|Active substance||Sofosbuvir + Velpatasvir|
|US Brand||Generic Epclusa|
|IN Brand||Sofosvel | Velpanat | Velasof|
|Manufacturing by||Beacon | Natco | Hetero|
|Strength||400mg + 100mg|
|Form release||blister 6 tabs | bottle 28 tabs|
|Estimated shipping time||7 – 18 days (Depending from the Country)|
|Availability, Prices & Order||through request form|
Sofosbuvir-velpatasvir is the first available pangenotypic NS5A-NS5B inhibitor single-pill combination regimen, and is highly efficacious across HCV genotypes 1 to 6. It provides a much-needed interferon-free option for patients with genotype 3 infection that is more economical than sofosbuvir plus daclatasvir, and in patients who have compensated cirrhosis with genotype 3, this single-pill option provides an important ribavirin-free combination that will prove a welcome alternative to what has been available to date. Notably, unlike ledipasvir-sofosbuvir, an abbreviated duration of 8 weeks has not been studied with sofosbuvir-velpatasvir for any of the genotypes, except in conjunction with a third agent (GS-9857, an investigational pangenotypic HCV protease inhibitor). Sofosbuvir-velpatasvir, like ledipasvir-sofosbuvir, will be susceptible to drug interactions with acid-reducing agents particularly proton-pump inhibitors and the impact of these agents on real-world clinical effectiveness remains to be determined.
The recommended dosage of Sofosvel/Velpanat is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)]. One tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Table 1 shows the recommended treatment regimen and duration based on patient population.
|Patient Population||Treatment Regimen and Duration|
|Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A)||Sofosvel/Velpanat 12 weeks|
|Patients with decompensated cirrhosis (Child-Pugh B or C)||Sofosvel/Velpanat + ribavirin* 12 weeks|
NO DOSAGE RECOMMENDATIONS IN SEVERE RENAL IMPAIRMENT AND END STAGE RENAL DISEASE
No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2) or with end stage renal disease (ESRD), due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Common side effects (in more than 10% of people) are headache, fatigue and nausea.