Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Jan 24;15(2):322.
doi: 10.3390/v15020322.

Dolutegravir Plus 3TC in Virologically Suppressed PLWHIV: Immunological Outcomes in a Multicenter Retrospective Cohort in Spain during the COVID-19 Pandemic

Luis Buzón  1 , Carlos Dueñas  2 , Roberto Pedrero  3 , Jose Antonio Iribarren  4 , Ignacio de Los Santos  5 , Alberto Díaz de Santiago  6 , Miguel Ángel Morán  7 , Guillermo Pousada  8 , Estela Moreno  9 , Eva Ferreira  10 , Alicia Iglesias  11 , Cristina Martín  12 , Julia Gómez  13 , Laura Rodríguez  2 , Miguel Egido  14 , María-Antonia Sepulveda  15 , Jesús Troya  16
Affiliations
Randomized Controlled Trial

Dolutegravir Plus 3TC in Virologically Suppressed PLWHIV: Immunological Outcomes in a Multicenter Retrospective Cohort in Spain during the COVID-19 Pandemic

Luis Buzón et al. Viruses. .

Abstract

Dolutegravir (DTG) based dual therapies for treating PLWHIV are a standard of care nowadays. Switching to DTG and lamivudine (3TC) safety and efficacy were proven in TANGO randomized clinical trial. This multicenter retrospective study included 1032 HIV virologically suppressed patients switching to DTG+3TC from 13 Spanish hospitals. DTG+3TC provided high rates of undetectable viral load over 96%, corresponding to 96.6% (889/921) at 24 weeks, 97.5% (743/763) at 48 weeks, and 98.3% (417/425) at 96 weeks. No significant differences are evident when comparing the total population according to sex, presence of comorbidity, or presence of AIDS. The analysis for paired data showed an increase in CD4+ cell count. A statistically significant increase in CD4+ lymphocyte count was found in those without comorbidities in the three-time series analyzed [average increase at 24 weeks: 48.7 (SD: 215.3) vs. 25.8 (SD: 215.5), p-value = 0.050; a mean increase at 48 weeks: 75.1 (SD: 232.9) vs. 42.3 (SD: 255.6), p-value = 0.003; a mean increase at 96 weeks: 120.1 (SD: 205.0) vs. 63.8 (SD:275.3), p-value = 0.003]. In conclusion, our cohort demonstrates that DTG+3TC is an effective treatment strategy for virologically-suppressed PLWHIV independent of age, sex, and HIV stage, as well as a safe and durable strategy.

Keywords: DTG+3TC; immune recovery; safety; switching; viral suppression.

PubMed Disclaimer

Conflict of interest statement

Luis Buzon, Jesús Troya, and Carlos Dueñas declare to have received advisory board and lecture fees from ViiV Healthcare, GILEAD, Jannsen, and MSD. They do not own stock options from any of those companies.

Figures

Figure 1
Figure 1
Difference between baseline absolute CD4+ lymphocytes (cells/mm3), baseline absolute CD8+ lymphocytes (cells/mm3), and baseline CD4/CD8 ratio of HIV-positive patients at 24, 48, and 96 weeks of DTG plus 3TC treatment. Panel (A): Gender differences; Panel (B): Differences between patients with and without comorbidities; Panel (C): Differences in patients with and without AIDS. Significant values: p-value < 0.05 = *; p-value < 0.01 = **.
See this image and copyright information in PMC

References

    1. Kanters S., Vitoria M., Doherty M., Socias M.E., Ford N., Forrest J.I., Popoff E., Bansback N., Nsanzimana S., Thorlund K., et al. Comparative efficacy and safety of first-line antiretroviral therapy for the treatment of HIV infection: A systematic review and network meta-analysis. Lancet HIV. 2016;3:e510–e520. doi: 10.1016/S2352-3018(16)30091-1. - DOI - PubMed
    1. Margolis A.M., Heverling H., Pham P.A., Stolbach A. A review of the toxicity of HIV medications. J. Med. Toxicol. 2014;10:26–39. doi: 10.1007/s13181-013-0325-8. - DOI - PMC - PubMed
    1. Carr A., Miller J., Law M., Cooper D.A. A syndrome of lipoatrophy, lactic acidaemia and liver dysfunction associated with HIV nucleoside analogue therapy: Contribution to protease inhibitor-related lipodystrophy syndrome. AIDS. 2000;14:F25–F32. doi: 10.1097/00002030-200002180-00001. - DOI - PubMed
    1. Arribas J.R., Girard P.M., Landman R., Pich J., Mallolas J., Martínez-Rebollar M., Zamora F.X., Estrada V., Crespo M., Podzamczer D., et al. Dual treatment with lopinavir-ritonavir plus lamivudine versus triple treatment with lopinavir-ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): A randomized, open-label, non-inferiority trial. Lancet Infect. Dis. 2015;15:785–792. - PubMed
    1. Osterholzer D.A., Goldman M. Dolutegravir: A next-generation integrase inhibitor for the treatment of HIV infection. Clin. Infect. Dis. 2014;59:265–271. doi: 10.1093/cid/ciu221. - DOI - PubMed

Publication types