Generic Name: bictegravir + tenofovir alafenamide + emtricitabine
Abbreviation: BIC + TAF + FTC
Other Market Name: N/A
Drug Class: Single-Tablet Regimens
Pharmaceutical Company: Gilead Sciences
Approval Status: Experimental
Generic Version Available: No
Experimental Code: N/A
BIC + TAF + FTC has not yet been approved by the U.S. Food and Drug Administration (FDA), nor has it been reviewed for inclusion in the Department of Health and Human Services' list of recommended HIV treatments.
BIC + TAF + FTC is an experimental HIV medication. It is currently in Phase III clinical trials. An application requested approval was submitted to the FDA in June 2017.
The single-tablet regimen contains an experimental integrase inhibitor (bictegravir), an approved nucleotide reverse transcriptase inhibitor (tenofovir alafenamide), and an approved nucleoside reverse transcriptase inhibitor (emtricitabine).
BIC + TAF + FTC is expected to be approved in the first half of 2018. Bictegravir is not expected to be available as a standalone drug for use in combination with antiretrovirals other than TAF and FTC.
Adult Dose: Each tablet is expected to contain 50 mg BIC, 25 mg TAF, and 200 mg FTC.
Pediatric Dose: N/A
Dosing Info: If approved, BIC + TAF + FTC will be a complete one-pill, once-daily drug regimen. It can be taken with or without food.
In a Phase II study of BIC + TAF + FTC, compared with the integrase inhibitor dolutegravir (DTG) + TAF + FTC, the most common side effects were diarrhea, nausea, muscle aches, fatigue and headache. However, these side effects were no more common in the BIC group, compared with those i nthe DTG group. DTG appeared more likely to cause moderate-to-severe increases in blood sugar levels, whereas BIG appears more likely to cause moderate-to-severe increases in liver enzyme levels.
Similar to other integrase inhibitors, BIC should not be taken at the same time as certain medications containing metal cations (such as calcium, magnesium, aluminum, and iron). Examples include certain antacids, laxatives, and mineral supplements. Generally speaking, this should be taken approximately two hours before or after BIC.
BIC + TAF + FTC is not expected to have many additional drug interactions.
Before taking this medication, tell your doctor if you have kidney disease or liver disease (including hepatitis B). In addition, tell your doctor if you are pregnant or planning to become pregnant; if you are breast feeding, and all your medical conditions, including all prescription and over-the-counter medications and supplements you are taking.
Last Revised: June 13, 2017