Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03110380 (A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed), which is not on this map. Cited by 53 papers, 3 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.
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed
Who cites it
53 citing papers in PubMed, 3 syntheses or guidelines pooled it, 108 citations in OpenAlex.
- Comparative safety of B/F/TAF versus other antiretroviral therapy regimens for treatment-experienced people with HIV-1: a systematic literature review and network meta-analysis.Journal of comparative effectiveness research · 2026Pooled it
- Systematic Literature Review and Meta-Analysis of INSTI-Based Antiretroviral Therapy Single- Versus Multiple-Tablet Regimens for the Treatment of HIV.Advances in therapy · 2026Pooled it
- Pooled it
- First-Line Switch to B/F/TAF for Treatment of HIV in Older Adults ≥60 Years in Kenya (the B/F/TAF-Elderly Study).Open forum infectious diseases · 2025Trial
- Three-Year Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide as a Switch Strategy in the Real World.Open forum infectious diseases · 2025Trial
- Trial
- Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy.The Journal of antimicrobial chemotherapy · 2025Trial
- Trial
- Changes in bone quality after switching from a TDF to a TAF based ART: A pilot randomized study.Frontiers in endocrinology · 2023Trial
- Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir/Lamivudine: The TANGO Study.Journal of acquired immune deficiency syndromes (1999) · 2021Trial
- Bictegravir/Tenofovir Alafenamide/Emtricitabine in Real-Life: A Multi-Year Experience.Journal of clinical medicine · 2026Article
- Renal Outcomes in People With HIV-1 and Renal Impairment Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide: Integrated Analysis From 9 Phase 3/3b Clinical Trials.Open forum infectious diseases · 2026Article
- Treatment-Emergent Bictegravir Resistance in a Treatment-Naive Individual With HIV Infection: A Case Report.Cureus · 2026Article
- The effect of antacid and mineral supplements on bictegravir pharmacokinetics: results from a Phase 1, open-label, drug-drug interaction study.Antimicrobial agents and chemotherapy · 2026Article
- Projecting lifetime HIV-related healthcare costs for youth with HIV in the United States.BMC health services research · 2025Article
- Clinical Evaluation of Drug-Drug Interactions Between Bictegravir and Strong Inhibitors/Inducers of the CYP3A4, UGT1A1, or P-gp Pathways.Journal of clinical pharmacology · 2025Article
- Clinical outcomes on B/F/TAF and dolutegravir-based regimens at 12 months following regimen switch: an observational cohort study.AIDS research and therapy · 2025Observational
- Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in People with HIV in Korea: 24-Month Data from BICSTaR.Infection & chemotherapy · 2025Article
- Selected comorbidities and the probability of ART switch in PWH with undetectable HIV-RNA: a retrospective analysis in Italy.The Journal of antimicrobial chemotherapy · 2025Article
- Effectiveness and safety of tenofovir alafenamide/emtricitabine/bictegravir as a first-line regimen in people with HIV: A retrospective observational study.IJID regions · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBictegravir (B)/emtricitabine (F)/tenofovir alafenamide (TAF) is guideline-recommended treatment for human immunodeficiency virus type 1 (HIV-1). We evaluated whether people receiving dolutegravir (DTG) plus F/TAF or F/TDF (tenofovir disoproxil fumarate) with viral suppression can switch to B/F/TAF without compromising safety or efficacy, regardless of preexisting nucleoside reverse transcriptase inhibitor (NRTI) resistance.
methodsIn this multicenter, randomized, double-blinded, active-controlled, noninferiority trial, we enrolled adults who were virologically suppressed for ≥6 months before screening (with documented/suspected NRTI resistance) or ≥3 months before screening (with no documented/suspected NRTI resistance) on DTG plus either F/TDF or F/TAF. We randomly assigned (1:1) participants to switch to B/F/TAF or DTG + F/TAF once daily for 48 weeks, each with matching placebo. The primary endpoint was proportion of participants with plasma HIV-1 RNA ≥50 copies/mL at week 48 (snapshot algorithm); the prespecified noninferiority margin was 4%.
resultsFive hundred sixty-seven adults were randomized; 565 were treated (284 B/F/TAF, 281 DTG + F/TAF). At week 48, B/F/TAF was noninferior to DTG + F/TAF, as 0.4% (1/284) vs 1.1% (3/281) had HIV-1 RNA ≥50 copies/mL (difference, -0.7% [95.001% confidence interval {CI}, -2.8% to 1.0%]). There were no significant differences in efficacy among participants with suspected or confirmed prior NRTI resistance (n = 138). No participant had treatment-emergent drug resistance. Median weight change from baseline at week 48 was +1.3 kg (B/F/TAF) vs +1.1 kg (DTG + F/TAF) (P = .46). Weight change differed by baseline NRTIs (+2.2 kg [F/TDF] and +0.6 kg [F/TAF], P < .001), with no differences between B/F/TAF and DTG + F/TAF.
conclusionsThe single-tablet regimen B/F/TAF is a safe, effective option for people virologically suppressed on DTG plus either F/TDF or F/TAF, including in individuals with preexisting resistance to NRTIs. CLINICAL TRIALS REGISTRATION: NCT03110380.
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.