Evidence map›Paper›PMID 33364598›Full record

ArticleContraception: X2020

Effect of efavirenz on levonorgestrel concentrations among Malawian levonorgestrel implant users for up to 30 months of concomitant use: a subanalysis of a randomized clinical trial.

Jennifer H Tang, Nicole L Davis, Amanda H Corbett, Lameck Chinula, Mackenzie L Cottrell, Yasaman Zia, Gerald Tegha, Frank Z Stanczyk, Stacey Hurst, Mina C Hosseinipour and 2 more

Open access · goldAbstract read
In one paragraph

Article in Contraception: X, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
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

12 authors at 6 institutions in 2 countries.

Jennifer H TangUniversity of North Carolina at Chapel Hill, 111 Mason Farm Road, CB #7577; Chapel Hill, NC, 27599-7577, USA.
Nicole L DavisUS Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA, 30329, USA.
Amanda H CorbettUniversity of North Carolina at Chapel Hill, 111 Mason Farm Road, CB #7577; Chapel Hill, NC, 27599-7577, USA.
Lameck ChinulaUniversity of North Carolina at Chapel Hill, 111 Mason Farm Road, CB #7577; Chapel Hill, NC, 27599-7577, USA.
Mackenzie L CottrellUniversity of North Carolina at Chapel Hill, 111 Mason Farm Road, CB #7577; Chapel Hill, NC, 27599-7577, USA.
Yasaman ZiaUS Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA, 30329, USA.
Gerald TeghaUNC Project Malawi, 100 Mzimba Drive, Private Bag A104, Lilongwe, Malawi.
Frank Z StanczykUniversity of Southern California, Keck School of Medicine, Reproductive Endocrine Research Laboratory, 1321 N. Mission Road, Los Angeles, CA, 90033, USA.
Stacey HurstUS Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA, 30329, USA.
Mina C HosseinipourUniversity of North Carolina at Chapel Hill, 111 Mason Farm Road, CB #7577; Chapel Hill, NC, 27599-7577, USA.
Lisa B HaddadEmory University School of Medicine, 100 Woodruff Circle, Atlanta, GA, 30322, USA.
Athena P KourtisUS Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA, 30329, USA.
Centers for Disease Control and Prevention · USUniversity of North Carolina at Chapel Hill · USCommunities In Schools of Orange County · USEmory University · USUniversity of Malawi · MWUniversity of Southern California · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Impact of progestin contraception on risk of HIV acquisition and transmissionK23HD078153 · NICHD · EMORY UNIVERSITY · PI HADDAD, LISA BLAKE · 2014 to 2018
$704k
Evaluation of the immunologic and genital tract changes among Malawian women K01TW009657 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI TANG, JENNIFER · 2013 to 2016
$565k
FIC NIH HHS K01 TW009657NCCDPHP CDC HHS U48 DP001944NIAID NIH HHS P30 AI050410NICHD NIH HHS K23 HD078153
6 · The paper itself

Abstract

objectivesOur primary objective was to compare geometric mean levonorgestrel concentrations between levonorgestrel implant users who were or were not taking the antiretroviral efavirenz, for up to 30 months after implant initiation. Our secondary objective was to evaluate the pregnancy rate among levonorgestrel implant users on efavirenz. STUDY

designWe performed a subanalysis of 42 Malawian women randomized to initiate the levonorgestrel implant as part of a parent randomized clinical trial. Our subset included 30 HIV-infected women taking efavirenz and 12 HIV-uninfected women not taking efavirenz. They underwent urine pregnancy testing every 3 months and serum levonorgestrel testing at day 3 and months 1, 3, 6, 12, 18, 24, 27 and 30 after implant initiation. Geometric mean levonorgestrel concentrations were calculated for efavirenz users and non-efavirenz users at each time point.

resultsThe geometric mean levonorgestrel concentrations were lower for efavirenz users than non-efavirenz users at every time point; the geometric mean ratio for efavirenz users:non-efavirenz users ranged from 0.60 [90% confidence interval (CI) 0.46-0.79] at 1 month to 0.27 (90% CI 0.12-0.61) at 30 months after implant insertion. No pregnancies occurred over 60 woman-years of concomitant levonorgestrel implant and efavirenz use, although 11 women had levonorgestrel concentrations < 180 pg/mL (the previously suggested minimum threshold concentration for efficacy).

conclusionsEfavirenz users had lower levonorgestrel concentrations than non-efavirenz users, and one third of our concomitant efavirenz and levonorgestrel implant users had concentrations < 180 pg/mL. Continued evaluation of the contraceptive efficacy of the levonorgestrel implant may be needed for efavirenz users. IMPLICATIONS: Among 42 Malawian women using the levonorgestrel implant for contraception, women who were taking the antiretroviral efavirenz had lower serum levonorgestrel concentrations than women who were not taking efavirenz. However, none of the women who were taking efavirenz became pregnant over 60 women-years of follow-up.

Indexed as

Contraceptive implantDrug concentrationsDrug interactionsEfavirenzLevonorgestrel

Identifiers

PMID33364598
PMCPMC7752709
OpenAlexW3028858293

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.