Evidence map›Paper›PMID 36059130›Full record

ArticleThe Journal of antimicrobial chemotherapy2022

Pharmacokinetics of levonorgestrel and etonogestrel contraceptive implants over 48 weeks with rilpivirine- or darunavir-based antiretroviral therapy.

Shadia Nakalema, Catherine A Chappell, Michelle Pham, Pauline Byakika-Kibwika, Julian Kaboggoza, Stephen I Walimbwa, Joseph Musaazi, Ritah Nakijoba, Leah Mbabazi, Isabella Kyohairwe and 7 more

Open access · greenAbstract read
In one paragraph

Article in The Journal of antimicrobial chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.6field-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

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. 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

17 authors at 5 institutions in 3 countries.

Shadia NakalemaInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Catherine A ChappellDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
Michelle PhamCollege of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.
Pauline Byakika-KibwikaDepartment of Medicine, Makerere University, Kampala, Uganda.
Julian KaboggozaInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Stephen I WalimbwaInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Joseph MusaaziInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Ritah NakijobaInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Leah MbabaziInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Isabella KyohairweInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Sylvia NassiwaInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Jeffrey JeppsonCollege of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.
Lee WinchesterCollege of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.
Marco SiccardiDepartment of Pharmacology, University of Liverpool, Liverpool, UK.
Courtney V FletcherCollege of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.ORCID 0000-0002-3703-7849
Kimberly K ScarsiCollege of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.ORCID 0000-0001-9406-693X
Mohammed LamordeInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Infectious Diseases Institute · UGUniversity of Nebraska Medical Center · USMakerere University · UGUniversity of Liverpool · GBUniversity of Pittsburgh · 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 HD085887NIH HHS
6 · The paper itself

Abstract

backgroundPharmacokinetic data are lacking for progestin-releasing subdermal contraceptive implants when used with either rilpivirine- or darunavir/ritonavir-based ART.

objectivesTo characterize the pharmacokinetics of etonogestrel or levonorgestrel implants when administered with these ART regimens over 48 weeks. PATIENTS AND

methodsTwo separate, parallel, three-group, non-randomized, pharmacokinetic studies evaluated either etonogestrel or levonorgestrel in women receiving rilpivirine- or darunavir-based ART compared with women without HIV (control group). Participants on ART were switched to rilpivirine-based ART with a run-in period of 6 weeks or darunavir-based ART with a run-in of 2 weeks prior to implant insertion. Plasma was collected on Day 0, and 1, 4, 12, 24, 36 and 48 weeks post-insertion. Plasma progestin concentrations were compared between ART and control groups by geometric mean ratio (GMR) and 90% CI.

resultsAt the primary endpoint of Week 24, progestin concentrations were similar between the rilpivirine and control groups [etonogestrel: 1.18 (0.99-1.37); levonorgestrel: 1.16 (0.97-1.33)]. At Week 24, progestin exposure was higher in the darunavir groups compared with the control group [etonogestrel: 2.56 (1.69-3.28); levonorgestrel: 1.89 (1.38-2.29)]. Results remained consistent through to Week 48. No differences in etonogestrel-related adverse events were observed, but both ART groups experienced more menstrual abnormalities versus the control group with levonorgestrel.

conclusionsEtonogestrel and levonorgestrel concentrations were not altered by rilpivirine-based ART. Although progestin concentrations were higher in the ART groups containing ritonavir-boosted darunavir, no implant-related serious adverse events were observed. Both progestin-releasing implants are an appropriate contraceptive option with either rilpivirine- or darunavir/ritonavir-based ART.

Indexed as

HIV InfectionsLevonorgestrelContraceptive AgentsDarunavirDesogestrelFemaleHumansProgestinsRilpivirineRitonavirContraceptive AgentsDarunavirDesogestreletonogestrelLevonorgestrelProgestinsRilpivirineRitonavir

Identifiers

PMID36059130
PMCPMC10205603
OpenAlexW4294605740

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.