This is a fixed-dose combination of sofosbuvir and velpatasvir, two antiviral medicines used together to treat chronic hepatitis C. It belongs to a class of medicines called direct-acting antivirals (DAAs), effective across all major hepatitis C genotypes. It is a prescription-only medicine.

• Therapeutic Class: Antiviral medicine for chronic hepatitis C.

• Pharmacological Class: HCV NS5B polymerase inhibitor (sofosbuvir) combined with HCV NS5A inhibitor (velpatasvir).

• Drug Family: Direct-acting antivirals (pangenotypic combination).

• ATC Classification: J05AP55 (Sofosbuvir and velpatasvir).

Approved: Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection, in adults and pediatric patients, without cirrhosis, with compensated cirrhosis, or with decompensated cirrhosis (used together with ribavirin in this last group).

Commonly used for: Adults and children with confirmed chronic hepatitis C, regardless of which genotype they have, making it a simplified single-tablet option.

Off-label use (only under medical guidance): Not typically used off-label, as its approval already spans all major HCV genotypes.

● Oral tablets: sofosbuvir 400 mg / velpatasvir 100 mg (standard adult strength), and a lower-strength 200 mg/50 mg tablet for younger or lower-weight patients.

● Oral pellets: 200 mg/50 mg and 150 mg/37.5 mg strengths, for younger children who cannot swallow tablets.

Sofosbuvir blocks an enzyme called NS5B polymerase that the hepatitis C virus needs to copy its genetic material, while velpatasvir blocks a different viral protein, NS5A, that the virus needs to assemble and replicate. Used together, they attack the virus at two different steps in its life cycle, making the combination effective across all major HCV genotypes.

Standard dose: One tablet (sofosbuvir 400 mg/velpatasvir 100 mg) taken orally once daily, with or without food, for 12 weeks.

Condition-wise dose: In patients with decompensated cirrhosis (Child-Pugh B or C), ribavirin is added, using weight-based dosing, for the same 12-week duration.

Route: Oral, once daily.

Missed dose: Take as soon as remembered on the same day; if a full day has passed, don't double up — take the next dose as scheduled and discuss with the doctor.

Overdose: No specific antidote; managed with supportive care and monitoring.

• Common: Headache and fatigue.

• Serious: Reactivation of hepatitis B virus in patients co-infected with both hepatitis B and C (boxed warning), and, when combined with amiodarone, serious slow heart rate (bradycardia).

• Emergency symptoms: Signs of liver problems (yellowing of skin/eyes, dark urine, severe fatigue), or symptoms of a very slow heart rate if also taking amiodarone.

• Recovery advice: Headache and fatigue are generally mild and don't usually require stopping treatment; report any new or worsening symptoms to the treating doctor.

• Pregnancy: Used only if clearly needed; if given with ribavirin, ribavirin's own significant pregnancy precautions apply.

• Breastfeeding: Discussed with the treating doctor, particularly if ribavirin is also used.

• Liver disease: The medicine itself treats the underlying liver infection; dosing adjusts based on the severity of cirrhosis.

• Kidney disease: No dose adjustment needed in mild/moderate impairment; limited data in severe impairment.

• Elderly: Used with routine monitoring; no specific age-based dose adjustment.

• Children: Approved from 3 years of age and older (or weighing at least 17 kg), with weight-based tablet or pellet dosing.

● Amiodarone: combining with sofosbuvir/velpatasvir can cause serious slow heart rate; generally avoided.

● Proton pump inhibitors, certain anti-seizure medicines (phenobarbital, phenytoin), rifabutin, rifapentine, efavirenz: not recommended, as they significantly reduce drug levels.

● Tenofovir-containing HIV medicines: levels of tenofovir may increase; monitored for tenofovir-related side effects.

● Antacids and acid-reducing medicines: velpatasvir absorption decreases as stomach acidity decreases; antacids should be separated by several hours.

● Hepatitis B virus testing before starting treatment.

● Liver function tests during and after treatment.

● HCV RNA testing to confirm cure (sustained virologic response) 12 weeks after completing treatment.

● ECG monitoring if used with amiodarone.

Glecaprevir/pibrentasvir, Sofosbuvir/ledipasvir (other direct-acting antiviral combinations).

This is itself a fixed combination of two antivirals; ribavirin is added specifically for patients with decompensated cirrhosis.

● Hepatitis C Medicines

● Direct-Acting Antivirals

● Chronic Liver Disease Treatments

1. https://hcp.epclusa.com/dosing

2. https://reference.medscape.com/drug/epclusa-sofosbuvir-velpatasvir-1000076

The information on this page is for educational purposes only and is not a substitute for medical advice. Please consult your doctor to know if this treatment is appropriate for your condition.