Tivicay
For adults and children weighing more than 44 pounds (20 kg), use standard dose listed above or see package labeling. Tivicay PD tablets (5 mg), taken with or without food, are dispersible in water (oral suspension) for pediatric patients ages four weeks and older weighing at least 6.6 pounds (3 kg). Children weighing at least 30.8 pounds (14 kg) may take either Tivicay or Tivicay PD, but Tivicay PD is preferred for those weighing 30.8 to 44 lbs. Dosing under 44 lbs. is weight-based; Tivicay is also available in 10 mg and 25 mg tablets. Do not chew, cut or crush Tivicay PD tablets. If dose is more than one Tivicay PD tablet, swallow one tablet at a time. If using a dispersible dose, see package insert for mixing instructions. Dosing of Tivicay and Tivicay PD for oral suspension cannot be interchanged on a milligram per milligram basis.
Take missed dose as soon as possible, as long as it is at least 12 hours before 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.
- HHS recommended as a component for rapid ART for someone newly diagnosed or entering care with minimal or no labs available.
- See package insert for more complete information on potential side effects and interactions.
viivhealthcare.com; tivicay.com
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JO-ANN JOSE, MD, MPH:
Some observational data suggest there may be weight gain associated with this drug. It’s a little bit complicated to parse, though. I would offer the same advice that I give everyone—your diet and exercise routines should be optimized when when you are living with HIV, regardless of whatever else is going on, to mitigate cardiovascular effects. It’s important to keep an eye on any weight gain and keep in close conversation with your doctor about it. If you’re noticing it, you may experience weight gain when initially starting HIV therapy for reasons that actually have nothing to do directly with that therapy. You may have lost a lot of weight or have low CD4 counts that could explain the weight loss. We do expect a little bit of rebound weight gain (called “return to health”), but we want to keep a close eye on that trend and any concerns that you may have. It’s also important to note that integrase inhibitors are the backbone of most countries’ treatment programs, in sub-Saharan Africa and in the rest of the world. So it’s really important as a class of drugs in terms of tolerability and ease of use and cost.
It is important to take Tivicay only with other HIV drugs recommended by your provider because it and similar drugs are contained in other HIV medications: Biktarvy, Genvoya, Isentress, Stribild, Triumeq, Dovato, Cabenuva and Juluca. 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, including vitamins or buffered medications. It can be taken with iron- or calcium-containing supplements/vitamins if taken together with food. Acid reducers (Pepcid, Zantac, Tagamet) and proton pump inhibitors (such as Aciphex, Dexilant, Prilosec, Prevacid, Protonix and Nexium) are okay to use. Avoid taking with Viramune, eslicarbazepine, oxcarbazepine, phenytoin, phenobarbital or St. John’s wort. Start metformin at lowest dose and titrate based on tolerability and clinical effect. Monitor for metformin adverse effects. Dose Tivicay twice daily if using with rifampin, carbamazepine, efavirenz, Aptivus/Norvir or Lexiva/Norvir. Tivicay may increase levels of the potassium channel blocker dalfampridine, which could increase the risk of seizures. No known interactions with Epclusa, Harvoni 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 that are not listed here.
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 observed in 7% of participants in one study. Increased CPK (creatine phosphokinase, a lab value indicating muscle damage), rhabdomyolysis (breakdown of muscle) and myopathy or myositis (muscle pain) were also reported. Data associate INSTIs with weight gain. In findings reported in 2021, the pediatric ODYSSEY/PENTA-29 trial did not observe the weight gain observed in adults. There have been rare reports of depression and suicidal ideation, primarily among people with a history of psychiatric illnesses, in people receiving INSTI-based regimens. HHS guidelines recommend closely monitoring people 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.
Tivicay is considered a second-generation INSTI—it may work in many individuals whose virus has developed resistance to other INSTIs, but they will need twice-daily dosing. Compared to other INSTIs, Tivicay has a high genetic barrier against developing resistance, similar to protease inhibitors (such as Prezista). Pediatric HIV guidelines include Tivicay as part of a preferred regimen. Tivicay is particularly useful when drug interactions are a concern with HIV protease inhibitor (PI) drugs. It is also a very small tablet, making it easier to swallow. Tivicay along with Truvada or Descovy is a preferred drug regimen for PEP (post-exposure prophylaxis—preventing HIV acquisition after a potential exposure), as well as two other regimens: Biktarvy or Isentress HD plus Truvada or Descovy.
Recommended as part of a preferred initial regimen in pregnancy (Tivicay plus Descovy or Epzicom or Truvada; Triumeq is also a preferred initial regimen). Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com.
JUAN MICHAEL PORTER II:
Tivicay is dolutegravir as a standalone drug. It can be taken with or without food and is super potent and flexible in terms of dosing. As one of my doctor friends told me, “It’s used by over 20 million people in one combination or another and is literally saving the world.” A double dose can be given to people who’ve developed drug resistance to other integrase inhibitors and is well tolerated by 19 out of 20 people. Its major flaw is that it may cause weight gain in some people, though the precise cause remains unknown.