Sofosbuvir and Velpatasvir is a fixed-dose combination antiviral medication used for the treatment of chronic hepatitis C virus (HCV) infection in adults. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor, while Velpatasvir is an NS5A inhibitor. This pan-genotypic combination offers a high cure rate (SVR12 >95%) across all six major HCV genotypes (1-6) without the need for ribavirin in most patients, representing a significant advancement in HCV therapy in India.
Adult: One tablet (Sofosbuvir 400mg + Velpatasvir 100mg) orally once daily, with or without food.
Note: Swallow the tablet whole with a glass of water. Do not crush, chew, or break. Can be taken with or without food, but should be consistent. If taken with an antacid, separate administration by at least 4 hours. If taken with an H2-receptor antagonist, administer simultaneously or 12 hours apart. If taken with a proton pump inhibitor (PPI), take the PPI simultaneously with food.
Sofosbuvir is a prodrug that undergoes intracellular phosphorylation to form the pharmacologically active uridine analog triphosphate (GS-461203). This analog acts as a defective substrate for the HCV RNA-dependent NS5B polymerase, causing chain termination during viral RNA replication. Velpatasvir directly inhibits the HCV NS5A protein, which is essential for viral RNA replication and virion assembly. The combination provides a high barrier to resistance and potent antiviral activity across all genotypes.
Pregnancy: Category B: No adequate human data. Animal studies show no risk. Use only if clearly needed. Ribavirin, if used in combination, is Category X and contraindicated in pregnancy.
Driving: Dizziness and fatigue have been reported. Patients should be cautioned about driving or operating machinery if they experience these effects.
| Amiodarone | Risk of serious symptomatic bradycardia, potentially fatal. | Contraindicated |
| Rifampin / St. John's Wort / Carbamazepine / Phenytoin | Markedly decrease plasma concentrations of sofosbuvir/velpatasvir, leading to loss of virologic response. | Contraindicated |
| Antacids (Al, Mg) | Decrease velpatasvir absorption. Separate administration by at least 4 hours. | Major |
| H2-Receptor Antagonists (e.g., Famotidine) | May decrease velpatasvir levels. Administer simultaneously or 12 hours apart. | Moderate |
| Proton Pump Inhibitors (e.g., Omeprazole) | Significantly decrease velpatasvir levels. Use with caution at doses equivalent to omeprazole 20mg or lower, administered simultaneously with food. | Major |
| Rifabutin / Efavirenz | Decrease velpatasvir concentrations. Not recommended. | Major |
| Topotecan | Increased topotecan exposure. Avoid. | Major |
| Rosuvastatin / Atorvastatin | Increased statin exposure, increasing risk of myopathy/rhabdomyolysis. Use lowest possible statin dose. | Moderate |
| Digoxin | Increased digoxin concentration. Monitor digoxin levels. | Moderate |
| Tenofovir Disoproxil Fumarate (TDF) | Increased tenofovir exposure in patients receiving HIV regimen containing TDF. Monitor for TDF-associated adverse effects. | Moderate |
Same composition (Sofosbuvir (400mg) + Velpatasvir (100mg)), different brands: