|What is Tivicay?
- Tivicay is an integrase inhibitor developed by ViiV Healthcare in collaboration with Japan-based Shionogi & Co. It was approved by the U.S. Food and Drug Administration (FDA) in August 2013. Tivicay is approved for HIV-positive adults and children 12 years and older (weighing at least 88 pounds) who are starting HIV treatment for the first time, as well as those who have used other antiretrovirals in the past, including other integrase inhibitors.
- After HIV's genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. A viral enzyme called integrase then helps to hide HIV's DNA inside the cell's DNA. Once this happens, the cell can begin producing genetic material for new viruses. Integrase inhibitors, such as Tivicay, are designed to block the activity of the integrase enzyme and to prevent HIV DNA from entering healthy cell DNA.
- Dolutegravir will need to be used in combination with other drugs.
What is already known about Tivicay?
- Each Tivicay tablet contains 50 mg of dolutegravir.
For people living with HIV starting antiretroviral therapy for the first time, or those who have been treated with other antiretrovirals in the past but have noted used an integrase inhibitor, the correct dose is one 50 mg Tivicay tablet, once a day.
For treatment-experienced individuals who have HIV that is resistant to the first-generation integrase inhibitors Isentress (raltegravir) or elvitegravir, one Tivicay tablet needs to be taken twice a day. Tivicay must also be taken twice a day by people who are using certain medications (see: "What about drug interactions?" below).
Dolutegravir can be taken either with or without food and doesn't need to be used with a boosting agent, such as low-dose Norvir (ritonavir).
- Tivicay holds promise for HIV-positive patients who are either starting HIV treatment for the first time or have used other HIV drugs, including Isentress or elvitegravir, in the past.
What about drug interactions?
- Tivicay should not be used at the same time as Tikosyn (dofetilide), a medication used to maintain a normal heart rhythm. Tivicay can increase Tikosyn blood levels, which can lead to life-threatening problems.
- The Tivicay dose should be one 50 mg tablet twice a day if it is taken at the same time as certain medications commonly prescribed to people living with HIV. These include: efavirenz (found in Sustiva and Atripla), Norvir-boosted Lexiva (fosemprenavir), Norvir-boosted Aptivus (tipranavir), and the tuberculosis medication rifampin.
- Tivicay should be taken two hours before or six hours after taking certain (cation-containing) antacids or laxatives, sucralfate, oral iron supplements, calcium supplements, or buffered medication.
What is known about side effects?
- The most common side effects associated with treatment containing Tivicay in clinical trials were difficulty sleeping/insomnia and headache.
Who should not take Tivicay?
- Tivicay can be used during pregnancy, but under the close supervision of a health care provider who understands both the benefits and risks of the drug. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
- It is not known whether Tivicay passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.
Where can I learn more about clinical trials of Tivicay?
- If you would like to find out if you are eligible for any clinical trials that include Tivicay, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email firstname.lastname@example.org.