Dolutegravir/lamivudine

Dolutegravir/lamivudine
Combination of
DolutegravirIntegrase inhibitor
LamivudineReverse-transcriptase inhibitor
Clinical data
Trade namesDovato
AHFS/Drugs.comMonograph
MedlinePlusa619043
License data
Pregnancy
category
Routes of
administration
By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
KEGG

Dolutegravir/lamivudine, sold under the brand name Dovato, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. each pill contains 50 mg dolutegravir, as the salt, an integrase strand transfer inhibitor (INSTI), and 300 mg lamivudine, a nucleoside analogue reverse transcriptase inhibitor (NRTI).[4][5] It is taken by mouth.[4][5]

It was approved for use in the United States in April 2019,[4][6][7] and in the European Union in July 2019,[5] and again with revisions in June 2022.[5][8]

The most common side effects are headache, diarrhea, nausea, and difficulty sleeping.[5] The most common serious side effects are allergic reactions, including rash and severe liver problems.[5]

Dolutegravir/lamivudine is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.[7]

  1. ^ "Dolutegravir / lamivudine (Dovato) Use During Pregnancy". Drugs.com. 14 May 2019. Archived from the original on 24 April 2020. Retrieved 24 April 2020.
  2. ^ "Regulatory Decision Summary - Dovato". Health Canada. 23 October 2014. Archived from the original on 7 June 2022. Retrieved 7 June 2022.
  3. ^ "Dovato 50 mg/300 mg film-coated tablets - Summary of Product Characteristics (SmPC)". (emc). 20 September 2021. Archived from the original on 5 March 2022. Retrieved 5 September 2022.
  4. ^ a b c d "Dovato- dolutegravir sodium and lamivudine tablet, film coated". DailyMed. 24 March 2020. Archived from the original on 24 April 2020. Retrieved 24 April 2020.
  5. ^ a b c d e f g "Dovato EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 24 April 2020. Retrieved 24 April 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ "Drug Approval Package: Dovato". U.S. Food and Drug Administration (FDA). 24 June 2019. Archived from the original on 24 April 2020. Retrieved 24 April 2020.
  7. ^ a b "FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on 22 April 2019. Retrieved 9 April 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ "Dovato". Union Register of medicinal products. Archived from the original on 6 September 2022. Retrieved 5 September 2022.