Velpaclear Tablet (Sofosbuvir (400mg) + Velpatasvir (100mg))

Velpaclear Tablet combines sofosbuvir 400 mg, an HCV NS5B nucleotide polymerase inhibitor, with velpatasvir 100 mg, a pan-genotypic NS5A inhibitor. It is a direct-acting antiviral (DAA) regimen used to cure chronic hepatitis C across major HCV genotypes. Treatment selection depends on cirrhosis status, prior DAA exposure, renal function, drug interactions, and, in decompensated cirrhosis, whether ribavirin can be used. The regimen is usually one tablet once daily under strict doctor supervision.

Velpaclear Tablet is used in the treatment of:

• Chronic hepatitis C (HCV) infection
  

Sofosbuvir 400mg tablets are an antiviral therapy that prevents the replication of HCV and enables the immune system to get rid of the virus. In patients who have never been treated before for HCV and do not have cirrhosis or compensated cirrhosis, the treatment usually takes 12 weeks. However, for patients who have decompensated cirrhosis, the therapy requires 12 weeks plus ribavirin. Also, before the treatment, patients are screened for hepatitis B due to the reactivation of the virus by the drug.

Sofosbuvir tablet is converted into an active drug in the body and inhibits NS5B, which is an enzyme required by HCV to replicate its RNA. This prevents replication of the virus. On the other hand, Velpatasvir 100mg tablet inhibits NS5A, which is required for replication of the RNA and formation of new virus particles. However, both drugs prevent multiplication of HCV.

ASTRAL-1 to ASTRAL-4: In these extensive clinical trials, it was evident that Velpaclear Tablet had the potential to attain sustained viral response in patients with various HCV genotypes and varying degrees of cirrhosis.

Real-world evidence: High rates of cure have been found through studies that involved patients who received treatment in their usual health care environment.

Velpatasvir 100 mg tablet is a safe medication; however, there might be some adverse effects on the health of some individuals. These might range from mild adverse effects to those requiring medical treatment. Some common side effects include:

Common side effects

• Headache
• Fatigue
• Nausea

Serious side effects

• Serious bradycardia with amiodarone-containing regimens
• HBV reactivation
• Drug-interaction-related virologic failure
  

Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine, or substitute treatment based on website information.

Take a missed dose as soon as remembered if it is not close to the next dose; do not double. Adherence is important to maximize cure and prevent treatment failure.

• It is important that HCV RNA be tested during appropriate times to determine the effectiveness of the treatment in removing the hepatitis C virus.
• HBV testing is recommended prior to therapy due to the possible reactivation of hepatitis B.
• Liver disease stage needs to be evaluated due to the possibility of advanced liver disease.
• Drug interactions are necessary in order to avoid complications due to other drugs.
• Evaluation of kidney function may be necessary depending on the condition of the patient.
• Adherence needs to be determined in order to finish the treatment course properly.
  

• Current sofosbuvir/velpatasvir prescribing information (Epclusa/reference) https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf​
• Feld JJ, et al. ASTRAL-1. New England Journal of Medicine https://pubmed.ncbi.nlm.nih.gov/26571066/​
• Curry MP, et al. ASTRAL-4. New England Journal of Medicine https://www.nejm.org/doi/full/10.1056/NEJMoa1512614​
• Current AASLD-IDSA/EASL HCV guidance https://www.idsociety.org/practice-guideline/hcv-guidance/​