Hepatitis Hepatitis C Taking Harvoni (Ledipasvir/Sofosbuvir) for Hepatitis C By James Myhre & Dennis Sifris, MD 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 Updated on February 23, 2022 Medically reviewed Verywell Health articles are reviewed by board-certified physicians and healthcare professionals. These medical reviewers confirm the content is thorough and accurate, reflecting the latest evidence-based research. Content is reviewed before publication and upon substantial updates. Learn more. by Jay N. Yepuri, MD, MS Medically reviewed by Jay N. Yepuri, MD, MS Facebook LinkedIn Twitter Jay Yepuri, MD, MS, is a board-certified gastroenterologist and a practicing partner at Digestive Health Associates of Texas (DHAT). Learn about our Medical Expert Board Print Gilead Science Harvoni is a fixed-dose combination drug used in the treatment of chronic hepatitis C (HCV) infection. The two drugs that comprise Harvoni, which are ledipasvir and sofosbuvir, work by blocking both a protein (NS5A) and an enzyme (RNA polymerase) vital to the replication of the virus. Harvoni was approved in October 2014 by the Food and Drug Administration (FDA) for use in adults 18 years or over with HCV genotypes 1 infection, including those with cirrhosis. Harvoni is approved for use in previously untreated (treatment-naïve) patients, as well as those with partial or no response to prior HCV therapy (treatment-experienced patients). Harvoni is the first FDA-approved HCV drug that does not need to be taken with either pegylated interferon (peg-interferon) or ribavirin, two drugs traditionally used for HCV combination therapy, both of which had high toxicity profiles. Harvoni is reported to have cure rates of between 94% and 99%, while phase 2 trials have reported a 100% cure rate in patients coinfected with human immunodeficiency virus (HIV) and HCV. Dosage One tablet (90 milligrams of ledipasvir and 400 milligrams of sofosbuvir) taken daily with or without food. Harvoni tablets are diamond shaped, ginger colored, and film coated, with "GSI" embossed on one side and "7985" on the other. Prescribing Recommendations Harvoni is prescribed over a 12- to 24-week course, as per the following recommendations: Treatment-naïve with or without cirrhosis: 12 weeksTreatment-experienced without cirrhosis: 12 weeksTreatment-experienced with cirrhosis: 24 weeks Additionally, an eight-week course can be considered for treatment-naïve patients without cirrhosis who have an HCV viral load of under 6 million HIV copies in a milliliter of blood (copies/mL). Common Side Effects The most common side effects associated with the use of Harvoni (occurring in 10% or fewer patients) are: FatigueHeadache Other possible side effects (under 10%) include nausea, diarrhea, and insomnia. Drug Interactions The following should also be avoided when using Harvoni: Rifampin-based tuberculosis medications: Mycobutin, Rifater, Rifamate, Rimactane, Rifadin, PriftinAnticonvulsants: Tegretol, Dilantin, Trileptal, phenobarbitalAptivus (tipranavir/ritonavir) used in HIV antiretroviral therapySaint-John's-wort Contraindications and Considerations There are no contraindications for the use of Harvoni in patients with HCV genotype 1. However, for patients with HIV using the drug tenofovir (including Viread, Truvada, Atripla, Complera, Stribild), extra care should be given in monitoring for any tenofovir-associated side effects, particularly renal (kidney) impairment. Antacids should be taken separately four hours before or after a Harvoni dose, while dosages of proton pump inhibitors and H2 receptor inhibitors, or H2 blockers, may need to be reduced in order to prevent decreasing ledipasvir absorption. While there is no contraindication for the use of Harvoni in pregnancy, little human clinical data is available. However, animal studies into the use of both ledipasvir and sofosbuvir have shown no effect to fetal development. Specialist consultation is recommended during pregnancy to assess the urgency of Harvoni therapy, specifically whether to start immediately or to wait until after delivery. It is recommended that all women of childbearing age be monitored monthly for pregnancy during the course of therapy. It is also recommended that the patient and male partners be provided at least two nonhormonal methods of contraception and that they be used during the course of therapy and for six months afterward. Hepatitis C Doctor Discussion Guide Get our printable guide for your next doctor's appointment to help you ask the right questions. Download PDF Email the Guide Send to yourself or a loved one. Sign Up This Doctor Discussion Guide has been sent to {{form.email}}. There was an error. Please try again. Was this page helpful? Thanks for your feedback! Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest 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 0 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. U.S. Food and Drug Administration (FDA). "FDA approves first combination drug to treat hepatitis C." Silver Spring, Maryland; press release issued October 10, 2014.