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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
AASLD-IDSA records the 2019 regulatory change for sofosbuvir in severe kidney disease/dialysis. Its DAA no-adjustment recommendation does not apply automatically to ribavirin or resolve every liver/renal combined evidence gap.
Before applying: Do not reuse a historical blanket severe-renal exclusion. Match the complete HCV regimen, hepatic status and any ribavirin requirement.
Also check: EPCLUSA: retain current DAA guidance and separate ribavirin rules
Rxlist source
GlobalRPh RX List - EPCLUSA
Product / population
Selected EPCLUSA renal guidance; regimen duration, liver status, age/weight and ribavirin eligibility still require the full protocol.
Renal measure
Qualitative renal impairment; the selected renal statement is not a numeric kidney-function algorithm.
RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.
Renal dosing, restrictions and evidence limits
No EPCLUSA dosage adjustment is recommended across mild, moderate or severe renal impairment, including ESRD requiring dialysis. The source identifies missing safety data for the combination of decompensated cirrhosis and severe renal impairment/ESRD, and for pediatric renal impairment. Any accompanying ribavirin requires its own renal assessment. This does not establish a complete regimen for those evidence-gap populations.
Source revision: Source revision date not established in selected retrieval. | Retrieved: 2026-09-08. Retrieval date is not the revision date.
All sources, comparison tools and evidence navigation
Source-first renal review
Evidence sources and renal implications
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Renal-context checklist: population, kidney trend and dialysis
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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.
guideline difference
EPCLUSA: retain current DAA guidance and separate ribavirin rules
AASLD-IDSA records the 2019 regulatory change for sofosbuvir in severe kidney disease/dialysis. Its DAA no-adjustment recommendation does not apply automatically to ribavirin or resolve every liver/renal combined evidence gap.
How to use this: Do not reuse a historical blanket severe-renal exclusion. Match the complete HCV regimen, hepatic status and any ribavirin requirement.
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.
Rxlist source
GlobalRPh RX List - EPCLUSA
Selected EPCLUSA renal guidance; regimen duration, liver status, age/weight and ribavirin eligibility still require the full protocol.
Method: Qualitative renal impairment; the selected renal statement is not a numeric kidney-function algorithm.
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.
GlobalRPh-hosted RX List · Selected EPCLUSA renal guidance; regimen duration, liver status, age/weight and ribavirin eligibility still require the full protocol.
Renal method: Qualitative renal impairment; the selected renal statement is not a numeric kidney-function algorithm. Source date: Source revision date not established in selected retrieval. Retrieved: 2026-09-08
Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
No EPCLUSA dosage adjustment is recommended across mild, moderate or severe renal impairment, including ESRD requiring dialysis. The source identifies missing safety data for the combination of decompensated cirrhosis and severe renal impairment/ESRD, and for pediatric renal impairment. Any accompanying ribavirin requires its own renal assessment. This does not establish a complete regimen for those evidence-gap populations.
RDM45-rxlist-sofosbuvir-velpatasvir-epclusa-14200d15a9-C1 · Source locator: Use in Specific Populations: Renal Impairment, lines 356-358.
AASLD / IDSA HCV Guidance · AASLD-IDSA HCV guidance for recommended DAA regimens in CKD; not a substitute for liver-stage and regimen eligibility.
Renal method: Guideline CKD/eGFR categories; selected table prints mL/min without a denominator. No unit conversion is inferred. Source date: Source revision date not established in selected retrieval. Retrieved: 2026-09-08
No adjustment within stated limits. This does not establish dosing outside the studied renal range or population.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
Recommended direct-acting antiviral regimens do not require renal dose adjustment. Ribavirin may require reduction in CKD stages 3 to 5. The sofosbuvir section records the November 2019 FDA change allowing use at eGFR <=30 and on dialysis, and discusses dialysis experience with sofosbuvir/velpatasvir. Do not preserve an older blanket severe-renal prohibition as current guidance, or apply the DAA no-adjustment statement to ribavirin.
Additional summaries stored on this page: 0 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.