Ledipasvir/​Sofosbuvir

DEA Class; Rx

Common Brand Names; Harvoni

• HCV NS5A Inhibitors; 
• HCV Polymerase Inhibitors

Combination antiviral containing a hepatitis C virus (HCV) NS5A protein inhibitor and a nucleotide analog HCV NS5B polymerase inhibitor
Used to treat chronic HCV genotype 1, 4, 5, and 6 infections in adults and pediatric patients 3 years and older
Black Box Warning regarding reactivation of hepatitis B virus (HBV) infection in HCV/HBV coinfected patients; screen all patients for HBV before initiating treatment

If coadministered with ribavirin, the contraindications to ribavirin also apply to this combination regimen

• Asthenia (31-36%)
• Fatigue (4-18%)
• Headache (13-29%)
• Cough (5-11%)
• Nausea (6-9%)
• Diarrhea (3-7%)
• Dizziness (1-5%)
• Dyspnea (3-9%)
• Insomnia (3-6%)
• Increased bilirubin >1.5 x ULN (<1 to 3%)
• Increased lipase >3 x ULN (<1 to 3%)
• Myalgia (4-9%)
• Irritability (7-8%)

Hepatitis B virus (HBV) reactivation reported in HCV/HBV coinfected patients undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy

Some cases have resulted in fulminant hepatitis, hepatic failure, and death; cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (eg, HBsAg negative and anti-HBc positive)

HBV reactivation also reported in patients receiving certain immunosuppressants or chemotherapeutic agents

Risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients

If the drug combination is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant; refer to ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy

It is not known whether ledipasvir or sofosbuvir, the drug combination, or their metabolites are present in human breast milk, affect human milk production or have effects on the breastfed infant.