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# Tabvolhep (velpatasvir/sofosbuvir) ## Overview Tabvolhep is a fixed-dose combination of velpatasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor. It is used for the treatment of chronic hepatitis C virus infection. ## Primary Indications Treatment of chronic hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5, and 6 infection without cirrhosis or with compensated cirrhosis. ## Adult Dosing The recommended dose is one tablet (velpatasvir 100 mg/sofosbuvir 400 mg) taken orally once daily. * **Duration:** * Genotypes 1, 2, 3, 4, 5, 6 without cirrhosis: 12 weeks. * Genotypes 1, 2, 3, 4, 5, 6 with compensated cirrhosis: 12 weeks. * In cases of prior treatment failure with an NS5A inhibitor and in patients with specific resistance-associated substitutions, treatment duration may be extended to 24 weeks, based on local protocol or specialist guidance. ## Pediatric Dosing The safety and efficacy in pediatric patients younger than 18 years have not been established. ## Dose Adjustments No dose adjustments are required for patients with mild, moderate, or severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease (ESRD) requiring hemodialysis. However, potential benefits and risks should be carefully considered. Dose adjustments are not needed for patients with hepatic impairment (Child-Pugh A, B, or C). ## Contraindications * Hypersensitivity to velpatasvir or sofosbuvir or any excipient in the formulation. * Concomitant use with strong P-glycoprotein (P-gp) inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort). ## Adverse Effects Common adverse effects include headache and fatigue. Less common but serious adverse effects can include bradycardia when used with amiodarone or other drugs that prolong the QT interval. ## Key Drug Interactions * **Strong P-gp Inducers:** Concomitant use with strong P-gp inducers significantly decreases velpatasvir and sofosbuvir concentrations, leading to loss of efficacy. Avoid coadministration. * **Amiodarone and other QT-prolonging agents:** Coadministration with amiodarone can lead to symptomatic bradycardia, potentially requiring monitoring. * **Antacids:** Separate administration of H2-receptor antagonists or proton pump inhibitors from Tabvolhep by at least 4 hours. ## Monitoring * HCV RNA levels to confirm sustained virologic response (SVR) post-treatment. * Monitor for bradycardia if coadministered with amiodarone. * Liver function tests. ## Clinical Pearls * Tabvolhep can be taken with or without food. * Ensure treatment duration is appropriate for the specific genotype and presence/absence of cirrhosis. * Consult prescribing information for a comprehensive list of drug interactions, especially with P-gp inducers. *** *Disclaimer: This information is intended for clinical pharmacists and prescribers. It is essential to consult the most current prescribing information and relevant clinical guidelines for definitive patient management decisions. This information does not substitute for professional clinical judgment.*