Skip to main content

What the FDA labels say about taking them together

Atazanavir and ledipasvir/sofosbuvir

Ledipasvir/sofosbuvir's FDA label of December 26, 2024 names atazanavir in its drug interactions section; the atazanavir labels PlainMeds reads (2) do 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 atazanavir FDA label on DailyMed (effective August 6, 2025, Aurobindo Pharma Limited); the ledipasvir/sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc).

What does the atazanavir label say about ledipasvir/sofosbuvir?

Atazanavir's label (effective August 6, 2025) and its 1 other brand-application label do 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 (Atazanavir Sulfate), Aurobindo Pharma Limited, effective August 6, 2025 (SPL set 7fbea274-d6b5-4faa-bbf0-05fefab42114), via openFDA; the full label on DailyMed

What does the ledipasvir/sofosbuvir label say about atazanavir?

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

4Atazanavir generic labelers
0Ledipasvir/sofosbuvir generic labelers
AtazanavirLedipasvir/sofosbuvir
Labeled forHIVHepatitis C
Boxed warningNoYes
Pharmacy cost (NADAC)$2.23 per capsule 300 mg capsulen/a
Shortage nowNo current entryNo 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?