bictegravir, emtricitabine, tenofovir AF BIC (INSTI)/FTC and TAF (two NRTIs)
Standard DoseOne tablet once daily, with or without food, for people taking HIV treatment for the first time (treatment-naïve) or individuals with suppressed viral load on a stable HIV regimen who have no history of treatment failure and no known resistance to components of the regimen.
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, contains BIC 30 mg/FTC 120 mg/TAF 15 mg; it is taken as one tablet daily, with or without food.
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 (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. 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.
Biktarvy is widely prescribed because of its efficacy, safety, and drug resistance profile. 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 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). However, people who have previously experienced virologic failure when using another integrase inhibitor, such as Isentress or Tivicay, are more prone to losing virologic control after switching to Biktarvy. There aren’t sufficient data to support the initiation of Biktarvy during pregnancy. People who become pregnant while on Biktarvy do not necessarily have to switch to another regimen, but may undergo closer monitoring of viral load. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; go to apregistry.com.
Dr. Melanie Thompson:
With a few exceptions, Biktarvy is recommended for initial therapy for most people with HIV, including for “rapid” or “same-day” start of HIV treatment. Pregnant people, however, should not begin Biktarvy because safety and efficacy data are lacking in pregnancy. Those who become pregnant with suppressed virus on Biktarvy should discuss with their care providers whether continuing the drug with close monitoring is an option. An important new issue has arisen because of INSTI resistance that emerged during PrEP studies with long-acting cabotegravir (Apretude). Guidelines now recommend that people who have acquired HIV after exposure to cabotegravir should not begin an INSTI-based regimen unless an INSTI genotype is available, due to possible cabotegravir resistance and cross-resistance to other INSTIs. (See more under Apretude.) Studies suggest that people with suppressed virus on dolutegravir (Tivicay) + TDF/FTC, TDF/3TC, or TAF/FTC may safely switch to Biktarvy, even in the presence of a past M184V mutation.
There are few drug-drug interactions with Biktarvy, although some are important. Dofetilide, a medication for heart rhythm disturbances cannot be co-administered because serious heart rhythm disturbances could occur. Some medicines for seizures or tuberculosis and the herbal supplement 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, or iron can decrease Biktarvy levels and are a common source of blips or persistent low-level viremia. Biktarvy should be taken at least 2 hours before or 6 hours after these supplements if fasting, although calcium and iron can be taken simultaneously with Biktarvy if taken with food.
Weight gain can be associated with INSTIs, especially dolutegravir and bictegravir, and also with TAF. It’s important to watch your diet and stay physically active regardless of what you are taking, but this is 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. Bictegravir elevates the blood creatinine level by just a small amount, about 0.1 mg/dL, but this is because of blocking creatinine secretion in the kidney, not because of kidney toxicity, and occurs within weeks of starting bictegravir.
Activist Joey Wynn:
Biktarvy is 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 prefer taking pills (as opposed to an injectable medication) and is ideal for people just starting their first regimen. Pricing can be a concern in some scenarios, but resources are available to help defray or remove costs based on your situation. Biktarvy definitely has the lion’s share of the field for now.