What the FDA labels say about taking them together
Darunavir and ledipasvir/sofosbuvir
Ledipasvir/sofosbuvir's FDA label of December 26, 2024 names darunavir in its drug interactions section; the darunavir label PlainMeds reads does not name ledipasvir/sofosbuvir. The ledipasvir/sofosbuvir label: “The safety of increased tenofovir concentrations in the setting of HARVONI and an HIV protease inhibitor/ritonavir or cobicistat has not been established. …”
Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the ledipasvir/sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc).
What does the darunavir label say about ledipasvir/sofosbuvir?
Darunavir's label (effective August 29, 2025) 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 (PREZISTA), Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), via openFDA; the full label on DailyMed
What does the ledipasvir/sofosbuvir label say about darunavir?
Ledipasvir/sofosbuvir label, drug interactionsConcomitant Drug Class/Drug Name: Regimens containing tenofovir DF and an HIV protease inhibitor/ ritonavir or cobicistat atazanavir/ritonavir or cobicistat + emtricitabine/tenofovir DF darunavir/ritonavir or cobicistat + emtricitabine/tenofovir DF lopinavir/ritonavir + emtricitabine/tenofovir DF; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ tenofovir; Clinical Comment: The safety of increased tenofovir concentrations in the setting of HARVONI and an HIV protease inhibitor/ritonavir or cobicistat has not been established. Consider alternative HCV or antiretroviral therapy to avoid increases in tenofovir exposures. …
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
| Darunavir | Ledipasvir/sofosbuvir | |
|---|---|---|
| Labeled for | HIV | Hepatitis C |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $1.16 per tablet 600 mg tablet | n/a |
| 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