Dolutegravir/lamivudine

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Dolutegravir/lamivudine
Combination of
DolutegravirIntegrase inhibitor
LamivudineReverse-transcriptase inhibitor
Names
Trade namesDovato
Clinical data
Main usesHIV/AIDS[1]
Side effectsHeadache, diarrhea, nausea, difficulty sleeping[2]
Pregnancy
category
  • AU: B3[3]
  • US: N (Not classified yet)[3]
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.[1] It may be a first line treatment option.[4] It may, also be the only medication a person requires.[1] It is taken by mouth.[1][2]

Common side effects are headache, diarrhea, nausea, and difficulty sleeping.[2] Other side effects may include allergic reactions, rash, and liver problems.[2] While there is no evidence of harm in pregnancy, such use has not been well studied.[5] It contains dolutegravir, an integrase inhibitor, and lamivudine, a reverse-transcriptase inhibitor.[1][2] Dolutegravir stops the activity of integrase, while lamivudine stops the activity of nucleoside reverse transcriptase.[2]

The combination was approved for medical use in the United States and Europe in 2019.[2][1] It is a generic medication.[6] In the United Kingdom a month of treatment costs the NHS about £660 as of 2021.[6] In the United States this amount costs about 2,500 USD.[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 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.[2]

Dosage

It is taken as one pill once per day.[1] In those on carbamazepine or rifampin one pill twice a day may be required.[1]

History

Dolutegravir/lamivudine was approved for use in the United States in April 2019,[8][9] and in the European Union in July 2019.[2]

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).[2]

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.[2]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Dovato- dolutegravir sodium and lamivudine tablet, film coated". DailyMed. 24 March 2020. Archived from the original on 24 April 2020. Retrieved 24 April 2020.
  2. 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 "Dovato EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 24 April 2020. Retrieved 24 April 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  3. 3.0 3.1 "Dolutegravir / lamivudine (Dovato) Use During Pregnancy". Drugs.com. 14 May 2019. Archived from the original on 24 April 2020. Retrieved 24 April 2020.
  4. "Dolutegravir and Lamivudine Monograph for Professionals". Drugs.com. Archived from the original on 21 January 2021. Retrieved 27 December 2021.
  5. "Dolutegravir / lamivudine (Dovato) Use During Pregnancy". Drugs.com. Archived from the original on 24 April 2020. Retrieved 27 December 2021.
  6. 6.0 6.1 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 692. ISBN 978-0857114105.
  7. "Dovato Prices, Coupons & Savings Tips - GoodRx". GoodRx. Archived from the original on 11 January 2022. Retrieved 27 December 2021.
  8. "Drug Approval Package: Dovato". accessdata.fda.gov. 24 June 2019. Archived from the original on 24 April 2020. Retrieved 24 April 2020.
  9. "FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment" (Press release). Food and Drug Administration. Archived from the original on 22 April 2019. Retrieved 9 April 2019.

External links

Identifiers:
  • "Dolutegravir". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 19 May 2021. Retrieved 14 July 2021.
  • "Lamivudine". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 17 April 2020. Retrieved 14 July 2021.