Dolutegravir

Dolutegravir (DTG), sold under the brand name Tivicay, is an antiretroviral medication used, together with other medication, to treat HIV/AIDS. It may also be used, as part of post exposure prophylaxis, to prevent HIV infection following potential exposure. It is taken by mouth. Dolutegravir (DTG), sold under the brand name Tivicay, is an antiretroviral medication used, together with other medication, to treat HIV/AIDS. It may also be used, as part of post exposure prophylaxis, to prevent HIV infection following potential exposure. It is taken by mouth. Common side effects include trouble sleeping, feeling tired, diarrhea, high blood sugar, and headache. Severe side effects may include allergic reactions and liver problems. There is tentative concerns that use during pregnancy can result in harm to the baby. It is unclear if use during breastfeeding is safe. Dolutegravir is an HIV integrase strand transfer inhibitor which blocks the functioning of HIV integrase which is needed for viral replication. Dolutegravir was approved for medical use in the United States in 2013. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. In 2015, the cost of the medication in the United Kingdom was £499 per month. Abacavir/dolutegravir/lamivudine, a combination with abacavir and lamivudine is also available. As of 2019, the WHO recommends DTG as the first- and second-line treatment for all persons with HIV. 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. 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. 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. In February, 2013 the Food and Drug Administration announced that it would fast track dolutegravir's approval process. On August 13, 2013, dolutegravir was approved by the FDA. On November 4, 2013, dolutegravir was approved by Health Canada. On January 16, 2014, it was approved by the European Commission for use throughout the European Union. In August 2019 a triple combination therapy, with dolutegravir replacing efavirenz, was introduced as the first line treatment for all HIV-infected patients in the South African Government (public) sector.