You searched “Biktarvy” because you want the right page fast-usually the official label, reliable dosing details, side effects, and how to get it covered. This guide gets you there in a few steps, then gives you the practical stuff people actually use day to day: what to click, what to print, how to handle antacids, missed doses, insurance forms, and what to ask your clinician. No fluff. I’m Andy in Portland, and I’ve helped more than a few friends navigate HIV meds, Oregon insurance, and ADAP paperwork. Consider this your shortcut.
Goal: reach the latest U.S. Prescribing Information, the Medication Guide, and the savings/patient assistance pages in the least number of clicks. Here’s the cleanest path without guesswork.
What to download or screenshot right now:
Sanity check you’re on the correct site/pages:
Here’s how clinicians and savvy patients read the label-and how you can make it actionable.
What is Biktarvy? It’s a complete, once-daily HIV-1 treatment in one pill: bictegravir (an INSTI), emtricitabine (FTC), and tenofovir alafenamide (TAF). No booster needed. It’s indicated for adults and for children who meet weight criteria (check the PI for current pediatric thresholds; as of 2025 it includes patients ≥14 kg, with specific lower-strength tablets for smaller kids).
Standard dosing: one tablet by mouth once daily, with or without food. Swallow whole. If swallowing is an issue, ask your pharmacist before crushing-changing the tablet can affect how the medicine works.
Missed dose rule of thumb: take it as soon as you remember. If it’s almost time for the next dose, skip the missed one-don’t double up. If you vomit within about one hour of taking it, consider that dose missed and take another. If it’s been longer, you’re likely fine and just take the next dose as scheduled.
Interactions you actually see in real life:
Kidneys and liver: Biktarvy is not recommended if your eGFR is below certain cutoffs (commonly <30 mL/min), with a specific exception for some people on chronic hemodialysis who are already undetectable-details are in the PI. Severe liver impairment (Child-Pugh C) is not recommended. Your clinician will track labs.
Hepatitis B matters: Because FTC and TAF fight hepatitis B too, stopping suddenly can flare HBV. You should be screened for HBV before starting. If you have HBV and ever stop, your clinician will monitor your liver for several months.
Side effects (what people report): most commonly nausea, diarrhea, headache. Many folks feel nothing after the first week. Like other modern HIV regimens, weight can creep up a bit over the first 12-24 months (a few pounds to several kilograms in some people). Serious events are uncommon, but hypersensitivity reactions, severe rash, liver issues, or lactic acidosis can occur-get help immediately if you feel very unwell or notice yellowing eyes/skin, dark urine, or severe abdominal pain.
Pregnancy and breastfeeding: As of 2025, U.S. DHHS Guidelines list Biktarvy as a recommended regimen for most adults; for pregnancy and people trying to conceive, the Perinatal Guidelines support several preferred options and provide guidance if you’re already suppressed on Biktarvy. If you’re pregnant or planning, have a direct talk with your HIV specialist before changing anything. Breastfeeding guidance in the U.S. uses shared decision-making-sustained viral suppression and close monitoring are key topics to discuss with your care team.
PEP and PrEP: Biktarvy is treatment for HIV, not PrEP. For non-occupational PEP (post-exposure prophylaxis), current U.S. guidance allows integrase-based single-tablet options-some clinicians do use Biktarvy for PEP. If that’s your situation, start as soon as possible (within 72 hours) and follow the exact 28-day plan your clinician gives you.
Adherence tips that actually stick:
Insurance and prior auth: Plans often approve Biktarvy as first-line. If they push back, your clinician can reference U.S. DHHS HIV Guidelines (2025) that list it as a recommended initial regimen. Keep denial letters; they’re your ticket to quick appeals or manufacturer support.
Here’s a compact fact set you can use with your clinician, case manager, or pharmacist.
Topic | Quick facts (2025) | Credible source |
---|---|---|
What it is | Fixed-dose combo: bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg; once daily, with/without food | U.S. Prescribing Information (FDA) |
Who it’s for | Adults and pediatric patients meeting weight criteria (pediatric strength available); complete regimen | U.S. Prescribing Information (FDA) |
Renal/hepatic | Not recommended in severe renal impairment except certain patients on hemodialysis; not recommended in severe hepatic impairment | U.S. Prescribing Information (FDA) |
Common side effects | Nausea, diarrhea, headache; possible weight gain over 12-24 months | Medication Guide; DHHS HIV Guidelines |
Serious warnings | HBV flare if stopped; severe rash/hypersensitivity; lactic acidosis; liver problems | U.S. Prescribing Information (FDA) |
Key interactions | Avoid rifampin, St. John’s wort; separate from Al/Mg antacids; review anticonvulsants | U.S. Prescribing Information (FDA) |
Effectiveness | ~89-92% virologic suppression at weeks 48-96 in Phase 3 trials; noninferior to comparators | GS‑US‑380‑1489/1490 Phase 3 trials |
Cost (U.S.) | List price often around $4,500-$5,000/month in 2025; most pay far less with insurance, ADAP, or manufacturer support | Manufacturer pricing; payer data |
Generics | No U.S. generic as of 2025 | Patent filings; market status |
Pregnancy | Discuss with specialist; Perinatal Guidelines provide recommendations; don’t switch without a plan | DHHS Perinatal Guidelines (2025) |
How to read the PI without getting lost:
Risks and how to lower them:
Cost and coverage, made simple:
Real-world scenarios and what to do:
Mini‑FAQ (quick hits):
Q: Can I take it with food?
A: Yes. Food is fine and can help if you get nausea.
Q: Any alcohol limits?
A: Moderate drinking isn’t a formal contraindication, but alcohol stresses the liver. If you have hepatitis or liver disease, talk to your clinician about limits.
Q: Can I use it for PEP?
A: Many clinicians do use it for PEP under current U.S. guidance. Don’t self-start-get evaluated and start within 72 hours.
Q: What if my creatinine rises a bit?
A: A small bump can happen with integrase regimens due to how kidneys handle creatinine; your clinician will check true kidney function and decide if it matters.
Q: Is it okay with birth control?
A: Most hormonal contraceptives are fine with Biktarvy. Always check the PI and confirm with your pharmacist.
Q: Vaccines?
A: Get routine vaccines. Live vaccines depend on your CD4 count-check with your provider.
Next steps if you’re starting soon:
Troubleshooting by situation:
Credible sources you can mention to your care team: U.S. Prescribing Information (FDA), U.S. DHHS Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV (2025), DHHS Perinatal Guidelines (2025), manufacturer’s Advancing Access program, and the Phase 3 trials GS‑US‑380‑1489/1490. If something you read conflicts with your clinician’s plan, ask them to walk you through the reasoning-meds are only as good as the plan you can follow comfortably.
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