Epclusa

Epclusa is a very well-tolerated medication with minimal side effects. Indeed, in clinical trials, very few people—0.2%— discontinued treatment due to side effects, and real-world experience has been similar. In patients without cirrhosis or in those with compensated cirrhosis, the most commonly reported side effects are headache and fatigue. Less frequently reported included 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, in addition to diarrhea. Again, these are all considered mild to moderate in severity; very few people have to discontinue treatment because of them. Epclusa has not been studied in pregnant women or nursing mothers, so its impact on fetal development or nursing babies is unknown. People who are pregnant or who are trying to become pregnant should avoid use if the addition of ribavirin is required (SEE ribavirin page).

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 recreational. It is important to report any changes to your medications as they happen during treatment. Epclusa should not be taken within 4 hours of antacids. If taking H2-receptor antagonists (used for heartburn), 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 (both of which are rarely used today). If taking tenofovir disoproxil fumarate (TDF) with an HIV protease inhibitor, ritonavir, or cobicistat, closely monitor for toxicities, due to possible increase in TDF concentrations resulting in adverse reactions, such as decreased renal function. 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 both components of Epclusa 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 determine if your statin should be continued or changed during treatment with Epclusa. Sofosbuvir-based HCV regimens should be avoided if taking amiodarone due to possible symptomatic bradycardia (slow heart rate). 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 is a pangenotypic (active against all 6 genotypes), once-per-day regimen that has minimal side effects and high cure rates.

Epclusa can be used in several special populations. It can safely be used in people with kidney disease, including those on dialysis, with no need for dosage adjustment. Epclusa is approved for children aged 3 years and older. It is also recommended for use in people after they receive a liver or kidney transplant.

Epclusa is taken for 12 weeks by people without cirrhosis or who have compensated cirrhosis. Ribavirin is added for people who have decompensated cirrhosis, or treatment is extended to 24 weeks if someone is not eligible for ribavirin.

For more information, GO TO hcvguidelines.org.

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 worsen 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 for more information and consult your medical provider.