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## Overview
Tabvoihep is a combination product containing sofosbuvir and velpatasvir, used for the treatment of chronic hepatitis C virus (HCV) infection. Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B polymerase. Velpatasvir is an inhibitor of the HCV NS5A protein.
## Primary Indications
Treatment of chronic hepatitis C virus (HCV) infection:
* Genotype 1, 2, 3, 4, 5, or 6 without cirrhosis or with compensated cirrhosis.
* Genotype 1, 2, 3, 4, 5, or 6 with decompensated cirrhosis (in combination with ribavirin).
## Adult Dosing
One tablet (sofosbuvir 400 mg/velpatasvir 100 mg) orally once daily.
* Treatment duration is typically 12 weeks for patients without cirrhosis or with compensated cirrhosis.
* Treatment duration is 12 weeks in combination with ribavirin for patients with decompensated cirrhosis. Consult specific guidelines or product information for ribavirin dosing.
## Pediatric Dosing
Not established.
## Dose Adjustments
No dose adjustment is necessary for patients with mild, moderate, or severe renal impairment (eGFR < 30 mL/min/1.73 m²). However, data is limited in this population, and caution is advised. No dose adjustment is necessary for patients with mild or moderate hepatic impairment (Child-Pugh A or B). In patients with severe hepatic impairment (Child-Pugh C), sofosbuvir/velpatasvir is not recommended without ribavirin. If used with ribavirin in severe hepatic impairment, dose adjustment of ribavirin may be necessary based on local protocol.
## Contraindications
* Concomitant use with strong P-glycoprotein (P-gp) inducers such as rifampin, St. John's wort, and carbamazepine, as they may significantly decrease sofosbuvir and velpatasvir plasma concentrations.
## Adverse Effects
The most common adverse effects include headache and fatigue. Less common but serious adverse effects may include:
* Hepatitis B virus (HBV) reactivation in patients coinfected with HBV.
* Bradycardia, especially when used with amiodarone or other drugs that cause bradycardia.
* Rash.
## Key Drug Interactions
* **Amiodarone:** Increased risk of severe symptomatic bradycardia.
* **Strong P-gp inducers (e.g., Rifampin, St. John's Wort, Carbamazepine):** Significant decrease in sofosbuvir and velpatasvir concentrations. Avoid concomitant use.
* **Antacids (Aluminum/Magnesium Hydroxide):** May decrease velpatasvir exposure. Separate administration by at least 4 hours.
* **Certain Antiretrovirals (e.g., Tenofovir Disoproxil Fumarate):** Increased tenofovir exposure. Monitor renal function.
* **Other direct-acting antivirals (DAAs):** Potential for drug-drug interactions. Consult specific product information.
## Monitoring
* HCV RNA levels to assess treatment response.
* Liver function tests.
* Hepatitis B serological markers in patients coinfected with HBV.
* Heart rate and rhythm in patients taking amiodarone or other medications known to cause bradycardia.
* Renal function if co-administered with certain antiretrovirals.
## Clinical Pearls
* Always test for HBV infection before initiating therapy.
* Consider treatment duration based on HCV genotype, prior treatment history, and presence/severity of cirrhosis.
* Ensure patients are not taking St. John's wort or other strong P-gp inducers.
* Counsel patients on the potential for HBV reactivation and the importance of follow-up.
**Disclaimer:** This information is intended for clinical pharmacist use. Always refer to the most current prescribing information and institutional protocols for definitive guidance.