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Velpanat

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Velpanat (Sofosbuvir, Velpatasvir) is a fixed-dose combination antiviral medication used for the treatment of chronic hepatitis C. It works by interfering with the proteins the virus needs to replicate, assisting the immune system in clearing the infection across various viral genotypes in adult patients.


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Product Sheet

Active Ingredient(s)
Sofosbuvir, Velpatasvir
Reference Brand
Epclusa
Manufacturer
Natco Pharma
Product Form
Tablet
Regulatory Classification
Rx
Primary Category
Hepatitis C Treatment
Product Category
Antivirals for treatment of HCV infections
Pharmacological Class
Direct-acting antivirals
Manufacturer Description
A curative treatment for chronic Hepatitis C across all major viral genotypes.
Mechanism of Action
A combination of two drugs that block the proteins (NS5B and NS5A) the Hepatitis C virus needs to grow and reproduce itself, eventually clearing the virus from the body.
Route of Administration
Oral
Onset Time
1-3 hours
Duration
24 hours
Contraindications
Concurrent use with potent CYP inducers (e.g., Rifampicin), Severe hypersensitivity
Severe Adverse Events
Hepatitis B reactivation, Severe bradycardia (when used with amiodarone), Liver impairment
Common Side Effects
Headache, Fatigue, Nausea
Uncommon Side Effects
Insomnia, Diarrhoea, Anaemia, Skin rash
Drug Interactions
Amiodarone, Digoxin, St. John's Wort, Proton pump inhibitors, Statins
Pregnancy Safety Warnings
Consult a doctor; limited data available.
Age Restrictions
Adults and children 6 years and older
Storage Guidelines
Store below 30°C.
Related Products
Maviret, Harvoni

Velpanat FAQ

What should I do if I miss a dose of Velpanat while traveling?

If you remember the missed dose on the same day, take it as soon as possible. If it is close to the time of your next scheduled dose, skip the missed tablet and continue with your regular once-daily schedule. Do not double the dose.

Can Velpanat be taken with antacids or proton-pump inhibitors?

Velpanat can be taken with antacids that do not contain aluminium or magnesium. Proton-pump inhibitors (e.g., omeprazole) do not significantly affect absorption, so they can be used together. Separate aluminium/magnesium-containing antacids by at least four hours.

Is Velpanat safe for people with mild kidney disease?

For patients with an estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher, no dose adjustment is required. However, severe renal impairment (eGFR < 30) is a relative contraindication because the metabolite of sofosbuvir can accumulate.

How does Velpanat differ from other hepatitis C treatments like Harvoni?

Both Velpanat and Harvoni contain a NS5B polymerase inhibitor and an NS5A inhibitor, providing pan-genotypic coverage. The primary difference lies in the specific agents: Harvoni combines ledipasvir with sofosbuvir, while Velpanat combines velpatasvir with sofosbuvir. Clinical outcomes are comparable, but the choice may depend on physician preference, drug-interaction profiles, or regional availability.

Will I need regular blood tests while on Velpanat?

Yes. Baseline HCV RNA, liver function, and renal function tests are required before starting therapy. During treatment, a repeat HCV RNA test at week 4 helps confirm viral suppression, and liver enzymes are usually checked once mid-course. A final HCV RNA test at 12 weeks post-treatment confirms cure (SVR).

Can I consume alcohol while being treated with Velpanat?

Moderate alcohol intake does not interfere with Velpanat’s efficacy, but heavy drinking can worsen liver damage and counteract the benefits of therapy. Discuss your alcohol consumption with your healthcare provider to determine a safe limit.

Is Velpanat compatible with my HIV medication regimen?

Velpanat may have moderate interactions with certain HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors, potentially reducing velpatasvir levels. Your prescriber can review your HIV regimen and may adjust doses or select alternative agents to avoid reduced effectiveness.

What are the signs of a serious reaction that require urgent care?

Seek immediate medical attention if you develop severe dizziness, fainting, a rapid drop in heart rate (bradycardia), significant yellowing of the skin or eyes (jaundice), or any signs of allergic reaction such as rash, swelling, or difficulty breathing.

How long does it take to achieve a cure after completing Velpanat?

Cure, defined as sustained virologic response, is assessed 12 weeks after finishing the 12-week course. If HCV RNA remains undetectable at that point, the infection is considered cured.

Do I need to continue any other medication after finishing Velpanat?

If you have underlying liver disease, especially cirrhosis, regular monitoring and possibly other supportive treatments (e.g., for portal hypertension) may continue. Otherwise, no antiviral therapy is required after confirmed SVR.

Velpanat: Antiviral Tablet Containing Sofosbuvir and Velpatasvir

Introduction

Velpanat is an antiviral medication that combines the active ingredients sofosbuvir (400 mg) and velpatasvir (100 mg) in a single tablet formulation. It belongs to the class of direct-acting antivirals (DAAs) used to treat chronic hepatitis C virus (HCV) infection. In the United Kingdom, Velpanat is a prescription-only medicine (POM) regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The tablet is designed for oral administration and is supplied in the strength 400 mg/100 mg.

How Velpanat Works in the Body

  • Sofosbuvir is a nucleotide analogue that inhibits the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. By terminating the RNA chain, it prevents the virus from copying its genetic material.
  • Velpatasvir blocks the NS5A protein, another key component of the HCV replication complex. Inhibition of NS5A disrupts viral assembly and release.

Together, the two agents provide a pan-genotypic attack on HCV, meaning they are active against all six major genotypes (1-6). The combined effect leads to rapid declines in viral load, typically achieving undetectable levels within weeks of starting therapy. Onset of action is within the first dose, with peak plasma concentrations reached in 3-5 hours. The drugs are primarily eliminated unchanged in the urine (sofosbuvir) and feces (velpatasvir).

Conditions Treated by Velpanat

  • Chronic hepatitis C infection (any genotype) in adult patients.
  • Velpanat is indicated for patients with compensated liver disease (no decompensation such as ascites or encephalopathy) and for those with compensated cirrhosis.

The medication is intended to achieve a sustained virologic response (SVR), which is considered a cure of HCV infection when viral RNA remains undetectable 12 weeks after treatment completion.

Off-Label and Investigational Applications

No robust, peer-reviewed evidence currently supports off-label use of the sofosbuvir/velpatasvir combination for indications outside chronic hepatitis C. Consequently, this section is omitted.

Who Should Not Use Velpanat?

Absolute Contraindications

  • Known hypersensitivity to sofosbuvir, velpatasvir, or any tablet excipient.
  • Current use of ribavirin in combination with sofosbuvir/velpatasvir, as safety data are lacking.

Relative Contraindications

  • Pregnancy - Sofosbuvir is classified as Pregnancy Category B1 in the UK; animal studies show no risk, but human data are limited. Velpatasvir is also Category B1. Women of child-bearing potential should use effective contraception during treatment and for at least 6 weeks after the last dose.
  • Severe renal impairment (eGFR < 30 mL/min/1.73 m²) - Sofosbuvir’s metabolite accumulates; dosing adjustment is not recommended.
  • Severe hepatic impairment (Child-Pugh class C) - Velpatasvir exposure may increase; use is not advised.

Special Populations

  • Elderly patients - No dose adjustment required, but careful monitoring is prudent due to potential comorbidities.
  • Patients with mild-to-moderate hepatic impairment (Child-Pugh A or B) - Standard dosing is appropriate.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Fatigue (commonly reported)
  • Headache
  • Nausea
  • Diarrhoea

These reactions are usually mild, transient, and resolve without intervention. Maintaining adequate hydration and taking the tablet with food can lessen gastrointestinal discomfort.

Serious Adverse Events

  • Elevated liver enzymes - Rare; monitor hepatic function especially in patients with existing liver disease.
  • Bradycardia - Extremely uncommon but reported when co-administered with certain anti-arrhythmic agents (e.g., amiodarone). Immediate medical review is warranted if a markedly slow heart rate occurs.

Drug Interactions

  • Major interactions (avoid co-administration):

  • Strong CYP3A4 inducers such as rifampicin, carbamazepine, phenytoin, and St. John’s Wort can reduce velpatasvir levels, risking treatment failure.

  • Amiodarone - May cause serious bradycardia; concurrent use requires cardiac monitoring and possible alternative therapy.

  • Moderate interactions (require dose adjustment or monitoring):

  • HIV protease inhibitors (e.g., darunavir, lopinavir) and non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz) can modestly lower velpatasvir concentrations.

  • Antacids containing aluminium or magnesium may reduce absorption of velpatasvir; separate administration by at least 4 hours is recommended.

  • Food and Lifestyle Interactions

  • Velpanat can be taken with or without food; a high-fat meal may slightly increase velpatasvir exposure but does not affect efficacy.

  • No known interaction with alcohol, but excessive intake can worsen underlying liver disease.

How to Take Velpanat

  • Standard regimen: One tablet (400 mg/100 mg) taken orally once daily for 12 weeks.
  • Administration: Swallow the tablet whole with a glass of water. Crushing, chewing, or splitting the tablet may alter drug release and is not advised.
  • Missed dose: Take the missed tablet as soon as remembered on the same day; if it is near the time of the next scheduled dose, skip the missed tablet and continue with the regular schedule. Do not double the dose.
  • Overdose: Symptoms may include nausea, vomiting, and abdominal pain. Seek emergency medical care; supportive treatment is the mainstay. No specific antidote exists.
  • Discontinuation: Therapy should not be stopped prematurely. If discontinuation is necessary, the provider will advise on monitoring for viral relapse.

Monitoring and Follow-Up

  • Baseline assessments: HCV RNA viral load, liver function tests (ALT, AST, bilirubin), renal function, and pregnancy test for women of child-bearing potential.
  • During treatment: HCV RNA at weeks 4 and 12 to confirm rapid viral decline; liver enzymes at least once mid-course.
  • End of therapy: HCV RNA 12 weeks after treatment completion to document SVR.
  • Post-treatment: Annual liver health evaluation is recommended for patients with pre-existing cirrhosis.

Storage and Handling

  • Store tablets at controlled room temperature (15-30 °C), away from moisture and direct sunlight.
  • Keep the container tightly closed and out of reach of children.
  • Do not use tablets beyond the printed expiry date.

Medication-Specific Glossary

Sofosbuvir
A nucleotide analogue that inhibits the HCV NS5B polymerase, halting viral RNA synthesis.
Velpatasvir
An NS5A inhibitor that interferes with viral assembly and release, providing pan-genotypic activity.
Sustained Virologic Response (SVR)
The absence of detectable HCV RNA in the blood 12 weeks after completing antiviral therapy, regarded as a cure.
NS5A inhibitor
A class of drugs that target the non-structural 5A protein, essential for HCV replication and assembly.
Pan-genotypic
Effective against all major HCV genotypes (1-6) without the need for genotype-specific dosing.

Medical Disclaimer

This article provides educational information about Velpanat and is not a substitute for professional medical advice. Treatment decisions, including use for unapproved indications, must be made under the guidance of a qualified healthcare provider. The content is intended for informational purposes and does not constitute medical recommendations. Always consult a physician before starting, stopping, or changing any medication regimen.

Information for Velpanat is sourced from established medical standards and updated frequently. It is provided for general guidance and should be confirmed with a healthcare professional before use.
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