Sovihep V Sofosbuvir And Velpatasvir Tablets, 500 mg

Strength/Dose (in mg or ml)sofosbuvir 400 mg and velpatasvir 100 mgPack Size28 TabProduct TypeFinish Product Indication: Sofosbuvir With Velpatasvir is a two-drug combination for the treatment of hepatitis C. It is administered as a single daily pill containing the viral NS5A inhibitor velpatasvir and sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase. It is the first treatment, that works for all genotypic, and is taken entirely by mouth. A single tablet regimen is used for adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Mechanism of action: Sofosbuvir With Velpatasvir is an oral fixed-dose combination of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor and velapatasvir, an NS5A complex inhibitor. Sofosbuvir is approved for the treatment of genotype 1, 2, 3 and 4 HCV infection with different regimens and durations dependent on the HCV genotype. Velpatasvir (formerly GS-5816) is a novel NS5A inhibitor that has potent invitro anti-HCV activity across all genotypes at the picomolar level. The combination of sofosbuvir-velpatasvir is the first once-daily single-tablet regimen with pangenotypic activity. Dosage and Administration: Sofosbuvir With Velpatasvir is available as a coformulated, once-daily single-pill combination of sofosbuvir 400 mg and velpatasvir 100 mg. The recommended dose is one tablet once daily, taken with or without food. Renal Impairment: For patients with mild to moderate renal impairment, no dosage adjustment of sofosbuvir-velpatasvir is recommended. There are insufficient data regarding the safety and efficacy of sofosbuvir-velpatasvir in patients with severe renal impairment (eGFR less than 30 ml/min/1.73m2) or end-stage renal disease requiring hemodialysis. Accordingly, no dosage recommendation has been given for patients with severe renal impairment or end-stage renal disease requiring dialysis. Hepatic Impairment: For patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C), no dosage adjustment for sofosbuvir-velpatasvir is recommended. For patients with decompensated cirrhosis who are receiving sofosbuvir-velpatasvir and ribavirin, clinical and laboratory monitoring is recommended. Precaution: Risk of Serious Symptomatic Bradycardia When Sofosbuvir Is Coadministered with Amiodarone and Another HCV Direct Acting Antiviral: Amiodarone is not recommended for use with Sofosbuvir With Velpatasvir due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia. Risk of Reduced Therapeutic Effect Due to Concomitant Use of Sofosbuvir With Velpatasvir with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John's wort, and carbamazepine are not recommended for use with Sofosbuvir With Velpatasvir as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.