Velpanex (Sofosbuvir 400 mg + Velpatasvir 100 mg)

Technical Composition and Classification

Each Velpanex tablet is a film-coated, fixed-dose combination (FDC). Each tablet contains two primary Direct-Acting Antivirals (DAAs):

• Sofosbuvir (INN): 400 mg

• Velpatasvir (INN): 100 mg

This combination is classified as a pangenotypic regimen, meaning it is scientifically validated to treat all six major genotypes (GT1 through GT6) of the Hepatitis C virus.

Clinical Indications

The Sofosbuvir/Velpatasvir combination is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adult patients. Its application is divided into two primary clinical categories:

1. Monotherapy (12-week course): For patients without cirrhosis or those with compensated cirrhosis (Child-Pugh A).

2. Combination Therapy (12-week course with Ribavirin): For patients with decompensated cirrhosis (Child-Pugh B or C).

Mechanism of Action

The therapeutic efficacy of this combination relies on the dual inhibition of the viral replication cycle.

• Sofosbuvir: A nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase. It acts as a “chain terminator,” effectively stopping the virus from copying its genetic material.

• Velpatasvir: A potent inhibitor of the HCV NS5A protein. NS5A is a non-structural protein required for both viral RNA replication and the assembly of new virus particles.

By targeting two distinct stages of the viral life cycle, the combination reduces the risk of the virus developing resistance and achieves high Sustained Virological Response (SVR) rates, often exceeding 95% in clinical trials.

Dosage and Administration

The standardized adult dosage is one tablet once daily, taken orally.

Administration Notes:

• The tablet can be taken with or without food.

• Consistency in timing is recommended to maintain stable plasma concentrations.

• If a dose is missed, it should be taken as soon as remembered, unless it is close to the time for the next dose. Two doses should not be taken simultaneously.

Safety Profile and Contraindications

Contraindications

• Hypersensitivity: Known allergic reactions to Sofosbuvir, Velpatasvir, or any excipients in the tablet.

• Ribavirin Co-administration: When used with Ribavirin, all contraindications for Ribavirin apply (e.g., pregnancy, certain hemoglobinopathies).

Warnings and Precautions

• HBV Reactivation: There is a documented risk of Hepatitis B Virus (HBV) reactivation in patients co-infected with HCV and HBV. Patients should be screened for HBV before starting therapy.

• Bradycardia: Serious symptomatic bradycardia (slow heart rate) has occurred when the combination is used with Amiodarone. Co-administration with Amiodarone is generally not recommended.

• Drug Interactions: Medications that significantly reduce gastric acid (like high-dose Proton Pump Inhibitors) or induce P-gp/CYP (like Rifampin or St. John’s Wort) may decrease the therapeutic effect.

Adverse Reactions

In clinical studies, the most frequently reported side effects were mild and included:

• Headache

• Fatigue

• Nausea

• Asthenia (physical weakness)

• Insomnia

• Anaemia (primarily when used with Ribavirin)

Use in Specific Populations

• Pregnancy: There is insufficient data to determine the risk to human pregnancy. However, if used with Ribavirin, the regimen is strictly contraindicated in pregnant women and their male partners due to Ribavirin’s known teratogenic effects.

• Lactation: It is unknown if the components are excreted in human breast milk. Consultation with a healthcare provider is required.

• Pediatric Use: While some regions have approved use in children aged 3 and older, standard adult formulations (400mg/100mg) require specific medical guidance for pediatric patients.

• Renal Impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. For patients with end-stage renal disease (ESRD), clinical data is evolving, and specialist consultation is necessary.

• Hepatic Impairment: No dosage adjustment is required for patients with mild, moderate, or severe hepatic impairment.

Storage and Handling

• Temperature: Store at room temperature, ideally below 30°C (86°F). (Note: Avoid extreme heat).

• Environment: Keep the medication in its original container to protect it from moisture.

• Safety: Ensure the medication is stored out of reach of children and pets.

Global Pricing and Availability (2026 Data)

The cost of Sofosbuvir and Velpatasvir varies significantly depending on local healthcare subsidies, patent status, and the use of generic versions.

Bangladesh (Generic Market)

Bangladesh is a major hub for high-quality generic DAAs. Brands such as Velpanex, Fixvel, and Panovir are widely available.

• Unit Price: Approximately ৳ 1,000 BDT per tablet.

• Full Course (12 Weeks/84 Tablets): Approximately ৳ 84,000 BDT.

• USD Equivalent: ~$250.00 – $280.00 USD per 28-tablet box (~$750 – $840 per full course).

Australia (Subsidized vs. Private)

Australia provides access to these medications through the Pharmaceutical Benefits Scheme (PBS), but private or imported costs differ.