Targeted Genotype: 1
Treatment Description: Harvoni (ledipasvir and sofosbuvir) is a combination of ledipasvir, a NS5A inhibitor, and sofosbuvir, a nucleotide NS5B polymerase inhibitor. NS5A inhibitors block the protein NS5A that HCV needs to reproduce. Nucleotide NS5B polymerase inhibitors directly target the hep C virus to stop it from making copies of itself in the liver.
Daily Dose: 1 pill
Harvoni contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single pill taken with or without food.
Length of Treatment:
|For the treatment of chronic hepatitis C genotype 1 in patients:||# of Weeks|
|Treatment-naïve with no cirrhosis, who have pre-treatment HCV RNA level < 6 million IU/mL, and mono-HCV infected only.||8 or 12|
|Treatment-naïve with no cirrhosis, who have pre-treatment HCV RNA level ≥ 6 million IU/mL||12|
|Treatment-naïve with compensated cirrhosis||12|
|Treatment-experienced with no cirrhosis||12|
|Treatment-naïve or treatment-experienced HCV/HIV-1 co-infected with no cirrhosis or with compensated cirrhosis|
|Treatment-experienced with compensated cirrhosis||24|
|Treatment-naïve and treatment-experienced with decompensated cirrhosis||12 weeks with RBV|
|Treatment-naïve and treatment-experienced liver transplant recipients with no cirrhosis or with compensated cirrhosis||12 weeks with RBV|
|*Viral load tests determine how much virus (HCV RNA) is in the blood. If the level of it is higher than a certain level, longer or additional treatments may be recommended. IU/ml means International Units per milliliter. It’s used in reporting viral load test results. In this case, for patients with an initial level of hep C virus of ≥ 6 million IU/mL, a 12-week regimen is optimal, as shorter durations have higher relapse rates.|
Common Side Effects:
- Difficulty sleeping
BC’s PharmaCare Eligibility for Harvoni
Harvoni is a limited coverage drug. To qualify for treatment coverage a patients must have:
- Treatment prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist or other physicians experienced with treating hepatitis C
- Lab-confirmed hepatitis C genotype 1
- Not currently taking another hep C treatment
- Detectable levels of hep C in the last 12 months
- A liver fibrosis stage F0
Talk to your healthcare provider for more information or to start the treatment process.
Gilead’s Momentum Patient Assistance Program
Canadians prescribed Harvoni (ledipasvir and sofosbuvir) can request to be enrolled in the Gilead Momentum Program. For more information, contact your doctor, nurse, or call the Gilead Momentum Program at: 1-866-207-4267.