Tab%252525252525252525252525252525252525252525252520voihep

# Tabovoihep (Sofosbuvir/Velpatasvir) ## Overview Tabovoihep is a fixed-dose combination of sofosbuvir, a nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B polymerase, and velpatasvir, an inhibitor of the HCV NS5A protein. ## Primary Indications Treatment of chronic hepatitis C virus infection in adults and pediatric patients (3 years and older or weighing at least 15 kg). Specific genotypes and treatment-naive/experienced status dictate regimen choice and duration. ## Adult Dosing * **Recommended Dose:** One tablet (SOF 400 mg/VEL 100 mg) orally once daily. * **Duration:** Typically 12 weeks, but may be 8 weeks for genotype 1, 2, 3, 4, 5, or 6 treatment-naïve patients with no cirrhosis and undetectable baseline NS5A resistance-associated substitutions (RAVs). May be 24 weeks for certain genotype 3 patients with prior treatment failure. Refer to specific guidelines for genotype and treatment history. ## Pediatric Dosing * **Ages 3 Years and Older and Weighing at Least 15 kg:** * **15 kg to < 30 kg:** One pediatric tablet (SOF 200 mg/VEL 50 mg) orally once daily. * **30 kg to < 60 kg:** One pediatric tablet (SOF 400 mg/VEL 100 mg) orally once daily. * **≥ 60 kg:** One adult tablet (SOF 400 mg/VEL 100 mg) orally once daily. * **Duration:** Typically 12 weeks, but refer to specific guidelines based on genotype and treatment history. ## Dose Adjustments No dose adjustment is required for patients with mild, moderate, or severe renal impairment. Use in patients with severe renal impairment or end-stage renal disease (ESRD) should be based on benefit-risk assessment, as efficacy and safety have not been fully established. No dose adjustment is necessary for mild or moderate hepatic impairment. Caution and close monitoring are advised in patients with severe hepatic impairment (Child-Pugh C); co-administration with ribavirin may be necessary based on clinical assessment. ## Contraindications * Hypersensitivity to the active substances or any of the excipients. * Strongly contraindicated with coadministration of oxcarbazepine. ## Adverse Effects Common adverse effects include headache and fatigue. Less common but serious adverse effects include bradycardia (especially when co-administered with amiodarone). ## Key Drug Interactions * **Amiodarone:** Increased risk of severe symptomatic bradycardia. Monitor heart rate closely; avoid concurrent use if possible. * **Oxcarbazepine:** Potent inducer of CYP3A4, leading to significantly reduced plasma concentrations of sofosbuvir and velpatasvir, potentially resulting in loss of efficacy. Contraindicated. * **Antacids:** May decrease velpatasvir exposure. Separate administration by at least 4 hours. * **Certain Anticonvulsants (e.g., carbamazepine, phenytoin):** May reduce exposure to sofosbuvir and velpatasvir. Monitor for virologic response. * **Rifampin and St. John's Wort:** May significantly decrease plasma concentrations of sofosbuvir and velpatasvir, leading to potential loss of efficacy. Avoid co-administration. ## Monitoring * HCV RNA levels to assess treatment efficacy. * Liver function tests. * Renal function. * Heart rate (if co-administered with amiodarone). ## Clinical Pearls * Treatment duration and specific regimen depend on HCV genotype, prior treatment history, and presence of cirrhosis. Always consult current AASLD or EASL guidelines. * Sofosbuvir/velpatasvir is generally well-tolerated. * Ensure patients are not taking medications that interact significantly with sofosbuvir or velpatasvir. * For patients with ESRD or severe renal impairment, consider the potential for increased exposure and limited safety data. **Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines before making treatment decisions.