Hepatitis Treatment Print FDA-Approved Hepatitis C Drugs By James Myhre and 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 and Dennis Sifris, MD Medically reviewed by Medically reviewed by Robert Burakoff, MD, MPH on January 13, 2020 linkedin Robert Burakoff, MD, MPH, is board-certified in gastroentrology. He is the vice chair for ambulatory services for the department of medicine at Weill Cornell Medical College in New York, where he is also a professor. He was the founding editor and co-editor in chief of Inflammatory Bowel Diseases. Learn about our Medical Review Board Robert Burakoff, MD, MPH on January 13, 2020 Hepatitis C Overview Symptoms Causes Diagnosis Treatment Coping Prevention When the drug Sovaldi (sofosbuvir) was first introduced in September 2014, it not only marked a sea change in how hepatitis C infection was treated, it made obsolete earlier generation medications which were nowhere near as effective. Within months of Sovaldi's arrival, such hepatitis C mainstays as Incivek (telaprevir) and Victrelis (boceprevir) were quickly yanked from the market, never to be seen again. Following fast on Sovaldi's heels was the introduction of five additional drug formulations able to treat an ever-widening range of hepatitis C genotypes. These newer drugs not only offered fewer side effects, but they also reduced the course of therapy by as much as three months. With cure rates now exceeding 95 percent in many cases, the only real challenge is how to expand access to the 130 to 150 million people chronically infected with hepatitis C worldwide. Drug Discontinuations As treatment durations decreased and cure rates climbed, less competitive direct-acting antivirals quickly lost popularity and were voluntarily withdrawn from the marketplace. These included the drug Olysio (simeprevir), which was pulled in May 2018, and the combination drugs Technivie (ombitasvir/paritaprevir/ritonavir) and Viekira Pak (ombitasvir/paritaprevir/ritonavir plus dasabuvir), both of which were discontinuation on January 1, 2019. The remaining mainstays of hepatitis C treatment are listed by the order of their FDA approval. 1 Mavyret Courtesy of Abbvie Approved by the U.S. Food and Drug Administration (FDA) in August 2017, Mavyret (glecaprevir/pibrentasvir) is a combination drug comprised of two viral protein inhibitors. By blocking these proteins, hepatitis C viral RNA replication cannot take place. Mavyret is effective at clearing all six hepatitis C genotypes in as little of eight weeks. The recommended dosage is three tablets taken once daily with food. The average wholesale price (AWP) of Mavyret is $26,400 for an 8-week course and $39,600 for a 12-week course. Mavyret for Hepatitis C 2 Vosevi Courtesy of Gilead Approved in July 2017 by the FDA, Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is used to treat any genotype of the hepatitis C virus. Vosevi is intended for people who have been previously treated with sofosbuvir but didn't achieve viral clearance (known as a sustained viral response, or SVR). The recommended dosage is one tablet one pill taken once daily with food for 12 weeks. The average wholesale price (AWP) of Vosevi is $74,760 for a 12-week course. 3 Epclusa Photo courtesy Gilead Sciences Approved on June 28, 2016, Epclusa (sofosbuvir/velpatasvir) is a two-in-one combination tablet able to treat all six major hepatitis C genotypes. It can be used to treat people with cirrhosis (including decompensated cirrhosis). Epclusa is prescribed in a once-daily dose for a period of 12 weeks. The average wholesale price (AWP) of Epclusa is $89,700 for an 8-week course. How to Treat Hepatitis C With Epclusa 4 Zepatier Courtesy Merck Approved in January 2016, Zepatier (elbasvir/grazoprevir) is a fixed-dose combination drug used to treat genotypes 1 and 4 with or without cirrhosis. Zepatier is a single-pill therapy that does not need to be administered with any other drug. It is taken once daily with or without food for 12 to 16 weeks, depending on the type of genotype a person has and whether or not the person has been previously treated for hepatitis C. The average wholesale price (AWP) of Zepatier is $54,000 for a 12-week course. Zepatier for Treating Hepatitis C 5 Daklinza Courtesy Bristol Myer Squibb Approved in July 2015, Daklinza (daclatasvir) is used in combination therapy to treat hepatitis C genotype 3 infection. Daklinza was the first direct-acting antiviral able to treat genotype 3 without the addition of peginterferon or ribavirin. Daklinza is taken along with Sovaldi once daily with or without food for a period of 12 weeks. The average wholesale price (AWP) of Daklinza is $25,200 for a 12-week course. FDA-Approved Hepatitis C Drugs 6 Harvoni Photo courtesy Gilead Sciences Approved in October 2014, Harvoni (ledipasvir, sofosbuvir) is a fixed-dose combination drug used to treat genotype 1 and 4 infections with or without cirrhosis. It can also be used in some cases of genotype 3. Harvoni was the first, all-in-one drug formulation that didn't require co-administration with peginterferon or ribavirin. The recommended dosage is one tablet daily taken with or without food. The treatment duration is from 12 to 24 weeks. The average wholesale price (AWP) of Harvoni is $94,500 for a 12-week course. Harvoni (ledipasvir/sofosbuvir) for Hepatitis C 7 Sovaldi Courtesy Gilead Sciences Approved in December 2013, Sovaldi (sofosbuvir) is a novel direct-acting antiviral drug used to treat genotypes 1, 2, 3 and 4. The recommended dosage is one tablet daily taken with or without food. Depending on the genotype, ribavirin may be incorporated into the therapy. For genotype 3 infection, Sovaldi is co-administered with Daklinza. The treatment duration is from 12 to 24 weeks. The average wholesale price (AWP) of Sovaldi is $84,000 for a 12-week course. FDA-Approved Hepatitis C Drugs 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 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. Mcquaid T, Savini C, Seyedkazemi S. Sofosbuvir, a significant paradigm change in HCV treatment. J Clin Transl Hepatol. 2015;3(1):27-35. doi:10.14218/JCTH.2014.00041 Jacobson IM, Lawitz E, Gane EJ, et al. Efficacy of 8 weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in patients with chronic HCV infection: 2 phase 3 randomized trials. Gastroenterology. 2017;153(1):113-122. doi:10.1053/j.gastro.2017.03.047 Zeuzem S, Foster GR, Wang S, et al. Glecaprevir-Pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med. 2018;378(4):354-369. doi:10.1016/j.cgh.2017.09.027. Sofosbuvir/velpatasvir/voxilaprevir for hepatitis C. Aust Prescr. 2019;42(3):108-109. doi:10.1007/s40265-018-0895-5 Zuckerman A, Chastain CA, Naggie S. Retreatment options following HCV direct acting antiviral failure. Curr Treat Options Infect Dis. 2017;9(4):389-402. doi:10.1007/s40506-017-0136-6 Zignego AL, Monti M, Gragnani L. Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection. Acta Biomed. 2018;89(3):321-331. doi:10.23750/abm.v89i3.7718 Takehara T, Sakamoto N, Nishiguchi S, et al. Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial. J Gastroenterol. 2019;54(1):87-95. doi:10.1007/s00535-018-1503-x Elbasvir/grazoprevir. Aust Prescr. 2017;40(1):32-34. doi:10.18773/austprescr.2017.010 Montgomery M, Ho N, Chung E, Marzella N. Daclatasvir (Daklinza): A treatment option for chronic hepatitis c infection. P T. 2016;41(12):751-755. Shiha G, Esmat G, Hassany M, et al. Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt. Gut. 2019;68(4):721-728. doi:10.1136/gutjnl-2017-315906 Mir F, Kahveci AS, Ibdah JA, Tahan V. Sofosbuvir/velpatasvir regimen promises an effective pan-genotypic hepatitis C virus cure. Drug Des Devel Ther. 2017;11:497-502. doi:10.2147/DDDT.S130945 Additional Reading AASLD-IDSA HCV Guidance Panel. Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clin Infect Dis. 2018:67(10):1477-92. DOI: 10.1093/cid/ciy585.