Evidence map›Paper›PMID 30199098›Full record

ArticleClinical pharmacology and therapeutics2018

HIV Antiretroviral Pre-Exposure Prophylaxis: Development Challenges and Pipeline Promise.

Craig W Hendrix

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

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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

1 author at 1 institution in 1 country.

Craig W Hendrix1Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Johns Hopkins University · US

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Tissue pharmacology imaging and modelingU19AI113127 · NIAID · JOHNS HOPKINS UNIVERSITY · PI BUMPUS, NAMANDJE N · 2014 to 2018
$20.7M
NIAID NIH HHS P30 AI094189NIAID NIH HHS U19 AI113127
6 · The paper itself

Abstract

The US Food and Drug Administration (FDA) approved oral daily tenofovir/emtricitabine (Truvada) for pre-exposure prophylaxis of human immunodeficiency virus (HIV) infection in 2012 on the basis of two randomized controlled trials (RCTs), one in men who have sex with men (MSM) and another in HIV serodiscordant heterosexual couples. Subsequently, even greater efficacy has been demonstrated in MSM with rapid population-level incidence reductions in some locations. In contrast, studies of antiretroviral pre-exposure prophylaxis (PrEP) in heterosexual women showed only modest or no efficacy, largely attributed to low adherence. The mixed results of antiretroviral-based PrEP bear witness to unique drug development challenges at this complicated intersection of sexual behavior, public health, and drug development. Multiple innovative methods and formulation strategies followed to address unmet medical needs of persons struggling with daily oral PrEP adherence or preference for nonsystemic PrEP options. Clinical pharmacology plays essential roles throughout this PrEP development process, especially in early product development and through pharmacologically informed enhancement and interpretation of clinical trials.

Indexed as

Administration, OralAnti-HIV AgentsDrug Administration ScheduleDrug DevelopmentEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationFemaleHIV-1HIV InfectionsHumansMaleMedication AdherencePre-Exposure ProphylaxisRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeAnti-HIV AgentsEmtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Identifiers

PMID30199098
PMCPMC6925668
OpenAlexW2889701031

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.