Harvoni (ledipasvir and sofosbuvir)

Harvoni (ledipasvir and sofosbuvir)Harvoni (ledipasvir and sofosbuvir) – General Information (PDF)

Targeted Genotype: 1

Approved by Health Canada and Covered by BC PharmaCare: Yes

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.

Usage Warning: Patients with Bradycardia taking amiodarone can not take Sovaldi (sofosbuvir) in any combination.

Daily Dose: 1 pill
Harvoni contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single pill taken with or without food.

SVR: 93% – 99%

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:

  • Diarrhea
  • Difficulty sleeping
  • Headache
  • Nausea
  • Tiredness

BC’s PharmaCare Eligibility for Harvoni

Harvoni is a limited coverage drug. To qualify for treatment coverage a patients must have:

  • Never tried to treat their hepatitis C (treatment naive)

AND have ALL of the following:

  • 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
  • Detectable levels of hep C in the last 12 months
  • A liver fibrosis stage F2 or greater OR

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.