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www.hcvadvocate.org a series of fact sheets written by experts in the field of liver disease HCSP FACT SHEET • H C V T RE AT ME N T: FD A-APPRO VE D MED I C ATI O NS• Genotype 1: Sovaldi (Sofosbuvir) Triple Therapy Written by: Alan Franciscus, Editor-in-Chief Foreword In December 2013, the Food and Drug Administration (FDA) approved the combination of sofosbuvir—brand name Sovaldi, plus pegylated interferon and ribavirin (PEG/RBV) to treat hepatitis C (HCV) genotype 1. This fact sheet will discuss the basics of the therapy for treatment of HCV genotype 1. For more detailed information please see the Sovaldi (sofosbuvir) Package Insert. The FDA approval was based on the NEUTRINO study except where otherwise noted. Overall the cure rates were 89% and were somewhat comparable between patients that are usually considered the ‘easiest’ to treatment and those who are the most ‘difficult’ to treat (see below). Medications and Dose: • Sofosbuvir (brand name Sovaldi) a HCV polymerase inhibitor. Sovaldi is a 400 mg pill taken once-a-day. • Pegylated interferon (PEG) is injected under the skin once-a-week. • Ribavirin (pill) taken twice daily. The dose of ribavirin is based on body weight (<75kg = 1000mg; ≥ 1000kg = 1200mg). Dose Modification: • The recommendation is that Sovaldi should not be dose reduced. If medications used with Sovaldi are discontinued—Sovaldi should also be discontinued. Food Requirements: • Sovaldi – no food requirements • Ribavirin – taken with food. • Pegylated interferon – no food requirement HCSP • VERSION 1 • December 2013 HCSP FACT SHEET A publication of the Hepatitis C Support Project EXECUTIVE DIRECTOR, EDITOR-IN-CHIEF, HCSP PUBLICATIONS Alan Franciscus DESIGN Leslie Hoex, Blue Kangaroo Design PRODUCTION C.D. Mazoff, PhD CONTACT INFORMATION Hepatitis C Support Project PO Box 15144 Sacramento, CA 95813 [email protected] The information in this fact sheet is designed to help you understand and manage HCV and is not intended as medical advice. All persons with HCV should consult a medical practitioner for diagnosis and treatment of HCV. This information is provided by the Hepatitis C Support Project a nonprofit organization for HCV education, support and advocacy Reprint permission is granted and encouraged with credit to the Hepatitis C Support Project. 1 © 2013 Hepatitis C Support Project HCSP FACT SHEET • HCV T REAT MENT: F DA- APPROVED M EDIC ATI ON S • a series of fact sheets written by experts in the field of liver disease Genotype 1: Sovaldi (Sofosbuvir) Triple Therapy Length of Treatment: • 12 weeks Sustained Virological Results (SVR- 12 weeks post treatment)/ Cure Rate • Treatment Naïve: 89% overall ♦ ♦ Genotype 1a = 92% ♦ ♦ Genotype 1b = 82% • Cirrhosis/No Cirrhosis ♦ ♦ No cirrhosis = 92% ♦ ♦ Cirrhosis = 80% • Race ♦ ♦ Black = 87%* ♦ ♦ Non-black = 91% *17% of trial participants were Black • Side effects ♦ ♦ The usual PEG/RBV side effects—fatigue, headache, nausea, insomnia and anemia. • Treatment Discontinuation ♦ ♦ The number of patients who discontinued treatment due to side effects was 2% for those who received Sovaldi, PEG/RBV for 12 weeks • The NEUTRINO clinical trial only included treatment naïve patients. The patients in the study who had negative predictors of treatment response—Metavir F3/F4 (severe fibrosis/compensated cirrhosis), high viral load (> 800,000 IU/mL) and an IL28B non C/C genotype—achieved a 71% (37 of 52 patients) cure rate. HCSP • VERSION 1 • December 2013 Additional indications • Sovaldi plus PEG/RBV is also approved to treat HCV in people coinfected with HIV. • The patients in the trial who were over 65 yo had similar cure rates as those under 65 yo— no dose adjustments were needed. • No Sovaldi dose adjustment for people with mild-to-moderate kidney impairment • No Sovaldi dose adjustment for people with liver impairment, but people with decompensated were not studied in the clinical trials • People with liver cancer pre-transplant can be treated with sofosbuvir/ribavirin Pregnancy The prior cautions and warnings of PEG/RBV also apply to the triple combination of Sovaldi, PEG/RBV. The use of ribavirin can cause birth defects. Women must have a negative pregnancy test prior to therapy and partners must use at least 2 effective non-hormonal methods of birth control. A woman must have monthly pregnancy tests. Drug-Drug Interactions Sovaldi should not be taken with certain medications such as HIV medications, antimycobacterials and anticonvulsants. Sovaldi should not be taken with the herb—St. John’s wort. (See the complete list in the Highlights of Prescribing Information) 2 © 2013 Hepatitis C Support Project HCSP FACT SHEET • HCV T REAT MENT: F DA- APPROVED M EDIC ATI ON S • a series of fact sheets written by experts in the field of liver disease Genotype 1: Sovaldi (Sofosbuvir) Triple Therapy Related publications: • Olysio (simeprevir) Package Insert www.hcvadvocate.org/hepatitis/factsheets_pdf/Olysio_pi.pdf • Sovaldi (sofosbuvir) Package Insert www.hcvadvocate.org/hepatitis/factsheets_pdf/sovaldi_pi.pdf • Patient Assistance Programs www.hcvadvocate.org/hepatitis/factsheets_pdf/Patient_Assistance.pdf For more information • American Association for the Study of LIver Diseases www.aasld.org • Food and Drug Administration (FDA): www.fda.gov • Centers for Disease Control and Prevention www.cdc.gov • Mayo Clinic www.mayoclinic.com Visit our websites to learn more about viral hepatitis: www.hcvadvocate.org • www.hbvadvocate.org www.hepatitistattoos.org HCSP • VERSION 1 • December 2013 3 © 2013 Hepatitis C Support Project