We have updated Epclusa’s information to include the approval for HIV and hepatitis C coinfection indication:
Hep C Medications Blog, click here
FDA Prescribing Information (Package Insert), click here
Drug: Epclusa (ep-KLOO-suh)
Epclusa is a combination of two drugs—sofosbuvir, a polymerase inhibitor and velpatasvir, a NS5A inhibitor, combined into one pill, taken once-a-day.Epclusa is taken with or without food. Epclusa is approved by the Food and Drug Administration to treat adults infected with chronic hepatitis C (HCV) genotype 1, 2, 3, 4, 5 and 6.It can be taken with and without ribavirin. Epclusa is manufactured by Gilead Sciences Inc.
The overall cure rates of Epclusa are up to and over 90%.The wholesale acquisition cost (WAC) for Epclusa is $74,760.00 for a 12-week course of treatment.
Patient Support: Support Path – 1-855-769-7284 – www.mysupportpath.com
Common Drug Interactions: The herb St. John’s wort should be avoided.Talk to your medical provider about any medications, supplements, herbs or over-the-counter medications you are taking to prevent any possible problems that may interfere with how well Epclusa will work.
See the Highlights of Prescribing Information for a complete listing of drug interactions.
Note: The Food and Drug Administration (FDA) is requiring that hepatitis C (HCV) medication guides (package inserts) list a warning about a possible risk of hepatitis B (HBV) reactivation while on HCV antiviral therapy. Reactivation of HBV can cause possible liver damage. However, the risk is extremely rare. The reactivation has been reported with interferon and direct-acting antiviral medications.
Patients should talk to their medical providers about the hepatitis B tests and vaccination prior to starting HCV treatment.
Side Effects: The most common side effects of Epclusa that occurred in more than 10% of patients in the clinical trials were headache and fatigue.
Pregnancy: There are no studies of Epclusa in pregnant women. Ribavirin can cause birth defects and miscarriages.If you are a male taking ribavirin, you and your female sexual partner must use two types of effective birth control. Your female sexual partner will have to take a pregnancy test before and during treatment and 6 months after treatment ends.If you are a female taking ribavirin, you and your male sexual partner must use two types of effective birth control.Additionally, women have to take a pregnancy test before, during and 6 months after treatment ends.
Pediatric Patients: Epclusa is not approved to treat children.
HIV/HCV Coinfection: The same dosage recommendation for people coinfected are as those who are monoinfected with HCV. Careful attention should be given to potential drug-drug interactions to HIV antiviral drugs.
Listed below are the cure rates for genotypes 1, 2, 3, 4, 5 and 6 without cirrhosis and with compensated cirrhosis.
Epclusa for 12 weeks – no ribavirin in patients (treatment naive and treatment experienced) without cirrhosis or with compensated cirrhosis:
|Genotype 1||Genotype 2||Genotype 3||Genotype 4||Genotype 5||Genotype 6|
*Genotype 1a cure rate = 98% (206 of 210 patients); Genotype 1b cure rate = 99% (117 of 118 patients)
Epclusa plus ribavirin for 12 weeks in treatment naive and treatment experienced patients with decompensated cirrhosis:
|1a||94% (51/54 pts)|
|1b||100% (14/14 pts)|
|2||100% (4/4 pts)|
|3||85% (11/13 pts)|
|4||100% (2/2 pts)|
Note: no genotype 5 or 6 patients were included in the above study of decompensated cirrhosis patients.