Dolutegravir/lamivudine

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Dolutegravir/lamivudine
Combination of
DolutegravirIntegrase inhibitor
LamivudineReverse-transcriptase inhibitor
Names
Trade namesDovato
Clinical data
Pregnancy
category
  • AU: B3[1]
  • US: N (Not classified yet)[1]
Routes of
use
By mouth
External links
AHFS/Drugs.comMonograph
US NLMDolutegravir/lamivudine
MedlinePlusa619043
Legal
License data
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)

Dolutegravir/lamivudine, sold under the brand name Dovato, is a combination medication used to treat HIV/AIDS. It is taken by mouth.[2][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] It contains dolutegravir, an integrase inhibitor, and lamivudine, a reverse-transcriptase inhibitor.[2][3] Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of another enzyme called reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).[3]

The combination was approved for use in the United States in April 2019,[4][5] and in the European Union in July 2019.[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 (below 50 copies per ml) after 48 weeks compared with 93% of those who were taking the triple combination. In both studies there were no cases of resistance to treatment after 48 weeks.[3]

References

  1. 1.0 1.1 "Dolutegravir / lamivudine (Dovato) Use During Pregnancy". Drugs.com. 14 May 2019. Retrieved 24 April 2020.
  2. 2.0 2.1 "Dovato- dolutegravir sodium and lamivudine tablet, film coated". DailyMed. 24 March 2020. Retrieved 24 April 2020.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 "Dovato EPAR". European Medicines Agency (EMA). 24 April 2019. Retrieved 24 April 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  4. 4.0 4.1 "Drug Approval Package: Dovato". accessdata.fda.gov. 24 June 2019. Retrieved 24 April 2020.
  5. 5.0 5.1 "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

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