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ARTICLE

Epclusa: What Have We Learned?

JAN 01, 2017 | AMANDA BINKLEY, PHARMD, AAHIVP, AND ASHLEY SHERIDAN, PHARMD

ADVERSE EVENTS 

Across all treatment trials, the most common AEs associated with sofosbuvir/velpatasvir included fatigue and headache. When combined with ribavirin, the AEs that were observed included fatigue, headache, insomnia, anemia, nausea, and diarrhea. Among patients who experienced an AE and received sofosbuvir/velpatasvir alone, only 0.2% of subjects discontinued treatment compared with 5% for those who received sofosbuvir/ velpatasvir plus ribavirin.10
 

CONTRAINDICATIONS 

There are no absolute contraindications with use of sofosbuvir/velpatasvir, but providers should administer the drug with caution among patients also receiving amiodarone. Bradycardia potentially leading to cardiac arrest was observed in one patient with the co-administration of sofosbuvir with amiodarone. In patients who have no alternative treatment options for chronic HCV, the combination may be utilized with very close monitoring. The manufacturer recommends cardiac monitoring in an inpatient setting for at least the first 48 hours after co-administration, followed by self-monitoring of the daily heart rate at home for at least the next two weeks.10
 
Bradycardia has also been observed in other patient populations, including those receiving concomitant beta-blockers and those with underlying cardiac comorbidities or advanced liver disease. The onset of bradycardia is generally seen within the first hours to days, but cases have been observed up to two weeks after initiation of HCV therapy.10
 
For patients who are receiving sofosbuvir/velpatasvir plus ribavirin, it is important to remember that contraindications with ribavirin also apply. Ribavirin is contraindicated among patients who have a history of hypersensitivity to ribavirin, are pregnant or may become pregnant, are males whose female partners are pregnant, have hemoglobinopathies, or are concomitantly using didanosine.10
 

DRUG-DRUG INTERACTIONS 

Drug-drug interactions should always be assessed when initiating therapy with sofosbuvir/velpatasvir and other DAA regimens. Sofosbuvir and velpatasvir are substrates for the p-glycoprotein and CYP2B6, CYP2C8, and CYP3A4 enzymes. Consequently, serum concentrations of sofosbuvir/velpatasvir might be reduced when this drug is co-administered with other agents that are moderate to potent inducers of these enzymes.10
 
Sofosbuvir/velpatasvir will potentially interact with other medications since velpatasvir is an inhibitor of the breast cancer resistance protein and organic anion transporting polypeptides (OATP1B1, OATP1B3, and OATP2B1). Co-administration of sofosbuvir/velpatasvir with drugs that are substrates of these transporters may increase the exposure of such drugs.10
 
Common drug-drug interactions encountered in clinical practice are listed in the Table10. Less common drug-drug interactions are included in the sofosbuvir/ velpatasvir package insert.10
 

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