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INTEGRASE STRAND TRANSFER INHIBITOR (INSTI)
Tivicay (dolutegravir) and Tivicay PD are prescription medications approved by the U.S. Food and Drug Administration (FDA) to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children who are at least 4 weeks old and weigh at least 3 kilograms.
These insights are based on 285 comments about Tivicay and Tivicay PD from myHIVteam members. These are the experiences of a small number of people and are not meant to be medical advice.
Members often report that Tivicay helps bring viral load down and keep it suppressed.
Tivicay can be taken with or without food.
Many members describe having few or no noticeable side effects.
Members report insomnia, fatigue, headache, nausea, and diarrhea.
Members discuss weight gain, which is also listed in postmarketing reports.
Creatinine can rise on lab tests without reflecting true kidney damage.
Tivicay and Tivicay PD contain dolutegravir, a type of HIV medicine called an integrase strand transfer inhibitor (INSTI). It works by blocking HIV integrase, an enzyme HIV needs to make more copies of itself.
Doctors prescribe Tivicay or Tivicay PD when treating HIV-1 in adults and children who are at least 4 weeks old and weigh at least 3 kilograms. Children who have been treated for HIV before must not have previously taken an INSTI.
Tivicay can also be used with rilpivirine as a complete HIV treatment for certain adults who are switching from their current HIV medicines. This option is for adults whose viral load is less than 50 copies per milliliter, who have been on a stable HIV treatment for at least six months, and who have no history of treatment failure or known resistance to either medicine.
HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).
Tivicay and Tivicay PD can be taken with or without food. Tivicay PD may be swallowed whole or mixed with drinking water. Do not chew, cut, or crush Tivicay PD.
Tivicay tablets and Tivicay PD tablets for oral suspension are different forms of the medicine. They cannot be substituted for each other using the same number of milligrams.
If you take antacids, laxatives, or certain other medicines that contain aluminum or magnesium, take Tivicay or Tivicay PD at least two hours before or six hours after these medicines.
If you take iron or calcium supplements, you may take them at the same time as Tivicay when Tivicay is taken with food. If you take Tivicay or Tivicay PD without food, take it at least two hours before or six hours after an iron or calcium supplement.
For adults who have not taken HIV treatment before, or who have been treated before but have not taken an INSTI, the recommended Tivicay dose is 50 milligrams once daily.
Some adults need Tivicay 50 milligrams twice daily. This may include people taking certain medicines that lower the amount of dolutegravir in the body and certain people with known or suspected resistance to integrase strand transfer inhibitors.
For children who are at least 4 weeks old and weigh at least 3 kilograms, the dose is based on body weight.
For Tivicay PD tablets for oral suspension, the recommended once-daily doses are:
For children who weigh at least 14 kilograms, Tivicay tablets may also be used. The recommended once-daily doses are:
Certain medicines can require Tivicay or Tivicay PD to be given twice daily instead of once daily.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
These insights are based on 285 comments about Tivicay and Tivicay PD from myHIVteam members.Members who use Tivicay often say that consistency, close communication with a doctor, and paying attention to side effects matter most. Many also mention watching lab results, asking about medication timing or interactions, and getting help quickly if cost or refill problems could interrupt treatment.
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In clinical studies of Tivicay, the most common moderate to severe side effects occurred in about 2 percent or more of people. These include:
Tivicay can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
ViiV Healthcare, the manufacturer of Tivicay and Tivicay PD, offers the ViiVConnect Savings Card. Eligible people with commercial insurance may pay as little as $0 per prescription fill, up to the program’s $5,000 annual maximum for Tivicay/Tivicay PD.
The program is not available to people enrolled in federal or state healthcare programs such as Medicare or Medicaid. The ViiVConnect Savings Card also offers reimbursement for eligible copay costs if your pharmacy can’t process the card.
To learn more, visit the ViiVConnect Savings Card or call 866-279-4705.
Before starting Tivicay or Tivicay PD, tell your doctor if you have any allergies to dolutegravir or any ingredients in Tivicay or Tivicay PD.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Also tell your doctor if you:
Do not take Tivicay or Tivicay PD if you:
Do not miss doses or let your supply of Tivicay or Tivicay PD run out. Missing doses may allow the amount of HIV-1 in your blood to increase and may make the virus harder to treat.
If you miss a dose of Tivicay or Tivicay PD, take it as soon as you remember. Do not take two doses at the same time or take more than your doctor prescribed.
If you are pregnant or plan to become pregnant, talk with your healthcare provider about the benefits and risks of taking Tivicay during pregnancy.
A pregnancy registry tracks pregnancy outcomes in people exposed to Tivicay or Tivicay PD. Healthcare providers can register pregnancies by visiting the Antiretroviral Pregnancy Registry or calling 800-258-4263.
Dolutegravir is present in breast milk. Talk with your healthcare provider about the risks of breastfeeding during treatment. These risks include:
These answers are fact-checked by our editorial staff.
How effective are Tivicay and Tivicay PD for HIV?
In adult studies, Tivicay-based treatment helped many people lower their HIV-1 viral load to less than 50 copies per milliliter. At week 96, 82 percent of people taking Tivicay plus two other HIV medicines had a viral load below 50 copies per milliliter. In another study, 80 percent of people receiving a Tivicay-based regimen had a successful treatment response at week 96.
At week 144, 71 percent of people taking Tivicay plus abacavir/lamivudine (Epzicom) had a viral load below 50 copies per milliliter. Among adults who were already virologically suppressed and switched to dolutegravir plus rilpivirine, 95 percent had a viral load below 50 copies per milliliter at week 48. In a pediatric study that included Tivicay and Tivicay PD, 62 percent of children had a viral load below 50 copies per milliliter at week 24, and 69 percent did at week 48.
How long does Tivicay or Tivicay PD take to work for HIV?
There is no single exact amount of time given for Tivicay or Tivicay PD to lower HIV levels in each person. Clinical study results were measured at different times, including week 24, week 48, week 96, and week 144.
With once-daily dosing, dolutegravir reaches steady-state levels in the body in about five days. This means the amount of medicine in the body becomes stable after repeated doses. It does not mean that everyone will have a specific HIV treatment response within five days.
What other medicines can interact with Tivicay or Tivicay PD?
Tivicay and Tivicay PD can interact with several medicines and supplements. Some may lower the amount of dolutegravir in your body, while others may have higher levels when taken with dolutegravir.
Examples include:
Some of these combinations should be avoided, while others may require a change in dose or careful timing. For example, Tivicay or Tivicay PD should generally be taken at least two hours before or six hours after medicines containing aluminum or magnesium. Calcium or iron supplements may be taken at the same time as Tivicay when taken with food.
Tell your healthcare provider about all prescription medicines, over-the-counter medicines, vitamins, and herbal supplements you take before starting Tivicay or Tivicay PD.
What tests or monitoring are needed with Tivicay or Tivicay PD for HIV?
Your healthcare provider may monitor your liver health while you take Tivicay or Tivicay PD because liver problems have been reported, including hepatitis and acute liver failure. Blood test changes have also been reported during treatment. These can include changes in liver enzymes, bilirubin, creatine kinase, blood sugar, lipase, and neutrophil counts.
Dolutegravir can also raise serum creatinine, a value measured in blood tests. This happens because it affects how creatinine is removed from the blood and does not mean that the kidneys are filtering less well.
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