BIC/FTC/TAF bictegravir/emtricitabine/tenofovir alafenamide
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.
For adults and children weighing at least 55 pounds (25 kg) (youngest patients in research were 6 years old). 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.
• 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 observed in study participants include nausea (5%), headache (5%), and diarrhea (6%). Six individuals in Study 1490 and none in Study 1489 stopped Biktarvy due to side effects, none of which were due to kidney problems. New data associate INSTIs and TAF with weight gain; see “Weighty Concerns,” beginning on page 8, and go to aidsinfo.nih.gov. Serum creatinine, estimated creatinine clearance, urine glucose, and urine protein should be obtained before initiating Biktarvy and should be monitored during therapy. There have been rare reports of depression and suicidal ideation, primarily in patients with a history of psychiatric illnesses, in people receiving INSTI-based regimens. The DHHS guidelines recommend closely monitoring patients with pre-existing psychiatric conditions on an INSTI. Prior to initiation, people should be tested for hepatitis B (HBV) infection. Severe exacerbations of hepatitis B have been reported in people who are co-infected with hepatitis B and have discontinued the emtricitabine and/or tenofovir components. Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted.
Potential Drug Interactions
Do not take with rifampin or the anti-arrhythmic dofetilide. Not recommended to be taken with Epivir-HBV, Hepsera, or Vemlidy, all three for treatment of hepatitis B. Biktarvy can be taken at least two hours before or six hours after taking laxatives or antacids, the ulcer medication sucralfate, oral iron or calcium supplements (but these two can be used with Biktarvy if taken together with food), or buffered medications. Start metformin at lowest dose and titrate based on glycemic control. 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 the hepatitis C medications Epclusa, Harvoni, Sovaldi, and Vosevi. Not intended to be taken with other HIV medications, unless prescribed that way.
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.
Received FDA approval in February 2018. For now, Biktarvy is a top dog in HIV treatment. See potential new side effect (weight gain). The data show that the bictegravir drug resistance barrier is comparable to that of dolutegravir and protease inhibitors (like Prezista). That is a huge advantage. Biktarvy is the first unboosted INSTI-containing STR with TAF, and one of four unboosted INSTI STRs overall (the others are Triumeq, Dovato, and Juluca). (“Unboosted” means that the primary antiretroviral drug, in this case bictegravir, does not require another medication such as Norvir or Tybost to increase its drug levels in the body.) This is a really big deal due to less drug interactions when there’s no boosting. Biktarvy is a small INSTI-based STR tablet, which may help some individuals who have difficulty swallowing pills. Pediatric study is ongoing. At this time, there isn’t sufficient data to support the use of Biktarvy during pregnancy.
Dr. Ross Slotten says:
Biktarvy, a single-tablet regimen (STR) that contains the potent INSTI bictegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), was approved by the FDA in February 2018. It is one of three A1 STRs recommended by the expert panel of the DHHS. Biktarvy has several virtues. Because bictegravir doesn’t have to be boosted, there are very few drug-to-drug interactions. As people with HIV age, they may develop a number of medical problems, or co-morbidities, requiring treatments that often interact with a boosting agent like ritonavir or cobicistat. It also contains tenofovir alafenamide or TAF, which has less potential for kidney toxicity or loss of bone density, a potential problem for tenofovir disoproxil (TDF, brand name Viread). Moreover, it is very well tolerated and has few significant upfront side effects, like nausea, vomiting, and diarrhea. Because Biktarvy contains TAF and FTC, it can be prescribed for people co-infected with hepatitis B. Biktarvy is less fussy than some other HIV medications because it can be taken with or without food. Unlike Triumeq (see Triumeq page), which requires HLA-B*5701 testing to rule out hypersensitivity to abacavir, one of its three components, Biktarvy can be used as a first-line same-day ART regimen, if one chooses to initiate treatment on the day of diagnosis of HIV infection, regardless of viral load or CD4 count. To date, no integrase resistance to Biktarvy has been reported. Although Biktarvy is not necessarily better than other 3-drug regimens, its simplicity, safety, and tolerability make it an obvious choice as a first-line therapy.
Activist Bridgette Picou says:
A single-tablet regimen containing three medications, Biktarvy is a popular option for those newly diagnosed or those looking to simplify their current regimen. It is also an option for quick/rapid start initiation. An additional plus is it can be taken with or without food. As long as you are not resistant to any of the components it’s worth a conversation with your healthcare provider. Side effects reported have been mild to moderate and usually clear within the first few weeks. Having said that, all side effects should be discussed with your healthcare provider, especially if severe (or even just annoying) enough for you to consider not taking your medication. Adherence matters for your long-term health.