Harvoni (ledipasvir and sofosbuvir) – General Information (PDF)
Targeted Genotype: 1 a/b
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 taking amiodarone should not take sofosbuvir in any combination. There have been reports of severe bradycardia (slow heart rate) or heart block (problems with conduction of electrical signals in the heart) as a result.
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: | # of Weeks |
| Patients who haven’t been treated, are without cirrhosis, with viral loads < 6 million IU/mL* | 8 |
| Patients who haven’t been treated, are without cirrhosis, with viral load ≥ 6 million IU/mL | 12 |
| Patients who haven’t been treated with compensated cirrhosis | 12 |
| Patients who have been treated with no cirrhosis | 12 |
| Patients who have been treated with compensated cirrhosis | 24 |
| *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)
OR
- Tried treatment and the virus came back (relapsed)
OR
- Tried treatment but weren’t cured (non-responder)
AND have ALL of the following:
- Lab-confirmed hepatitis C genotype 1
- Detectable levels of hep C in the last 6 months
- A liver fibrosis stage F2 or greater
- Special Authority request completed by a specialist or experienced physician
AND NOT
- Currently being treated with another hep C antiviral treatment
- At high risk of not following the treatment obligations
- Requesting re-treatment
Additional PharmaCare Coverage Information
Harvoni (sofosbuvir-ledipasvir) is preferable to the other therapies because of its:
- Reported high cure rates
- Once-daily dose
- Well-tolerated regimen (compared to interferon-containing regimens)
- Shorter duration of therapy for most patients
In exceptional cases, requests that do not meet the above criteria may receive special consideration for coverage if the physician provides additional documentation of disease progression and/or for other patient-specific considerations. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews all requests for coverage of exceptional cases.
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.