Evidence map›Paper›PMID 40836601›Full record

ArticleJournal of the International AIDS Society2025

A cross-sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV-1 in tenofovir disoproxil fumarate-based pre-exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa.

Urvi M Parikh, Lauren D Kudrick, Lisa Levy, Everline Bosek, Bhavna H Chohan, Irene Mukui, Sarah Masyuko, Nonhlanhla Ndlovu, Imelda Mahaka, Owen Mugurungi and 18 more

Abstract read
In one paragraph

Article in Journal of the International AIDS Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. HIV-1 testing in the context of expanding PrEP modalities.Journal of the International AIDS Society · 2025
    Article
  5. Review
  6. 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

28 authors.

Urvi M ParikhUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-4016-0629
Lauren D KudrickUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Lisa LevyFHI 360, Durham, North Carolina, USA.
Everline BosekUniversity of Washington-Kenya, Nairobi, Kenya.
Bhavna H ChohanKenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Irene MukuiNational AIDS and STI Programme, Ministry of Health, Nairobi, Kenya.
Sarah MasyukoNational AIDS and STI Programme, Ministry of Health, Nairobi, Kenya.ORCID https://orcid.org/0000-0002-9836-4616
Nonhlanhla NdlovuPangaea Zimbabwe, Harare, Zimbabwe.
Imelda MahakaPangaea Zimbabwe, Harare, Zimbabwe.
Owen MugurungiMinistry of Health and Child Care, Harare, Zimbabwe.
Gertrude NcubeMinistry of Health and Child Care, Harare, Zimbabwe.
Anita HettemaClinton Health Access Initiative, Mbabane, Eswatini.ORCID https://orcid.org/0000-0002-9764-2178
Sindy N MatseMinistry of Health, Mbabane, Eswatini.
Saiqa MullickWits RHI, The University of the Witwatersrand, Johannesburg, South Africa.
Carole L WallisBARC-SA and Lancet Laboratories, Johannesburg, South Africa.
Amy L HeapsUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Kerri J PenroseUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Kevin D McCormickUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Peter L AndersonUniversity of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.ORCID https://orcid.org/0000-0002-1200-8494
Jill M PetersonFHI 360, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0002-7075-3003
Connie CelumDepartments of Global Health, Medicine, Epidemiology and Biostatistics, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-8813-3419
Barbra A RichardsonDepartments of Global Health, Medicine, Epidemiology and Biostatistics, University of Washington, Seattle, Washington, USA.
Delivette CastorColumbia University Irving Medical Center, New York, New York, USA.ORCID https://orcid.org/0000-0002-0988-9489
Shannon AllenUnited States Agency for International Development (USAID), Washington, DC, USA.
Kristine TorjesenFHI 360, Durham, North Carolina, USA.
John W MellorsUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Global Evaluation of Microbicide Sensitivity (GEMS) Project

Funding

United States Agency for International Development 7200AA21CA00011United States Agency for International Development AID-OAA-A-15-00031
6 · The paper itself

Abstract

introductionThe ongoing rollout of oral tenofovir-based pre-exposure prophylaxis (PrEP) has the potential to reduce HIV-1 incidence, but HIV drug resistance (HIVDR) in individuals who acquire HIV-1 on PrEP could threaten the treatment effectiveness of overlapping antiretrovirals (tenofovir/emtricitabine), contribute to development of resistance, and undermine HIV control efforts. Accordingly, the Global Evaluation of Microbicide Sensitivity (GEMS) project was established to monitor HIVDR in PrEP rollout programmes in Southern and Eastern Africa.

methodsGEMS monitored resistance in >100,000 estimated persons who accessed PrEP through national programmes or implementation projects in Southern/Eastern Africa. Participants self-reported demographics and PrEP adherence. HIV-1 RNA and tenofovir-diphosphate levels were measured in blood samples collected at the time of study enrolment from consenting participants diagnosed with HIV who had received PrEP. HIVDR mutations were detected by population genotyping.

resultsOf 283 reported seroconversions on PrEP from December 2017 through September 2023, 255 (90%) individuals enrolled in GEMS, of which 81 (32%) were from Kenya, 77 (30%) from South Africa, 69 (27%) from Zimbabwe and 28 (11%) from Eswatini. Half (130; 51%) were 15-24 years of age at seroconversion, and three-quarters (193; 76%) were female. Thirty-four seroconversions occurred within 30 days of PrEP initiation. Tenofovir-diphosphate levels were consistent with moderate to high levels (≥350 femtomoles per punch) in 53% (120 of 226) individuals with drug-level data. Of 154 samples successfully genotyped, 34 (22%; 95% CI [16%, 30%]) had PrEP-associated mutations; these included 27 samples with M184I/V, one sample with K65KR, and six samples with both K65R and M184I/V.

conclusionsThe frequency of HIVDR mutations associated with tenofovir or emtricitabine among individuals diagnosed with HIV who had received PrEP (22%) exceeded background levels of transmitted nucleoside reverse transcriptase inhibitor resistance in Southern and Eastern Africa (≤5%) but people with PrEP-associated mutations are likely to achieve virologic suppression with current first-line antiretroviral therapy (ART). Improved screening for acute infection before initiating PrEP, surveillance of HIVDR with the introduction of new PrEP programmes and the monitoring of longer-term ART outcomes in individuals who acquire HIV-1 on PrEP will be essential to preserve antiretroviral options for both treatment and prevention.

Indexed as

Anti-HIV AgentsDrug Resistance, ViralHIV-1HIV InfectionsPre-Exposure ProphylaxisTenofovirAdenineAdolescentAdultCross-Sectional StudiesEmtricitabineFemaleHumansKenyaMaleMiddle AgedAdenineAnti-HIV AgentsEmtricitabineTenofovirdrug resistanceHIVHIV preventionpre‐exposure prophylaxissub‐Saharan Africatenofovir disoproxil fumarate/emtricitabine

Identifiers

PMID40836601
PMCPMC12367864

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.