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Velpanat is used for the treatment of chronic hepatitis C virus (HCV) infection in adults. The medication is a fixed‑dose combination of sofosbuvir (a nucleotide polymerase inhibitor) and velpatasvir (an NS5A inhibitor) that directly blocks viral replication across all major HCV genotypes (1‑6).
The usual dosage of Velpanat is one tablet (400 mg sofosbuvir / 100 mg velpatasvir) once daily, with or without food.
The administration form is film‑coated tablets.
The effect of the medication begins within several days to weeks, with undetectable viral load typically achieved after 4‑8 weeks of treatment.
The duration of action is typically 12 weeks, depending on the presence of cirrhosis and prior treatment history.
Alcohol consumption is not recommended during treatment.
The most common side effects are headache and fatigue.
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Basic Velpanat Information

• INN (International Nonproprietary Name): Sofosbuvir / Velpatasvir
• Brand names available in USA: Epclusa®
• ATC Code: J05AP51
• Forms and dosages: Film‑coated tablets – 400 mg sofosbuvir / 100 mg velpatasvir
• Manufacturers in USA: Gilead Sciences, Inc.
• Registration status in USA: Approved by FDA
• OTC / Rx classification: Prescription only (Rx)

Mechanism and Pharmacology

Velpanat contains sofosbuvir, a nucleotide analog inhibitor of HCV NS5B RNA‑dependent RNA polymerase, and velpatasvir, an inhibitor of HCV NS5A protein. Sofosbuvir is incorporated into viral RNA and acts as a chain terminator, while velpatasvir disrupts viral replication complex formation. The combination provides pan‑genotypic activity against HCV genotypes 1‑6, with a high barrier to resistance. Both drugs are metabolized primarily in the liver and excreted via the kidneys.

Indications and Usage

Velpanat is indicated for the treatment of chronic hepatitis C virus infection in adults with genotype 1, 2, 3, 4, 5, or 6 infection, without cirrhosis or with compensated cirrhosis (Child‑Pugh A), as well as for patients with decompensated cirrhosis (Child‑Pugh B or C) when used in combination with ribavirin. It is also indicated for patients with HCV/HIV‑1 coinfection. Velpanat is a direct‑acting antiviral that achieves cure (sustained virological response at 12 weeks post‑treatment, SVR12) in over 95% of patients.

Critical Warnings and Limitations

High‑Risk Groups
Elderly: No dose adjustment required based solely on age; use with caution in patients with significant renal impairment.
Pregnancy: Not recommended during pregnancy when used with ribavirin (ribavirin is teratogenic). For Velpanat alone, there are insufficient data; use only if potential benefit justifies potential risk.
Breastfeeding: Unknown whether sofosbuvir or velpatasvir passes into breast milk; advise caution.

Activity Interactions
Driving: May cause fatigue or headache – use caution when operating vehicles or machinery.
Alcohol: Avoid alcohol consumption as it may worsen liver damage and reduce treatment adherence.

Dosage Guide

Standard Regimens
One tablet (400 mg sofosbuvir / 100 mg velpatasvir) taken orally once daily with or without food.
Treatment duration:
- Patients without cirrhosis or with compensated cirrhosis (Child‑Pugh A): 12 weeks.
- Patients with decompensated cirrhosis (Child‑Pugh B or C): 12 weeks plus ribavirin (weight‑based).
- For patients with genotype 3 and prior treatment experience, 12 weeks with ribavirin may be considered.

Special Populations
Renal impairment: For eGFR ≥30 mL/min, no dose adjustment. For eGFR Hepatic impairment: No dose adjustment for mild, moderate, or severe (Child‑Pugh A, B, C) hepatic impairment.
Pediatric: Safety and efficacy in children under 18 years have not been established for this combination.

Side Effects and Contraindications

Common side effects:
- Headache
- Fatigue
- Nausea
- Insomnia
- Diarrhea
- Upper respiratory tract infection

Serious side effects requiring medical attention:
- Symptomatic bradycardia when coadministered with amiodarone
- Hepatitis B reactivation in patients coinfected with HBV and HCV (screen all patients for HBV)
- Severe allergic reactions (rash, angioedema, bronchospasm)
- Depression or suicidal ideation (rare)

Absolute contraindications:
- Hypersensitivity to sofosbuvir, velpatasvir, or any excipient
- Coadministration with potent P‑gp inducers (e.g., rifampin, St. John’s wort, carbamazepine)
- For the ribavirin‑containing regimen: pregnancy, severe renal impairment (eGFR

Drug Interactions

Significant interactions include:
- Potent P‑gp and CYP inducers (rifampin, carbamazepine, phenytoin, St. John’s wort): Decrease sofosbuvir/velpatasvir levels – contraindicated.
- Amiodarone: Risk of severe bradycardia and heart block – avoid coadministration or monitor closely.
- Antacids (aluminum/magnesium) and H2 blockers: Separate administration by at least 4 hours.
- Proton pump inhibitors (e.g., omeprazole): Can reduce velpatasvir exposure; use the lowest effective dose or take Velpanat with food and separate dosing by 12 hours.
- Rosuvastatin: Velpatasvir increases rosuvastatin levels; use lowest necessary dose.
- Other HCV direct‑acting antivirals: May increase risk of additive effects – not recommended unless studied.

Practical Guidelines

Administration
Take Velpanat once daily at the same time each day, with or without food. Swallow tablet whole; do not crush or chew. If a dose is missed within 18 hours of the usual time, take it as soon as possible; if more than 18 hours have passed, skip the missed dose and take the next at the regular time. Do not double dose.

Monitoring
Regular blood tests required before and during treatment:
- HCV RNA viral load (baseline, week 4, end of treatment, and 12 weeks post‑treatment)
- Liver function tests (ALT, AST, bilirubin)
- Renal function (creatinine, eGFR)
- Pregnancy test for women of childbearing potential (if ribavirin is used)
- HBV screening (HBsAg, anti‑HBc) to detect risk of reactivation

Storage
Store at room temperature (20‑25°C / 68‑77°F), excursions permitted to 15‑30°C (59‑86°F). Protect from moisture and heat. Keep tablets in original bottle with desiccant; do not remove desiccant. Close tightly after each use.

Alternative Medications

• Harvoni (ledipasvir/sofosbuvir): For genotypes 1, 4, 5, 6; not pan‑genotypic.
• Mavyret (glecaprevir/pibrentasvir): Pan‑genotypic, 8‑week treatment for non‑cirrhotic patients.
• Vosevi (sofosbuvir/velpatasvir/voxilaprevir): For retreatment after prior DAA failure.
• Zepatier (elbasvir/grazoprevir): For genotypes 1 and 4; requires baseline resistance testing.
• Daklinza (daclatasvir) + sofosbuvir: For genotypes 1‑4; limited use.

Clinical Effectiveness

In pivotal clinical trials (ASTRAL‑1, ‑2, ‑3, ‑4, ‑5), Velpanat (Epclusa) achieved SVR12 rates of 95‑99% across all HCV genotypes 1‑6, including patients with compensated cirrhosis, prior treatment experience, and HIV coinfection. For patients with decompensated cirrhosis (Child‑Pugh B/C), SVR12 rates were 83‑94% when ribavirin was added. The pan‑genotypic profile eliminates the need for genotype testing, simplifying treatment. Velpanat is well‑tolerated with low rates of serious adverse events.

Important: Velpanat requires medical supervision and should only be used under prescription. Do not stop treatment without consulting your doctor. Complete the full course as prescribed to achieve cure. Regular monitoring for HBV reactivation and drug interactions is essential. If you experience signs of bradycardia (dizziness, fainting, chest pain) while on amiodarone, seek immediate medical attention.

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