Evidence map›Paper›PMID 39015350›Full record

Trial reportOpen forum infectious diseases2024

Dolutegravir/Lamivudine Efficacy and Safety Outcomes in People With HIV-1 With or Without Historical Resistance Results at Screening: 48-Week Pooled Analysis.

Stefan Scholten, Pedro Cahn, Joaquín Portilla, Fiona Bisshop, Sally Hodder, Peter Ruane, Richard Kaplan, Brian R Wynne, Choy Y Man, Richard Grove and 5 more

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in Open forum infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT03446573 phase3completednot on this map

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed

TypeinterventionalSponsorViiV HealthcareRan2018 to 2022Enrolled743ConditionsHIV InfectionsArmsDTG + 3TC, TAF based regimen (TBR)
NCT04021290 phase3completednot on this map

A Phase III, Randomized, Multicenter, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine Fixed Dose Combination in HIV-1 Infected Adults Who Are Virologically Suppressed

TypeinterventionalSponsorViiV HealthcareRan2019 to 2022Enrolled493ConditionsHIV InfectionsArmsDTG/3TC FDC, CAR
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

15 authors.

Stefan ScholtenPraxis Hohenstaufenring, Cologne, Germany.
Pedro CahnFundación Huésped, Buenos Aires, Argentina.
Joaquín PortillaHospital General Universitario de Alicante, Alicante, Spain.
Fiona BisshopHoldsworth House Medical Brisbane, Queensland, Australia.
Sally HodderWest Virginia Clinical and Translational Science Institute, Morgantown, West Virginia, USA.
Peter RuaneRuane Clinical Research, Los Angeles, California, USA.
Richard KaplanDesmond Tutu Health Foundation, Cape Town, South Africa.
Brian R WynneViiV Healthcare, Durham, North Carolina, USA.
Choy Y ManViiV Healthcare, Durham, North Carolina, USA.
Richard GroveGSK, Brentford, UK.
Ruolan WangViiV Healthcare, Durham, North Carolina, USA.
Bryn JonesViiV Healthcare, Brentford, UK.
Mounir Ait-KhaledViiV Healthcare, Brentford, UK.
Michelle KisareViiV Healthcare, Brentford, UK.ORCID https://orcid.org/0009-0004-9413-5295
Chinyere OkoliViiV Healthcare, Brentford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Drug resistance testing aids in appropriate antiretroviral therapy selection to improve treatment success but may not be readily available. We evaluated the impact of switching to dolutegravir/lamivudine (DTG/3TC) using pooled data from the TANGO and SALSA trials in adults who were virologically suppressed with or without historical resistance results at screening. Methods: Adults who were virologically suppressed (HIV-1 RNA <50 copies/mL for >6 months) with no prior virologic failure were randomized to switch to DTG/3TC (TANGO, n = 369; SALSA, n = 246) or continue their current antiretroviral regimen (CAR; TANGO, n = 372; SALSA, n = 247). Week 48 HIV-1 RNA ≥50 and <50 copies/mL (Snapshot algorithm, Food and Drug Administration; intention-to-treat exposed), CD4+ cell count, and safety were analyzed by availability of historical resistance results. Results: Overall, 294 of 615 (48%) participants in the DTG/3TC group and 277 of 619 (45%) participants in the CAR group had no historical resistance results at screening. At week 48, proportions with Snapshot HIV-1 RNA ≥50 copies/mL were low (≤1.1%) and similar across treatment groups and by historical resistance results availability. High proportions (91%-95%) maintained virologic suppression through week 48, regardless of results availability. Across both subgroups of results availability, greater increases in CD4+ cell count from baseline to week 48 occurred with DTG/3TC vs CAR. No participants taking DTG/3TC had confirmed virologic withdrawal, regardless of historical resistance results availability. One participant undergoing CAR without historical resistance results had confirmed virologic withdrawal; no resistance was detected. Overall, DTG/3TC was well tolerated; few adverse events led to withdrawal. Conclusions: Findings support DTG/3TC as a robust switch option for adults who are virologically suppressed with HIV-1 and no prior virologic failure, regardless of historical resistance results availability. Clinical trial registration: TANGO: NCT03446573, https://clinicaltrials.gov/study/NCT03446573. SALSA: NCT04021290, https://clinicaltrials.gov/study/NCT04021290.

Indexed as

DTG/3TChistorical resistanceresistance mutationssuppressed switchvirologically suppressed

Identifiers

PMID39015350
PMCPMC11250229

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.