Vosevi: 7 things you should know
Medically reviewed by Carmen Fookes, BPharm. Last updated on Dec 21, 2020.
1. How it works
- Vosevi is a name for a combination tablet containing sofosbuvir, velpatasvir, and voxilaprevir that may be used to treat chronic hepatitis C virus (HCV) infection in people who have already undergone treatment with certain other HCV medications.
- Because Vosevi contains three different active ingredients (sofosbuvir, velpatasvir, and voxilaprevir), it works in three different ways. Sofosbuvir interferes with the reproduction of genetic material of the hepatitis C virus, by inhibiting an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself. Sofosbuvir initially greatly reduces and then completely stops the production of new copies of the hepatitis C virus.
- Velpatasvir is an NS5A (hepatitis C virus nonstructural protein 5A) inhibitor. Velpatasvir works by interfering with a protein, called HCV NS5A that is needed by the virus to replicate itself.
- Voxilaprevir inhibits an enzyme called NS3/4A protease, which is necessary for the HCV encoded polyprotein to cleave itself and therefore essential for viral replication.
- Vosevi belongs to the class of medicines known as combination hepatitis C antivirals.
- Vosevi may be used to treat adults with HCV genotypes 1, 2, 3, 4, 5, or 6 infection (without cirrhosis, or with compensated cirrhosis) that has previously been treated with an NS5A inhibitor regimen.
- Vosevi may also be used to treat adults HCV genotype 1a or 4 infection (without cirrhosis, or with compensated cirrhosis) that has previously been treated with a sofosbuvir regimen without an NS5A inhibitor.
- Vosevi contains three antiviral medications: sofosbuvir 400mg, velpatasvir 100mg, and voxilaprevir 100mg. These have been combined into one tablet so that only one tablet needs to be taken once daily.
- Vosevi is a stand-alone treatment. No other HCV medications need to be taken alongside Vosevi. Each antiviral agent contained in Vosevi works differently but they all affect viral growth and replication. Having three different antivirals with three different mechanisms of action increases the cure rate against HCV and reduces the risk of resistance developing.
- Vosevi is usually taken once a day with food for 12 weeks.
- Cure rates range from 91% to 100% depending on a person's HCV genotype.
- The tablets are capsule-shaped to allow for easier swallowing.
- Usually, the side effects that occur with Vosevi are mild.
- The dosage of Vosevi does not need to be modified in those with kidney disease, including those with end-stage renal disease (ESRD) on dialysis.
- Gilead, the manufacturer of Vosevi has a special patient assistance program called Support Path™ that may assist with co-pay insurance coupons or make Vosevi available at no charge for eligible and qualified uninsured patients.
- Vosevi works directly on the virus, not on human cells.
If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:
- Vosevi is usually well-tolerated, but the most common side effects reported include headache, fatigue, itching, asthenia (lack of energy), nausea or an upset stomach, diarrhea, or difficulty sleeping.
- Reactivation of hepatitis B has been reported in people who have a current or prior hepatitis B virus (HBV) infection before initiating treatment with Vosevi. In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death. All patients should be tested for current or prior hepatitis B virus (HBV) infection before initiating treatment with Vosevi.
- Weight gain has not been reported in clinical trials as a side effect of Vosevi.
- No additional benefit of Vosevi over sofosbuvir/velpatasvir was seen in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.
- Vosevi is expensive. The wholesale cost of Vosevi is $930 per tablet and a 12-week treatment course is approximately $78,078. Most insurance companies and Medicare cover Vosevi; however, you may have to meet certain criteria and you should always check with your insurance company first before you and your doctor make it your preferred treatment. There may also be a co-pay. Gilead, the manufacturer of Vosevi has a special patient assistance program called Support Path™ that may assist with co-pay insurance coupons or make Vosevi available at no charge for eligible and qualified uninsured patients.
- Vosevi may cause elevations in laboratory levels of bilirubin, lipase, and creatinine kinase.
- Vosevi is not recommended in people with moderate to severe hepatic impairment (Child-Pugh B or C) or those with a history of liver disease. Vosevi should be discontinued in those who develop liver damage.
- There is currently no generic for Vosevi.
Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects
- Before you start taking Vosevi your doctor will test you for hepatitis B virus (HBV) infection. This is because treating HCV may reactivate an underlying hepatitis B infection (HBV). Any underlying HBV infection should be treated before Vosevi is started.
- Vosevi is best taken at the same time every day. Take Vosevi for 12 weeks or for the duration that is recommended by your physician.
- Take Vosevi with food. Food increases how much Vosevi is absorbed, which increases its effectiveness.
- Tell your doctor if you take any other medications or supplements, including those purchased from a supermarket or health store. Some medications, such as amiodarone, should not be taken with Vosevi.
- Seek urgent medical attention if you develop a very slow heartbeat, feel faint or unwell, or experience symptoms such as dizziness or lightheadedness, weakness, excessive tiredness, shortness of breath, chest pains, confusion, or memory problems.
- There is limited data as to the effects of Vosevi on a developing fetus. It is best not to become pregnant while taking Vosevi; however, if you inadvertently become pregnant, see your doctor immediately. The effects of Vosevi on a breastfeeding infant are also not known.
- While you are taking Vosevi to treat hepatitis C, you should take steps to ensure you do not pass HCV to others. This includes not sharing needles and practicing safe sex.
6. Response and Effectiveness
- Vosevi cures HCV in most people depending on their genotype and prior exposure to other antiviral agents.
- Cure rates range from 91% to 100% depending on a person's HCV genotype.
- Trials evaluated how effective Vosevi was in people without cirrhosis or with compensated cirrhosis who had either previously received an NS5A inhibitor, or another type of antiviral treatment. A cure is defined as a sustained virologic response (SVR) for a certain period (usually 12 weeks) and is usually written as SVR12. It reflects how long the hepatitis C virus is undetectable in the blood. An overall SVR12 rate of 96% was reported for all genotypes. This means that Vosevi cured 96% of people overall.
- When looking at specific genotypes, cure rates in those that had previously received an NS5A inhibitor in a trial called POLARIS 1 were as follows: genotype 1a: 96%, genotype 1b: 100%, genotype 2:100%, genotype 3: 95%, genotype 4: 91%, genotype 5: 100%, genotype 6: 100%.
- Relapse rates of 5% were reported for genotypes 3 and 4, and a relapse rate of 1% for genotype 1a. No other genotypes had relapses.
- Cure rates for people who had previously received other antivirals that were NOT NS5A inhibitors in a trial called POLARIS 4 (only administered to genotypes 1 to 4) were: genotype 1a: 97%, genotype 1b: 94%, genotype 2:100%, genotype 3: 96%, genotype 4:100%.
- Food enhances the bioavailability of Vosevi.
Medicines that interact with Vosevi may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Vosevi. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.
Common medications that may interact with Vosevi include:
- acid-suppressing agents, such as omeprazole or pantoprazole
- amiodarone (not recommended because symptomatic bradycardia, fatal cardiac arrest, and pacemaker intervention have occurred)
- antacids, such as aluminum carbonate, magnesium carbonate, or sodium bicarbonate
- antibiotics, such as nafcillin
- anticancer treatments such as lorlatinib or tucatinib
- anticoagulants, such as dabigatran (monitor dabigatran)
- anticonvulsants, such as carbamazepine, phenytoin or phenobarbital
- antimicrobials, such as rifabutin or rifampin
- digoxin (monitor plasma concentrations of digoxin)
- HIV medications, such as amprenavir or atazanavir
- inducers of P-glycoprotein such as carbamazepine, dexamethasone, doxorubicin, nefazodone, phenobarbital, phenytoin, prazosin, rifampicin, St. John's wort, tenofovir, tipranavir, trazodone, and vinblastine
- prostate cancer treatments such as apalutamide or enzalutamide
- statins, such as atorvastatin or simvastatin
Vosevi contains sofosbuvir which is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) and medications that are P-gp inducers in the intestine such as rifampin or St. John's wort may decrease Vosevi plasma concentrations, leading to a reduced therapeutic effect of Vosevi. Avoid concomitant use.
Note that this list is not all-inclusive and includes only common medications that may interact with Vosevi. You should refer to the prescribing information for Vosevi for a complete list of interactions.
Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) [Package Insert]. Updated 11/2019. Gilead Sciences, Inc. https://www.drugs.com/pro/vosevi.html
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Vosevi only for the indication prescribed.
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More about Vosevi (sofosbuvir / velpatasvir / voxilaprevir)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: antiviral combinations
- FDA Alerts (1)
- FDA Approval History