Epclusa receives FDA approval for treating HCV in HIV/HCV co-infected persons

On August 1, 2017 the Food and Drug Administration (FDA) updated the approval for the Gilead HCV medication sofosbuvir/velpatasvir (400mg/100mg), brand name “Epclusa” to include HIV/HCV coinfection. This single tablet medication comprises sofosbuvir (SOF), a nucleotide polymerase inhibitor, and velpatasvir (VEL), an NS5A inhibitor, and is active against all HCV genotype (GT) 1, 2, 3, 4, 5 and 6.

These frequently asked questions will help you understand what Epclusa is, how it works, and help you decide if it is the right medication for you.

What is Epclusa?

Epclusa is a medication used to treat hepatitis C (HCV). It is actually two drugs in one pill: sofosbuvir and velpatasvir. Each of these drugs work to prevent the HCV virus from reproducing, and if it can’t reproduce, the virus can’t survive inside you.

What genotypes does Epclusa work against?

Epclusa works for people who have HCV genotype (GT) 1, 2, 3, 4, 5 and 6.

How is Epclusa taken?

Epclusa is a single pill that you take once per day. You can take it with or without food. In a perfect world, you take it at the same time each day. If you forget, take it as soon as you remember. If you miss a day, never double-dose: Just take the pill as prescribed and maintain that once-a-day regimen from there. If you find it is hard to remember to take the pills and you miss a few days—either consecutively or off and on—call your medical provider and talk about it. There are lots of ways to help remind you to take Vosevi. You can also call a Help-4-Hep, a national HCV support phoneline, at 1-877-435-7443, and talk about it.

Do I have to take Epclusa with pegylated interferon? How about ribavirin?

You do not have to take Epclusa with pegylated interferon! Thankfully, the era of this medication is behind us, and there is no current HCV medication that needs interferon to go with it.

If you don’t have cirrhosis or have compensated cirrhosis, then you can take Epclusa without ribavirin. If you have decompensated cirrhosis, then you will need to take Epclusa with ribavirin.

How long do I have to take Epclusa?

You will take Epclusa for 12 weeks. Check out the chart below for the treatment regimen and length of treatment:

Genotype Patient Population: Treatment
1, 2, 3, 4, 5, 6 Patients without cirrhosis or patients with compensated cirrhosis (Child-Pugh A) Epclusa for 12 weeks
1, 2, 3, 4, 5, 6 Patients with decompensated cirrhosis

(Child-Pugh B or C)

Epclusa + ribavirin for 12 weeks

I also have HIV. Can I take Epclusa?

Yes. Epclusa was not originally FDA approved for treating HCV in HIV/HCV coinfected persons, but it has been used “off-label” (meaning, not FDA approved but we know it can be taken). In a clinical trial looking at Epclusa’s effectiveness if curing HCV in HIV/HCV coinfected persons, 95% of patients were cured. As of August 1, 2017, Epclusa received FDA approval for treating HCV in HIV/HCV coinfected persons. Epclusa may interact with your HIV medications, and your medical provider will review these before prescribing. If your HCV provider is different from you HIV one, make sure each of them are in communication with one another so they know what each is prescribing and there is no chance of accidental drug interactions.

I have cirrhosis. Can I take Epclusa?

Yes, you can take Epclusa if you have cirrhosis, both compensated and decompensated. If you have decompensated cirrhosis, that is you have been given a score of Child-Pugh B or Child-Pugh C (this a score given to assess cirrhosis), you can take Epclusa but must also include ribavirin. Talk to your medical provider about the state of cirrhosis you may or may not have before starting any HCV treatment.

I am on methadone. Can I take Epclusa?

Yes, Epclusa is safe to take while on methadone. There are no drug interactions between methadone (and buprenorphine) and Epclusa. Some people are concerned that medication side effects might lead to relapse, but this does not need to be the case. In fact, many people manage their HCV treatment without relapsing. There are also many people who are able to successfully do HCV treatment while continuing to use drugs. Don’t let substance use or fear of relapse prevent you from HCV treatment: If you’re motivated and ready, you will likely succeed! If you find yourself in need of support, use your support network and/or call Help-4-Hep.

What side effects might I experience with Epclusa?

Overall, Epclusa is a very well-tolerated medication. The most commonly reported side effects are headache and fatigue. Nausea, muscle weakness and insomnia can happen, but they are very rare.

For those who have to take ribavirin, the side effects are fatigue, anemia, nausea, headaches, insomnia and diarrhea.

Not everyone gets side effects and for those who do, they tend to be mild and people were able to manage it. If the side effects are a problem for you, call medical provider and Help-4-Hep to talk about ways to manage them.

Will Epclusa cure me of HCV?

There are no guarantees and everyone’s individual case is unique, but in the studies that looked at the effectiveness of Epclusa, the cure rates ranged from 95% to 100%, depending on a person’s genotype. Cure rates are a little lower in people with decompensated cirrhosis, but are still quite high: 94% overall. In HCV, a cure is defined as a sustained virologic response (SVR) 12 weeks after you finished taking the medications. That is, if there is no virus in your body 12 weeks after you’ve taken your last pill, you’re cured. The virus very rarely returns after this timeframe, but there is a chance for re-infection. If you are still at risk for HCV infection following cure, take the necessary precautions to prevent re-infection: clean syringes and injecting equipment if you still use drugs, condoms if you’re at risk of sexual exposure, etc. Call Help-4-Hep to talk about ways to stay negative for HCV.

I can’t afford Epclusa. Is there help out there for me?

Yes, there are options for people who either have no health insurance, or have a co-pay that too high for them. The Gilead patient assistance can help uninsured patients in many cases. People can receive co-pay assistance or, for those eligible, offer the entire 12-week course of treatment at no cost. If you have insurance, you may be eligible for co-pay assistance. For more information on these programs and to determine eligibility, call 1-800-769-7284 or visit www.mysupportpath.com.

There are other, non-pharmaceutical company support options, too. Call Help-4-Hep and discuss what options may be available to you.

What is HELP-4-HEP and how can it help me?
Help‑4‑Hep is a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of HCV head-on. Callers talk one-to-one with a real person, typically someone who’s had HCV touch their own life. And they talk about the specifics of their particular situation. If you need information and resources about finding financial help to pay for low cost testing, or finding a free or low cost clinic, or financial help with payment for treatments, please call us. We know how to find doctors and support groups. We know how to help you find resources where you live. The phone call, support and information are all provided free of charge. Call us at 1-877-HELP-4-HEP (1-877-435-7443).