What the FDA labels say about taking them together
Ledipasvir/sofosbuvir and tenofovir disoproxil
Ledipasvir/sofosbuvir's FDA label of December 26, 2024 names tenofovir disoproxil in its drug interactions section, and tenofovir disoproxil's label names ledipasvir/sofosbuvir too. The ledipasvir/sofosbuvir label: “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. …”
Check it at the source: the ledipasvir/sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc); the tenofovir disoproxil FDA label on DailyMed (effective June 7, 2024, Aurobindo Pharma Limited).
What does the ledipasvir/sofosbuvir label say about tenofovir disoproxil?
Ledipasvir/sofosbuvir label, drug interactionsConcomitant 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
What does the tenofovir disoproxil label say about ledipasvir/sofosbuvir?
Tenofovir disoproxil label, drug interactionsHepatitis C Antiviral Agents: sofosbuvir/velpatasvir sofosbuvir/velpatasvir/ voxilaprevir ledipasvir/sofosbuvir ↑ tenofovir Monitor patients receiving tenofovir disoproxil fumarate concomitantly with EPCLUSA ® (sofosbuvir/velpatasvir) for adverse reactions associated with TDF.
Viread label (Gilead Sciences, Inc., February 18, 2025), drug interactionsNamed in a table that the FDA label file prints without its column breaks; the full label shows the table.
Source: FDA drug label (Viread, NDA021356), Gilead Sciences, Inc., effective February 18, 2025 (SPL set 33fd6418-fbdc-42ca-a50d-ce2a476a5418), via openFDA
Source: FDA drug label (Tenofovir Disoproxil Fumarate), Aurobindo Pharma Limited, effective June 7, 2024 (SPL set a75c6be8-3719-4bb3-8a9e-06e5254d2a82), 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
| Ledipasvir/sofosbuvir | Tenofovir disoproxil | |
|---|---|---|
| Labeled for | Hepatitis C | HIV, Hepatitis B |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | n/a | $0.294 per tablet 300 mg tablet |
| Shortage now | No current entry | No 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?
- Check more medicines together
- up to five at once