Dolutegravir (DTG), sold under the brand name Tivicay, is an antiretroviral medication used, together with other medication, to treat HIV/AIDS.[6] It may also be used, as part of post exposure prophylaxis, to prevent HIV infection following potential exposure.[7] It is taken by mouth.[6]
Dolutegravir is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.[13]
In the European Union it is indicated, in combination with other anti-retroviral medicinal products, for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above six years of age.[5]
In June 2020, the indication for dolutegravir in the US was updated to include children at least four weeks old and weighing at least 3 kg (6.61 pounds).[14]
Common side effects of dolutegravir in clinical trials included insomnia and headache. Serious side effects included allergic reactions and abnormal liver function in patients who were also infected with hepatitis B or C.[15] The package insert warns against a mean rise in serum creatinine of 0.11 mg/dL due to inhibition of tubular secretion of creatinine and does not affect GFR.[4]
In 2019 there were tentative concerns[16] that usage during pregnancy can result in the increased risk of neural tube defects however further studies have refuted that claim finding no statistical difference between dolutegravir and other antiretrovirals.[8] As of 31 January 2024[17] dolutegravir is the NIH preferred antiretroviral drug for pregnant or nonpregnant people trying to conceive.[18]
In February 2013, the U.S. Food and Drug Administration (FDA) announced that it would fast track dolutegravir's approval process.[19] On 13 August 2013, dolutegravir was approved for medical use in the United States.[20] On 4 November 2013, dolutegravir was approved by Health Canada.[21] On 16 January 2014, it was approved by the European Commission for use throughout the European Union.[5]
In June 2020, dolutegravir was approved in the US with an indication to treat HIV-1 infection in children at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments.[14] It is intended to treat children at least 4 weeks old and 3 kg who have never been treated for HIV or who have been treated, but not with an integrase strand transferase inhibitor (INSTI) class drug.[14][22]
Dolutegravir, used by 24 million people in low- and middle-income countries, has significantly reduced carbon emissions compared to the previous standard of care, efavirenz.[23] This is the first report to analyze the environmental impact of a widely used medicine compared to its alternative. According to Unitaid, this transition will prevent over 26 million tons of CO2 from entering the atmosphere between 2017 and 2027, equivalent to eliminating 10 years of carbon emissions from Geneva, Switzerland.[24]
^World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^Ciccullo A, Baldin G, Borghetti A, Di Giambenedetto S (April 2020). "Dolutegravir plus lamivudine for the treatment of HIV-1 infection". Expert Review of Anti-infective Therapy. 18 (4): 279–292. doi:10.1080/14787210.2020.1729742. PMID32067525. S2CID211160876.
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