Evidence map›Paper›PMID 36949442›Full record

SynthesisAIDS research and therapy2023

An indirect comparison of 144-week efficacy, safety, and tolerability of dolutegravir plus lamivudine and second-generation integrase inhibitor-based, 3-drug, single-tablet regimens in therapy-naive people with HIV-1.

Lee A Evitt, Sakina Nanji, Richard A Grove, Chinyere Okoli, Jean van Wyk, Sonya J Snedecor

Open access · goldFull text readSystematic Review
In one paragraph

Synthesis in AIDS research and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.9field-weighted citation impact, top 15% 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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Observational
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

6 authors at 4 institutions in 3 countries.

Lee A EvittGSK, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK. lee.a.evitt@gsk.com.
Sakina NanjiOPEN Health, Bethesda, MD, USA.
Richard A GroveGSK, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
Chinyere OkoliViiV Healthcare, Brentford, UK.
Jean van WykViiV Healthcare, Brentford, UK.
Sonya J SnedecorOPEN Health, Bethesda, MD, USA.
Open Health Systems Laboratory · USViiV Healthcare (United Kingdom) · GBGlaxoSmithKline (Germany) · DEWest Middlesex University Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe long-term efficacy and safety of the 2-drug regimen dolutegravir (DTG) + lamivudine (3TC) and 3-drug single-tablet regimens recommended for antiretroviral therapy (ART)-naive people with HIV-1 (PWH) have yet to be compared directly in clinical trials. This indirect treatment comparison (ITC) was conducted to compare the durability of efficacy and long-term safety of DTG + 3TC vs second-generation, integrase strand transfer inhibitor (INSTI)-based, 3-drug, single-tablet regimens bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and DTG/abacavir/3TC (DTG/ABC/3TC) at Week 144 after treatment initiation.

methodsA systematic literature review identified 4 trials evaluating the treatment regimens of interest in ART-naive PWH (GEMINI-1, GEMINI-2, GS-US-380-1489, and GS-US-380-1490). Safety, efficacy, and tolerability results were compared using fixed-effects Bucher ITC methodology to calculate relative outcomes.

resultsRates of virologic suppression (HIV-1 RNA < 50 copies/mL, US Food and Drug Administration Snapshot analysis) and virologic failure (HIV-1 RNA ≥ 50 copies/mL) as well as mean change in CD4 + cell count were similar with DTG + 3TC, BIC/FTC/TAF, and DTG/ABC/3TC at Week 144. Serious adverse events occurred less frequently with DTG + 3TC compared with both BIC/FTC/TAF (odds ratio [OR], 0.51; 95% CI 0.29-0.87; P = 0.014) and DTG/ABC/3TC (OR, 0.38; 95% CI 0.19-0.75; P = 0.006). Discontinuations and overall adverse events were similar across all 3 regimens.

conclusionsThese results suggest that the 2-drug regimen DTG + 3TC offers comparable and durable efficacy with fewer serious adverse events vs BIC/FTC/TAF and DTG/ABC/3TC through 144 weeks of treatment in ART-naive PWH. These long-term comparative data support the therapeutic value of DTG + 3TC for PWH.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsHIV Integrase InhibitorsHIV SeropositivityDolutegravirHeterocyclic Compounds, 3-RingHumansLamivudineRNATabletsAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsLamivudineRNATabletsAntiretroviral agentsBictegravirDolutegravirEmtricitabineHIV-1 infectionLamivudineTenofovir alafenamide

Identifiers

PMID36949442
PMCPMC10031916
OpenAlexW4353075211

What Socratic holds

Textfull text, public
LicenceCC BY
measurements read36
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 Socratic graph.