Tivicay

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.

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, Tivicay, 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 (for example, 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.

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.

Dr. Melanie Thompson:

Dolutegravir is recommended as initial therapy for any adult with HIV (in combination with TAF or TDF and FTC or 3TC), and as a preferred drug in pregnancy, based on the IMPAACT 2010 trial. Updated data have found no statistically significant difference in the rate of neural tube defects when dolutegravir is taken during conception compared with regimens not containing dolutegravir. Folate supplementation decreases the risk of neural tube birth defects and is routinely recommended for all pregnant persons.

There is ongoing debate about whether weight gain is associated with dolutegravir, as has been seen in some studies. Weight should be monitored and healthy eating and physical activity should be part of a wellness routine when beginning HIV treatment. The substantial benefits of INSTIs in potency and rapidity of viral load suppression, low pill burden, high genetic barrier to resistance, improved tolerability and decreased drug interactions are felt to outweigh the potential risk of weight gain, which generally can be managed. Rash has been seen with dolutegravir, as has liver toxicity, especially for people with hepatitis B or C. All INSTIs can cause insomnia or depression. Depression, including suicidal ideation, occurs most often in people with pre-existing mental health issues. Dolutegravir increases blood creatinine levels by about 0.1-0.15 mg/dL due to changes in tubular secretion of creatinine in the kidneys without any actual kidney damage.

Dolutegravir levels can be decreased by taking sucralfate or supplements and antacids containing aluminum, calcium, magnesium, zinc or iron, so you should take dolutegravir at least 2 hours before or 6 hours after these medications. Calcium and iron can be taken simultaneously with dolutegravir only if taken with food.

Activist Joey Wynn:

Tivicay is safe, effective, and tolerable. It is potent, relatively easy to take and with “little to no” side effects from anyone I know taking this. In south Florida, the “Dolly Dezzy” combo (dolutegravir/Descovy) is a great choice if you’re okay with taking pills. On the downside, for some people, weight gain is a thing, for real. Have a serious conversation with your medical provider to see if this is the right choice for you.