Standard DoseOne 50 mg tablet once daily without regard to food, for individuals on HIV therapy for the first time (treatment-naïve) or treatment-experienced individuals who have never had treatment failure with an INSTI. One 50 mg tablet twice daily, without regard to food, for adults who have or who are suspected of having 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.
For adults and children weighing more than 44 pounds (20 kg), use standard dose listed above or see package labeling. New Tivicay PD tablets (5 mg), taken without regard to food, were approved in June and are dispersable in water (oral suspension) for pediatric patients age four weeks and older weighing at least 6.61 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 up to 44 pounds. Dosing under 44 pounds 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, 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.
See package insert for more complete information on potential side effects and interactions.
AWP50 mg tablets: $2,191.76/month
Potential Side Effects and Toxicity
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. New data associate INSTIs and TAF with weight gain; see “Weighty Concerns,” beginning on page 8, and go to aidsinfo.nih.gov. 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.
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, Tagamet) 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 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 which are not listed here.
Tivicay (dolutegravir) is part of Juluca, Dovato, and Triumeq, all 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. Dolutegravir is now a preferred medication in pregnancy as well as an alternative drug for those who are trying to conceive, according to U.S. HIV perinatal treatment guidelines updated in December 2019 (go to aidsinfo.nih.gov/guidelines/html/3/perinatal-guidelines/0). This clears preliminary concerns over the potential for birth defects with dolutegravir raised in 2018 by a study in Botswana.
Dr. Ross Slotten says:
Tivicay, first approved in 2013 as a single-tablet agent, is now the highest performing INSTI, either as part of an STR (Triumeq) or in combination with Descovy or Truvada. It is a very potent INSTI and has not been shown, convincingly, to have developed resistance in people who failed therapy. Interestingly, dolutegravir has been associated with weight gain in treatment-naïve patients. In an observational study conducted at the Vanderbilt University Comprehensive Care Clinic, patients taking dolutegravir experienced on average a 6 kg (13.2-pound) weight gain as opposed to patients taking elvitegravir (Genvoya) or raltegravir (Isentress). Those on elvitegravir gained 0.5 kg while those on an NNRTI gained 2.6 kg. It should be noted that this was an observational and therefore not a controlled study. Another ACTG study (A5202 and A5237) showed that those who gained weight after the initiation of HAART had higher levels of proteins associated with immune activation than those who maintained their weight so it’s not clear if any medication in particular caused weight gain.
Activist Bridgette Picou says:
Tivicay is a tablet taken as part of an HIV cocktail with other drugs. Tivicay is potent and works well. It is dosed either once daily, or twice a day in the presence of resistance to other integrase inhibitors. Side effects may include headache, insomnia, and diarrhea.