Evidence map›Paper›PMID 37200995›Full record

ArticleEClinicalMedicine2023

Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials.

Paul E Sax, José R Arribas, Chloe Orkin, Adriano Lazzarin, Anton Pozniak, Edwin DeJesus, Franco Maggiolo, Hans-Jürgen Stellbrink, Yazdan Yazdanpanah, Rima Acosta and 6 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 3 pooled it
28.5field-weighted citation impact, top 1% 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

54 citing papers in PubMed, 3 syntheses or guidelines pooled it, 82 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

16 authors at 11 institutions in 6 countries.

Paul E SaxBrigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
José R ArribasInfectious Diseases Unit, Hospital Universitario La Paz, IdiPaz, CIBERINFEC, Madrid, Spain.
Chloe OrkinBarts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London, United Kingdom.
Adriano LazzarinSan Raffaele Scientific Institute, Milan, Italy.
Anton PozniakChelsea & Westminster Hospital NHS Foundation Trust and LSHTM, London, United Kingdom.
Edwin DeJesusOrlando Immunology Center, Orlando, FL, USA.
Franco MaggioloUnit of HIV-related Diseases and Experimental Therapies, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
Hans-Jürgen StellbrinkDepartment of Internal Medicine, Infectious Diseases, University of Hamburg, Hamburg, Germany.
Yazdan YazdanpanahUniversité Paris Diderot and Hôpital Bichat-Claude Bernard, Paris, France.
Rima AcostaGilead Sciences, Foster City, CA, USA.
Hailin HuangGilead Sciences, Foster City, CA, USA.
Jason T HindmanGilead Sciences, Foster City, CA, USA.
Hal MartinGilead Sciences, Foster City, CA, USA.
Jared M BaetenGilead Sciences, Foster City, CA, USA.
David WohlUniversity of North Carolina School of Medicine, Chapel Hill, NC, USA.
GS-US-380-1489 and GS-US-380-1490 study investigators
Gilead Sciences (United States) · USBarts Health NHS Trust · GBBrigham and Women's Hospital · USChelsea and Westminster Hospital NHS Foundation Trust · GBHospital Universitario La Paz · ESOrlando Immunology Center · USOspedale Papa Giovanni XXIII · ITSan Raffaele University of Rome · ITUniversität Hamburg · DEUniversité Claude Bernard Lyon 1 · FRUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended for HIV-1 treatment. The safety and efficacy of B/F/TAF as initial therapy was established in two Phase 3 studies: 1489 (vs dolutegravir [DTG]/abacavir/lamivudine) and 1490 (vs DTG + F/TAF). After 144 weeks of randomized follow-up, an open-label extension evaluated B/F/TAF to 240 weeks. Methods: Of 634 participants randomized to B/F/TAF, 519 completed the double-blinded treatment, and 506/634 (80%) chose the 96-week open-label B/F/TAF extension, which was completed by 444/506 (88%) participants. Efficacy was based on the secondary outcome of the proportion of participants with HIV-1 RNA <50 copies/mL at Week 240 by missing = excluded and missing = failure methods. All 634 participants who were randomized to B/F/TAF and received at least one dose of B/F/TAF were included in efficacy and safety analyses. (Study 1489: ClinicalTrials.govNCT02607930; EudraCT 2015-004024-54. Study 1490: ClinicalTrials.govNCT02607956; EudraCT 2015-003988-10). Findings: Of those with available virologic data, 98.6% (95% CI [97.0%-99.5%], 426/432) maintained HIV-1 RNA <50 copies/mL at Week 240 (missing = excluded); when missing virologic data were considered as failure, 67.2% (95% CI [63.4%-70.8%], 426/634) maintained HIV-1 RNA <50 copies/mL. Mean (SD) change in CD4+ count from baseline was +338 (236.2) cells/μL. No treatment-emergent resistance to B/F/TAF was detected. Adverse events led to drug discontinuation in 1.6% (n = 10/634) of participants (n = 5 with events considered drug-related). No discontinuations were due to renal adverse events. Median (IQR) total cholesterol increased 21 (1,42) mg/dL from baseline; the change in total cholesterol:HDL was 0.1 (-0.5,0.6) Interpretation: Through 5 years of follow-up, B/F/TAF maintained high rates of virologic suppression with no treatment-emergent resistance and rare drug discontinuations due to adverse events. These results demonstrate the durability and safety of B/F/TAF in people with HIV. Funding: Gilead Sciences.

Indexed as

Antiretroviral therapyBone safetyIntegrase strand transfer inhibitorLong-termRenal safety

Identifiers

PMID37200995
PMCPMC10186485
OpenAlexW4377092972

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.