Biktarvy
For adults and children weighing at least 55 pounds (25 kg), use standard dose above or see package labeling. A pediatric formulation is 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, as long as it is at least 12 hours before 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.
- HHS recommended for rapid ART for someone newly diagnosed or entering care with minimal or no labs available.
- 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.
gilead.com; biktarvy.com
(800) GILEAD-5 (445–3235)
JO-ANN JOSE, MD, MPH:
Biktarvy is the most commonly used drug for most people who start HIV therapy. It is recommended for everyone except people who were taking long-acting cabotegravir for PrEP (brand name Apretude) before they acquired HIV. Biktarvy is well tolerated; it’s a small pill size. It has a relatively low side effect burden, and a relatively high genetic barrier to resistance, which means it is not easy for the virus to develop resistance to the medication. There are a couple of rare side effects that are important to be aware of, so talk to your doctor about those. Multi-vitamins that include minerals containing metals like calcium, magnesium and zinc may interfere with absorption of Biktarvy, so take them at least six hours apart from Biktarvy. There are other potential drug interactions, so go over a list of all medications, drugs and supplements that you take with your doctor. The integrase inhibitors (INSTI) drug class has an association with weight gain, same may be true of the bictegravir component. It is difficult to know how this applies to Biktarvy. Weight gain is not a reason to avoid an INSTI-based therapy, but it is a reason to have a good, optimized lifestyle that includes a healthy diet and exercise. If you’re noticing a disproportionate amount of weight gain, though, make sure to tell your doctor. For people who also have hepatitis B, the TAF (tenofovir alafenamide) component of Biktarvy will treat both of those infections. But if you have hepatitis B and you’re thinking about switching to something else, it’s important to talk with your care provider to make sure that the new regimen will also treat both HIV and hep B. There are potential bone density issues with TDF (tenofovir disoproxil fumarate, the older version of tenofovir) that are well documented at this point; it is not a common side effect, but it can happen. The risk appears to be much lower with the TAF that’s in Biktarvy. However, if you already have significant bone density loss, like osteoporosis or severe osteopenia, have a discussion with your doctor.
Do not take with rifampin or dofetilide. Not recommended to be taken with Cimduo, 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. Still, these supplements can lower bictegravir levels and may be a common source of viral blips (temporary bumps above undetectable levels) or a constant low-level viral load. 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.
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.
Biktarvy is widely prescribed because of its favorable efficacy, safety, tolerability and drug resistance profile. In 2024, the FDA approved Biktarvy for use by individuals with NRTI drug resistance (the M184V change in the virus). 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 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 dolutegravir, 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 an alternative initial regimen in pregnancy. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com.
JUAN MICHAEL PORTER II:
Biktarvy was the second HIV medication I took. Six years later, I’m still on it and am thriving. Many consider it the gold standard for once-a-day oral HIV treatment. It’s small, easy to swallow and—in case you’re worried about someone finding your pills—so basic in appearance that no one thinks to give it a second thought. It also has few side effects but avoid using it if you use dofetilide or rifampin. Like many non-generics, Biktarvy is also expensive, though patient assistance programs can help cover its cost.