HopSo-VL 400 mg+100 mg (Tablet)

Indications

• Treatment of chronic HCV genotype 1-6 infection
• For adult and pediatric patients 3 years of age and older
• With or without cirrhosis
• With compensated or decompensated cirrhosis (in combination with ribavirin)

Pharmacology

• Sofosbuvir inhibits HCV NS5B RNA-dependent RNA polymerase
• Velpatasvir inhibits HCV NS5A protein
• Metabolism of sofosbuvir forms active uridine analog triphosphate (GS-461203)
• Velpatasvir targets NS5A as its mode of action
• Effect on QTc interval
• Inhibition of human DNA and RNA polymerases
• Biochemical assay inhibition of NS5B polymerase for HCV genotypes 1b, 2a, 3a, and 4a

Dosage & Administration

• Recommended treatment regimen and duration based on patient population
• Dosage recommendation in adults and pediatric patients 3 years and older
• Dosage adjustment based on weight for ribavirin administration
• Dosing for pediatric patients with genotype 1-6 HCV

Interaction

• Drugs affecting plasma concentrations of sofosbuvir and/or velpatasvir
• Drugs affected by velpatasvir as P-gp, BCRP, OATP1B1, OATP1B3, and OATP2B1 inhibitor

Contraindications

• Contraindicated in patients for whom ribavirin is contraindicated

Side Effects

• Common side effects including fatigue, nausea, headache, anemia, diarrhea, insomnia, pruritus, muscle spasm, dyspnea, and cough
• Rare adverse events such as reduced hemoglobin, lymphocyte, neutrophil, and platelet count
• Serious symptomatic bradycardia when coadministered with Amiodarone

Pregnancy & Lactation

• Contraindicated in pregnant women and in men whose female partners are pregnant
• Unknown effects on human milk production and breastfed infant

Precautions & Warnings

• Risk of hepatitis B virus reactivation in HCV/HBV coinfected patients
• Serious symptomatic bradycardia when coadministered with Amiodarone
• Risks associated with ribavirin and sofosbuvir & velpatasvir combination treatment

Use in Special Populations

• Effect of age on exposure to sofosbuvir, GS-331007, and velpatasvir
• Pharmacokinetics in patients with renal impairment and ESRD
• Pharmacokinetics in patients with hepatic impairment

Overdose Effects

• No specific antidote available
• Monitoring for evidence of toxicity
• General supportive measures including vital signs monitoring
• Hemodialysis may efficiently remove Sofosbuvir metabolite GS-331007

Therapeutic Class

• Hepatic viral infections (Hepatitis C)

Storage Conditions

• Store in a cool and dry place (preferably below 30°C)
• Keep out of reach of children

Related Brands

• Sovel 400 mg+100 mg (Tablet) - aci-limited
• Velsovir 400 mg+100 mg (Tablet) - unimed-unihealth-pharmaceuticals-ltd