HIV/AIDS Related Conditions Zepatier Hepatitis C Drug Information By James Myhre & Dennis Sifris, MD Dennis Sifris, MD, is an HIV specialist and Medical Director of LifeSense Disease Management. James Myhre is an American journalist and HIV educator. Learn about our editorial process James Myhre & Dennis Sifris, MD Medically reviewed by Medically reviewed by Latesha Elopre, MD, MSPH on October 25, 2020 linkedin Latesha Elopre, MD, is a board-certified internist specializing in HIV and an assistant professor of infectious diseases at the University of Alabama at Birmingham. Learn about our Medical Review Board Latesha Elopre, MD, MSPH on October 25, 2020 Print Merck Table of Contents View All Efficacy Dosage Prescribing Recommendations Common Side Effects Drug Interactions Treatment Considerations Zepatier (elbasvir/grazoprevir) is a fixed-dose combination drug used in the treatment of chronic hepatitis C (HCV) infection. The two drugs that comprise Zepatier (elbasvir, grazoprevir) work by blocking both a protein (NS5a) and an enzyme (NS3/4a protease) vital to the replication of the virus. Zepatier was approved on January 28, 2016, by the U.S. Food and Drug Administration (FDA) for use in adults 18 years or over with HCV genotype 1 or 4 infections, including those with cirrhosis. It is approved for use in both untreated (treatment-naïve) or previously treated (treatment-experienced) patients, depending on the HCV genotype and treatment status. Efficacy Zepatier is reported to have exceptional cure rates in Phase II human trials. An HCV cure is defined as sustaining an undetectable viral load for 24 weeks following completion of therapy (also known as a sustained virologic response, or SVR). The overall SVR rates ranged from 94% to 97% in patients with HCV genotype 1 infection, while patients with genotype 4 infection were reported to have SVR rates of 97% to 100%. Dosage One tablet (50mg/100mg) taken daily with or without food. Zepatier tablets are oval-shaped, beige-colored and film-coated, with "770" embossed on one side. Prescribing Recommendations Zepatier is prescribed either with or without ribavirin for genotype 1 or 4 infection. Unlike previous HCV therapies, peginterferon (a drug associated with often intolerable side effect) is not required. Prior to initiation of therapy, genetic testing may be performed to determine whether you have a type of virus that is resistant to the elbasvir component of Zepatier (known as an NS5a resistance-associated polymorphism). Duration of therapy ranges from 12-16 weeks, depending on HCV genotype and treatment status. Genotype Treatment status Taken withribavirin? Duration Genotype 1a treatment-naïve without elbasvir- resistantvirus no 12 weeks treatment-naïve with elbasvir-resistantvirus yes 16 weeks previously treated with ribavirin +peginterferon without elbasvir-resistant virus no 12 weeks previously treated with ribavirin +peginterferon with elbasvir-resistant virus yes 16 weeks previously treated with ribavirin +peginterferon + an HCV protease inhibitor yes 12 weeks Genotype 1b treatment-naïve no 12 weeks previously treated with ribavirin +peginterferon no 12 weeks previously treated with ribavirin +peginterferon + an HCV protease inhibitor* yes 12 weeks Genotype 4 treatment-naïve no 12 weeks previously treated with ribavirin +peginterferon yes 16 weeks Common Side Effects The most common side effects associated with Zepatier use (occurring in over 5% of patients) are: FatigueHeadacheNausea When used with ribavirin, the most commonly reported treatment side effects (occurring in over 5% of patients) include: HeadacheFatigueAnemiaNauseaItchinessIndigestionShortness of breathInsomniaMuscle painDecreased appetiteCoughIrritabilityRash Drug Interactions The following medications should not be used when taking Zepatier as they may cause significant drug-drug interactions: Antibiotics: nafcillinAnticonvulsives: Dilantin (phenytoin), Tegretol (carbamazepine)Antifungals: Nizoral oral tablets (ketoconazole)Anti-hypertensive drugs: Tracleer (bosentan)Herbal products: St. John's WortHIV antiretroviral drugs: Aptivus (tipranavir), Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), Intelence (etravirine), Invirase (saquinavir), Kaletra (lopinavir, ritonavir), Prezista (darunavir), Reyataz (atazanvir), Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disproxil), Sustiva (efavirenz)Immunosuppressant drugs used to prevent organ transplant rejection: cyclosporineRifampin-based drugs used in tuberculosis treatment: Mycobutin, Priftin, Rifater, Rifamate, Rimactane, Rifadin Treatment Considerations It has been reported in clinical studies that 1% of patients on Zepatier developed a severe elevation of liver enzymes indicative of liver toxicity, generally at or after the eighth week of therapy. As such, liver-related blood tests need to be performed before the initiation of therapy and regularly during the course of HCV therapy. Zepatier should not be prescribed to patients with severe liver impairment. The use of ribavirin is contraindicated in pregnancy and should not be prescribed either with Zepatier or any other hepatitis C drug. Female patients on a ribavirin-based therapy should be advised to avoid pregnancy and to use at least two non-hormonal methods of contraception during the course of therapy and for six months following completion of therapy. Was this page helpful? Thanks for your feedback! Get information on prevention, symptoms, and treatment to better ensure a long and healthy life. Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit Article Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Merck. "Zepatier - Highlights of Prescribing Information." Kenilworth, New Jersey. U.S. Food and Drug Administration (FDA). "FDA approves Zepatier for treatment of chronic hepatitis C genotype 1 and 4 infections." Silver Spring, Maryland; press release issued January 28, 2016.