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Velpanat (sofosbuvir 400 mg / velpatasvir 100 mg) tablets — generic Epclusa (Natco, India)

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  • EMC post

Delivery time

  • 7-10 days
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Description

Epclusa is a pan-genotypic combination intended for the interferon-free treatment of HCV genotypes 1 through 6.

Active substance:
Velpatasvir 100 mg and Sofosbuvir 400 mg

Manufacturer:
Gilead Sciences International Ltd, Cambridge

Generic manufacturer NATCO India

Indications:
Epclusa is used to treat chronic hepatitis C for all genotypes of the virus (1-6) without cirrhosis, with compensated or decompensated cirrhosis of the liver (in combination with ribavirin).

Description:
One ??Epclusa tablet contains fixed doses sofosbuvir (an inhibitor of hepatitis C virus NS5B polymerase) and velpatasvir (an inhibitor of NS5A) and is indicated for the treatment of adult patients with chronic hepatitis C infected with the virus of all major genotypes (1, 2, 3, 4, 5 or 6).

Sofosbuvir, as is known, was developed and approved back in 2013, and velpatasvir appeared quite recently.
This is the first drug that can treat patients with genotypes 2 and 3 of the virus without the need to take ribavirin. 

Dosage:
This is the first combination drug with a regimen of taking one tablet once a day. Based on the FDA conclusion, Epclusa is capable of combating all six genotypes of the hepatitis C virus; a complete cure is guaranteed for 95% of patients.

In addition to the fact that the drug is intended for the treatment of all HCV genotypes, a feature of the use of this combination is that without cirrhosis and with compensated cirrhosis (Child-Pugh class A), the duration of therapy is 12 weeks, without the use of ribavirin. In decompensated cirrhosis (class B and C), a doubled duration of 24 weeks and a combination with ribavirin are recommended.

Side effects:
Most common adverse reactions (?10%) Epclusa is headache and increased fatigue; When used with Ribavirin in cases of decompensated cirrhosis, fatigue, anemia, nausea, headache, insomnia, and diarrhea were noted.

Interaction with other drugs:
The use of Sofosbuvir and Velpatasvir is not recommended with drugs that are P-gp inducers and/or CYP2B6 inducers, as these combinations may result in a significant decrease in plasma levels of Sofosbuvir and Velpatasvir. Please note that the solubility of Velpatasvir decreases as gastric pH increases, and drugs that increase gastric pH may decrease the concentration of Velpatasvir; Co-administration of proton pump inhibitors with Epclusa is also not recommended.

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