Evidence map›Paper›PMID 27699622›Full record

ArticleClinical pharmacokinetics2017

A Two-Way Steady-State Pharmacokinetic Interaction Study of Doravirine (MK-1439) and Dolutegravir.

Matt S Anderson, Sauzanne Khalilieh, Ka Lai Yee, Rachael Liu, Li Fan, Matthew L Rizk, Vedangi Shah, Azra Hussaini, Ivy Song, Lisa L Ross and 1 more

Erratum issuedAbstract readClinical Trial, Phase I
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. An erratum has been issued. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.1field-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

12 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Results of a Doravirine-Atorvastatin Drug-Drug Interaction Study.Antimicrobial agents and chemotherapy · 2017
    Trial
  3. Observational
  4. Article
  5. Pharmacogenomics of Antiretroviral Drug Metabolism and Transport.Annual review of pharmacology and toxicology · 2021
    Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Antimicrobial agents and chemotherapy · 2019
    Article
  11. Clinical Pharmacokinetics and Drug Interactions of Doravirine.European journal of drug metabolism and pharmacokinetics · 2018
    Review
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Matt S AndersonMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA. matt_anderson@merck.com.
Sauzanne KhaliliehMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA.
Ka Lai YeeMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA.
Rachael LiuMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA.
Li FanMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA.
Matthew L RizkMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA.
Vedangi ShahMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA.
Azra HussainiPAREXEL, Baltimore, MD, USA.
Ivy SongGlaxoSmithKline, Research Triangle Park, NC, USA.
Lisa L RossViiV Healthcare, Research Triangle Park, NC, USA.
Joan R ButtertonMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USResearch Triangle Park Foundation · USTriangle · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDoravirine, a non-nucleoside reverse-transcriptase inhibitor in development for the treatment of patients with human immunodeficiency virus-1 infection, has potential to be used concomitantly in antiretroviral therapy with dolutegravir, an integrase strand transfer inhibitor. The pharmacokinetic interactions between these drugs were therefore assessed.

methodsOral formulations of doravirine and dolutegravir were dosed both individually and concomitantly once daily in healthy adults. Twelve subjects (six were male), 23-42 years of age, were enrolled and 11 completed this phase I, open-label, three-period, fixed-sequence study per protocol; one subject was discontinued for a positive cotinine test at admission to period 2. In period 1, dolutegravir 50 mg was administered for 7 days. After a 7-day washout, doravirine 200 mg was dosed for 7 days in period 2, followed (without washout) by both doravirine and dolutegravir simultaneously for 7 days in period 3. Plasma samples were taken to determine dolutegravir and doravirine concentrations.

resultsThe steady-state concentration 24 h post-dose (C

conclusionThe results of this study demonstrate that concomitant administration of doravirine and dolutegravir in healthy subjects causes no clinically significant alteration in the pharmacokinetic and safety profiles of the two drugs, thereby supporting further evaluation of co-administration of these agents for human immunodeficiency virus-1 treatment.

Indexed as

AdultArea Under CurveDolutegravirDrug InteractionsDrug Therapy, CombinationFastingFemaleHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsHumansMaleOxazinesPiperazinesPyridonesReverse Transcriptase InhibitorsTriazolesDolutegravirdoravirineHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsOxazinesPiperazinesPyridonesReverse Transcriptase InhibitorsTriazoles

Identifiers

PMID27699622
OpenAlexW2528141927

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.