Tivicay® (dolutegravir) is an integrase strand transfer inhibitor (INSTI) that is indicated for use in combination with other antiretroviral (ARV) medicines for the treatment of HIV infection. Tivicay is a 50mg tablet, which may be taken with or without food. In treatment-naïve patients, and in treatment-experienced patients who have not taken an integrase inhibitor, Tivicay is taken in most cases once a day and is booster free.1
Tivicay has been extensively studied in five phase III clinical trials involving over 3,000 adult people living with HIV.2-6
Tivicay was approved by the U.S. Food and Drug Administration (FDA) in August 2013;7 by the European Commission in January 2014;1 by the Canadian regulatory authority Health Canada in October 20138 and by the Japanese Pharmaceuticals and Medical Devices Agency in April 2014.9
In 2016, the FDA approved a reduction in the weight limit from at least 40kg to at least 30kg for the treatment of HIV with Tivicay, meaning children and adolescents aged 6 – 12 years old will now be eligible to receive this treatment option.
Tivicay is now available in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.
If you are a healthcare professional, for more information please visit our promotional website.
- Tivicay Summary of Product Characteristics (SmPC) (Updated 23/04/2015) Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002753/WC500160680.pdf. Last accessed January 2017.
- Raffi F, Jaeger H, Quiros-Roldan E, et al. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013;13:927-35.
- Walmsley S, Baumgarten A, Berenguer J, et al. Brief Report: Dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection in Antiretroviral therapy-naïve patients: Week 96 and Week 144 Results from the SINGLE randomized clinical trial. JAIDS. 2015;70(5):515-19.
- Cahn P, Pozniak AL, Mingrone H, et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382(9893):700-708.
- Molina J, Clotet B, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015;2:e127-136.
- Eron JJ, Clotet B, Durant J et al. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING study. J Infect Dis. 2013;207(5):740-48.
- Tivicay® (dolutegravir) updated US prescribing information. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF. Last accessed January 2017.
- Tivicay Summary Basis of Decision. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_tivicay_161084-eng.php. Last accessed January 2017.
- Tivicay Report on Deliberation Results. Japanese Pharmaceuticals and Medical Devices Agency. 2014. Available at: http://www.pmda.go.jp/files/000209096.pdf. Last accessed January 2017.