FDA Approves Epclusa for Treatment of Children with Any Genotype of Hep C

The United States Food and Drug Administration (US FDA) has approved Epclusa to treat hep C in children with any genotype. Epclusa is a combination of two drugs, sofosbuvir and velpatasvir. It can be used by children who are at least 6 years old or who weigh at least 37 pounds.

Epclusa can be used on its own to treat hep C in kids with no cirrhosis or mild cirrhosis. For kids with severe cirrhosis, Epclusa can be combined with ribavirin, another antiviral drug. It is not known how Epclusa might affect kids younger than 6 years old.

How does Epclusa work?

Epclusa belongs to a class of drugs called direct-acting antivirals. These are newer drugs that have fewer side effects and higher cure rates than older options. Epclusa targets specific steps in the life cycle of the virus. This blocks the virus from replicating or spreading in the body.

An important change for kids with hep C

With this new approval, Epclusa will now be the second direct-acting antiviral that can be used in children. Mavyret was also approved for use in kids. Both Epclusa and Mavyret can be used in kids who have any genotype of hep C. This means, many kids will be able to try these options. Also, since they treat all genotypes, they can be used in areas where genotype testing may not be available. This can help save resources and time when it comes to treating hep C.

Epclusa in clinical trials

Before this approval, Epclusa was studied in a clinical trial. Over 170 kids with different hep C genotypes took Epclusa for 12 weeks. Overall, there were no differences in the way the body absorbed and broke down the drug between kids and adults. Epclusa was also found to be just as safe and effective in kids as it is in adults.

Specifically, for kids between 12 and 17 years old: 93 percent with genotype 1 were cured and 100 percent with genotypes 2, 3, 4, and 6 were cured.

For kids between the ages of 6 and 11 years old: 93 percent with genotype 1 were cured, 100 percent with genotypes 2 and 4 were cured, and 91 percent with genotype 3 were cured.

These results suggest that Epclusa is safe and has very high cure rates in kids with all genotypes.

Side effects of Epclusa

When used by children, the most common side effects of Epclusa are tiredness and headache. These are the same side effects found in adults taking Epclusa.

When Epclusa is combined with ribavirin, more side effects may occur. These include headache, nausea, tiredness, trouble sleeping, diarrhea, and low red blood cell count.

Things to know about Epclusa

Epclusa can cause hepatitis B reactivation. Hepatitis B can come back, or reactivate, in people who have had the virus in the past. Before starting Epclusa, tell your doctor if you currently have hepatitis B or if you have had hepatitis B in the past. Even if you do not think you have had hepatitis B, your doctor may still have you tested to be safe.

Epclusa may interact with other medications. Tell your doctor about any other medications, vitamins, and supplements you take before starting to take Epclusa. Also tell your doctor if you have any other liver problems, kidney issues, HIV infection, or are pregnant or planning to become pregnant before starting Epclusa.¹

Read the prescribing information to learn more about Epclusa.