When is Epclusa contraindicated? | Hepatitis Central

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Epclusa (sofosbuvir and velpatasvir)

When is Epclusa contraindicated?

Epclusa and ribavirin combination regimen is contraindicated in those patients for whom ribavirin is contraindicated.

The following chart provides information regarding potentially significant drug interactions with Epclusa (the table is not all-inclusive). Alteration in dose or regimen may be recommended based on drug interaction studies or predicted interactions. (For more information regarding the effect of co-administration of these medications with Epclusa and recommendations for alterations in dose or regimen please view the Full Prescribing Information.)

 

Drug Class Specific Drugs Within Class Contraindicated with Harvoni®
Acid Reducing Agents Antacids (e.g. aluminum and magnesium hydroxide)
H2-receptor antagonists (e.g. famotidine)
Proton-pump inhibitors (e.g. omeprazole)
Antiarrhythmics Amiodarone
Digoxin
Anticancers Topotecan
Anticonvulsants Carbamazepine
Phenytoin
Phenobarbital
Oxcarbazepine
Antimycobacterials Rifabutin
Rifampin
Rifapentine
HIV Antiretrovirals Efavirenz
Regimens containing tenofovir DF
Tipranavir/ritonavir
Herbal Supplements St. Johns’ wort (Hypericum perforatum)
HMG-CoA Reductase Inhibitors Rosuvastatin
Atorvastatin

 

Based on drug interaction studies conducted with either Epclusa or the components of Epclusa, the following had no clinically significant interactions:

With Epclusa:

  • atazanavir/ritonavir
  • cyclosporine
  • darunavir/ritonavir
  • dolutegravir
  • elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
  • emtricitabine
  • raltegravir
  • rilpivirine

With Sofosbuvir:

  • ethinyl estradiol/norgestimate
  • methadone
  • tacrolimus

With Velpatasvir:

  • ethinyl estradiol/norgestimate
  • ketoconazole
  • pravastatin

 

Last Updated: June 2016

 

"Co-pay Coupon | EPCLUSA®." Gilead.com. Gilead Sciences, Inc., https://www.epclusainfo.com/co-pay-coupon-registration. Retrieved June 29, 2016

"Highlights of Prescribing Information." FDA.gov. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf. Retrieved June 29, 2016.

"Support Path Harvoni® and Epclusa® Tablets Treatment Support." Gilead.com. Gilead Sciences, Inc., http://www.mysupportpath.com/. Retrieved June 29, 2016.

"U.S. Food and Drug Administration Approves Gilead's Epclusa (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C. Gilead.com". http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&. Retrieved June 29, 2016.