Observational studyThe lancet. HIV2016
Association of age, baseline kidney function, and medication exposure with declines in creatinine clearance on pre-exposure prophylaxis: an observational cohort study.
Observational study in The lancet. HIV, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00458393 (Chemoprophylaxis for HIV Prevention in Men), which is not on this map. Cited by 52 papers, 2 of them syntheses that pooled 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.
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.
Chemoprophylaxis for HIV Prevention in Men
Who cites it
52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 75 citations in OpenAlex.
- Pooled it
- Antiretroviral Concentration in Hair as a Measure for Antiretroviral Medication Adherence: A Systematic Review of Global Literature.AIDS and behavior · 2020Pooled it
- Changes in kidney function among men having sex with men starting on demand tenofovir disoproxil fumarate - emtricitabine for HIV pre-exposure prophylaxis.Journal of the International AIDS Society · 2020Trial
- Daily HIV pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine reduced Streptococcus and increased Erysipelotrichaceae in rectal microbiota.Scientific reports · 2018Trial
- Pre-exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Kidney Tubular Dysfunction in HIV-Uninfected Individuals.Journal of acquired immune deficiency syndromes (1999) · 2018Trial
- Brief Report: Frequency of Monitoring Kidney Function in HIV-Uninfected Persons Using Daily Oral Tenofovir Disoproxil Fumarate Pre-exposure Prophylaxis.Journal of acquired immune deficiency syndromes (1999) · 2018Trial
- Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots following Directly Observed Therapy.Antimicrobial agents and chemotherapy · 2018Trial
- Four-Year Experience of HIV Pre-exposure Prophylaxis (PrEP) from an Italian Multicentre Cohort: Incidence of Sexually Transmitted Infections and Renal Toxicity.AIDS and behavior · 2025Article
- Renal Outcomes Over the Course of 5 Years of Oral HIV Preexposure Prophylaxis Using Tenofovir Disoproxil/Emtricitabine.Kidney international reports · 2025Article
- Review
- Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01.Nature communications · 2023Article
- Complex PrEP: the factors requiring consultant-led review of PrEP users.Sexually transmitted infections · 2022Article
- Kidney function and daily emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis against HIV: results from the real-life multicentric demonstrative project PrEP Brazil.AIDS research and therapy · 2022Article
- Clinical Considerations in the Selection of Preexposure Prophylaxis for HIV Prevention in Canada.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2022Review
- High Acceptability of Donating Hair and Other Biological Samples for Research Among People Living with HIV in an Outpatient Clinic in Lagos, Nigeria.AIDS research and human retroviruses · 2021Article
- Tenofovir and emtricitabine concentrations in hair are comparable between individuals on tenofovir disoproxil fumarate versus tenofovir alafenamide-based ART.Drug testing and analysis · 2021Article
- Pre-Exposure Prophylaxis (PrEP) for HIV Infection in Cisgender and Transgender Women in the U.S.: A Narrative Review of the Literature.Archives of sexual behavior · 2021Review
- Patient-Focused Selection of PrEP Medication for Individuals at Risk of HIV: A Narrative Review.Infectious diseases and therapy · 2021Review
- HIV incidence after pre-exposure prophylaxis initiation among women and men at elevated HIV risk: A population-based study in rural Kenya and Uganda.PLoS medicine · 2021Article
- Article
Corrections and comments
- Commented on by
Authors and funding
15 authors at 9 institutions in 4 countries.
Funding
Abstract
backgroundAs pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine for the prevention of HIV infection is rolled out internationally, strategies to maintain effectiveness and to minimise adverse effects merit consideration. In this study, we aimed to assess reductions in renal function and predictors of renal toxicity in a large open-label study of PrEP.
methodsAs part of the iPrEx open-label extension (OLE) study, men who have sex with men or transgender women aged 18-70 years who were HIV negative and had participated in three previous PrEP trials from Brazil, Ecuador, Peru, South Africa, Thailand, and the USA were enrolled into an open-label PrEP study. There were no restrictions on current renal function for enrolment into iPrEx OLE, in which participants were given combination tablets of tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) and advised to take one tablet per day. At follow-up sessions every 12 weeks, participants' creatinine clearance on PrEP was estimated and in a subset of participants, hair samples were collected to measure tenofovir and emtricitabine concentrations (a measure of adherence and exposure) via liquid-chromatography-tandem-mass-spectrometry. Reductions in creatinine clearance from baseline were calculated and predictors of decline were identified by use of multivariate models. iPrEx is registered with ClinicalTrials.com, number NCT00458393.
findingsBaseline characteristics were similar between all participants in iPrEx-OLE (1224 participants with 7475 person-visits) and those participating in the hair substudy (220 participants with 1114 person-visits). During a median of 72 weeks, the mean decline in creatinine clearance was -2·9% (95% CI -2·4 to -3·4; p
interpretationOur data suggest that the frequency of safety monitoring for PrEP might need to be different between age groups and that pharmacological measures can monitor for toxic effects as well as adherence.
fundingNational Institutes of Health.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.