sofosbuvir/velpatasvir/voxilaprevir, or SOF/VEL/VOX
Treatment of patients with chronic hepatitis C virus (HCV).
Not FDA approved for HIV/HCV co-infection, but may be considered.
One tablet once daily with food. Each tablet contains 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir.
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.
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.
Gilead Sciences, Inc.
(800) GILEAD-5 (445–3235)
Vosevi is very well-tolerated with minimal side effects. In fact, in the clinical trials for Vosevi, there were very few people—0.2%—who 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 the impact it may have on fetal development or nursing babies is unknown.
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 also important to inform them of 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. 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, and 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 decide 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. 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. Of particular importance is this medication’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.
Taking your Vosevi tablets exactly as your doctor prescribes is extremely important. That’s because following your treatment plan increases your chances of curing your hepatitis C (HCV). It also helps reduce your risk of long-term effects of HCV, such as cirrhosis and liver cancer.
Missing doses can interfere with how well Vosevi treats your hepatitis C. In some cases, if you miss doses, your HCV may not be cured.
So be sure to follow your doctor’s instructions and take your Vosevi tablet every day for the duration of your treatment. Using a reminder tool can be helpful in making sure you take Vosevi each day.
If you have any questions or concerns about your treatment, talk with your doctor or pharmacist. They can help resolve any issues for you and help you get the most out of your treatment.
Our pharmacists are experts in treating hepatitis C, medication therapy and finding valuable treatment resources. We keep Vosevi in stock for the duration of your treatment so you never have to wait to receive your medication. If you have any issues with your insurance plan or coverage, we’ll find a solution so you don’t miss a dose. You can rest assured that you have picked a partner who will work with you and your doctor to achieve your treatment goals.
Drug Mart offers free prescription delivery to any location (home or office) in New Jersey, New York or Pennsylvania.
Drug Mart is licensed in New Jersey, New York and Pennsylvania. If you live in one of these States, complete the form at Get Started, and our pharmacy team will handle the rest.
Gilead, the maker of Vosevi has a prescription copay assistance program. Our staff is trained to find these savings and help lower the price you pay for your prescription. In most cases, patients pay zero dollar out-of-pocket for their Vosevi prescription.
Vosevi is approved to treat hepatitis C in:
- people who don’t have cirrhosis
- people with compensated cirrhosis (where the liver is damaged but can still carry out its basic functions)
- people with HCV genotype 1, 2, 3, 4, 5, or 6 who’ve tried antiviral drugs called nonstructural protein 5A (NS5A) inhibitors, which include elbasvir, ledipasvir, ombitasvir, and velpatasvir
- people with HCV genotype 1a or 3 who’ve tried the antiviral drug called sofosbuvir, taken without an NS5A inhibitor
The recommended dosage is one Vosevi tablet taken once a day for 12 weeks.
It doesn’t matter what time of day you choose to take Vosevi, but you should take it at about the same time each day. This helps the medication work the right way inside your body.
Take Vosevi with food (either a meal or a snack). This helps your body absorb the medication.
It’s important that you don’t miss or skip doses of Vosevi and that you take the full course of treatment. Missing doses or not completing the course will make Vosevi less effective against the hepatitis C virus. This could mean that your hepatitis C won’t be cured.
To help make sure you don’t miss a dose, try setting a reminder on your phone.
If you forget to take a dose at your usual time, take it as soon as you remember that day. But if you don’t remember until the following day, just take your regular dose. Never take two doses to make up for a missed dose. This could raise your risk for getting side effects.
You shouldn’t crush, split, or chew Vosevi tablets because they have a very bitter taste. Also, the effect of crushing, chewing, or breaking Vosevi hasn’t been studied.
It could affect the way your body absorbs the medication. It’s not known if this would change how safe or effective the drug is.
If you have trouble swallowing Vosevi tablets whole, talk with your doctor about your options for other treatments.
Vosevi is a type of drug called a direct-acting antiviral. It contains three active drugs: sofosbuvir, velpatasvir, and voxilaprevir. Each of these drugs works in a slightly different way to stop the hepatitis C virus from making copies of itself.
The hepatitis C virus uses certain proteins within the virus to make copies of itself. Each of the drugs in Vosevi stops a different protein from working. This means the virus can’t multiply.
Viruses that can’t make copies of themselves eventually die or are removed by your immune system. This clears up the infection and prevents further damage to your liver.
Vosevi will start working right away, but you’ll need to take the full 12-week course of treatment to cure the infection.
Your doctor will test your blood for the virus during treatment and 12 weeks after you finish treatment. If the virus is not detected in your blood 12 weeks after your treatment ends, you’re considered cured of hepatitis C.
Vosevi is not FDA approved to be used as a treatment in HIV and HCV co-infection. However, your doctor may consider it in certain clinical situations.
Yes, your doctor will do blood tests to check for the hepatitis B virus before you start treatment.
If these tests show you have the hepatitis B virus, you may need to take medication to treat it. This is because taking Vosevi can make the hepatitis B virus become active in your body again, which can lead to liver failure and death.
Your doctor will also do blood tests to check your liver and kidney function. If the tests show your liver or kidneys are not working very well, you may not be able to take Vosevi.
Yes, you can take antacids during your treatment. However, don’t take them in the 4 hours before or after you take your Vosevi dose.
It’s not known if Vosevi is safe to take during pregnancy. It hasn’t been studied in pregnant women.
Studies in animals didn’t show harm to the fetus when the mother was given any of the active drugs in Vosevi. However, studies in animals don’t always predict what’ll happen in humans.
If you’re pregnant or considering becoming pregnant, talk with your doctor about your treatment options.
It’s not known if Vosevi is safe to take while breastfeeding. It’s unknown if the active drugs in Vosevi pass into human breast milk.
In animal studies, the drugs were found in breast milk. However, studies in animals don’t always predict what’ll happen in humans.
If you’re breastfeeding, talk with your doctor about the risks and benefits of taking Vosevi.
Hepatitis C was cured in 96% of people who took Vosevi for 12 weeks.
There are six different types, or strains, of hepatitis C viruses that infect people. These strains are called genotypes.
Genotypes are identified by differences in the genetic code of the viruses. Genotype 1 is the most common hepatitis C strain in the United States, but other strains are also seen in this country.
Your doctor will do a blood test to figure out which genotype you have. Your hepatitis C genotype will help your doctor choose the right medication for you.
You should avoid drinking alcohol while you’re taking Vosevi to treat hepatitis C. Drinking alcohol could cause further damage to your liver. It can also increase your risk for getting Vosevi side effects such as headaches, diarrhea, nausea, and fatigue (lack of energy).
Talk with your doctor if you’re concerned about avoiding alcohol during your Vosevi treatment.
Do not use more Vosevi than your doctor recommends.
If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool.
If your symptoms are severe, call 911 or go to the nearest emergency room right away.
Call us at the pharmacy and we’ll be glad to answer any questions. You can reach us at (800) 877-0337.