{
 "query": "bictegravir / emtricitabine / tenofovir alafenamide",
 "ingredient": "bictegravir / emtricitabine / tenofovir alafenamide",
 "slug": "bictegravir-emtricitabine-tenofovir-alafenamide",
 "rxcui": "1996259",
 "brands": [
  "Biktarvy"
 ],
 "names": [
  "bictegravir / emtricitabine / tenofovir alafenamide"
 ],
 "components": [
  {
   "ingredient": "bictegravir",
   "slug": "bictegravir",
   "grade": "C",
   "total": 69,
   "scores": {
    "safety": "C",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "F"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "",
   "first_approval": ""
  },
  {
   "ingredient": "emtricitabine",
   "slug": "emtricitabine",
   "grade": "B",
   "total": 82,
   "scores": {
    "safety": "C",
    "evidence": "C",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "07/02/2003",
   "first_approval": "20030702"
  },
  {
   "ingredient": "tenofovir alafenamide",
   "slug": "tenofovir-alafenamide",
   "grade": "C",
   "total": 69,
   "scores": {
    "safety": "D",
    "evidence": "C",
    "regulatory": "A",
    "conflict": "C",
    "options": "A"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "11/10/2016",
   "first_approval": "20161110"
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "20030702",
  "first_approval_fmt": "",
  "anda": 0,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 2846141.38,
  "records": 4668,
  "by_name": [
   [
    "Biktarvy",
    2846141.38
   ]
  ],
  "names_checked": [
   "bictegravir / emtricitabine / tenofovir alafenamide",
   "Biktarvy"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "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)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, bictegravir (46)",
    "52 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "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)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "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"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "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)"
   ],
   "weight": 0.1
  }
 },
 "total": 59,
 "grade": "D",
 "questions": [
  "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?"
 ]
}