Evidence map›Paper›PMID 37540331›Full record

Trial reportDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2023

Tenofovir alafenamide plus dolutegravir as a switch strategy in HIV-infected patients: a pilot randomized controlled trial.

Golbarg Alavian, Ladan Abbasian, Hossein Khalili, Seyed Ahmad Seyed Alinaghi, Malihe Hasannezhad, Masoumeh Farrokh Ashtiani, Seyed Ali Dehghan Manshadi

Open access · greenAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 49% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Pooled it
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

7 authors at 3 institutions in 1 country.

Golbarg AlavianDepartment of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Ladan AbbasianIranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran. la-abbasian@tums.ac.ir.ORCID http://orcid.org/0009-0004-4235-6969
Hossein KhaliliDepartment of Clinical Pharmacy (Pharmacotherapy), Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Seyed Ahmad Seyed AlinaghiIranian Research Center for HIV/AIDS (IRCHA), Tehran University of Medical Sciences (TUMS), Tehran, Iran.
Malihe HasannezhadDepartment of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Masoumeh Farrokh AshtianiDepartment of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Seyed Ali Dehghan ManshadiIranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.
Imam Khomeini Hospital · IRTehran University of Medical Sciences · IRIranian Institute for Health Sciences Research · IR

Funding

Tehran University of Medical Sciences and Health Services IRCT20191005044984N1
6 · The paper itself

Abstract

backgroundCurrently, two-drug antiretroviral regimens are emerging fields in life-long treatment in people living with HIV.

objectivesThis randomized non-inferiority open-label controlled trial was designed to compare the 48-week efficacy and safety of tenofovir alafenamide plus dolutegravir versus the standard triple therapy in virologically suppressed people living with HIV. To the best of our knowledge this combination has not been studied before.

methodsThis open-label randomized controlled trial was conducted in treatment-experienced people with HIV who had HIV-RNA < 47 copies/mL for at least two years. Patients received either tenofovir alafenamide plus dolutegravir combination (26 patients) or a standard three-drug regimen (29 patients). The primary outcome was the proportion of patients maintaining HIV-RNA < 47 copies/mL during 48 weeks, and the secondary outcomes were CD4 cell count changes, the adherence rate, and adverse drug reactions, all over 48 weeks of study.

resultsHIV viral load remained undetectable (HIV-RNA < 47 copies/mL) during the 48 weeks of the study in both arms. The absolute CD4 cell count change was not significant between the two groups. The overall proportion of adverse effects in each group was comparable. The rate of adherence to treatment was acceptable in both groups, and no significant difference was observed.

conclusionsTreatment simplification with tenofovir alafenamide plus dolutegravir regimen as maintenance therapy was non-inferior in terms of efficacy and safety compared to the standard triple therapy. Comparing efficacy of antiretroviral therapy.

Indexed as

Anti-HIV AgentsDrug-Related Side Effects and Adverse ReactionsHIV InfectionsAdenineDolutegravirDrug Therapy, CombinationEmtricitabineHumansPilot ProjectsRNATenofovirTreatment OutcomeAdenineAnti-HIV AgentsDolutegravirEmtricitabineRNATenofovirAntiretroviral therapyDual therapyHIV TreatmentTenofovir Alafenamide plus DolutegravirTreatment simplification

Identifiers

PMID37540331
PMCPMC10624796
OpenAlexW4385564581

What Socratic holds

Textmetadata
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.