Evidence map›Paper›PMID 36787829›Full record

ArticleContraception2023

Effect of double-dose levonorgestrel subdermal implant in women taking efavirenz-based antiretroviral therapy: The DoubLNG pharmacokinetic study.

Lauren R Cirrincione, Shadia Nakalema, Catherine A Chappell, Pauline Byakika-Kibwika, Isabella Kyohairwe, Lee Winchester, Hope Mackline, Michelle M Pham, Susan E Cohn, Marco Siccardi and 4 more

Open access · hybridAbstract readControlled Clinical Trial
In one paragraph

Article in Contraception, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 17% 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

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

14 authors at 8 institutions in 3 countries.

Lauren R CirrincioneDepartment of Pharmacy, University of Washington, Seattle, WA, USA.
Shadia NakalemaInfectious Diseases Institute, Kampala, Uganda.
Catherine A ChappellDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
Pauline Byakika-KibwikaDepartment of Medicine, Makerere University, Kampala, Uganda.
Isabella KyohairweInfectious Diseases Institute, Kampala, Uganda.
Lee WinchesterDepartment of Pharmacy Practice and Science, University of Nebraska Medical Center, Omaha, NE, USA.
Hope MacklineInfectious Diseases Institute, Kampala, Uganda.
Michelle M PhamDepartment of Pharmacy Practice and Science, University of Nebraska Medical Center, Omaha, NE, USA.
Susan E CohnDivision of Infectious Diseases, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Marco SiccardiDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Andrew OwenDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Courtney V FletcherDepartment of Pharmacy Practice and Science, University of Nebraska Medical Center, Omaha, NE, USA; Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA.
Mohammed LamordeInfectious Diseases Institute, Kampala, Uganda.
Kimberly K ScarsiDepartment of Pharmacy Practice and Science, University of Nebraska Medical Center, Omaha, NE, USA; Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: kim.scarsi@unmc.edu.
Infectious Diseases Institute · UGUniversity of Nebraska Medical Center · USUniversity of Liverpool · GBMakerere University · UGNebraska Medical Center · USNorthwestern University · USUniversity of Pittsburgh · USUniversity of Washington · US

Funding

Pharmacological Strategies to use the Levonorgestrel Implant in HIV-infected WomenR01HD085887 · NICHD · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SCARSI, KIMBERLY K. · 2015 to 2020
$1.4M
NICHD NIH HHS R01 HD085887
6 · The paper itself

Abstract

objectiveWe evaluated the pharmacokinetics of double-dose levonorgestrel (LNG) implants to overcome the drug-drug interaction with efavirenz-based antiretroviral therapy (ART). STUDY

designWe conducted a nonrandomized, open-label, parallel-group, longitudinal pharmacokinetic study among Ugandan women ages 18-45 years. Participants with HIV on ART containing efavirenz 600 mg received 300 mg of LNG implants (Jadelle®, Bayer, New Zealand): 300LNG+ART group. We compared our outcomes with women without HIV using standard dose, 150 mg of LNG implants: 150LNG group. The implant was placed on day zero in both groups, and we quantified plasma LNG concentrations over 48 weeks post implant insertion. LNG pharmacokinetic parameters were estimated using noncompartmental techniques. Our primary outcome was the geometric mean ratio with 90% confidence intervals of LNG area under the concentration-time curve over 24 weeks (AUC

resultsWe enrolled 27 women in the 300LNG+ART group (34 [28.0 to 40.5] years and 61.0 [49.8-66.0] kg) and 19 women in the 150LNG group (33 [30.0 to 34.5] years and 64.9 [59.0 to 74.5] kg). LNG AUC

conclusionDouble-dose LNG implant did not completely overcome the drug-drug interaction with efavirenz. IMPLICATION: In women using ART containing efavirenz, placing two implant systems (300 mg) did not normalize LNG pharmacokinetics compared with the standard-dose implant (150 mg), and some women had evidence of ovulatory activity. Alternative ART without drug-drug interactions, such as dolutegravir, is recommended with contraceptive implants.

Indexed as

Contraceptive Agents, FemaleHIV InfectionsAdolescentAdultAlkynesBenzoxazinesCyclopropanesFemaleHumansLevonorgestrelMiddle AgedPregnancyYoung AdultAlkynesBenzoxazinesContraceptive Agents, FemaleCyclopropanesefavirenzLevonorgestrelDrug interactionsEfavirenzHIVLevonorgestrelLong-acting reversible contraceptivesPharmacokinetics

Identifiers

PMID36787829
PMCPMC10149595
OpenAlexW4320181892

What OpenQuestion holds

Textmetadata
LicenceTDM
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.