Evidence map›Paper›PMID 41467354›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

Pharmacokinetics of Twice-daily Tenofovir Alafenamide in Adults With HIV-associated Tuberculosis on Bictegravir/Emtricitabine/Tenofovir Alafenamide and Rifampicin.

Emmanuella Chinonso Osuala, Ivan Nicholas Nkuhairwe, Marothi Peter Letsoalo, Kogieleum Naidoo, Rubeshan Perumal, James F Rooney, Lubbe Wiesner, Roeland E Wasmann, Paolo Denti, Kelly E Dooley and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04734652 (A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug Susceptible-TB on a Rifampicin-based Regimen), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04734652 phase2completednot on this map

A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug Susceptible-TB on a Rifampicin-based Regimen

TypeinterventionalSponsorCentre for the AIDS Programme of Research in South AfricaRan2022 to 2024Enrolled122ConditionsHIV/AIDS, Tuberculosis, PulmonaryArmsBiktarvy®, TLD- fixed-drug combination single tablet
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. HBV/HCV coinfection and anti-tuberculosis drug-induced liver injury: from risk assessment and exploration of mechanisms to preventive considerations.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026
    Review
  2. Review
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

12 authors.

Emmanuella Chinonso OsualaCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.ORCID 0000-0002-2035-0935
Ivan Nicholas NkuhairweDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-5921-7904
Marothi Peter LetsoaloCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.ORCID 0000-0003-2170-6312
Kogieleum NaidooCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.ORCID 0000-0002-8874-6661
Rubeshan PerumalCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.ORCID 0000-0001-8892-2904
James F RooneyMedical Affairs, Gilead Sciences, Foster City, California, USA.ORCID 0000-0003-3261-0711
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-9070-8699
Roeland E WasmannDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-5769-8150
Paolo DentiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0001-7494-079X
Kelly E DooleyDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID 0000-0001-9013-5256
Anushka NaidooCentre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.ORCID 0000-0001-9550-9501
INSIGHT Study Team

Funding

Mentoring Investigators in HIV and Tuberculosis Therapeutics ResearchK24AI150349 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI DOOLEY, KELLY E. · 2020 to 2025
$789k
Dolutegravir for the treatment of HIV in patients with Tuberculosis in KwaZulu-Natal South AfricaK43TW011437 · FIC · CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA · PI NAIDOO, ANUSHKA · 2019 to 2023
$616k
FIC NIH HHSNational Institute of Allergy and Infectious DiseasesNational Research Foundation Postgraduate Scholarship MND 210503598667NIAID NIH HHS K24 AI150349NIH HHS K24AI150349NIH HHS K43TW011437South African Medical Research Council R01AI152142
6 · The paper itself

Abstract

backgroundTenofovir alafenamide (TAF) is a key component of many fixed-dose combinations used to treat HIV. There are limited data on the pharmacokinetics of plasma TAF, tenofovir (TFV), or intracellular tenofovir diphosphate (TFV-DP), among people with HIV (PWH) and tuberculosis (TB) who are taking rifampicin-based TB treatment.

methodsParticipants in the intervention arm of the INSIGHT trial (NCT04734652) receiving bictegravir/emtricitabine/TAF (BIC/FTC/TAF 50/200/25 mg) were enrolled into the semi-intensive pharmacokinetic substudy. BIC/FTC/TAF was administered twice-daily during rifampicin-based TB treatment (∼24 weeks) and once-daily thereafter. Plasma (TAF/TFV) and dried blood spot samples (TFV-DP) were collected at weeks 4 and 12 (predose, 1, 2, 4, 6, and 8-12 hours postdose) during TB treatment and at week 32 (predose, 1, 2, 4, 6-8 and 24-25 hours postdose) post-TB treatment. Pharmacokinetic parameters were determined using noncompartmental analysis. Clinical and safety data were collected.

resultsAmong 43 participants enrolled; median (IQR) age and weight were 35 (30-39) years and 58 (52-65) kg; 77% were male. Geometric least square mean ratios (90% CI) at week 12 (twice-daily TAF) relative to week 32 (once-daily TAF) for TAF AUC0-4, TFV, and TFV-DP AUC0-24 were 1.55 (1.13-2.13), 1.24 (1.07-1.44), and 1.32 (1.13-1.53), respectively. At week 24, 95% of participants achieved viral suppression, with no treatment-related serious adverse events or drug discontinuations.

conclusionsTwice-daily TAF was safe and efficacious and achieved similar exposures of intracellular TFV-DP in PWH taking rifampicin for TB compared to once-daily TAF taken alone. These data support the use of TAF in a fixed-dose combination of BIC/FTC/TAF during rifampicin-containing TB treatment.

Indexed as

AdenineAnti-HIV AgentsAntitubercular AgentsHIV InfectionsTenofovirTuberculosisAdultAlanineAmidesDrug CombinationsEmtricitabineFemaleHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsHumansMaleAdenineAlanineAmidesAnti-HIV AgentsAntitubercular AgentsbictegravirDrug CombinationsEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsPiperazinesPyridonesRifampinTenofovirtenofovir alafenamidedrug interactionsHIV-associated tuberculosispharmacokineticsrifampicintenofovir alafenamide

Identifiers

PMID41467354
PMCPMC13131919

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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.