Pacheco P, Marques N, Rodrigues P, Mansinho K, Maltez F, Janeiro N, Franco C, Trigo D, Batista J, Duque L, Lopes MJ, Aleixo MJ, Silva AR, Tavares R, Alves J, Peres S, Póvoas D, Lino S, Gomes P, Araújo V, and Lopes C
Background: Integrase strand transfer inhibitor-based regimens are recommended for first-line therapy in human immunodeficiency virus type 2 (HIV-2). Nonetheless, dolutegravir (DTG) clinical trial data are lacking., Methods: We conducted a phase 2, single-arm, open-label trial to evaluate the safety and efficacy of a triple therapy regimen that included DTG in persons with HIV-2 (PWHIV-2) in Portugal. Treatment-naive adults receive DTG in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs). Treatment efficacy was evaluated by the proportion of patients who achieved a plasma viral load (pVL) <40 copies/mL and/or by the change from baseline in CD4+ T-cell count and in CD4/CD8 ratio at week 48., Results: A total of 30 patients were enrolled (22 women; median age, 55 years). At baseline, 17 (56.7%) individuals were viremic (median, pVL 190 copies/mL; interquartile range [IQR], 99-445). The median CD4 count was 438 cells/μL (IQR, 335-605), and the CD4/CD8 ratio was 0.8. Three patients discontinued the study. At week 48, all participants (27) had pVL <40 copies/mL. No virological failures were observed. Mean changes in CD4 count and CD4/CD8 ratio at week 48 were 95.59 cells/µL (95% confidence interval [CI], 28-163) and 0.32 (95% CI, .19 to .46). The most common drug-related adverse events were headache and nausea. One participant discontinued due to central nervous system symptoms. No serious adverse events were reported., Conclusions: DTG plus 2 NRTIs is safe and effective as first-line treatment for PWHIV-2 with a tolerability profile previously known. No virological failures were observed that suggest a high potency of DTG in HIV-2 as occurs in HIV-1., Clinical Trials Registration: M NCT03224338., Competing Interests: Potential conflicts of interest. A. R. S. reports consulting fees from and participation on a data and safety monitoring board (DSMB) or advisory board for MSD; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events; and support for attending meetings and/or travel from ViiV Healthcare, Gilead Sciences, and MSD. F. M. reports consulting fees from ViiV Healthcare, Gilead, Merck Sharp & Dohme, and Astra Zeneca; payment or honoraria for presentations from ViiV Healthcare, Gilead, and MercK Sharp & Dohme; and participation on an advisory board for ViiV Healthcare, Gilead, and MercK Sharp & Dohme. J. B. reports consulting fees from ViiV Healthcare and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Gilead and ViiV Healthcare. K. M. reports payment or honoraria as a conference speaker from Merck Sharp & Dome and ViiV Healthcare and payment for expert testimony for an advisory board from Gilead Sciences and ViiV Healthcare. N. M. reports payment or honoraria for speakers bureaus from Merck Sharpe & Dohme and Gilead Sciences. S. L. reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ViiV Healthcare, MSD, Pfizer, and Gilead Sciences; support for attending meetings and/or travel from MSD; and participation on a DSMB or advisory board for ViiV Healthcare. D. T. reports payment or honoraria for presentations or educational events from ViiV Healthcare, Gilead, and MSD; support for attending an international meeting, scientific update from MSD; and participation on an advisory board from ViiV Healthcare, Gilead, and MSD. P. P. reports payment or honoraria for presentations from ViiV Healthcare, Gilead, MSD, and Janssen Cilag; support for attending meetings and/or travel from Janssen Cilag; and participation on an advisory board for Gilead Sciences, ViiV Healthcare, and MSD. P. G. reports grants or contracts from Gilead Sciences; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ViiV Healthcare, Gilead Sciences, MSD, and Janssen; support for attending meetings and/or travel from ViiV Healthcare and MSD; and participation on a DSMB or advisory board from ViiV Healthcare and MSD. J. A. reports honoraria for an education event from ViiV Healthcare; support for attending meetings and/or travel from ViiV Healthcare; and participation on an advisory board from ViiV Healthcare. M. J. L. reports payment for a presentation from ViiV Healthcare. C. F. reports payment or honoraria as a specialist and speaker from ViiV Healthcare Unipessoal LDA and Gilead Sciences LDA and participation on an advisory board for ViiV Healthcare Unipessoal LDA and Gilead Sciences LDA. L. D. reports support for a virtual meeting registration from ViiV Healthcare; participation on an advisory board from Gilead Sciences; and a role as a member and paid collaborator from the GAT—Grupo de Ativistas em Tratamentos. D. P. reports consulting fees from ViiV Healthcare; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ViiV Healthcare, AbbVie, and Roche; and support for attending meetings and/or travel from ViiV Healthcare and Merck Sharpe & Dohme. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)