A fixed combination of 3 drugs in one pill.
Sold as Biktarvy.
A combination is graded by its riskiest ingredient: each part of the score is the lowest of the ingredients' scores. This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Each ingredient has its own full page with the FDA label, side-effect reports, recalls, evidence, and payments. Open them for the detail behind this grade.
Score breakdown (59/100)
Safety ×35%
D
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
C
Options ×10%
F
Safety: 55
Graded by its riskiest ingredient, tenofovir alafenamide (55)
Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
8,916 FDA reports naming it as the suspect drug per million Medicare fills, 3.2x the median drug on this site (-10)
Death share in reports is near or below the FAERS average (1.2x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 46
Graded by its riskiest ingredient, bictegravir (46)
52 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Regulatory history: 91
Graded by its riskiest ingredient, tenofovir alafenamide (91)
No recalls on record since 2016
2 label changes approved since 2021 (-4)
Label lists recent major changes to warnings or indications (-5)
Money & lawsuits: 70
Graded by its riskiest ingredient, tenofovir alafenamide (70)
Pharma paid doctors $1,038,234 tied to this drug last year (-30)
Not named in any pending federal MDL
For the combination product itself:
Pharma paid doctors $2,846,141 tied to this drug last year (-30)
Not named in any pending federal MDL
Options: 40
Graded by its riskiest ingredient, bictegravir (40)
No generic version approved: brand-only pricing (-30)
No same-class alternatives found: little leverage to switch (-30)
Money and lawsuits
In 2024, drug companies reported $2,846,141 in payments to US physicians and hospitals tied to this combination's brands across 4,668 transactions (Biktarvy $2,846,141).
No pending federal MDL names this combination or its brands.
The ingredients' own payments and lawsuits are on their pages and already count toward this grade.
Who takes it and what it costs
Not in the Medicare Part D spending file.
Questions to ask your prescriber
This is a fixed combination of bictegravir and emtricitabine and tenofovir alafenamide. Why both together, instead of only the one I need?
This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
The most-reported problems in FDA's adverse event data are drug resistance, viral mutation identified. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
There is no generic. Is there an older generic in the same class that works as well for my situation?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)
The most-reported problems in FDA's adverse event data are foetal exposure during pregnancy, drug interaction, drug resistance, anxiety. How would we recognize and handle those?
Why this one over abacavir, adefovir dipivoxil, didanosine? What would make you pick one of those instead?
The most-reported problems in FDA's adverse event data are death, product dose omission issue, fatigue. How would we recognize and handle those?
The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?