LEDIPASVIR AND SOFOSBUVIR

Other

Brand names: Ledipasvir and Sofosbuvir

Oral

Mechanism of Action

12.1 Mechanism of Action Ledipasvir and sofosbuvir tablets (90 mg/400 mg) are a fixed-dose combination of ledipasvir and sofosbuvir, which are direct-acting antiviral agents against the hepatitis C virus [see Microbiology (12.4) ].

Indications

or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with decompensated cirrhosis

for use in combination with ribavirin genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis

for use in combination with ribavirin Ledipasvir and sofosbuvir is a fixed-dose combination of ledipasvir

a hepatitis C virus (HCV) NS5A inhibitor

and sofosbuvir

an HCV nucleotide analog NS5B polymerase inhibitor

Contraindications

• 4 CONTRAINDICATIONS If ledipasvir and sofosbuvir is administered with ribavirin
• all contraindications to ribavirin also apply to ledipasvir and sofosbuvir combination therapy. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment
1 ) Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease
1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were 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

Known Side Effects

11 documented side effects by frequency

Fatigue

>10%

Headache

>10%

Nausea

1-10%

Drug Not Working

1-10%

Diarrhea

1-10%

Insomnia

1-10%

Vomiting

0.1-1%

Dizziness

0.1-1%

Rash

0.1-1%

Weakness

0.1-1%

Joint Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral