HARVONI (harVOEnee) (ledipasvir and （HARVONI(harVOEnee)(ledipasvir和）.pdf

Patient Information ® HARVONI (har-VOE-nee) (ledipasvir and sofosbuvir) tablets Important: If you take HARVONI with ribavirin, you should also read the Medication Guide for ribavirin. What is the most important information I should know about HARVONI? HARVONI can cause serious side effects, including, Hepatitis B virus reactivation: Before starting treatment with HARVONI, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with HARVONI. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking HARVONI. For more information about side effects, see the section “What are the possible side effects of HARVONI?” What is HARVONI? HARVONI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (HCV): • genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis • genotype 1 infection with advanced cirrhosis (decompensated) in combination with ribavirin • genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis who have had a liver transplant, in combination with ribavirin HARVONI is used to treat children 12 years of age and older or weighing at least 77 pounds (at least 35 kg) with chronic HCV genotype 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis. It is not known if HARVONI is safe and effective in children with HCV under 12