Biktarvy

Most common side effects (although rarely experienced) include headache, nausea, and diarrhea. Data associate INSTIs and TAF with weight gain. Serum creatinine, estimated creatinine clearance, urine glucose, and urine protein should be obtained before initiating Biktarvy and should be monitored. BIC can cause a small, reversible increase in serum creatinine within the first few weeks of treatment that does not affect actual kidney function. There have been rare reports of depression and suicidal ideation with INSTIs, primarily among people with a history of psychiatric illnesses. HHS guidelines recommend closely monitoring people with pre-existing psychiatric conditions.

Prior to initiation, test for hepatitis B virus (HBV). Severe exacerbations of HBV have been reported in people with co-infection who have discontinued Biktarvy (due to elimination of the emtricitabine and TAF components, which also treat HBV). Monitor liver enzymes closely. Initiation of HBV therapy may be warranted upon discontinuation of Biktarvy. Call your health care provider right away if you develop any of the following signs of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs.

Do not take with rifampin or dofetilide. Not recommended to be taken with Cimduo or Temixys, Descovy, Emtriva, Epivir-HBV, Hepsera, Truvada, Vemlidy, or Viread, all for treatment of hepatitis B, as the emtricitabine and tenofovir components of Biktarvy already treat HBV. Biktarvy can be taken at least two hours before or six hours after taking laxatives or antacids, sucralfate, oral iron or calcium supplements (but either of these two can be used with Biktarvy if taken with food at the same time), or buffered medications. Start metformin at lowest dose and titrate based on tolerability and clinical effect. Monitor for metformin adverse effects. When starting or stopping Biktarvy in people on metformin, dose adjustment of metformin may be necessary to maintain optimal glycemic control. Not recommended with carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine and St. John’s wort. Can be taken with Epclusa, Harvoni, Sovaldi, and Vosevi. 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.

Biktarvy is widely prescribed because of its favorable efficacy, safety, tolerability and drug resistance profile. The FDA granted approval in February for Biktary use by individuals with NRTI drug resistance. Five-year data released in 2022 show 98% undetectable viral load rate in more than 1,000 individuals from Studies 1489 and 1490, with no development of drug resistance, in the open-label extension (OLE) at Weeks 144–240. Data had accumulated showing that Biktarvy works for people who have detectable virus when they switch to it from another regimen (having experienced virologic failure on their previous regimen).

However, people who have previously experienced virologic failure when using another integrase inhibitor, such as Isentress or Tivicay, may be prone to losing virologic control after switching to Biktarvy. Biktarvy is a preferred drug regimen for PEP (post-exposure prophylaxis—preventing HIV acquisition after a potential exposure), as well as two other regimens: Tivicay along with Truvada or Descovy or Isentress HD with Truvada or Descovy. Biktarvy is now an alternative initial regimen in pregnancy (see page 10). Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO  apregistry.com.

Dr. Melanie Thompson:

Unless previously on long-acting cabotegravir (Apretude) as PrEP, Biktarvy is recommended for initial therapy, including for “rapid” or “same-day” start of HIV treatment. Based on accumulating safety data, Biktarvy was recently upgraded to an “alternate” treatment in pregnancy by the HHS perinatal antiretroviral guidelines. Studies suggest that people with suppressed virus (who are undetectable) on dolutegravir (Tivicay) + TDF/FTC (Truvada), TDF/3TC or TAF/FTC (Descovy) may safely switch to Biktarvy, even in the presence of a past M184V mutation.

Dofetilide, a medication for heart arrhythmia, cannot be co-administered because serious heart rhythm disturbances could occur. Some medicines for seizures or tuberculosis and St. John’s wort also cannot be taken with Biktarvy. Biktarvy increases metformin levels, so talk with your HIV clinician if you are on this drug when starting Biktarvy. Importantly, supplements containing aluminum, magnesium, calcium, zinc, or iron can decrease bictegravir levels and are a common source of blips or persistent low-level viremia. Biktarvy should be taken 2 hours before or 6 hours after aluminum, magnesium, zinc, calcium or iron supplements, although calcium and iron may be taken at the same time as Biktarvy if taken with a meal. It’s also very important to know that Biktarvy contains TAF, which treats hepatitis B (HBV), and that stopping Biktarvy without continuing a drug with activity against HBV can result in a hepatitis flair that could be serious. Pay attention to this especially if switching to a two-drug regimen like Dovato, Juluca, or Cabenuva.

Several studies have shown weight gain in some people who are beginning INSTIs, especially dolutegravir or bictegravir, but the mechanism and clinical significance are not yet clear. Concern about weight gain should not be a reason to avoid INSTIs because of their substantial benefits. The association of TAF with weight gain appears to be modest and is still being studied. It’s important to watch your diet and stay physically active regardless of what you are taking. All INSTIs have the potential for insomnia or, rarely, worsening of depression or suicidal ideation, particularly if there are pre-existing mental health issues. Within weeks of starting bictegravir, the blood creatinine level is expected to rise by about 0.1 mg/dL because BIC blocks creatinine secretion in the kidney. The effect persists and remains steady as long as bictegravir is taken, but it is important to recognize that this is not because of kidney toxicity.

Activist Joey Wynn:

Biktarvy is still the current king of the hill, a relatively small, once-a-day pill with an entire regimen in it. This is one of the best options for people who are okay with taking pills daily, and is ideal for people just starting their first regimen. Pricing can be a concern in some scenarios, but many resources are available to help defray or remove costs entirely based on your situation. Biktarvy definitely has the lion’s share of the field for now, with relatively few side effects and is easily tolerated.