Standard DoseOne tablet once daily with food. Each tablet contains 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir.
NS3/4A protease inhibitors, such as voxilaprevir, are not recommended for patients with moderate or severe liver impairment (Child-Pugh B/C), which is also called decompensated cirrhosis. Using Vosevi in decompensated cirrhosis may cause significantly higher amounts of voxilaprevir in the blood and may increase ALT (a liver enzyme).
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
Not FDA approved for use in HIV co-infection, but may be considered.
Black Box Warning
Before starting treatment with any direct-acting antiviral (DAA), including Vosevi, patients should take a blood test to check for hepatitis B (HBV) infection. HBV infection could get worse or reactivate during or after DAA treatment, potentially leading to serious liver problems, including liver failure or death. Patients with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment. See HBV Reactivation on page 33 for more information and consult your medical provider.
Patients previously treated with an HCV regimen containing:
|Length of treatment|
|1, 2, 3, 4, 5, 6||NS5A inhibitor*||12 weeks|
|1a or 3||Sofosbuvir** without
an NS5A inhibitor
* In clinical studies, this included daclatasvir, elbasvir, ledipasir, ombitasvir, and velpatasvir
** In clinical studies, this included sofosbuvir alone or in combination with any of the following: peginterferon/ribavirin, ribavirin, boceprevir, simeprevir, or telaprevir
AWP$29,904 / month
Potential Side Effects and Toxicity
Vosevi is very well tolerated with minimal side effects. In fact, in clinical trials, very few people—0.2%—discontinued treatment due to side effects. The most commonly reported side effects are headache, fatigue, diarrhea, and nausea. Asthenia (weakness), insomnia, rash, and depression have also been reported, but in less than 10% of people. All adverse events are generally mild to moderate in severity and similar between people with and without compensated cirrhosis. There are no significant lab abnormalities of concern. Vosevi has not been studied in pregnant women or nursing mothers, so its impact on fetal development or nursing babies is unknown.
Potential Drug Interactions
Be sure to tell your medical provider or pharmacist about all the medications, supplements, and herbal products you take, whether they are prescribed, over-the-counter, or illicit. It is important to report any changes as they happen during treatment. Vosevi should not be taken within 4 hours before or after you take antacids. If taking H2-receptor antagonists, take Vosevi at the same time or separate by 12 hours at a dose that does not exceed doses comparable to famotidine 40 mg twice per day. Use of proton pump inhibitors (PPI) is not recommended, but if medically necessary, Vosevi can be taken with a PPI comparable to omeprazole 20 mg or lower. Vosevi should not be taken with the following HIV medications: efavirenz, atazanavir, lopinavir/ritonavir, or tipranavir/ritonavir. Use caution and monitor renal function when taking Vosevi with tenofovir disoproxil fumarate (TDF). It should not be taken with the rifamycin antimicrobials, such as rifabutin, rifampin, or rifapentine, nor should it be taken with the anticonvulsants carbamazepine, phenytoin, phenobarbital, or oxcarbazepine. It cannot be taken with St. John’s wort; in general, herbal products should be avoided due to lack of information regarding potential for interaction. There are no interactions with methadone or other common medications used for opioid, alcohol, or nicotine dependency. Use with certain statins (cholesterol medicine) may cause increased risk of muscle pain (myopathy) or muscle breakdown (rhabdomyolysis). Your doctor should determine if your statin should be continued or changed during treatment with Vosevi. No sofosbuvir-based HCV regimens are to be used with amiodarone due to possible symptomatic bradycardia (slow heart rate). Signs of bradycardia include fainting, dizziness, lightheadedness, weakness, excessive fatigue, shortness of breath, chest pains, and confusion or memory problems. Consult a medical provider should any
of these symptoms occur.
Approved in 2017, Vosevi marks the next generation of Gilead drugs for treatment of hepatitis C and will provide people who have been considered difficult to treat with a new option to get cured. A very important update for Vosevi occurred in November, 2019: The FDA approved Vosevi’s use for people with kidney disease, including those on dialysis, with no need for dosage adjustment. Of particular importance is Vosevi’s effectiveness in people with previous DAA treatment experience and HCV drug resistance. It is FDA approved for the re-treatment of HCV in people who are treatment-experienced, and although it can be used off-label for the initial treatment of HCV, it’s best to use other options and save this one just in case it is needed later. In POLARIS-1, 97% of patients with GT1 achieved SVR12 (cure), and neither compensated cirrhosis nor presence of baseline resistance mutations appeared to affect outcomes. This is a wonderful achievement and offers hope to people living with HCV-associated cirrhosis. See the chart below for general treatment recommendations and hcvguidelines.org for additional information.