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What the FDA labels say about taking them together

Emtricitabine and ledipasvir/sofosbuvir

Ledipasvir/sofosbuvir's FDA label of December 26, 2024 names emtricitabine in its drug interactions section; the emtricitabine 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 emtricitabine FDA label on DailyMed (effective December 2, 2025, Gilead Sciences, Inc.); the ledipasvir/sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc).

What does the emtricitabine label say about ledipasvir/sofosbuvir?

Emtricitabine's label (effective December 2, 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 (Emtriva), Gilead Sciences, Inc., effective December 2, 2025 (SPL set d6599395-3944-44f9-97f2-e0424c6b6a1f), via openFDA; the full label on DailyMed

What does the ledipasvir/sofosbuvir label say about emtricitabine?

Ledipasvir/sofosbuvir label, drug interactions

Concomitant 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

2Emtricitabine generic labelers
0Ledipasvir/sofosbuvir generic labelers
EmtricitabineLedipasvir/sofosbuvir
Labeled forHIVHepatitis C
Boxed warningYesYes
Pharmacy cost (NADAC)$12.69 per capsule 200 mg capsulen/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)

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