On July 18, 2017, the U.S. Food and Drug Administration (FDA) approved Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for the re-treatment of adults with hepatitis C virus (HCV) who have previously been treated with certain antivirals. Vosevi is a medication that combines two previously approved drugs (sofosbuvir and velpatasvir) with a new drug (voxilaprevir).
Researchers have identified at least six genotypes, or strains, of the virus that causes hepatitis C. Most Americans with HCV (approximately 75%) have genotype 1, and another 20-25% have genotype 2 or 3. Genotypes 4, 5, and 6 are more rarely found in people with HCV. Knowing the genotype of HCV can help physicians guide treatment recommendations.
Vosevi is approved to treat adults with genotype 1, 2, 3, 4, 5, or 6 who have previously been treated with an NS5A inhibitor, or adults with genotype 1a or 3 who have previously been treated with a sofosbuvir regimen without an NS5A inhibitor.1,2
Clinical trial evidence of the benefit of Vosevi in hepatitis C
The effectiveness and safety of Vosevi was studied in two large clinical trials in adults with HCV who did not have cirrhosis (chronic liver damage with scarring) or who had mild cirrhosis. In the first trial, a 12-week course of Vosevi was compared against placebo (an inert substance) in patients with genotype 1 who had previously been treated with an NS5A inhibitor, as well as patients with genotypes 2, 3, 4, 5, or 6. The second trial compared a 12-week course of Vosevi to placebo in patients with genotypes 1, 2, or 3 who had previously had treatment with sofosbuvir. In both trials, 96-97% of patients treated with Vosevi had no HCV detected in their blood 12 weeks after completing treatment, suggesting that the HCV had been cured.1
Dosing of Vosevi
Vosevi comes in a tablet that is taking once daily with food. Each tablet contains 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir. Vosevi should be taken daily for a duration of 12 weeks.3
Side effects of Vosevi
The most common side effects experienced by people taking Vosevi were headache, fatigue, diarrhea, and nausea.2,3
Things to know about Vosevi
In patients who also have hepatitis B virus (HBV), treatment with Vosevi may reactivate their HBV infection, which may result in serious liver problems or death. All patients should be screened for a current or prior HBV infection before starting treatment with Vosevi.
Patients who are taking rifampin should not use Vosevi.
The medication amiodarone is not recommended for use in patients taking Vosevi due to the risk of bradycardia (abnormally slow heart beat), especially in patients who are taking beta blockers or who have cardiac problems or advanced liver disease. One patient who was taking amiodarone and a sofosbuvir containing regimen experienced a fatal cardiac arrest.
Other medications and herbs that can affect the concentrations of the ingredients in Vosevi and should not be taken during treatment with Vosevi include phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, tipranavir/ritonavir, efavirenz, rosuvastatin, pitavastatin, cyclosporine, St. John’s wort, and carbamazepine.1-3
U.S. Food and Drug Administration, press release. Accessed online on 7/19/17 at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm
Gilead Sciences, Inc. press release. Accessed online on 7/19/17 at http://www.gilead.com/news/press-releases/2017/7/us-food-and-drug-administration-approves-gileads-vosevi-sofosbuvirvelpatasvirvoxilaprevir-for-retreatment-of-adults-with-chronic-hepatitis-c-virus.
Vosevi prescribing information. Accessed online on 7/19/17 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209195s000lbl.pdf