Dolutegravir/lamivudine

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

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

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]

Medical uses

In the EU, dolutegravir/lamivudine 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 kilograms (88 lb), with no known or suspected resistance to the integrase inhibitor class, or lamivudine.[5]

In the US, it is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.[4][7]

History

The efficacy and safety of dolutegravir/lamivudine were demonstrated in two identical, randomized, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no prior antiretroviral treatment history.[7] The trials showed that a drug regimen containing dolutegravir and lamivudine had a similar effect of reducing the amount of HIV in the blood compared to another drug regimen, which included dolutegravir, emtricitabine, and tenofovir.[7] The treatment was considered successful if the participant maintained low-levels (less than 50 copies/mL) of HIV RNA in their blood for at least 48 weeks.[7][5] In these studies, 91% of subjects with HIV-1 who took the dolutegravir/lamivudine combination no longer had detectable levels of HIV (i.e. they had fewer than 50 copies per ml) after 48 weeks compared with 93% of those who were taking the triple combination. In neither study was there a case of resistance to treatment after 48 weeks.[5]

References
  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. "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. "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. "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. 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.
  • "Dolutegravir". Drug Information Portal. U.S. National Library of Medicine.
  • "Lamivudine". Drug Information Portal. U.S. National Library of Medicine.


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