Standard DoseOne tablet once daily, usually for 12 weeks, with or without food. See treatment table for this page online. Each tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Ribavirin may be added in patients with decompensated cirrhosis. The brand name is dispensed in a bottle, and the authorized generic is dispensed in a blister pack. The authorized generic was created to help lower cost and has identical ingredients as the brand name.
Sofosbuvir-based regimens are not recommended in people with creatinine clearance (CrCl) less than 30 mL/min.
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
BLACK BOX WARNING
Before starting treatment with any direct-acting antiviral (DAA), including Epclusa, patients should take a blood test to check for hepatitis B (HBV) infection. HBV infection could get worse or reactivate during or after DAA treatment, potentially leading to serious liver problems, including liver failure or death. Patients with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment. See HBV Reactivation page for more information and consult your medical provider.
AWP$29,904 / month; authorized generic: $9,600 / month
Potential Side Effects and Toxicity
Epclusa is a very well-tolerated medication with minimal side effects. Indeed, in the clinical trials for Epclusa, there were very few people—0.2%—who discontinued treatment due to side effects, and the real world experience has been very similar. In patients without cirrhosis or in those with compensated cirrhosis, the most commonly reported side effects are headache and fatigue. Less frequently reported side effects include nausea, insomnia, and asthenia (weakness). The majority of these side effects are considered to be mild and occurred at similar rates to placebo in clinical trials. Similar side effects can occur in patients with decompensated cirrhosis, with the addition of diarrhea. Again, these are all considered mild to moderate in severity, and very few people have to discontinue treatment because of them. Epclusa has not been studied in pregnant women or nursing mothers, so the impact it may have on fetal development or nursing babies is unknown. Pregnant women or women who are trying to become pregnant should avoid use if the addition of ribavirin is required.
Potential Drug Interactions
Before starting Epclusa, be sure to tell your medical provider or pharmacist about all of the medications, supplements, and herbal products you take, whether they are prescribed, over-the-counter, or illicit. It is also important to inform them of any changes as they happen during treatment. Epclusa should not be taken within 4 hours of antacids. If taking H2-receptor antagonists, take Epclusa at the same time or separate by 12 hours at a dose that does not exceed doses comparable to famotidine 40 mg twice per day. Use of proton pump inhibitors (PPI) is not recommended, but if medically necessary, Epclusa should be taken with food and 4 hours before taking a PPI comparable to omeprazole 20 mg or lower. Epclusa should not be taken with the following HIV medications: efavirenz or tipranavir/ritonavir. Use caution and monitor renal function when taking Epclusa with tenofovir disoproxil fumarate (TDF). Avoid use if taking TDF with an HIV protease inhibitor, ritonavir, or cobicistat due to possible increase in TDF concentrations resulting in adverse reactions. It should not be taken with the rifamycin antimicrobials, such as rifabutin, rifampin, or rifapentine, nor should it be taken with the anticonvulsants carbamazepine, phenytoin, phenobarbital, or oxcarbazepine, as they reduce the concentrations of sofosbuvir and may reduce its effectiveness. It cannot be taken with St. John’s wort, and in general, herbal products should be avoided due to lack of information regarding potential for interaction. There are no interactions with methadone or other common medications used for opioid, alcohol, or nicotine dependency. Use with certain statins (cholesterol medicine) may cause increased risk of muscle pain (myopathy) or muscle breakdown (rhabdomyolysis). Your doctor should decide if your statin should be continued or changed during treatment with Epclusa. No sofosbuvir-based HCV regimens are to be used with amiodarone due to possible symptomatic bradycardia. Signs of bradycardia include fainting, dizziness, lightheadedness, weakness, excessive fatigue, shortness of breath, chest pains, and confusion or memory problems. Consult a medical provider should any of these symptoms occur.
Epclusa marked an exciting development for treating HCV: a pangenotypic (active against all 6 genotypes) once-per-day regimen taken for 12 weeks without ribavirin (in most situations) that has minimal side effects and high cure rates.
It is an effective and highly tolerable treatment option for people with GT3, with SVR12 rates as high as 98% for treatment-naïve patients without cirrhosis. Treatment experience and the presence of cirrhosis appear to lower the SVR12 rates (94 and 93%, respectively), but this is still a good, interferon- and ribavirin-free, option for this hard-to-treat patient group. It's also an excellent treatment for people with more advanced cirrhosis: The ASTRAL-4 study, which looked at patients with decompensated liver disease, resulted in an SVR12 of 83% for people taking Epclusa for 12 weeks and 86% for people taking Epclusa for 24 weeks. The rate of SVR12 increased to 94% when ribavirin was added to Epclusa for 12 weeks, which is why this is the recommendation in patients with decompensated cirrhosis. Finally, it’s also an excellent choice for HIV/HCV co-infected persons. The ASTRAL-5 study, which looked at treating HIV/HCV co-infected persons with Epclusa, had an overall 95% SVR12 and included treatment-experienced patients and those with compensated cirrhosis.
Epclusa is taken for 12 weeks by people without cirrhosis or who have compensated cirrhosis, with ribavirin added for people who have decompensated cirrhosis (or extended for 24 weeks if not eligible for ribavirin). Treatment is for all genotypes and whether treatment-experienced or not (although this depends on what previous medicines were taken). Go to hcvguidelines.org for additional information on clinical studies and treatment recommendations.