Ledipasvir / Sofosbuvir
| Interaction Color Code | Clinical Bottom Line | Clinical Effects | Drug 1 effect | Drug 2 dose | Drug 2 effect | Management | |
|---|---|---|---|---|---|---|---|
| Darunavir LDV/SOF 913 | Green: Administer standard doses | Administer standard doses | No significant change |
90 / 400 mg once daily | Ledipasvir Cmax increase 45%, AUC increase 39%, Cmin increase 39%; Sofosbuvir Cmax increase 45%, AUC increase 34% |
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| Atazanavir LDV/SOF 803 | Green: Administer standard doses | Administer standard doses | Potentially increased ledipasvir adverse effects. Potentially increased tenofovir disoproxil fumarate adverse effects if coadministered with protease inhibitor and ledipasvir. |
Atazanavir AUC increased 27%, Cmin increased 63% |
90 / 400 mg | Ledipasvir AUC(tau) increased 96%, Cmax increased 68%. |
If coadministering, monitor for tenofovir disoproxil fumarate toxicity if used in the regimen. |
| Atazanavir LDV/SOF 802 | Green: Administer standard doses | Administer standard doses | Potentially increased ledipasvir adverse effects. Potentially increased tenofovir disoproxil fumarate adverse effects if coadministered with protease inhibitor and ledipasvir. |
Atazanavir AUC(tau) increased 43% |
90 / 400 mg | Ledipasvir AUC(tau) increased 134%, Cmax increased 75% |
If coadministering, monitor for tenofovir disoproxil fumarate toxicity if used in the regimen. |
| Tenofovir disoproxil fumarate LDV/SOF 753 | Orange: Minimal data to guide interaction | Minimal data to guide interaction: weigh risks and benefits of using this combination | Increased risk of TDF adverse effects (e.g. renal function decline) |
AUC increase 40%-98%, Cmin increase 55-80% when TDF coadministered with rilpivirine and efavirenz or various PIs, INSTIs, and NNRTIs |
90 / 400 mg once daily | Not studied |
If coadministering, monitor for TDF adverse effects. Avoid use if CrCl >60 ml / min. |
| Tenofovir alafenamide LDV/SOF 711 | Green: Administer standard doses | Administer standard doses | Cmax decreased 10%; AUC decreased 14% |
90 / 400 mg once daily | Not reported |
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| Tenofovir alafenamide LDV/SOF 708 | Green: Administer standard doses | Administer standard doses | Cmax increased 3 - 17%, AUC increased 27-32% |
90 / 400 mg once daily | Ledipasvir: Cmax increased 1%, AUC increased 2%, Cmin increased 2%; sofosbuvir: Cmax decreased 4%, AUC increased 5%; sofosbuvir metabolite: Cmax 8%, AUC increased 8%, Cmin increased 10% |
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| Efavirenz LDV/SOF 416 | Green: Administer standard doses | Administer standard doses | 90 / 400 mg daily x 14 days | Ledipasvir / Sofosbuvir auc decreased 34%, Cmin decreased 34%, Cmax decreased 34%. |
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| Efavirenz LDV/SOF 415 | Green: Administer standard doses | Administer standard doses | 90 / 400 mg daily x 14 days | Ledipasvir / Sofosbuvir auc decreased 34%, Cmin decreased 34%, Cmax decreased 34%. |
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| Efavirenz LDV/SOF 414 | Green: Administer standard doses | Administer standard doses | Ledipasvir 90 mg with sofosbuvir 400 mg daily | Ledipasvir AUC, Cmin, Cmax all decreased 34%; Sofosbuvir: no significant effect |
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| Raltegravir LDV/SOF 305 | Green: Administer standard doses | Administer standard doses | Raltegravir AUC decreased 15-27% |
90 / 400 mg daily | No significant change |
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| Elvitegravir LDV/SOF 142 | Orange: Minimal data to guide interaction | Minimal data to guide interaction: weigh risks and benefits of using this combination | Potential increase in ledipasvir toxicity |
Cmax decreased 12%, AUC increased 2%, Cmin increased 36% |
90 / 400 mg once daily | Ledipasvir Cmax increased 63%, AUC increased 78%, Cmin increased 91%; Sofosbuvir Cmax increased 33%, AUC increased 36%; Sofosbuvir metabolite Cmax increased 33%, AUC increased 44%, Cmin increased 53% |
Manufacturer does not recommend co-administration of ledipasvir / sofosbuvir with Stribild due to interaction with tenofovir disoproxil fumarate. If coadministering, monitor for tenofovir renal toxicity. May coadminister with Genvoya. |
| Elvitegravir LDV/SOF 138 | Orange: Minimal data to guide interaction | Minimal data to guide interaction: weigh risks and benefits of using this combination | Potential increase in ledipasvir toxicity |
AUC increased 11%, Cmin increased 46% |
90 / 400 mg once daily | Ledipasvir Cmax increased 65%, AUC increased 79%, Cmin increased 93%; Sofosbuvir Cmax increased 28%, AUC increased 47%; Sofosbuvir metabolite Cmax increased 29%, AUC increased 48%, Cmin increased 66%% |
Manufacturer does not recommend co-administration of ledipasvir / sofosbuvir with Stribild due to interaction with tenofovir disoproxil fumarate. May coadminister with Genvoya. |
| Bictegravir LDV/SOF 69 | Green: Administer standard doses | Administer standard doses | Cmax decreased 2%, Cmin increased 4% |
90 / 400 mg once daily | Ledipasvir Cmax decreased 15%, AUC decreased 13%. Sofosbuvir Cmax increased 11%, AUC increased 7% |

