DOVATO HAS A WELL-
ESTABLISHED SAFETY PROFILE[1]

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 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

DOVATO IS GENERALLY WELL-TOLERATED[1]

The frequency of adverse reactions observed in clinical studies and post-marketing experiences is listed below.[1]

Efficacy of DOVATO across treatment settings

See data from the pivotal randomised controlled trials and real-world evidence

Explore the data

Proven high barrier to resistance in data up to 5 years[27]

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Dosing and drug-drug interactions

DOVATO has a lower rate of clinically relevant DDIs vs. other single-tablet ARV regimens[8]

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ALT, alanine aminotransferase; ARV, antiretroviral; AST, aspartate aminotransferase; CPK, creatine phosphokinase; DDI, drug-drug interaction.
*Particularly in patients with a pre-existing history of depression or psychiatric illness.[1]
This adverse reaction was identified through post-marketing surveillance for dolutegravir in combination with other antiretrovirals. The frequency category of rare was estimated based on post-marketing reports.[1]
Observed in combination with increased transaminases.[1]

References:

  1. DOVATO (dolutegravir/lamivudine) Summary of Product Characteristics (SmPC).
  2. ViiV Healthcare. Data on File. REF-223795. 2024.
  3. Cahn P et al. AIDS 2022; 36(1): 39–48.
  4. Cordova E et al. Poster presented at the 12th IAS Conference on HIV Science. 23–26 July 2023. Brisbane, Australia. TUPEB02.
  5. Rolle C et al. Open Forum Infect Dis 2023; 10(3): 1–9.
  6. De Wit S et. J Acquir Immune Defic Syndr 2024. doi: 10.1097/QAI.0000000000003395. [Epub ahead of print].
  7. Llibre J et al. Clin Infect Dis 2023; 76(4): 720–729.
  8. European AIDS Clinical Society (EACS) Guidelines. Version 12.0. October 2023.

PM-GB-DLL-WCNT-240007. August 2024

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.