Welcome to Zepatier, the newest FDA-approved medicine to treat hepatitis C. Zepatier is manufactured by Merck. The wholesale acquisition cost was set at a very competitive price of $54,600 for 12 weeks of Zepatier. Here is a brief summary of the newest drug on the block:
- Zepatier contains an NS5A replication complex inhibitor (elbasvir) and an NS3/4A protease inhibitor (grazoprevir) combined into a single tablet.
- Zepatier is an oral medication approved to treat people with chronic hepatitis C who have genotype 1 or 4, including those with cirrhosis. Zepatier should not be used by those with moderate or severe cirrhosis (Child-Pugh B or C).
- In some cases, Zepatier may be prescribed with ribavirin, but not with peginterferon.
- Treatment involves taking Zepatier daily for 12 to 16 weeks, with or without ribavirin. Duration of treatment and whether Zepatier is prescribed with ribavirin are determined by genotype and prior treatment experience. People with genotype 1a may need screening for certain viral genetic variations (NS5A polymorphisms) prior to starting treatment with Zepatier to determine dosage duration.
Warnings: Zepatier should not be given to patients with moderate or severe cirrhosis (Child-Pugh B or C).
Adverse Events (Side Effects): Side effects associated with Zepatier are considered mild. The most common are fatigue, headache, and nausea. Less frequently reported side effects included diarrhea and insomnia.
Taking Zepatier with ribavirin increases the type, frequency and intensity of side effects. The most common side effects of Zepatier with ribavirin were anemia and headache.
Approximately 1 percent of clinical trial subjects had increases in liver enzymes (ALT) to more than 5 times the upper limit of normal.
Interactions: Before taking this medication, tell your medical provider and pharmacist about any drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit. Zepatier should not be taken with certain drugs and herbs that are metabolized in the liver and intestines such as St. John’s wort, cyclosporine, and rifampin. Additional drug-drug interactions may occur, and these are listed in Zepatier ’s full prescribing information.
Efficacy: In clinical studies, approximately 94-97 percent of genotype 1 participants were cured and 97-100 percent of genotype 4 participants were cured with 12 to 16 weeks of therapy.
Pregnancy and Breastfeeding: Pregnant women or those who are trying to become pregnant should not take Zepatier if it is prescribed with ribavirin. Women of childbearing age and their male sexual partners must use two forms of birth control throughout treatment and for six months after treatment if ribavirin is prescribed.
There are no adequate, well-controlled studies in pregnant women who have taken Zepatier without ribavirin. Zepatier should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
The safety of breastfeeding while taking Zepatier has not been established.
Will insurance cover Zepatier? I assume so, especially with the very competitive price point. Merck is offering a coupon for privately insured patients that may reduce the cost to as little as $5 per qualifying prescription of Zepatier.
Patient Support and Assistance: www.zepatier.com 866-251-6013