bictegravir/emtricitabine/tenofovir alafenamide BIC/FTC/TAF
Standard DoseOne tablet once daily without regard to food for people taking HIV treatment for the first time (treatment-naïve) or individuals with suppressed viral load on a stable HIV regimen with no history of treatment failure and no known resistance to components of the regimen: bictegravir, emtricitabine, or tenofovir. Tablet contains 50 mg of the INSTI bictegravir plus 200 mg emtricitabine and 25 mg TAF.
For adults and children weighing at least 55 pounds (25 kg), use standard dose above or see package labeling. New pediatric formulation available for children at least 2 years old and weighing 30.8–55 pounds (14–25 kg), Biktarvy Low Dose—use one tablet daily with or without food. Each Biktarvy Low Dose tablet contains BIC 30 mg/FTC 120 mg/TAF 15 mg. 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. Biktarvy is not recommended for people with CrCl less than 30 mL/min or people with severe liver impairment. Biktarvy may be used for people with an undetectable viral load and CrCl less than 15 mL/min who are also receiving hemodialysis.
- See also Descovy, which is contained in this drug (bictegravir is not available separately).
- See package insert for more complete information on potential side effects and interactions.
ManufacturerGilead Sciences, Inc.
(800) GILEAD-5 (445–3235)
Potential Side Effects and Toxicity
Most common side effects (rarely experienced) include headache, nausea, and diarrhea. INSTIs and TAF are associated 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. DHHS 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.
Potential Drug Interactions
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 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.
New pediatric formulation, Biktarvy Low Dose, became available late last year. Biktarvy is widely prescribed because of its efficacy and safety profile as well as relative lack of resistance emerging from use of this treatment in clinical trials. Data are accumulating that show Biktarvy works for people who have detectable virus when they switch to it from another regimen (having experienced virologic failure on their previous regimen). At this time, there aren’t sufficient data to support the use of Biktarvy during pregnancy. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; go to apregistry.com.
Dr. Melanie Thompson:
Small and potent, Biktarvy is a popular “go-to” initial therapy, including for same-day HIV treatment start. It has a high resistance barrier. A recent randomized open label study, GS-380-4030, found that individuals with suppressed virus on DTG + TDF/FTC or TAF/FTC could safely switch to Biktarvy even in the presence of some previous NRTI resistance, including the M184V mutation associated with resistance to FTC and 3TC. Weight gain can be associated with INSTIs and TAF, and among INSTIs, bictegravir and dolutegravir were associated with more weight gain than elvitegravir/COBI, NNRTIs, and PIs in several studies. In an analysis of 8 randomized trials, the average weight gain for BIC- and DTG-containing regimens was 3.5 kg (7.7 lbs.) at 96 weeks. It’s important to watch your diet and exercise regardless of what you are taking, but that can be especially true with a TAF + INSTI combo. All INSTIs have the potential for insomnia or, rarely, worsening of depression or suicidal ideation, particularly if there are pre-existing mental health issues. INSTIs have fewer drug-drug interactions than most NNRTIs and PIs. A Gilead-sponsored chart review study in 350 persons who were at least 50 years old who had switched to Biktarvy found that 140 drug interactions in 121 people were avoided by the switch, addressing a common polypharmacy issue in older persons who have multiple comorbidities. Never take Biktarvy with dofetilide, a heart rhythm medicine, as levels of defetilide are increased and serious rhythm disturbances could occur. Biktarvy increases metformin levels and the metformin dose may need to be adjusted if there are side effects. Several medications for seizures or tuberculosis cannot be taken with Biktarvy. St. John’s wort decreases Biktarvy levels and should be avoided. Take aluminum- or magnesium-containing supplements, vitamins, or antacids at least 2 hours after or 6 hours before Biktarvy, although iron- and calcium-containing compounds can be taken with Biktarvy and a meal. I have seen lots of “low-level viremia” cured by adjusting supplements. Don’t take Biktarvy if you are planning to become pregnant because of lack of data for safety in pregnancy. If you are already pregnant and taking Biktarvy, talk with your HIV care provider about whether it’s advisable to continue the drug.
Activist Michael Broder:
Most people taking Biktarvy (approved in 2018) have no side effects. Concerns have emerged about weight gain on INSTI-containing regimens. As always, your provider should help you weigh the benefits against the risks.