Hepcvel

Product Name Velpatasvir + Sofosbuvir
Dose/Strength 400 mg + 90 mg
Packaging Size 28 Tablet
Brand

Salt

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Description

Hepcvel (sofosbuvir 400mg + velpatasvir 100mg) is a fixed-dose combination (FDC) drug recommended against chronic hepatitis C viral (HCV) infection in adults. Among the 9 different genotypes of HCV, the Hepcvel (sofosbuvir 400mg + velpatasvir 100mg) is specified for patients suffering from HCV genotype 1 to 6.

The FDC combination belongs to the class of direct-acting antiviral (DAA) drugs which explicitly inhibits a specific type of proteins (RNA polymerase) that stops the multiplication (RNA replication) of cells reducing the viral load. Sofosbuvir 400 mg inhibits NS5B protein whereas Velpatasvir inhibits NS5A protein.

Sustained virologic response (SVR) rates of Hepcvel (sofosbuvir 400mg + velpatasvir 100mg)

HCV disease type Overall SVR rate (%) Duration (weeks) Other anti-HCV agents
Without cirrhosis or cirrhosis with a functional system   98-100 12 No
Cirrhosis with an unfunctional system  86-94 12-24 With or without ribavirin

The FDC combination is known for their unique characteristics like,

  • Treatment of almost all genotypes (1-6) of HCV infection
  • Simple, 12-week drug regimen
  • The favourable safety profiles
  • An SVR between 95 to 100% after 12 weeks of treatment
  • More than 90% of SVR in HCV patients with scarring of the liver (cirrhosis) irrespective of genotype

Administration of Hepcvel (sofosbuvir 400mg + velpatasvir 100mg):

The drug is administered in a form a fixed-dose combination i.e. 1 tablet (sofosbuvir + velpatasvir combination) once daily. It can be taken with or without food.

Suggested dosage of Hepcvel (sofosbuvir 400mg + velpatasvir 100mg) in patients with genotype 1,2,3,4,5, or 6 HCV:

  1. Without cirrhosis or cirrhosis with a functional system: Hepcvel (sofosbuvir 400mg + velpatasvir 100mg) for 12 weeks
  2. Cirrhosis patients with an unfunctional system: Hepcvel (sofosbuvir 400mg + velpatasvir 100mg) plus ribavirin for 12 weeks

Other properties of FDC combination drug:

Properties Sofosbuvir 400 mg Velpatasvir 100 mg
Absorption in the system (Bio-availability 30 minutes to 2 hours 3 hours
Binding affinity with cancer cells 61 to 65% 99%
Metabolism Liver Liver
Excretion time 40 minutes to 27 hours for 50% drug molecule 15 hours

When should Hepcvel (sofosbuvir 400mg + velpatasvir 100mg) be avoided or used cautiously?

  • If patients are suffering from or had a history of Hepatitis B viral infection before taking sofosbuvir.
  • If patients are suffering from kidney disease or undergoing dialysis or other severe medical condition
  • If patients had a liver transplant before the initiation of dosage
  • If patients have complications in the liver other than HCV infection
  • If patients are pregnant and planning to breastfeed

Side-effects of Hepcvel (sofosbuvir 400mg + velpatasvir 100mg)

The FDC combination has a decent safety and tolerability profile with minimal side-effects. Due to its safety profile, it has therapeutic benefits over other anti-HCV combinational drugs.

Most common side-effects:

  • Headache
  • Tiredness (Fatigue)

Serious side-effects: Slow heart rate (bradycardia)

Side-effects in HCV patients without cirrhosis or cirrhosis with a functional system:

  • Nausea
  • Physical weakness (Asthenia)
  • Lack of sleep (Insomnia)
  • Headache
  • Tiredness

Side-effects in HCV patients with cirrhosis and an unfunctional system:

  • Diarrhea
  • Low count of red blood cells (RBCs) (Anemia)
  • Lack of sleep
  • Headache
  • Tiredness
  • Nausea

Uncommon side-effects: 

  • Depression
  • Severe rashes on the skin

Note: These are not all possible side-effects of Hepcvel (sofosbuvir 400mg + velpatasvir 100mg), please ask your doctor for more information regarding the same.

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