Evidence map›Paper›PMID 42010018›Full record

Trial reportScientific reports2026

Population pharmacokinetics of tenofovir alafenamide delivered via an annual subdermal implant in South African women.

Martin Beliveau, Colin Chang, Lara Lewis, Marothi P Letsoalo, Quarraisha Abdool Karim, Salim S Abdool Karim, Mark A Marzinke, John A Moss, Tanuja N Gengiah, Marc M Baum

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Martin BeliveauCertara Drug Development Solutions, 2000 Peel Street, Suite 570, Montreal, QC, Canada.
Colin ChangCertara Drug Development Solutions, 2000 Peel Street, Suite 570, Montreal, QC, Canada.
Lara LewisCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu Natal, Durban, South Africa.
Marothi P LetsoaloCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu Natal, Durban, South Africa.
Quarraisha Abdool KarimCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu Natal, Durban, South Africa.
Salim S Abdool KarimCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu Natal, Durban, South Africa.
Mark A MarzinkeDepartment of Medicine, Johns Hopkins University, 600 N. Wolfe Street, Baltimore, MD, USA.
John A MossDepartment of Chemistry, Oak Crest Institute of Science, 128-132 W. Chestnut Ave, Monrovia, CA, USA.
Tanuja N GengiahCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu Natal, Durban, South Africa.
Marc M BaumDepartment of Chemistry, Oak Crest Institute of Science, 128-132 W. Chestnut Ave, Monrovia, CA, USA. m.baum@oak-crest.org.

Funding

Systemic Sustained Release Delivery of Antiretroviral Agents for HIV PreventionR01AI162151 · NIAID · OAK CREST INSTITUTE OF SCIENCE · PI BAUM, MARC MICHAEL · 2021 to 2025
$4.3M
EDCPT SRIA2015-1061EDCTP SRIA2015-1061National Institute of Allergy and Infectious Diseases R01AI162151NIAID NIH HHS R01 AI162151
6 · The paper itself

Abstract

A diverse portfolio of HIV prevention products likely will be needed to help attain the ambitious targets set by UNAIDS for the global reduction in HIV incidence. Ultralong-acting systemic drug regimens with dosing frequencies of one year or longer represent a promising strategy for HIV-1 pre-exposure prophylaxis (PrEP) as they hold the potential of being discreet and overcoming some of the adherence burden associated with daily oral drug dosing. We have developed an innovative subdermal implant delivering the potent antiretroviral prodrug tenofovir alafenamide (TAF) evaluated in CAPRISA 018, a first-in-human, randomized, placebo-controlled clinical trial in South African women. Population PK modeling was used to present an in-depth analysis of the CAPRISA 018 results. A literature model was adapted and applied to predict plasma TAF and tenofovir (TFV) concentrations, as well as peripheral blood mononuclear cell (PBMC) TFV diphosphate (TFV-DP) concentrations that agreed with measured values. A Weibull model was used to calculate the in vivo TAF release kinetics based on plasma TAF concentrations. While the release profiles were variable, at least half the implants (57%) displayed linear in vivo TAF release profiles. The relationship between implant TAF release rates and PBMC TFV-DP concentrations informed targets for future studies (0.39–1.4 mg d-1, depending on the selected prophylactic TFV-DP concentration) assuming the local tolerability issues can be overcome, fulfilling a key objective of the CAPRISA 018 trial.

Indexed as

AdenineAnti-HIV AgentsHIV InfectionsTenofovirAdultAlanineDrug ImplantsFemaleHumansPre-Exposure ProphylaxisSouth AfricaYoung AdultAdenineAlanineAnti-HIV AgentsDrug ImplantsTenofovirtenofovir alafenamide

Identifiers

PMID42010018
PMCPMC13265933

What OpenQuestion holds

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Registered trials

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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.