Indications, Usage, Dosage and Administration

Myvelap is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection

• Without cirrhosis or with compensated cirrhosis
• With decompensated cirrhosis for use in combination with ribavirin,

Recommended dosage: One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily with or without food.

Contraindications

Myvelpa and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated.

Adverse Reaction

Serious Symptomatic Bradycardia When Sofosbuvir Is Coadministered with Amiodarone and Another HCV Direct Acting Antiviral.The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with Myvelpa for 12 weeks are headache and fatigue.

The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with Myvelpa and ribavirin for 12 weeks in patients with decompensated cirrhosis are fatigue, anemia, nausea, headache, insomnia and diarrhea.

Precautions

1.Serious Symptomatic Bradycardia When Sofosbuvir Is Coadministered with Amiodarone and Another HCV Direct Acting Antiviral
2. Risk of Reduced Therapeutic Effect Due to Concomitant Use of Myvelpa with Inducers of P-gp and/or Moderate to Potent 3.Risks Associated with Ribavirin and Myvelpa Combination Treatment Inducers of CYP “