Sovaldi (sofosbuvir)

Sovaldi (sofosbuvir)Sovaldi (sofosbuvir) – General Information   (PDF)

Targeted Genotype: 1, 2, 3, 4, 5, 6

Approvals: Please see the Sovaldi Treatment Combinations section below for more information.

Treatment Description: Sovaldi (sofosbuvir) is a nucleotide NS5B polymerase inhibitor. Nucleotide NS5B polymerase inhibitors are used in combination with other treatments to directly target the hep C virus and stop it from making copies of itself in the liver.

Usage Warning: Patients taking amiodarone should not take Sovaldi (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.

Sovaldi Treatment Combinations

Genotype Sovaldi (sofosbuvir) Treatment Combination Approved by Health Canada for use in Canada
 Covered by BC PharmaCare
1 Sovaldi + Pegylated Interferon with Ribavirin (PR) Yes Yes
4 Sovaldi + Pegylated Interferon with Ribavirin (PR) Yes No
2, 3 Sovaldi + Ribavirin (RBV) Yes Yes
1 Galexos (simeprevir) + Sovaldi Yes No
1, 2, 3 Daklinza (daclatasvir) + Sovaldi Yes No
3 Zepatier (grazoprevir and elbasvir) + Sovaldi Yes No
1, 2, 4, 5, 6* Sofosbuvir / Velpatasvir No No
*The treatment combinations that are covered by BC PharmaCare are only done so as limited coverage drugs. Harvoni also includes Sovaldi, however, isn’t considered a combination for the purposes of this table because Harvoni is a single pill that can’t be broken down into its two parts. Also, sofosbuvir / velpatasvir has just begun the approval process in Canada, therefore, the genotypes it is eventually approved to treat may change. See Hep C Drug Pipeline Treatments for information about Sovaldi (sofosbuvir) combinations not covered by BC PharmaCare.

Sovaldi Treatment Combinations that are BC PharmaCare Covered

Treatment Patients # of Weeks
Sovaldi with pegylated interferon and ribavirin (PR) Genotype 1 patients who have never tried treatment 12
Sovaldi with ribavirin (RBV) Genotype 2 patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried pegylated interferon with ribavirin (PR)* 12
Sovaldi with ribavirin (RBV) Genotype 3 patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried pegylated interferon with ribavirin (PR) 24
*Genotype 2 or 3 patients who have tried treatment are patients who have previously been treated with pegylated interferon with ribavirin but weren’t cured. Similar treatment lengths are also used to treat genotype 2 or 3 HCV patients co-infected with HIV. The information for genotype 4 patients is the same as it is for genotype 1 patients. See Hep C Drug Pipeline Treatments for information about Sovaldi combinations not covered by BC PharmaCare.
Sovaldi with Pegylated Interferon and Ribavirin (PR)

Genotypes: 1, 4

Dose: 1 pill of Sovaldi daily + 2 pills of ribavirin daily + pegylated interferon once weekly

SVR: 93% – 95%

Length of Treatment: 12 weeks

Common Side Effects of Sovaldi + Pegylated Interferon with Ribavirin:

  • Difficulty sleeping
  • Headache
  • Low red blood cell count
  • Nausea
  • Tiredness
Sovaldi with Ribavirin (RBV)

Genotype: 2, 3

Dose: 1 pill of Sovaldi + 2 pills of ribavirin

SVR: GT2 95%, GT3 75%

Length of Treatment:

Treatment Patients # of Weeks
Sovaldi with ribavirin Genotype 2 patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried pegylated interferon with ribavirin (PR)* 12
Sovaldi with ribavirin Genotype 3 patients who have never tried treatment AND who can’t take interferon for medical reasons OR have already tried pegylated interferon with ribavirin (PR) 24
*Genotype 2 or 3 patients who have tried treatment are patients who have previously been treated with pegylated interferon with ribavirin but weren’t cured. Similar treatment lengths are also used to treat genotype 2 or 3 HCV patients co-infected with HIV.

Common Side Effects of Sovaldi + Ribavirin:

  • Headache
  • Tiredness

BC PharmaCare Eligibility for Sovaldi-Based Treatments

Sovaldi is a limited coverage drug accessed through Special Authority request, usually by a specialist.  Sovaldi is for patients with chronic hepatitis C genotype 1, 2, or 3, with or without compensated cirrhosis, and who meet criteria similar to the other limited coverage hep C treatments.

In order to qualify for Sovaldi 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:

AND NOT

  • Currently being treated with another hep C antiviral agent
  • Requesting re-treatment

Additional BC PharmaCare Coverage Information for Sovaldi by Genotype

Genotype 1
Genotype 2 or 3

Patients, who qualify for hep C treatment, may be prescribed Sovaldi and ribavirin if they cannot be treated with interferon because of:

  • Abnormally bad reactions to any part of pegylated interferon or interferon that made the patient stop taking it
  • Autoimmune hepatitis
  • Decompensated liver disease

OR

They have documented proof of conditions that may worsen with interferon, such as:

  • Neuropsychiatric disorders (such as depression, anxiety or PTSD)
  • Autoimmune conditions (like lupus, type 1 diabetes, rheumatoid arthritis, or MS)
  • Cardiac abnormalities (heart conditions)
  • Hematologic (blood diseases)
  • Retinal diseases (eye problem)
  • Neurological or endocrine conditions (for instance thyroid or parathyroid diseases)

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 Sovaldi  (sofosbuvir) have the opportunity to request to be enrolled in the Gilead Momentum Program. For more information, contact your doctor, nurse, or call the Gilead Momentum Program at: 1-855-447-7977. One can also find more information about the assistance program by clicking the above link and then scrolling down the page.

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