HARVONI® (ledipasvir 90 mg/sofosbuvir 400 mg)
HEP C TREATMENT WAS TRANSFORMED WITH HARVONI
HARVONI revolutionized Hep C treatment by combining two drugs (ledipasvir and sofosbuvir) into one pill. HARVONI was the first cure that’s one pill, once a day for the majority of patients.
In clinical studies, HARVONI was proven to cure 96–99% of adult patients who had Hep C genotype 1 and no prior treatment with just 12 weeks of therapy.* Certain patients were cured with just 8 weeks of therapy.† Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed.
Like HARVONI, EPCLUSA® (sofosbuvir 400 mg/velpatasvir 100 mg) is a clear step forward in Hep C treatment. See EPCLUSA clinical study results here.
*In a study of 865 patients with genotype 1 Hep C and no prior Hep C treatment, with or without cirrhosis, 99% (210 out of 213) of those who received HARVONI once daily for 12 weeks were cured. In a separate study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 96% (208 out of 216) of those who received HARVONI once daily for 12 weeks were cured.
†In a study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 97% (119 out of 123) of those with lower levels of the virus (less than 6 million IU/mL) who received HARVONI once daily for 8 weeks were cured.
These studies did not include patients with advanced cirrhosis (decompensated)‡ or those who have had a liver transplant.
‡Advanced cirrhosis (decompensated) is when the liver is extensively scarred and can no longer do its job effectively.
What is HARVONI?
HARVONI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype (GT) 1, 4, 5 or 6 infection with or without cirrhosis (compensated). In those with GT 1 and advanced cirrhosis (decompensated) or with GT 1 or 4 with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin.
Important Safety Information
What is the most important information I should know about HARVONI?
HARVONI can cause serious side effects, including:
- Hepatitis B virus reactivation: Before starting HARVONI treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with HARVONI. This may cause serious liver problems, including liver failure and death. If you are at risk, your healthcare provider will monitor you during and after taking HARVONI.
What should I tell my healthcare provider before taking HARVONI?
- Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection, liver problems other than hepatitis C infection, or a liver transplant; if you have severe kidney problems or are on dialysis; if you have HIV; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if HARVONI will harm your unborn baby or pass into your breast milk. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
- Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI and certain other medicines may affect each other, or may cause side effects.
What are the possible side effects of HARVONI?
Serious side effects may also include:
- Slow heart rate (bradycardia): HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems.
The most common side effects of HARVONI include tiredness, headache and weakness.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Important Facts about HARVONI including Important Warning on hepatitis B reactivation.
Please see Important Facts about EPCLUSA including Important Warning on hepatitis B reactivation.