Treatment of adult patients with chronic hepatitis C virus (HCV). FDA approved for HIV/HCV co-infection.
One tablet once daily, usually for 12 weeks, with or without food. See treatment table for this page online. Each tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Ribavirin may be added in patients with decompensated cirrhosis. The brand name is dispensed in a bottle, and the authorized generic is dispensed in a blister pack. The authorized generic was created to help lower cost and has identical ingredients as the brand name.
Sofosbuvir-based regimens are not recommended in people with creatinine clearance (CrCl) less than 30 mL/min.
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 Epclusa, 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.
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Epclusa is a very well-tolerated medication with minimal side effects. Indeed, in the clinical trials for Epclusa, there were very few people—0.2%—who discontinued treatment due to side effects, and the real world experience has been very similar. In patients without cirrhosis or in those with compensated cirrhosis, the most commonly reported side effects are headache and fatigue. Less frequently reported side effects include nausea, insomnia, and asthenia (weakness). The majority of these side effects are considered to be mild and occurred at similar rates to placebo in clinical trials. Similar side effects can occur in patients with decompensated cirrhosis, with the addition of diarrhea. Again, these are all considered mild to moderate in severity, and very few people have to discontinue treatment because of them. Epclusa has not been studied in pregnant women or nursing mothers, so the impact it may have on fetal development or nursing babies is unknown. Pregnant women or women who are trying to become pregnant should avoid use if the addition of ribavirin is required.
Before starting Epclusa, be sure to tell your medical provider or pharmacist about all of 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. Epclusa should not be taken within 4 hours of antacids. If taking H2-receptor antagonists, take Epclusa 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, Epclusa should be taken with food and 4 hours before taking a PPI comparable to omeprazole 20 mg or lower. Epclusa should not be taken with the following HIV medications: efavirenz or tipranavir/ritonavir. Use caution and monitor renal function when taking Epclusa with tenofovir disoproxil fumarate (TDF). Avoid use if taking TDF with an HIV protease inhibitor, ritonavir, or cobicistat due to possible increase in TDF concentrations resulting in adverse reactions. 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, as they reduce the concentrations of sofosbuvir and may reduce its effectiveness. 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 Epclusa. 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.
Epclusa marked an exciting development for treating HCV: a pangenotypic (active against all 6 genotypes) once-per-day regimen taken for 12 weeks without ribavirin (in most situations) that has minimal side effects and high cure rates.
It is an effective and highly tolerable treatment option for people with GT3, with SVR12 rates as high as 98% for treatment-naïve patients without cirrhosis. Treatment experience and the presence of cirrhosis appear to lower the SVR12 rates (94 and 93%, respectively), but this is still a good, interferon- and ribavirin-free, option for this hard-to-treat patient group. It’s also an excellent treatment for people with more advanced cirrhosis: The ASTRAL-4 study, which looked at patients with decompensated liver disease, resulted in an SVR12 of 83% for people taking Epclusa for 12 weeks and 86% for people taking Epclusa for 24 weeks. The rate of SVR12 increased to 94% when ribavirin was added to Epclusa for 12 weeks, which is why this is the recommendation in patients with decompensated cirrhosis. Finally, it’s also an excellent choice for HIV/HCV co-infected persons. The ASTRAL-5 study, which looked at treating HIV/HCV co-infected persons with Epclusa, had an overall 95% SVR12 and included treatment-experienced patients and those with compensated cirrhosis.
Epclusa is taken for 12 weeks by people without cirrhosis or who have compensated cirrhosis, with ribavirin added for people who have decompensated cirrhosis (or extended for 24 weeks if not eligible for ribavirin). Treatment is for all genotypes and whether treatment-experienced or not (although this depends on what previous medicines were taken). Go to hcvguidelines.org for additional information on clinical studies and treatment recommendations.
Taking your Epclusa 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 Epclusa 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 one Epclusa tablet every day for 12 weeks. Using a reminder tool can be helpful in making sure you take Epclusa 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 Epclusa 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 Epclusa 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 Epclusa prescription.
Epclusa is a prescription brand-name medication that’s used to treat hepatitis C virus (HCV) in adults. Epclusa was approved in 2016 and was the first medication to treat all six hepatitis C genotypes. It can be used for people with or without cirrhosis (scarring of the liver).
You’ll take Epclusa once daily for 12 weeks.
Epclusa can be taken at any time of day. If you experience fatigue during your treatment with the drug, taking it at night might help you avoid that side effect.
Epclusa can be taken with or without food. However, taking it with food might help decrease any nausea that could be caused by the medication.
It’s important to take Epclusa every day, to give you the best chance of curing your hepatitis C.
But if you do miss a dose, take it as soon as you remember. If it’s almost time for your next dose, only take one dose. Taking two doses at once can increase your risk of side effects.
It’s not known whether crushing Epclusa is safe. If you have trouble swallowing tablets, talk to your doctor about alternative medications rather than crushing your Epclusa tablets.
Epclusa is a direct-acting antiviral (DAA) medication. DAAs treat HCV by preventing the virus from reproducing (making copies of itself). Viruses that can’t reproduce eventually die and are cleared from the body.
Clearing the virus from the body will reduce liver inflammation and prevent additional scarring.
You may start to feel better days to weeks after you start taking Epclusa, but you’ll still need to take the full 12 weeks of treatment. It’s important to both take the full treatment and avoid missing any doses. These steps help the medication succeed in clearing the HCV from your body.
There haven’t been enough studies in humans to know if Epclusa is safe to take during pregnancy. Studies in animals didn’t show harm to the fetus when the mother received the drug. However, animal studies don’t always predict what would happen in humans.
If you become pregnant while taking this drug, call your doctor right away.
It isn’t known if Epclusa passes into breast milk in humans. In animal studies, Epclusa was found in breast milk, but it didn’t cause harmful effects. However, animal studies don’t always reflect what will happen in humans.
If you’re breastfeeding your child and considering taking Epclusa, talk with your doctor about the potential risks and benefits.
In clinical studies, between 89 percent and 99 percent of people who received Epclusa were cured of the virus. Cure rates were slightly different based on genotype, liver function, and previous hepatitis C treatment.
If you take Epclusa during the 12 weeks of treatment as your doctor prescribed and you maintain a healthy lifestyle, the virus shouldn’t come back.
However, it’s possible to relapse (have the infection reappear). A relapse is when medication has cured the virus from your body, but blood tests detect the virus again, months to years after treatment. In clinical trials, up to 4 percent of people treated with Epclusa had a relapse.
You can also become reinfected with the virus after taking any hepatitis C medication, including Epclusa. Reinfection can happen in the same way the original infection was contracted. Sharing needles used for injecting drugs and having sex without using a condom are possible routes of reinfection.
However, avoiding these behaviors can help prevent reinfection with hepatitis C.
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.
Yes, you can. Epclusa can be safely used to treat hepatitis C in people who are also infected with HIV.
In a clinical study involving people who had both hepatitis C and HIV, up to 95 percent of people who received Epclusa were cured of hepatitis C. Importantly, treatment with Epclusa didn’t cause worsening of HIV.
Drinking alcohol while taking Epclusa can increase your risk of certain side effects from the drug. These side effects include:
In addition, both hepatitis C and excessive alcohol use cause inflammation and scarring in the liver. The combination increases your risk of cirrhosis and liver failure.
Alcohol may also interfere with your ability to stick to your treatment plan as directed by your doctor. For instance, it may cause you to forget to take your medication on time. Missing doses could make Epclusa less effective in treating your HCV.
For all of these reasons, you should avoid drinking alcohol when you have hepatitis C, especially when you’re being treated with Epclusa. If you have trouble avoiding alcohol, talk with your doctor.
If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But 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.