Hepatitis C is one of the most common viral infections in the United States. Without treatment, hepatitis C can lead to severe health issues. Epclusa was approved to treat chronic hepatitis C by the FDA in 2016. Epclusa combines two antiviral medicines, sofosbuvir and velpatasvir. They prevent the hepatitis C virus from making copies of itself, reducing the amount of virus in your body.
How Does Epclusa Work for Hepatitis C?
When hepatitis C virus (HCV) infects the liver, it causes inflammation. Hepatitis C can cause mild illness lasting for a short period (acute) or a serious disease that can last the rest of your life (chronic). If the infection is not treated properly, it can lead to cirrhosis (liver damage and scarring that prevents it from working properly), liver cancer, and liver failure.
Epclusa works in the body by targeting specific proteins that the HCV uses to grow and spread within the body.
How Do I Take Epclusa?
Epclusa is available in tablet and oral pellet forms. The oral pellets can be mixed with non-acidic food like pudding or mashed potatoes for anyone with trouble swallowing tablets. Epclusa should be taken once daily, with or without food.
How Was Epclusa Studied for Treating Hepatitis C?
Several clinical studies were done to test how safe and effective Epclusa is for treating people with different types of HCV, including those with cirrhosis. The study included different groups of people: some had never been treated for hepatitis C before, some had had previous treatments, and others had had different stages of liver damage, from no liver scarring to mild (compensated) and severe (decompensated). The four studies, ASTRAL-1, -2, -3, and -4 included 1,825 people. Most of the people in the study were White (85%), followed by Black (6%), Asian (7%), and others (2%). The median age was 48, and over half were male (62%). The main goal was to see if the treatment worked by measuring how many people had no detectable HCV in their blood 12 weeks after the treatment. This result is called a sustained virologic response (SVR12).
- In ASTRAL-1, 740 people with genotypes 1, 2, 4, 5, or 6 were given Epclusa or a placebo (a pill with no medicine) for 12 weeks. People with genotype 5 all received Epclusa.
- In ASTRAL-2, 266 people with genotype 2 received either Epclusa or a combination of sofosbuvir and another drug called ribavirin for 12 weeks.
- In ASTRAL-3, 552 people with genotype 3 were given either Epclusa for 12 weeks or sofosbuvir plus ribavirin for 24 weeks.
- In ASTRAL-4, the study focused on 267 people with genotype 3 of hepatitis C who had advanced liver disease (cirrhosis). People were chosen randomly to receive either:
- Epclusa for 12 weeks, or
- Epclusa for 24 weeks, or
- Epclusa and ribavirin for 12 weeks
What Benefits Were Seen With Epclusa?
The studies showed that overall, 98% of the people treated with Epclusa had no detectable virus 12 weeks after treatment. Similar results were seen across all the different types of hepatitis C, even in people with liver damage.
- In ASTRAL-1, 98% of the people who took Epclusa had no detectable virus 12 weeks after treatment (SVR12). Those who took a placebo did not clear the virus.
- In ASTRAL-2, 99% of the people with genotype 2 who took Epclusa achieved SVR12, compared to 94% of those who took sofosbuvir and ribavirin.
- In ASTRAL-3, 95% of people with genotype 3 who took Epclusa achieved SVR12, compared to 80% of those who took sofosbuvir and ribavirin.
- In ASTRAL-4, 85% of the people with genotype 3 achieved SVR12.
Researchers also tested to see how quickly virus levels reduced during the treatment. By the fourth week, 91% of the people had very low or undetectable virus levels.
How Long Does It Take for Epclusa to Work? How Can I Tell If It Is Working?
Your health care provider will monitor your progress with blood tests to ensure the virus is undetectable by the end of your treatment. Most people taking Epclusa will see significant reductions in the HCV in their blood within the first few weeks of treatment. However, to fully reduce the virus to an undetectable level in the blood, it's essential to complete the entire 12-week course of treatment as prescribed by your health care provider.
What Are the Side Effects, and How Can You Manage Them?
The most common side effects of Epclusa include headaches, tiredness, and nausea. To manage headaches, stay hydrated and limit your caffeine intake. Tiredness is common, but it can often be managed by getting plenty of rest and maintaining a balanced diet. You may also try taking short naps not too close to bedtime. If you feel nauseous, eat smaller, more frequent meals and avoid food that upsets your stomach.
These aren't all the possible side effects. If any symptoms bother you, talk to your health care provider. You can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088.
What Interactions With Foods and Other Medicines Should You Be Aware Of?
You should not take Epclusa with a medicine called amiodarone. This heart medicine can seriously slow the heart rate when taken with Epclusa. Avoid using these together.
Acid-reducing agents are medicines that reduce stomach acid to help with conditions like heartburn or stomach ulcers. Medicines like famotidine or omeprazole can lower Epclusa's effectiveness. Another group of medicines, proton pump inhibitors (PPI), can also lower Epclusa's effectiveness. Examples are esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex). Your health care provider may adjust how you take PPIs or recommend alternatives while taking Eplcusa.
Here are some medicines that can decrease Epclusa's effectiveness and should be avoided:
- St. John's wort, which is an herbal supplement that may be used to treat depression
- Certain cancer medicines such as topotecan
- Anticonvulsants such as carbamazepine (Carbatrol, Tegretol)
- Rifampin (Rifadin), an antibiotic used to treat tuberculosis and other bacterial infections
- HIV antiretrovirals, which help manage HIV infection by preventing the virus from spreading in your body
Taking certain medicines with Epclusa can cause muscle pain and muscle breakdown, known as rhabdomyolysis. These medicines include statins, which lower blood cholesterol levels by decreasing the amount of cholesterol made by your liver, increasing the breakdown of bad cholesterol, and lowering high cholesterol. Examples are atorvastatin and rosuvastatin.
This is not a complete list of medicines that may interact with Epclusa. Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. It will help them determine if there are any interactions with Epclusa or if you need a dosage adjustment. Talk to your health care provider about all your medical conditions.
Are There Any Special Steps Required to Get Epclusa?
Epclusa is prescribed by a health care provider specializing in liver diseases or infectious diseases, such as a hepatologist, gastroenterologist, or infectious diseases provider. In some cases, primary care providers with experience in treating hepatitis C may also prescribe it.
Because Epclusa is a specialized medicine, it is typically available through specialty pharmacies. Your health care team will assist you in obtaining the medicine and ensure you follow the correct dosage regimen. Your insurance may require prior authorization, and your health care provider will provide the necessary information to your insurance company.
Is There Any Cost Assistance Available?
Epclusa's manufacturer offers programs to help with the cost of treatment. These programs can provide information about insurance coverage, financial assistance, and help with reimbursement. A co-pay program is also available for eligible people with health insurance, which may help reduce out-of-pocket costs. To learn more about these assistance programs and check your eligibility, visit the manufacturer's website at www.epclusa.com/saving-on-epclusa or speak with your health care provider. For questions about cost, insurance coverage, or anything else, contact the drugmaker at 844-4-EPCLUSA or visit www.epclusa.com.
