Generic Name: sofosbuvir/velpatasvir/voxilaprevir
Abbreviation: SOF + VEL + VOX
Other Market Name: N/A
Drug Class: Multi-Class Combination Drugs
Company: Gilead Sciences
Approval Status: Approved
Generic Version Available: No
Experimental Code: GS-7977 + GS-5816 + GS-9857
This drug regimen was approved by the FDA to treat genotypes 1 through 6 in adults without cirrhosis or with compensated cirrhosis, and who have previously been treated with an HCV regimen containing an NS5A inhibitor, or have genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Vosevi has not yet been reviewed for inclusion in the AASLD/IDSA list of recommended HCV treatments.
Vosevi contains an approved nucleotide analog NS5B polymerase inhibitor (sofosbuvir) and NS5A inhibitor (velpatasvir), and an NS3 protease inhibitor (voxilaprevir).
- In clinical studies, approximately 96-97 percent of participants were cured with 12 weeks of therapy.
Vosevi was approved by the U.S. Food and Drug Administration for treatment of chronic hepatitis C infection in adults for all genotypes on July 18, 2017.
Adult Dose: Vosevi combines thress drugs into a single tablet taken orally once daily with food for 12 weeks.
Pediatric Dose: N/A
Dosing Info: Treatment recommendations for Vosevi are determined by genotype and prior treatment experience.
The most common side effects are headache, fatigue, diarrhea and nausea.
- Before taking this medication, tell your medical provider and pharmacist about any drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit.
- Vosevi should not be taken with certain drugs and herbs that are metabolized in the liver and intestines such as St. John’s wort, cyclosporine, and rifampin. Additional drug-drug interactions may occur, and these are listed in Vosevi’s full prescribing information. Potential interactions are listed at hep-druginteractions.org.
- Warning: Patients who are coinfected with hepatitis B and C who take this medication may be at risk of hepatitis B virus (HBV) reactivation. Before taking this medication, be sure your doctor has tested you for evidence of current or prior hepatitis B virus infection. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in serious hepatitis flares, liver failure, and death.
- There are no adequate, well-controlled studies in pregnant women who have taken Vosevi. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- The safety of breast feeding while taking Vosevi has not been established.
For More Info: http://www.mysupportpath.com
Co-Pay Program Info: http://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment
Patient Assistance Program Info: http://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment
Last Revised: July 18, 2017