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What the FDA labels say about taking them together

Cobicistat and ledipasvir/sofosbuvir

Ledipasvir/sofosbuvir's FDA label of December 26, 2024 names cobicistat in its drug interactions section; the cobicistat label PlainMeds reads does not name ledipasvir/sofosbuvir. The ledipasvir/sofosbuvir label: “… regimen containing tenofovir DF without an HIV protease inhibitor/ritonavir or cobicistat. Refer to VIREAD or TRUVADA prescribing information for recommendations on renal monitoring.”

Check it at the source: the cobicistat FDA label on DailyMed (effective February 10, 2026, Gilead Sciences, Inc.); the ledipasvir/sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc).

What does the cobicistat label say about ledipasvir/sofosbuvir?

Cobicistat's label (effective February 10, 2026) does not name ledipasvir/sofosbuvir in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Tybost), Gilead Sciences, Inc., effective February 10, 2026 (SPL set 3784c35c-e87f-410c-900b-8fd6313c6010), via openFDA; the full label on DailyMed

What does the ledipasvir/sofosbuvir label say about cobicistat?

Ledipasvir/sofosbuvir label, drug interactions

Concomitant Drug Class/Drug Name: Regimens containing tenofovir DF without an HIV protease inhibitor/ ritonavir or cobicistat; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ tenofovir; Clinical Comment: Monitor for tenofovir-associated adverse reactions in patients receiving HARVONI concomitantly with a regimen containing tenofovir DF without an HIV protease inhibitor/ritonavir or cobicistat. Refer to VIREAD or TRUVADA prescribing information for recommendations on renal monitoring.

Source: FDA drug label (Harvoni), Gilead Sciences, Inc, effective December 26, 2024 (SPL set f4ec77e4-bae8-4db0-b3d5-bde09c5fa075), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

0Cobicistat generic labelers
0Ledipasvir/sofosbuvir generic labelers
CobicistatLedipasvir/sofosbuvir
Labeled forHIVHepatitis C
Boxed warningNoYes
Pharmacy cost (NADAC)n/an/a
Shortage nowA presentation being discontinuedNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?