Evidence map›Paper›PMID 39907097›Full record

Observational studyHIV medicine2025

Impact of HBV serological status on HIV virological efficacy of two-drug antiretroviral regimens: A retrospective observational study on virologically suppressed people with HIV switching to lamivudine/dolutegravir.

Pierluigi Francesco Salvo, Arturo Ciccullo, Elena Visconti, Francesca Lombardi, Carlo Torti, Simona Di Giambenedetto, Gianmaria Baldin

Abstract readObservational Study
In one paragraph

Observational study in HIV medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

7 authors.

Pierluigi Francesco SalvoDipartimento di Sicurezza e Bioetica - Sezione di Malattie Infettive, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID https://orcid.org/0000-0001-7559-7364
Arturo CicculloInfectious Diseases Unit, San Salvatore Hospital, L'Aquila, Italy.ORCID https://orcid.org/0000-0001-5941-883X
Elena ViscontiDipartimento di Scienze Mediche e Chirurgiche, UOC Malattie Infettive, Fondazione Policlinico Universitario "Agostino Gemelli", IRCCS, Rome, Italy.
Francesca LombardiDipartimento di Scienze Mediche e Chirurgiche, UOC Malattie Infettive, Fondazione Policlinico Universitario "Agostino Gemelli", IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0001-5757-8346
Carlo TortiDipartimento di Sicurezza e Bioetica - Sezione di Malattie Infettive, Università Cattolica del Sacro Cuore, Rome, Italy.
Simona Di GiambenedettoDipartimento di Sicurezza e Bioetica - Sezione di Malattie Infettive, Università Cattolica del Sacro Cuore, Rome, Italy.
Gianmaria BaldinDipartimento di Scienze Mediche e Chirurgiche, UOC Malattie Infettive, Fondazione Policlinico Universitario "Agostino Gemelli", IRCCS, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study aimed to evaluate the HIV virological efficacy of two-drug regimens (2DR) with lamivudine (3TC) and dolutegravir (DTG) in people with HIV (PWH), classified by their hepatitis B virus (HBV) serological status. Specifically, it explored whether isolated anti-hepatitis B core (anti-HBc) positivity impacts virological outcomes.

methodsA retrospective observational study was conducted at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, enrolling 606 virologically suppressed (HIV-RNA < 50 copies/mL) PWH who switched to a 2DR regimen with 3TC/DTG. Participants were categorized into four groups based on their HBV serological status: hepatitis B surface antibody (HBsAb)-positive/hepatitis B core antibody (HBcAb)-positive, HBsAb-negative/HBcAb-negative, HBsAb-positive/HBcAb-negative, and isolated HBcAb positivity. Viral failure (VF) was defined as two consecutive HIV viral loads above 50 copies/mL or a single HIV viral load above 1000 copies/mL, and viral blips (VBs) as a single HIV-RNA measurement between 50 and 200 copies/mL followed by suppression.

resultsDuring 2216.4 patient-years of follow-up (PYFU), we observed 30 VFs (1.3 per 100 PYFU) and 63 VBs (2.9 per 100 PYFU). No statistically significant differences in VF or VB were noted between the serological groups. Additionally, no significant alanine aminotransferase (ALT) flares or HBV-DNA breakthroughs were observed, with HBV-DNA remaining undetectable throughout.

conclusionsThe study supports the virological efficacy of 3TC/DTG-based 2DR in PWH, regardless of HBV serological status. Isolated anti-HBc positivity did not influence virological outcomes independently. Larger studies are warranted to further investigate HIV-HBV interactions in this context.

Indexed as

Anti-HIV AgentsHepatitis BHeterocyclic Compounds, 3-RingHIV InfectionsLamivudineAdultDolutegravirFemaleHepatitis B AntibodiesHepatitis B virusHumansMaleMiddle AgedOxazinesPiperazinesPyridonesAnti-HIV AgentsDolutegravirHepatitis B AntibodiesHeterocyclic Compounds, 3-RingLamivudineOxazinesPiperazinesPyridonesantiretroviral therapyHBVHIV

Identifiers

PMID39907097
PMCPMC11970343

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Registered trials

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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.