Dolutegravir/lamivudine
Combination of | |
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Dolutegravir | Integrase inhibitor |
Lamivudine | Reverse-transcriptase inhibitor |
Clinical data | |
Trade names | Dovato |
AHFS/Drugs.com | Monograph |
MedlinePlus | a619043 |
License data | |
Pregnancy category |
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Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status |
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Identifiers | |
CAS Number |
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KEGG |
Dolutegravir/lamivudine, sold under the brand name Dovato, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. It contains dolutegravir, an integrase inhibitor, and lamivudine, a reverse-transcriptase inhibitor.[2][3] It is taken by mouth.[2][3]
Dolutegravir is an integrase inhibitor, while lamivudine is a nucleoside reverse-transcriptase inhibitor.[3]
It was approved for use in the United States in April 2019,[4][5] and in the European Union in July 2019.[3]
The most common side effects are headache, diarrhoea, nausea (feeling sick) and difficulty sleeping.[3] The most common serious side effects are allergic reactions, including rash and severe liver problems.[3]
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 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.[3]
History[]
Dolutegravir/lamivudine was approved for use in the United States in April 2019,[4][5] and in the European Union in July 2019.[3]
Two main studies, involving 1,441 subjects, have shown that the combination of dolutegravir and lamivudine is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).[3]
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 there was there a case of resistance to treatment after 48 weeks.[3]
References[]
- ^ a b "Dolutegravir / lamivudine (Dovato) Use During Pregnancy". Drugs.com. 14 May 2019. Retrieved 24 April 2020.
- ^ a b "Dovato- dolutegravir sodium and lamivudine tablet, film coated". DailyMed. 24 March 2020. Retrieved 24 April 2020.
- ^ a b c d e f g h i j "Dovato EPAR". European Medicines Agency (EMA). 24 April 2019. Retrieved 24 April 2020. This article incorporates text from this source, which is in the public domain.
- ^ a b "Drug Approval Package: Dovato". accessdata.fda.gov. 24 June 2019. Retrieved 24 April 2020.
- ^ a b "FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment" (Press release). Food and Drug Administration. Retrieved 9 April 2019.
External links[]
- "Dolutegravir". Drug Information Portal. U.S. National Library of Medicine.
- "Lamivudine". Drug Information Portal. U.S. National Library of Medicine.
- Fixed dose combination (antiretroviral)
- Antiinfective agent stubs