Confirm the product, indication and renal measure. The selected summary is not a complete prescribing monograph.
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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.
1 additional source qualifications - review before use
The retrieved SOVALDI label retains a severe-renal/ESRD limitation while the guideline discusses recommended sofosbuvir-containing regimens in these populations.
Before applying: Have HCV pharmacy/specialist review the exact regimen and companion drugs. No blended dose is generated.
Also check: Product labeling and regimen-level HCV guidance require reconciliation
Official source
SOVALDI - official product-specific renal limitation
Product / population
SOVALDI - official product-specific renal limitation; selected renal passages, not a complete prescribing monograph.
Renal measure
eGFR in mL/min/1.73 m2; preserve body-surface-area indexing.
Renal dosing, restrictions and evidence limits
The December 2024 SOVALDI prescribing information still gives no dose recommendation at eGFR <30 mL/min/1.73 m2 or ESRD, while requiring no adjustment for mild/moderate impairment. Sections 2.7 and 8.6 retain this limitation. Ribavirin and peginterferon renal instructions require separate review. Do not present the broader guideline statement about sofosbuvir-containing regimens as proof that this exact product label has changed. Severe-renal use requires specialist reconciliation of the selected regimen and sources; no blended dose is generated here.
Source revision: Prescribing information revised December 2024. | Retrieved: 2026-09-09. Retrieval date is not the revision date.
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.
Limited or unstudied renal evidence. Not studied does not mean no adjustment is required.
Single-agent SOVALDI sofosbuvir tablets/oral pellets used as part of combination HCV treatment. Not standalone HCV monotherapy or a substitute for fixed-combination labels.
AASLD-IDSA - recommended HCV regimens in renal impairment
Professional guidance with defined scope. Publication date, institutional setting and source limitations remain controlling. This is not automatic preference over another source.
Recommended HCV regimens in renal impairment. This guideline summary is not a complete antiviral treatment algorithm.
Renal method: CKD severity and dialysis in a regimen-selection guideline; not a product-specific dose conversion. Retrieved: 2026-09-09
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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.
Select two distinct source versions. The complete stored summaries will appear below.
Source-by-source comparison
These protocols may disagree and may apply to different settings. This view does not reconcile or endorse a patient-specific regimen.
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.
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.
source scope difference
Product labeling and regimen-level HCV guidance require reconciliation
The retrieved SOVALDI label retains a severe-renal/ESRD limitation while the guideline discusses recommended sofosbuvir-containing regimens in these populations.
How to use this: Have HCV pharmacy/specialist review the exact regimen and companion drugs. No blended dose is generated.
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.
Official source
SOVALDI - official product-specific renal limitation
SOVALDI - official product-specific renal limitation; selected renal passages, not a complete prescribing monograph.
Method: eGFR in mL/min/1.73 m2; preserve body-surface-area indexing.
Single-agent SOVALDI sofosbuvir tablets/oral pellets used as part of combination HCV treatment. Not standalone HCV monotherapy or a substitute for fixed-combination labels.
Method: eGFR in mL/min/1.73 m2; preserve body-surface-area indexing.
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.
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.
Single-agent SOVALDI sofosbuvir tablets/oral pellets used as part of combination HCV treatment. Not standalone HCV monotherapy or a substitute for fixed-combination labels.
RDM53-SCOPE-sofosbuvir-sovaldi · Source section: Selected source product scopeRenal section finder
Separate U.S. product-label layer
FDA / DailyMed dosing and renal information
Official
SOVALDI - official product-specific renal limitation
DailyMed / Gilead Sciences, Inc. · SOVALDI - official product-specific renal limitation; selected renal passages, not a complete prescribing monograph.
Renal method: eGFR in mL/min/1.73 m2; preserve body-surface-area indexing. Source date: Prescribing information revised December 2024. Retrieved: 2026-09-09
Limited or unstudied renal evidence. Not studied does not mean no adjustment is required.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
The December 2024 SOVALDI prescribing information still gives no dose recommendation at eGFR <30 mL/min/1.73 m2 or ESRD, while requiring no adjustment for mild/moderate impairment. Sections 2.7 and 8.6 retain this limitation. Ribavirin and peginterferon renal instructions require separate review. Do not present the broader guideline statement about sofosbuvir-containing regimens as proof that this exact product label has changed. Severe-renal use requires specialist reconciliation of the selected regimen and sources; no blended dose is generated here.
RDM53-official-sofosbuvir-sovaldi-29291349cc-C1 · Source locator: Sections 2.7 and 8.6; label header and PI revision.
GlobalRPh-hosted RX List · Single-agent SOVALDI sofosbuvir tablets/oral pellets used as part of combination HCV treatment. Not standalone HCV monotherapy or a substitute for fixed-combination labels.
Renal method: eGFR in mL/min/1.73 m2; preserve body-surface-area indexing. Source date: Source revision date not established in selected retrieval. Retrieved: 2026-09-09
Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
Limited or unstudied renal evidence. Not studied does not mean no adjustment is required.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
The RX source permits the usual dosage in mild/moderate impairment but gives no dose recommendation for severe impairment (eGFR <30 mL/min/1.73 m2) or ESRD requiring hemodialysis. Its renal information must remain attached to the SOVALDI product and combination-treatment context. Broader guidance for sofosbuvir-containing regimens is separately displayed; it does not silently replace this product-specific limitation or eliminate ribavirin-related renal restrictions.
RDM53-rxlist-sofosbuvir-sovaldi-beebc90da9-C1 · Source locator: Use in specific populations: renal impairment; dosage and administration.
AASLD-IDSA HCV Guidance · Recommended HCV regimens in renal impairment. This guideline summary is not a complete antiviral treatment algorithm.
Renal method: CKD severity and dialysis in a regimen-selection guideline; not a product-specific dose conversion. Source date: Current retrieved guidance page; exact page revision date not established. Retrieved: 2026-09-09
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
AASLD-IDSA advises that recommended direct-acting antiviral regimens need no renal adjustment; ribavirin may require reduction in CKD stages 3-5. The guidance describes use of sofosbuvir-containing regimens in severe kidney disease and dialysis after 2019 labeling changes. This is a regimen-level recommendation, not evidence that every single-agent product label or combination is identical. Preserve the separately retrieved SOVALDI label limitation and obtain HCV specialist/pharmacy adjudication rather than selecting an empiric dose to reconcile the difference.
RDM53-professional-sofosbuvir-sovaldi-1ac91708fd-C1 · Source locator: Recommendations for CKD; Sofosbuvir-Based Regimens.
Source-specific limits
Underlying trials were referenced by the guidance, not independently reanalyzed in this release.
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.
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.