Ledipasvir/sofosbuvir - HARVONI

The selected source requires no HARVONI dose adjustment for any degree of renal impairment, including end-stage renal disease treated with dialysis. This is a product-specific statement, not permission to ignore treatment duration, genotype, cirrhosis status or interactions.

When ribavirin is part of the regimen, use its separate renal instructions; the source points to modification when CrCl is 50 mL/min or less. Safety data are lacking for pediatric renal impairment and for combined decompensated cirrhosis with severe renal impairment or dialysis. Do not extrapolate the adult statement to those evidence gaps.

Ledipasvir/sofosbuvir increases tenofovir exposure when used with tenofovir disoproxil fumarate (TDF). HCV Guidance advises avoiding this combination at indexed eGFR <60 mL/min/1.73 m2. Ritonavir- or cobicistat-containing regimens can raise exposure further; consider changing antiretroviral therapy with the HIV clinician.

The guidance also describes baseline and monthly renal monitoring when patients below that threshold are nevertheless taking the combination, including creatinine, electrolytes/phosphorus and urine protein/glucose. That monitoring paragraph does not cancel the avoidance recommendation. This is an interaction-driven restriction and is not contradicted by HARVONI's product-specific no-renal-adjustment statement. Do not generalize TDF instructions to tenofovir alafenamide.