Clinical Pharmacology Details


Sofosbuvir, Velpatasvir and Voxilaprevir


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Indications & Dose:

Treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis


(Child-Pugh A) who have :


- Genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.


-Coadministration with rifampin. 


 Genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.


Additional benefit of over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection


previously treated with sofosbuvir without an NS5A inhibitor.


ORALLY


Adult


One tablet 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir) taken orally once daily with food. 


 

Contraindications:

Coadministration with rifampin. 


 

Side Effects:

The most common adverse reactions observed with treatment with  for 12 weeks were headache, fatigue, diarrhea, and nausea.


 

Cautions:

Precautions:

- Risk of Hepatitis B Virus Reactivation. Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment.


Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment followup. Initiate appropriate patient management for HBV infection as clinically indicated. 


- Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease: Hepatic decompensation/failure, including fatal outcomes, have been reported mostly in patients with cirrhosis and baseline moderate or severe liver impairment (Child-Pugh B or C) treated with HCV NS3/4A protease inhibitor-containing regimens. Monitor for clinical and laboratory evidence of hepatic decompensation. Discontinue in patients who develop evidence of hepatic decompensation/failure.


- Bradycardia with Amiodarone Coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone with , a sofosbuvir-containing regimen, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with is not recommended. patients without alternative viable treatment options, cardiac


monitoring is recommended. 

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: