Dolutegravir/lamivudine
Combination drug
From Wikipedia, the free encyclopedia
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]
| Combination of | |
|---|---|
| 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 | |
| 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]
