Finished product reference
Sofosbuvir / Velpatasvir
Tablet · Oral · 400 mg/100 mg
- List code
- 51994
- Pharmacologic class
- Hepatitis C Virus NS5A Inhibitor · Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir and velpatasvir.
What it is and how it works
Mechanism of Action Sofosbuvir and velpatasvir tablets (400 mg/100 mg) are a fixed-dose combination of sofosbuvir and velpatasvir, which are direct-acting antiviral agents against the hepatitis C virus .
Mechanism class: Breast Cancer Resistance Protein Inhibitors · P-Glycoprotein Inhibitors · Organic Anion Transporting Polypeptide 1B1 Inhibitors
Indications
Sofosbuvir and velpatasvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection : without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin. Sofosbuvir and velpatasvir is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection : without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin.
Dosage and administration (summary)
Testing prior to the initiation of therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. See recommended treatment regimen and duration in patients 3 years of age and older with genotypes 1, 2, 3, 4, 5, or 6 HCV in table below: Patient Population Regimen and Duration Treatment-naïve and treatment-experienced In clinical trials, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir).
Contraindications
Sofosbuvir and velpatasvir and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin . Sofosbuvir and velpatasvir and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated.
Warnings and precautions
Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Pregnancy
Pregnancy Risk Summary If sofosbuvir and velpatasvir is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy.
Storage and supply
Store below 30 °C (86 ºF).
Source: Velpatasvir And Sofosbuvir (Sofosbuvir And Velpatasvir) — US FDA prescribing information, 2025-03-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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