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# Tabvoihep (Sofosbuvir/Velpatasvir)
## Overview
Tabvoihep is a fixed-dose combination containing sofosbuvir (a nucleotide analog NS5B polymerase inhibitor) and velpatasvir (an NS5A replication complex inhibitor). It is a pangenotypic direct-acting antiviral (DAA) used to treat chronic hepatitis C virus (HCV) infection.
## Primary Indications
Treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection in adults and pediatric patients ≥3 years old. Indicated for patients with or without compensated cirrhosis; in patients with decompensated cirrhosis, it is used in combination with ribavirin.
## Adult Dosing
* **Without decompensated cirrhosis:** 400 mg sofosbuvir/100 mg velpatasvir orally once daily for 12 weeks.
* **With decompensated cirrhosis (Child-Pugh B or C):** 400 mg/100 mg orally once daily for 12 weeks, plus weight-based ribavirin.
## Pediatric Dosing
Dosing is based on weight:
* **Weight 17 kg to <30 kg:** 200 mg sofosbuvir/50 mg velpatasvir once daily for 12 weeks.
* **Weight ≥30 kg:** 400 mg sofosbuvir/100 mg velpatasvir once daily for 12 weeks.
## Dose Adjustments
* **Renal Impairment:** No dose adjustment required for patients with mild, moderate, or severe renal impairment (including ESRD).
* **Hepatic Impairment:** No dose adjustment for mild, moderate, or severe hepatic impairment; however, use with ribavirin in decompensated cases requires ribavirin dose modification based on renal function and hemoglobin levels per local protocol.
## Contraindications
* Hypersensitivity to the active ingredients.
* When used in combination with ribavirin, all contraindications to ribavirin apply (e.g., pregnancy, hemoglobinopathies).
## Adverse Effects
* Common: Headache, fatigue, nausea, nasopharyngitis, insomnia.
* Serious: Risk of Hepatitis B Virus (HBV) reactivation. Symptomatic bradycardia has been reported when used in combination with amiodarone.
## Key Drug Interactions
* **Acid-reducing agents:** Proton pump inhibitors (PPIs) decrease velpatasvir absorption. Avoid if possible; if necessary, take 4 hours apart at a maximum dose equivalent to famotidine 40 mg twice daily.
* **P-gp/CYP inducers:** Avoid co-administration with rifampin, St. John’s wort, or carbamazepine as they significantly decrease DAA concentrations.
* **Amiodarone:** Avoid concomitant use due to the risk of severe, symptomatic bradycardia.
## Monitoring
* **Pre-treatment:** HBsAg and anti-HBc testing for all patients to assess HBV reactivation risk. Assessment of baseline renal function and liver function tests (LFTs).
* **On-treatment:** During therapy, monitor for signs of HBV reactivation. If ribavirin is used, monitor hemoglobin/hematocrit periodically.
* **Post-treatment:** Sustained Virologic Response (SVR) assessed by HCV RNA levels 12 weeks after completion of therapy.
## Clinical Pearls
* Take with or without food.
* If a dose is missed, it may be taken within 18 hours of the scheduled time; otherwise, skip the missed dose and resume the normal schedule.
* Patients should be screened for HBV prior to initiation, and active HBV should be managed concurrently if clinically indicated.
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*Disclaimer: This information is for educational purposes only. Always consult the most current official prescribing information (package insert) or a verified clinical decision support database before prescribing or administering medications.*
