On July 18, 2017 the Food and Drug Administration (FDA) approved Gilead’s HCV medication sofosbuvir/velpatasvir/voxilaprevir (400mg/100mg/100mg), brand name “Vosevi” for the re-treatment of HCV in treatment-experienced people. This single tablet medication comprises sofosbuvir (SOF), a nucleotide polymerase inhibitor, velpatasvir (VEL), an NS5A inhibitor, and voxilaprevir (VOX), an NS3/4A protease 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 Vosevi is, how it works, and help you decide if it is the right medication for you.
What is Vosevi?
Vosevi is a medication used to treat hepatitis C (HCV). It is actually three drugs in one pill: sofosbuvir, velpatasvir and voxilaprevir. 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 Vosevi work against?
Vosevi works for people who have HCV genotype (GT) 1, 2, 3, 4, 5 and 6.
Who should take Vosevi?
Vosevi is approved for “treatment-experienced” patients for whom a prior HCV treatment didn’t work. It could be used in people who are treatment naïve (that is, never taken HCV treatment before), but its not really needed: There are other treatments that are just as effective for this patient group. The addition of that third drug in Vosevi—voxilaprevir—is what really helps the drug cure treatment experienced.
How is it taken?
Vosevi is a single pill that you take once per day. You need to take it with 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 it with pegylated interferon? How about ribavirin?
You do not have to take Vosevi with pegylated interferon! Thankfully, the era of this medication is behind us, and there really is no current HCV medication that needs interferon to go with it.
Just like interferon, you don’t have to take ribavirin with Vosevi.
How long do I have to take Vosevi?
You will take Vosevi for 12 weeks. Check out the chart below for the treatment regimen and length of treatment:
|Genotype||Patients Previously Treated with an HCV Regimen Containing:||Length of Treatment|
|1, 2, 3, 4, 5, 6||NS5A inhibitor||12 weeks|
|GT 1a or 3||Sovosbuvir without an NS5A inhibitor||12 weeks|
I also have HIV. Can I take Vosevi?
Yes. Vosevi was not FDA approved to treating HCV in HIV/HCV coinfected persons, but it can be taken “off-label” (meaning, not FDA approved but we know it can be taken). Vosevi 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 Vosevi?
You may be able to take Vosevi if you have cirrhosis, but if you have moderate to severe cirrhosis this is not the medication for you. If you have ever been told you have a “Child-Pugh B” or a “Child-Pugh C” (this a score given to assess cirrhosis), you should not take Vosevi. 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 Vosevi?
Yes, Vosevi is safe to take while on methadone. There are no drug interactions between methadone (and buprenorphine) and Vosevi. 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?
Overall, Vosevi is a very well-tolerated medication. The most commonly reported side effects are headache, fatigue, diarrhea, nausea but not everyone gets them 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 Vosevi 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 Vosevi, the cure rates were around 96-97%. Cure rates are dependent upon HCV genotype, treatment experience, and whether or not a person has cirrhosis. 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 Vosevi. 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).