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Dovato have a growing wealth of Real-World Data that continues to reinforce robust efficacy in the switch to Dovato.
See the Real-World (new word) Data for both Naive and Switch PLHIV
DOVATO IS RECOMMENDED IN TREATMENT GUIDELINES
DOVATO IS RECOMMENDED IN TREATMENT GUIDELINES
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
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.
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:
- 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
- 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.
- 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.
- 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.
- 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.
- 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
- European AIDS Clinical Society, Guidelines, Version 12.1, November 2024. https://eacs.sanfordguide.com/
- 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
- 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
