Standard DoseOne 50 mg tablet once daily without regard to food, for people on HIV therapy for the first time (treatment-naïve) or treatment-experienced people who have never taken an INSTI. One 50 mg tablet twice daily, without regard to food, for people who have or who are suspected to have certain INSTI drug resistance or who are taking certain other medications. Must be taken in combination with another antiretroviral(s) which does not contain this medication or medication from the same drug class.
Tivicay is approved for adults and children weighing at least 66 pounds (30 kg). For patients weighing 66 pounds (30 kg) to 88 pounds (40 kg), the dose is one 10 mg tablet and one 25 mg tablet (35 mg total dose) once daily without regard to food. For patients weighing at least 88 pounds (40 mg), the dose is one 50 mg tablet once daily without regard to food.
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose. Not recommended for people with severe liver impairment. Use with caution in people with severe kidney impairment who have INSTI drug resistance or suspected resistance, because Tivicay levels may be decreased.
AWP50 mg tablets: $2,088.59/month
Potential Side Effects and Toxicity
• See package insert for more complete information on potential side effects and interactions.
In general, Tivicay is well tolerated with infrequent side effects. The most common moderate to severe side effects in clinical studies were insomnia (3%), headache (2%), and fatigue (2%). Mild insomnia was seen in 7% of participants in one study. Additionally, increased CPK (creatine kinase, a lab value indicating muscle damage), rhabdomyolysis (breakdown of muscle), and myopathy or myositis (muscle pain) were reported. There have been rare reports of depression and suicidal ideation, primarily in patients with a history of psychiatric illnesses, in people receiving INSTI-based regimens. The DHHS guidelines recommend closely monitoring patients on an INSTI who have pre-existing psychiatric conditions. Tivicay can cause a small, reversible increase in kidney function test (serum creatinine) within the first few weeks of treatment without affecting actual kidney function. Liver enzymes should be monitored in people with hepatitis B or C. There may be a possibility of birth defects—see “More information.”
Potential Drug Interactions
Do not take with the anti-arrhythmic dofetilide. Intelence decreases Tivicay levels by 88%, therefore, these two medications must be co-administered with Kaletra, boosted Prezista, or boosted Reyataz. Tivicay should be taken two hours before or six hours after taking laxatives or antacids, the ulcer medication sucralfate, oral iron or calcium supplements, or buffered medications. It can be taken with iron- or calcium-containing supplements if taken together with food. Acid reducers (Pepcid, Zantac, Tagament) and proton pump inhibitors (for example, Aciphex, Dexilant, Prilosec, Prevacid, Protonix, and Nexium) are okay to use. Avoid taking with Viramune, oxcarbazepine, phenytoin, phenobarbital, and St. John’s wort. Start metformin at lowest dose and titrate based on glycemic control. Monitor for metformin adverse effects. Use alternatives to rifampin, carbamazepine, efavirenz, Aptivus/Norvir, and Lexiva/Norvir when possible in people with confirmed or suspected INSTI drug resistance, but these medications can be taken with Tivicay 50 mg twice daily. Should be okay to take with Daklinza, Epclusa, Harvoni, Olysio, Sovaldi, Viekira Pak, or Zepatier. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
Tivicay is part of Juluca as well as Triumeq, both single-tablet regimens. Tivicay is considered a second-generation INSTI—it may work in many individuals whose virus has developed resistance to other INSTIs, but it needs to be dosed twice daily in these people. Compared to other INSTIs, Tivicay has a high genetic barrier against the development of resistance, similar to the protease inhibitors (such as Prezista). Tivicay has also demonstrated superiority to Prezista when looking at virologic results. Pediatric HIV guidelines added Tivicay as part of a preferred regimen. Tivicay is particularly useful when drug interactions are a concern with the HIV protease inhibitor (PI) drugs. Tivicay is a small tablet, a benefit for patients who have difficulty swallowing.
Tivicay as part of Juluca is used as a medication to switch to for people with undetectable viral loads on their current regimen for at least six months; see Juluca. Another ART (antiretroviral therapy) switch strategy with some supporting evidence for its consideration in people with viral suppression in the DHHS guidelines that uses Tivicay is switching to a boosted protease inhibitor + integrase inhibitor. In two small observational studies, individuals were switched from their current ART regimens to Prezista + Norvir + Tivicay, and viral suppression was maintained in over 97% of participants. Another strategy with some supporting evidence suggests switching patients with a suppressed viral load to a regimen of Tivicay + Epivir (lamivudine, 3TC) for maintenance therapy. A fixed-dose combination pill with these two medications is expected to be approved this year; see dolutegravir/3TC page.
New preliminary data from an observational study in Botswana suggest that there may be an increased risk of birth defects in infants born to those who were receiving dolutegravir at the time of conception. Until more information is available, regimens containing dolutegravir are not recommended for use in ART-naïve patients who are pregnant or within 12 weeks of conception. It is unclear whether dolutegravir is the only integrase inhibitor with the potential to cause these birth defects (neural tube defects), or if other integrase inhibitors also carry this risk. Consult your provider to discuss guidance on how to manage regimens containing dolutegravir or a different integrase inhibitor if there is any possibility of conception.
Dr. David Hardy says:
Tivicay was the third integrase inhibitor approved, in 2013, initially as a single agent and a year later as a component of the STR Triumeq (Tivicay/Ziagen/Epivir). What makes Tivicay stand out from other integrase inhibitors or STRs containing integrase inhibitors is its proven high barrier to HIV resistance. To date (more than five years since initial approval), there have been few, if any, well-confirmed cases of resistance to Tivicay in PLWH taking this medication as first-time ART. In addition, clinical trial data show that Triumeq is superior to (better than) Atripla and both Prezista/Norvir and Reyataz/Norvir in terms of suppressing viral loads as well as having fewer side effects. As mentioned before, many HIV treaters are not always comfortable with prescribing Triumeq due to the Ziagen (abacavir) which it contains for reasons mentioned on other pages. For those treaters, the two-pill combination of Tivicay and Descovy has become their favorite “go-to” first-line ART regimen. How this is now changing with the availability of Biktarvy is not yet clear. Some HIV treaters and the PLWH for whom they prescribe antiretrovirals may opt to simplify to Biktarvy or stick with what is already working well. In 2018, preliminary results from the Tsepamo study from Botswana unexpectedly showed an increased occurrence of neural tube defects in infants of HIV-positive women who were taking Tivicay at the time of conception. Until the final results of this study are known sometime in 2019, the use of Tivicay in HIV-positive women desiring to become pregnant and those able to become pregnant who are not using contraception is recommended to be avoided (see Triumeq).
Activist Moisés Agosto-Rosario says:
Tivicay is approved once a day for HIV-positive individuals initiating HIV treatment for the first time and for those on HIV treatment who have not taken integrase inhibitors before. It is prescribed twice a day, however, for those who have developed resistance to other integrase inhibitors.