbbVie Inc, 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA.
AbbVie (United States) · USShanghai Xuhui Central Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background/purposeThe 3 direct-acting antiviral (3D) regimen of ombitasvir/paritaprevir/ritonavir plus dasabuvir has recently been approved in several Asian geographic regions for the treatment of hepatitis C virus (HCV) genotype (GT) 1 infection. The pharmacokinetics of the components of the 3D regimen with or without ribavirin were evaluated in healthy Chinese subjects and HCV GT1b-infected Chinese, South Korean, and Taiwanese patients, with or without cirrhosis, to determine how the drug exposures in Asian populations compare with historical data in Western populations.

methodsParticipants received ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily plus dasabuvir 250 mg twice daily for 14 days (healthy subjects, n = 36) or 12 weeks (HCV patients, n = 754). Patients with compensated cirrhosis also received ribavirin 1000 or 1200 mg divided twice daily, per the local label. Intensive or sparse pharmacokinetic sampling was performed for assessments of plasma drug concentrations.

resultsThe exposures [maximum plasma concentration (C

conclusionCollectively, the results of these pharmacokinetic analyses support the use of the same dose of the 3D regimen for Asian and Western patients. CLINICALTRIALS.GOV: NCT02534870, NCT02517515, NCT02517528.

Indexed as

2-NaphthylamineAdultAnilidesAntiviral AgentsAsian PeopleCarbamatesChinaCyclopropanesFemaleHealthy VolunteersHepatitis C, ChronicHumansLactams, MacrocyclicMacrocyclic CompoundsMaleProline2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesdasabuvirLactams, MacrocyclicMacrocyclic CompoundsombitasvirparitaprevirProlineRitonavirSulfonamidesUracilValine

Identifiers

PMID29909549
OpenAlexW2808626751

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.