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This study was supported by a research grant from Instituto de Salud Carlos III (PI16/01085) and Red de Investigacion en Sida (RIS): RIS-EST29 and RD12/0017/0001, RD12/0017/0005, RD17/0017/0022 and RD17/0017/0029.

Analysis of institutional authors

Sanchez Palomino, Maria SonsolesAuthorBlanco Arevalo, Jose LuisAuthorInciarte Portillo, AlexyAuthorLaguno Centeno, MontserratAuthorPlana Prades, MontserratAuthorCarne Cladellas, XavierAuthorMartinez Crespo, Jose MªAuthorMartinez Ponsdomenech, JuditAuthorLonca Dolade, MontserratAuthorCrespo Guardo, AlbertoAuthorVidal Martin, FrancescaAuthorMartinez Quintanilla Martinez, JordiAuthorPlana, Maria TeresaAuthorRojas, JAuthorMallolas, JAuthorGatell, JmAuthorDe Lazzari, EAuthorMartinez, ECorresponding Author
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Article

Dolutegravir-based maintenance monotherapy versus dual therapy with lamivudine: a planned 24 week analysis of the DOLAM randomized clinical trial

Publicated to:Journal Of Antimicrobial Chemotherapy. 73 (7): 1965-1971 - 2018-07-01 73(7), DOI: 10.1093/jac/dky093

Authors: Blanco, Jose L; Rojas, Jhon; Paredes, Roger; Negredo, Eugenia; Mallolas, Josep; Casadella, Maria; Clotet, Bonaventura; Gatell, Jose M; de Lazzari, Elisa; Martinez, Esteban

Affiliations

Hosp Badalona Germans Trias & Pujol, Badalona, Spain - Author
Hosp Badalona Germans Trias & Pujol, Badalona, Spain      Hospital Germans Trias i Pujol - Author
Univ Barcelona, Hosp Clin IDIBAPS, Barcelona, Spain - Author
Univ Barcelona, Hosp Clin IDIBAPS, Barcelona, Spain.      University of Barcelona    Hospital Clinic de Barcelona    IDIBAPS - Author
Univ Barcelona, Hosp Clin IDIBAPS, Barcelona, Spain      Hospital Clinic de Barcelona    IDIBAPS    University of Barcelona - Author
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Abstract

Background: No controlled comparisons between dolutegravir/lamivudine or dolutegravir maintenance therapy have been done. We hypothesized that these options would have similar efficacy to triple ART. Methods: We used an open-label non-inferiority randomized controlled trial comprising two phases: phase A was established to test that experimental arms did not have an unacceptable (>= 5%) failure rate; phase B was intended to include the full number of patients followed for 48 weeks. Treated HIV-1-infected adults with viral load,50 copies/mL for >= 12months, no prior viral failure or resistance mutations to study drugs, nadir CD4.200 cells/mm(3), and hepatitis B virus surface antigen negative were randomized 1: 1: 1 to maintain triple therapy (control arm), or to switch to dolutegravir/lamivudine, or to dolutegravir monotherapy stratifying by anchor drug. Premature discontinuation was considered if viral failure or therapy interruption due to adverse events, concurrent illness, protocol deviation or patient's wish occurred. Blips were registered. Planned phase A results at 24 weeks are reported here. The study is registered at EudraCT: 201500027435. Results: Ninety-one (control, n = 31; dual therapy, n = 29; monotherapy, n = 31) patients were randomized. Three patients (none previously exposed to integrase inhibitors) prematurely discontinued treatment due to viral failure: dolutegravir/lamivudine (n = 1), no resistance mutations (subject A); dolutegravir (n = 2), N155H, S147G and Q148R resistance mutations (subject B), and E138K, G140S and N155H resistance mutations (subject C). There were no discontinuations for other reasons. One patient (dolutegravir/lamivudine) experienced a blip in viral load. The Data Safety Monitoring Board recommended stopping the dolutegravir monotherapy arm. Conclusions: In contrast to dolutegravir/lamivudine, a higher than expected risk of viral failure with development of cross-resistance integrase mutations occurred with dolutegravir maintenance monotherapy.

Keywords
hiv-infected patientsAdultAnti-hiv agentsAntiretroviral therapy, highly activeDrug therapy, combinationFemaleHeterocyclic compounds, 3-ringHiv infectionsHiv integrase inhibitorsHiv seropositivityHiv-1Hiv-infected patientsHumansLamivudineMaleMiddle agedMutationOxazinesPiperazinesProtease inhibitor monotherapyPyridonesRna, viralViral load

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Journal Of Antimicrobial Chemotherapy due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2018, it was in position 7/88, thus managing to position itself as a Q1 (Primer Cuartil), in the category Pharmacology & Pharmacy. Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 2.71. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

  • Weighted Average of Normalized Impact by the Scopus agency: 2.93 (source consulted: FECYT Feb 2024)
  • Field Citation Ratio (FCR) from Dimensions: 10.16 (source consulted: Dimensions May 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-05-02, the following number of citations:

  • WoS: 49
  • Scopus: 54
  • Europe PMC: 30
  • Google Scholar: 78
  • OpenCitations: 53
Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-05-02:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 119.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 119 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 13.
  • The number of mentions on the social network X (formerly Twitter): 1 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

Leadership analysis of institutional authors

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: First Author (Blanco, JL) and Last Author (Martinez Chamorro, Esteban).

the author responsible for correspondence tasks has been Martinez Chamorro, Esteban.