Generic Name: dolutegravir
Drug Class: Integrase Inhibitors
Company: ViiV Healthcare
Approval Status: Approved
Generic Version Available: No
Experimental Code: S/GSK1349572
A recommended component treatment regimens for antiretroviral-naive people living with HIV, as indicated by the U.S. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Visit https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/0 for the full DHHS guidelines.
Tivicay is an HIV medication in a category called integrase inhibitors. Tivicay was approved by the U.S. Food and Drug Administration for use by people living with HIV in August 2013.
Tivicay must be used in combination with other HIV drugs. Tivicay is available as a stand-alone drug, for use in combination with other medications, or in the single-tablet regimens Triumeq (with abacavir and lamivudine), Juluca (with rilpivirine) and Dovato (with lamivudine).
Adult Dose: One 50 mg tablet once a day for those starting antiretroviral therapy for the first time, or for those who have not used an integrase inhibitor in the past.
One 50 mg tablet twice a day for treatment-experienced individuals who have HIV that is resistant to other integrase inhibitors, and when taken with certain ARVs.
Pediatric Dose: For those who are starting antiretroviral therapy for the first time, or for those who have not used an integrase inhibitor in the past: one 50 mg tablet once a day for those who are at least 88 lbs (40 kg); one 10 mg tablet and one 25 mg tablet once a day for those who weigh 66 lbs (30 kg) to less than 80 lbs (40 kg).
Dosing Info: Take with or without food.
Common side effects include trouble sleeping, headache, tiredness.
Tivicay has been linked to a small risk of neural tube birth defects in infants born to mother who took the medication during early pregnancy. The Food and Drug Administration recommends that women avoid Tivicay around the time of cenception through the first trimester of pregnancy.
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.
One additional 50mg tablet of Tivicay (dolutegravir) taken 12 hours apart Tivicay is taken with Sustiva (efavirenz), boosted-Lexiva (fosamprenavir/ritonavir), boosted-Aptivus (tipranavir/ritonavir), rifampin, or Tegretol (carbamazepine).
Trileptal (oxcarbazepine), phenytoin, phenobarbital, and St. John’s wort can reduce levels of Tivicay in the blood. These drugs should be avoided while using Tivicay.
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.
An increased methadone dose may be required in a small number of patients.
Important hepatitis C treatment drug-drug interactions: Tivicay can be combined with Sovaldi (sofosbuvir), Harvoni (ledipasvir/sofosbuvir), Olysio/Sovriad (simeprevir), ribavirin, or pegylated interferon alfa. Interactions with Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) have not been fully evaluated.
Other drug interactions are possible. Consult the Tivicay package insert for more details: https://www.gsksource.com/gskprm/htdocs/documents/TIVICAY-PI-PIL.PDF
Before taking this medication, tell your doctor if you have kidney disease or liver disease (including hepatitis B). In addition, tell your doctor if you are pregnant or planning to become pregnant, if you are breast feeding, and all your medical conditions, including all prescription and over-the-counter medications and supplements you are taking.
Co-Pay Program Info: https://www.poz.com/basics/hiv-basics/drug-assistance-programs
Patient Assistance Program Info: https://www.poz.com/basics/hiv-basics/drug-assistance-programs
Last Reviewed: April 19, 0019