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  • DTG + 3TC in Real-World studies

  • Treatment-experienced

  • Treatment-naive

DOVATO IS RECOMMENDED IN TREATMENT GUIDELINES

DOVATO IS RECOMMENDED IN TREATMENT GUIDELINES

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EACS Guidelines 2024

Recommended as an initial regimen for treatment-naïve patients and as a switch strategy for virologically suppressed patients7

Requirements for treatment-naïve patients:

  • HBsAg negative
  • HIV viral load <500,000 copies/mL
  • Not recommended after PrEP failure

Requirements for switch patients:

  • No historical resistance
  • HBV immunity, or if non-immune, concomitant HBV vaccination
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DHHS Guidelines 2024

Recommended as an initial regimen for most people living with HIV (AI)* and as a good option for virologically suppressed patients who have no evidence of resistance to either drug8

Exclusions for treatment-naïve patients:

  • HIV viral load >500,000 copies/mL
  • HBV co-infection
  • Where ART is to be started before the results of HIV genotype resistance testing for reverse transcriptase or HBV testing are available
  • For people who have a history of CAB-LA use as PrEP, INSTI genotype resistance testing should be performed before starting ART

*Rating of recommendations: A=strong; B=moderate; C=optional. Rating of evidence: I=data from randomised controlled trials; II=data from well-designed non-randomised trials, observational cohort studies with long-term clinical outcomes, relative bioavailability/bioequivalence studies or regimen comparisons from randomised switch studies; III=expert opinion.8

Please refer to the latest DHHS guidelines for further information about treatment options.

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IAS Guidelines 2024

Recommended as an initial regimen for most people with HIV and as an appropriate switch strategy for virologically suppressed patients (AIa)*9

Not recommended in:

  • Rapid start, because baseline laboratory evaluation results must be reviewed before initiation
  • Chronic hepatitis B
  • HIV-1 RNA >500 000 c/mL, There are limited data on using DTG/3TC for initial therapy in people who have CD4+ cell counts below 200/μL.
  • Patients being treated for an active opportunistic infection
  • If lamivudine resistance is present

Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.6

References:

  1. Cahn P, Sierra Madero J, Arribas JR, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naive adults with HIV-1 infection - 3-year results from the GEMINI studies. Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Poster P018
  2. van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG/3TC fixed dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 96 weeks (TANGO study). Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Slides O441.
  3. Rolle C-P, Berhe M, Singh T, et al. Feasibility, efficacy and safety of using dolutegravir/lamivudine (DTG/3TC) as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV (PLWH): The STAT study. Presented at: 14th Annual American Conference for the Treatment of HIV; August 20-22, 2020; Virtual.
  4. Llibre JM, Alves Brites C, Cheng C-Y, et al. Switching to the 2-drug regimen of dolutegravir/lamivudine (DTG/3TC) fixed-dose combination is noninferior to continuing a 3-drug regimen through 48 weeks in a randomized clinical trial (SALSA). Presented at: International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual. Slides OALB0303.
  5. Vandekerckhove L, Trypsteen W, Bloome E, et al. Impact of switch towards 3TC/dolutegravir on the intact and total HIV-1 viral reservoir in the Rumba study. Presented at: HIV Glasgow 2022; October 23-26, 2022; Glasgow, UK. Slides MO42.
  6. DOVATO Summary of Product Characteristics. Last Accessed May 2025. Available at: https://www.medicines.ie/medicines/dovato-50-mg-300-mg-film-coated-tablets-34871/spc
  7. European AIDS Clinical Society, Guidelines, Version 12.1, November 2024. https://eacs.sanfordguide.com/
  8. National Institutes of Health. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. clinicalinfo.hiv.gov. Published September 12, 2024. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/what-start-initial-combination?view=full
  9. Gandhi RT, Landovitz RJ, Sax PE, et al. Antiretroviral Drugs for Treatment and Prevention of HIV in Adults: 2024 Recommendations of the International Antiviral Society–USA Panel. JAMA. Published online December 1, 2024. doi:https://doi.org/10.1001/jama.2024.24543

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255, or via the online patient safety reporting form at gsk.public.reportum.com.

Dovato is a registered trade mark of the ViiV Healthcare group of companies or its licensor.

Date of preparation: April 2025 PM-IE-DLL-WCNT-200016