Evidence map›Paper›PMID 28302065›Full record

Trial reportBMC infectious diseases2017

Lamivudine/dolutegravir dual therapy in HIV-infected, virologically suppressed patients.

Franco Maggiolo, Roberto Gulminetti, Layla Pagnucco, Margherita Digaetano, Simone Benatti, Daniela Valenti, Annapaola Callegaro, Diego Ripamonti, Cristina Mussini

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
7.1field-weighted citation impact, top 2% 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

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. A systematic review of the genetic mechanisms of dolutegravir resistance.The Journal of antimicrobial chemotherapy · 2019
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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

9 authors at 3 institutions in 1 country.

Franco MaggioloDivision of Infectious Diseases, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy. franco31556@hotmail.com.ORCID 0000-0002-9791-0072
Roberto GulminettiDivision of Infectious Diseases, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Layla PagnuccoDivision of Infectious Diseases, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Margherita DigaetanoDivision of Infectious Diseases, University of Modena, Modena, Italy.
Simone BenattiDivision of Infectious Diseases, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.
Daniela ValentiDivision of Infectious Diseases, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.
Annapaola CallegaroMicrobiology and Virology Laboratory, ASST Papa Giovanni XXIII, Bergamo, Italy.
Diego RipamontiDivision of Infectious Diseases, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.
Cristina MussiniDivision of Infectious Diseases, University of Modena, Modena, Italy.
Ospedale Papa Giovanni XXIII · ITPoliclinico San Matteo Fondazione · ITUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLittle is known about the applicability of dual treatments based on integrase inhibitors. We explored the combination of lamivudine + dolutegravir as an option when switching from standard cART in virologically suppressed patients.

methodsIn this prospective cohort we enrolled patients previously switched to 3TC + DTG who were 18 years or older, with no previous resistance mutations to the used drugs, having a HIV-RNA <50 copies/ml for 6 months or longer, negative for HBsAg and on a stable (>6 months) cART.

resultsNinety-four individuals were included. They were mostly men (77.7%) with a mean age of 53 years. They presented 159 co-morbidities including cardiovascular, bone, hepatic, kidney, and CNS diseases. Because of these pathologies, they took 207 non-ARV drugs (mean 2.2 per patient). Median duration of viral suppression was 77.5 months (IQR 61). All subjects were prospectively followed up to week 24 and all remained on dual therapy during the whole period. Neither virological failure, nor viral blip was detected. The median CD4 count rose from 658 cells/mcl (IQR 403) to 724 cells/mcl (IQR 401) (P = 0.006) without a significant (P = 0.44) change in the CD4/CD8 ratio. A significant (P < 0.0001) increment of median creatinine from 0.87 mg/dl (IQR 0.34) to 0.95 mg/dl (IQR 0.29) was observed in the first 2 months but thereafter leveled on these values (1.00 mg/dl; IQR 0.35) (P = 0.111 compared to 2 months). The lipid profile slightly improved. The daily cost of cART was significantly (P < 0.0001) reduced of 6.89 euros (SD 6.10). DISCUSSION: Switching to a dual cART regimen based on lamivudine + dolutegravir maintains virological efficacy up to week 24, and is associated to slight improvements of the immunologic and metabolic status. The strategy allows to freely using concomitant medications for associated pathologies. The dual therapy is less expensive in economic terms.

conclusionAlthough still limited evidence exists, a dolutegravir-based dual therapy in combination with lamivudine shows promising results to be confirmed in larger controlled trials.

Indexed as

CD4 Lymphocyte CountComorbidityDolutegravirDrug Therapy, CombinationFemaleHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsHumansLamivudineMaleMiddle AgedOxazinesPiperazinesProspective StudiesPyridonesDolutegravirHeterocyclic Compounds, 3-RingLamivudineOxazinesPiperazinesPyridonesRNA, ViralCohortCostsDolutegravirDual cARTLamivudineSimplificationSwitch

Identifiers

PMID28302065
PMCPMC5356275
OpenAlexW2595476392

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.