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Real-World Tolerability
in treatment naïve patients
Dovato Adverse Events
The most frequently reported adverse reactions are headache (3%), diarrhoea (2%), nausea (2%) and insomnia (2%). The most severe adverse reaction reported with dolutegravir was a hypersensitivity reaction that included rash and severe liver effects.
Precautions & Contraindications
Hypersensitivity to any of the active ingredients. Co-administration with medicinal products with narrow therapeutic windows, that are substrates of organic cation transporter (OCT) 2, including but not limited to fampridine. Weight and metabolic parameters, liver disease, IRS, Mitochondrial dysfunction following exposure in utero, osteonecrosis, opportunistic infections, moderate renal impairment.
Dosage & Administration
The recommended dose of Dovato in adults and adolescents is one 50 mg/300 mg tablet once daily.
References:
- Ryan P, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASO-DOBLE (GeSIDA 11720) randomized clinical trial. Abstract presented at: AIDS 2024; July 22-26, 2024; Virtual and Munich, Germany. Oral abstract OAB3606LB.
- Osiyemi O, De Wit S, Ajana F, et al. Efficacy and safety of switching to dolutegravir/lamivudine (DTG/3TC) versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with HIV-1: results through week 144 from the phase 3, non-inferiority TANGO randomized trial. Clin Infect Dis. 2022;ciac036. doi:10.1093/cid/ciac036
- Llibre JM, Alves Brites C, Cheng CY, et al. Switching to the 2-drug regimen of dolutegravir/lamivudine (DTG/3TC) fixeddose combination is non-inferior to continuing a 3-drug regimen through 48 weeks in a randomized clinical trial (SALSA). Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual. Slides OALB030.
- 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.
- Cahn P, Sierra Madero J, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naïve adults with HIV-1 infection. AIDS. 2022;36(1):39-48. doi:10.1097/QAD.000000000000307
- Rolle C-P, Berhe M, Singh T, et al. High rates of virologic suppression with DTG/3TC in newly diagnosed adults with HIV-1 infection and baseline viral load ≥500,000 c/mL: 48-week subgroup analysis of the STAT study. Presented at: IDWeek 2021; September 29-October 3, 2021; Virtual.
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: May 2025 | PM-IE-DLL-WCNT-250005
