GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Bictegravir / emtricitabine / tenofovir alafenamide - BIKTARVY

Local official-label summaryBase record retrieved 2026-09-10See the evidence for this drug3 sources available - open source summaries, references and comparisons

BIKTARVY / bictegravir emtricitabine tenofovir alafenamide / BIC FTC TAF

READ THE SOURCE-SPECIFIC ANSWER

Renal guidance at a glance

Cautions / source differences (1)
Review first - source-specific qualification

A panel-practice exception is not unrestricted renal eligibility

The NIH panel note describes uncertain practice at CrCl 15-29; its table still says not recommended. Product-label dialysis eligibility is narrower than the abbreviated table.

Before applying: Confirm virologic suppression, treatment history, weight and dialysis setting with an HIV specialist. Do not silently adopt the panel minority practice as a standard regimen.

Evidence for this qualification

Source-specific qualification; independent clinician review pending.

Confirm the product, indication and renal measure. The selected summary is not a complete prescribing monograph.

Choose a source to read (3)

Display order is not a clinical ranking. Date of retrieval is not the label revision date. Sources are never merged into one regimen. Other sources and conflicts remain below.

Official source

DailyMed / BIKTARVY exact product label

Product / population
BIKTARVY fixed-dose HIV-1 treatment tablets. Renal eligibility depends on weight, treatment history and dialysis status, not clearance alone.
Renal measure
Estimated CrCl, mL/min; Cockcroft-Gault in adult source PK section

Exact DailyMed HTML label identity and selected named sections checked. A page update is not proof that renal instructions changed.

No raw SPL XML, original XML hash or separate Drugs@FDA revision-history review was performed.

Renal dosing, restrictions and evidence limits

At estimated CrCl at least 30 mL/min, adults and children weighing at least 25 kg receive one 50/200/25 mg tablet daily; children 14 to below 25 kg receive one 30/120/15 mg tablet daily. These strengths are BIC/FTC/TAF, respectively.

The 50/200/25 mg daily regimen is also specified for virologically suppressed adults with CrCl below 15 on chronic hemodialysis; administer after dialysis on treatment days. This exception is not permission for treatment-naive dialysis patients, children on dialysis, or CrCl 15-29. Renal monitoring remains required. Consult the full indication, resistance and interaction requirements; this extract does not establish individual treatment eligibility.

Source revision: 7/2026 | Retrieved: 2026-09-10. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=664cb8f0-1f65-441b-b0d9-ba3d798be309

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v6.6.

Full source card / provenance

All sources, comparison tools and evidence navigation
Source-first renal review

Evidence sources and renal implications

Choose a source to jump directly to its locally stored result. Qualitative precautions and evidence gaps remain visible even when no numerical clearance schedule is supplied.

Read 1 source difference / applicability notes

Official product label

DailyMed / BIKTARVY exact product label

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

BIKTARVY fixed-dose HIV-1 treatment tablets. Renal eligibility depends on weight, treatment history and dialysis status, not clearance alone.

Renal method: Estimated CrCl, mL/min; Cockcroft-Gault in adult source PK section
Retrieved: 2026-09-10

Read local renal resultOpen original reference
GlobalRPh RX List

GlobalRPh RX List - BIKTARVY

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

BIKTARVY fixed-dose HIV-1 treatment tablets. Renal eligibility depends on weight, treatment history and dialysis status, not clearance alone.

Renal method: Estimated CrCl, mL/min; Cockcroft-Gault in adult source PK section
Retrieved: 2026-09-10

Read local renal resultOpen original reference
Professional guidance

NIH HIV guidelines - BIKTARVY renal table

Professional guidance with defined scope. Publication date, institutional setting and source limitations remain controlling. This is not automatic preference over another source.

Adult/adolescent antiretroviral renal dosing guidance; a panel-practice qualification is not a product-label approval.

Renal method: CrCl, mL/min; chronic hemodialysis separately addressed
Retrieved: 2026-09-10

Read local renal resultOpen original reference

Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.

Product / population check

Confirm the exact formulation before using a renal source

These links compare product identities, not interchangeable doses. A selected summary is not a complete prescribing monograph.

Source-specific review points

A panel-practice exception is not unrestricted renal eligibility

Read the attributed comparison notes and source cards below. No conflict has been silently adjudicated.

Source-quality holds
Find text within this drug
Find a term without leaving this drug

Search the stored clinical text

Locate a word or phrase within this drug's source summaries. Choose all sources or one source to focus the search. The selection never hides warnings or source text, changes a dose, or proves that a renal finding is absent.

Find:

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All source summaries, original wording and provenance
Before applying a renal protocol

Check the setting. Compare whole sources.

No patient-specific dose is calculated. Context choices only display reminders; they do not validate, hide or change any regimen.

Share a reproducible source review

Choose sources below, then open a print-ready comparison with product scope, renal method, dates and cautions. Links can pin the exact local cards; they never contain patient values or choose a dose.

Open / share selected sources
Jump to renal guidanceRead 1 difference / caution notesClinician guide

Select two distinct source versions. The complete stored summaries will appear below.

Build a source-review outline for documentation

This creates a blank decision outline with the source identities you select, not a dose recommendation or completed clinical assessment. No patient fields are collected, saved or sent. Complete the clinical decisions in your approved documentation system.

Choose one or two sources above or use the source checkboxes below.

Renal-context checklist: population, kidney trend and dialysis

These prompts are a reading aid, not a prescription checklist or proof that all requirements have been met. No selections are stored or sent to a server.

Read the exact source scope, renal metric and date before selecting a row. No applicability assessment has been performed.

See source-specific renal methods and the clinical interpretation guide for the supporting context.

Read before choosing a regimen

Source differences and product cautions

Search differences across all drugs

These are specific issues found during source review, not an automated judgment that one source is universally correct. A label mirror and its original label are not independent evidence.

guideline qualification and product eligibility

A panel-practice exception is not unrestricted renal eligibility

The NIH panel note describes uncertain practice at CrCl 15-29; its table still says not recommended. Product-label dialysis eligibility is narrower than the abbreviated table.

How to use this: Confirm virologic suppression, treatment history, weight and dialysis setting with an HIV specialist. Do not silently adopt the panel minority practice as a standard regimen.

GlobalRPh RX List - BIKTARVYDailyMed / BIKTARVY exact product labelNIH HIV guidelines - BIKTARVY renal table

Source-specific interpretation; independent clinician adjudication pending.

Go directly to the relevant source section

Renal dosing and precautions

Choose a source, then jump to its renal or dialysis section. These links locate stored text; they do not merge regimens or certify that sources agree.

New source summary - independent clinical review pending. Summaries of the identified label sections are included locally. Source import and numeric transcription checks are not independent two-reference validation. Do not treat this card as an approved institutional dosing protocol.

No dialysis or renal heading shown? Read the complete source summary. Absence of a heading is not evidence that dose adjustment is unnecessary.

Compare or copy source versions

All content below is stored locally. Read a whole source version; do not combine its dose with another source's interval, renal metric or dialysis assumptions.

Original content / product scopeDailyMed / BIKTARVY exact product labelGlobalRPh RX List - BIKTARVYNIH HIV guidelines - BIKTARVY renal table
Choose two source checkboxes below.
Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.
Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://globalrph.com/rx-list/biktarvy-drug/

Exact product and population

BIKTARVY fixed-dose HIV-1 treatment tablets. Renal eligibility depends on weight, treatment history and dialysis status, not clearance alone.

RDM56-SCOPE-bictegravir-emtricitabine-tenofovir-biktarvy · Source section: Selected source product scopeRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

DailyMed / BIKTARVY exact product label

Open original reference

Open / share this exact local source

DailyMed / Gilead Sciences, Inc. · BIKTARVY fixed-dose HIV-1 treatment tablets. Renal eligibility depends on weight, treatment history and dialysis status, not clearance alone.

Renal method: Estimated CrCl, mL/min; Cockcroft-Gault in adult source PK section
Source date: 7/2026
Retrieved: 2026-09-10

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

At estimated CrCl at least 30 mL/min, adults and children weighing at least 25 kg receive one 50/200/25 mg tablet daily; children 14 to below 25 kg receive one 30/120/15 mg tablet daily. These strengths are BIC/FTC/TAF, respectively.

The 50/200/25 mg daily regimen is also specified for virologically suppressed adults with CrCl below 15 on chronic hemodialysis; administer after dialysis on treatment days. This exception is not permission for treatment-naive dialysis patients, children on dialysis, or CrCl 15-29. Renal monitoring remains required. Consult the full indication, resistance and interaction requirements; this extract does not establish individual treatment eligibility.

RDM56-official-bictegravir-emtricitabine-tenofovir-biktarvy-c93ee6af87-C1 · Source locator: Sections 2.1-2.3, 2.5, 5.4 and 8.6

Source-specific limits

Exact DailyMed HTML label identity and selected named sections checked. A page update is not proof that renal instructions changed.

No raw SPL XML, original XML hash or separate Drugs@FDA revision-history review was performed.

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=664cb8f0-1f65-441b-b0d9-ba3d798be309
Retrieved
2026-09-10
Exact label title
BIKTARVY - bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate tablet
DailyMed Set ID
664cb8f0-1f65-441b-b0d9-ba3d798be309
Labeler
Gilead Sciences, Inc.
Label revision
7/2026
Renal-function method
Estimated CrCl, mL/min; Cockcroft-Gault in adult source PK section
Source date/version
7/2026
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
da97949508d2fa7fd28b521aa4c56442ca418d89d856e137b27096c541d4a5be
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - BIKTARVY

Open original reference

Open / share this exact local source

GlobalRPh-hosted RX List · BIKTARVY fixed-dose HIV-1 treatment tablets. Renal eligibility depends on weight, treatment history and dialysis status, not clearance alone.

Renal method: Estimated CrCl, mL/min; Cockcroft-Gault in adult source PK section
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-10

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

The mirror does not recommend use at estimated CrCl 15 to below 30 mL/min, below 15 without chronic hemodialysis, or in antiretroviral-naive patients with ESRD on hemodialysis. Its dialysis exception is limited to virologically suppressed adults; give the daily dose after hemodialysis.

Check serum creatinine, estimated CrCl, urine glucose and urine protein; include phosphorus in CKD. Clinically significant renal deterioration or Fanconi syndrome requires discontinuation. A creatinine-transport effect does not exclude tenofovir-associated injury. Do not construct a renal regimen by independently adjusting one component inside this fixed-dose tablet.

RDM56-rxlist-bictegravir-emtricitabine-tenofovir-biktarvy-3e57336799-C1 · Source locator: Recommended dosage; Not recommended in severe renal impairment; New onset or worsening renal impairment; renal PK

Source-specific limits

Selected sections only. A hosted mirror is not independent confirmation of the underlying label.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/biktarvy-drug/
Retrieved
2026-09-10
Renal-function method
Estimated CrCl, mL/min; Cockcroft-Gault in adult source PK section
Source date/version
Source revision date not established in selected retrieval.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
f52caa07c4e3cc5f04615cc0c37d2210f94d7ff32f02690ade0f0831026b6190
Separate professional-source layer

University and professional protocols

Professional

NIH HIV guidelines - BIKTARVY renal table

Open original reference

Open / share this exact local source

NIH ClinicalInfo HIV guidelines · Adult/adolescent antiretroviral renal dosing guidance; a panel-practice qualification is not a product-label approval.

Renal method: CrCl, mL/min; chronic hemodialysis separately addressed
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-10

Professional guidance with defined scope. Publication date, institutional setting and source limitations remain controlling. This is not automatic preference over another source.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

The NIH table lists BIKTARVY as not recommended at CrCl 15-29 mL/min. It explicitly notes insufficient evidence for or against full-dose daily emtricitabine below 30; some panel members use full-dose emtricitabine at 15-29 to retain the fixed-dose combination. This is a described practice under uncertainty, not a universal recommendation.

For chronic hemodialysis, the table states no adjustment and administration after dialysis. Apply the product label's separate population and virologic-suppression requirements rather than extending this abbreviated table to every dialysis patient.

RDM56-professional-bictegravir-emtricitabine-tenofovir-biktarvy-9335c87ac0-C1 · Source locator: Appendix B full table: Integrase strand transfer inhibitors, BIC/TAF/FTC row

Source-specific limits

Professional guidance is separately attributed from product labeling. The panel-practice note describes uncertainty, not independent approval of an alternative regimen.

Source identity and provenance
Source family
professional_guidance
Source
https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/drug-characteristics-tables-renal-hepatic-insufficiency-full
Retrieved
2026-09-10
Renal-function method
CrCl, mL/min; chronic hemodialysis separately addressed
Source date/version
Source revision date not established in selected retrieval.
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
96f68c52984a02942c5b249b552251b8809bf43d9e886043668fcd352f45585c

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 1 RX List, 1 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://globalrph.com/rx-list/biktarvy-drug/
Source retrieval
2026-09-10. This is not the source publication or label revision date.
Original source type
rxlist summary
Local text SHA-256
59562bdf2044f17bb4398a56d7d79763bf65dd08cff1ef033e6e8c3cd292d782
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

Read the full coverage report