Does Epclusa cure Hep C, what is the success rate?
Yes, Epclusa (sofosbuvir and velpatasvir) can cure hepatitis C virus (HCV) in many patients and has a 98% overall cure rate in all 6 of the main types of hepatitis C. "Cure” means the Hep C virus is not detected in the blood when measured three months after treatment is completed.
In studies, these cure rates were seen in patients with genotype 1-6 without cirrhosis (a serious liver disease) or with compensated cirrhosis (meaning you have cirrhosis, but with mild or no symptoms).
The direct-acting HCV oral treatments now on the market, such as Epclusa, are capable of causing a sustained virologic response (SVR).
- With an SVR, the virus is no longer detectable and 80% to 100% of patients can be cured, sometimes after only 8 to 12 weeks of treatment.
- However, resistance can develop; therefore, two or more oral HCV drugs will be used together to help prevent resistance.
It is important to seek medical treatment early for hepatitis C to increase your chances for a cure and help prevent serious liver damage and possible death.
The CDC recommends testing for hepatitis C virus in all adults aged 18 years and older, as well as many other groups. Ask your doctor if you should be tested for hepatitis C virus. Symptoms with hepatitis C may not appear for many years, sometimes decades, so it's important to be tested.
When was Epclusa approved by the FDA?
Epclusa was first approved by the FDA in June of 2016.
- It is approved for use in adults and pediatric patients at least 3 years of age with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection.
- Epclusa is used with ribavirin in patients with advanced liver disease (decompensated cirrhosis).
- In August 2017, the FDA also approved Epclusa to treat chronic HCV in patients co-infected with HIV.
Gilead Science's Epclusa is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) infection.
Epclusa was the first direct-acting antiviral (DAA) to target all the major HCV genotypes 1 through 6, in patients with or without cirrhosis.
- In clinical studies, 95% to 99% of Epclusa-treated patients without cirrhosis or with mild cirrhosis had no virus detected in the blood 12 weeks after finishing a 12-week regimen.
- In patients with moderate to severe cirrhosis, some of whom also required ribavirin treatment, 94% were cleared of the virus 12 weeks after finishing treatment.
Epclusa is an oral tablet taken once a day, with or without food. It comes in two strengths: 400 mg sofosbuvir/100 mg velpatasvir and 200 mg/50 mg tablets.
Epclusa also comes as oral pellets (200 sofosbuvir/50 velpatasvir and 150/37.5 oral pellets) for use in children who cannot swallow tablets. For children less than 6 years of age, administer Epclusa oral pellets with food to enhance palatability. Dosing in children is weight-based.
What are most common adverse reactions with Epclusa?
- The most common side effects of Epclusa in adults and children 6 years and older include headache and tiredness.
- When used with ribavirin in advanced liver disease in adults, common side effects also include anemia (not enough red blood cells), upset stomach (nausea), trouble sleeping, and diarrhea.
- In children less than 6 years old, vomiting and spitting up the drug are the most common side effects.
This is not all of the side effects that can occur with Epclusa, including serious side effects. Review the full listing of side effects here and discuss them with your doctor.
- Epclusa has a 98% overall cure rate in all 6 of the main types of hepatitis C in patients without cirrhosis (a serious liver disease) or with compensated cirrhosis (mild or no symptoms).
- Seek medical treatment for hepatitis C quickly to increase your chances for a full cure and to help prevent or slow liver damage.
- Common side effects with Epclusa can include headache and tiredness. Children under 6 years may vomit or spit up the medicine.
This is not all the information you need to know about Epclusa for safe and effective use. Review the full Epclusa information here, and discuss this information with your doctor or other health care provider.
- Epclusa [product information]. Gilead Sciences, Inc. Foster City, CA. 2020. Accessed June 14, 2021 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208341s017lbl.pdf
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