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SOFOSBUVIR

All products: Limited Use (codes 485, 487)

Other products in the same Health Canada class (J05A, J05AP) — coverage varies; not interchangeable

  • Glecaprevir + pibrentasvir (Maviret): limited Use 550, 551, 552
  • Ledipasvir + sofosbuvir (Harvoni): limited Use 482, 483, 484
  • Sofosbuvir + velpatasvir (Epclusa): limited Use 488
  • Sofosbuvir + velpatasvir + voxilaprevir (Vosevi): limited Use 524
  • Abacavir + lamivudine + zidovudine (Trizivir): general benefit
  • Abacavir (Ziagen): general benefit

48 more in the class list below

Sovaldi · DIN 02418355 · 400mg · tablet

Limited Use — Reason for Use code 485, 487 requiredMarketed · checked 2026-09-20
StatusLimited Use — Reason for Use code 485, 487 required
Write on scriptLU code 485, 487 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 485, 487
Reason for Use code 485 In combination with ribavirin (Ibavyr) for treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 2; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) as the preferred therapeutic option over sofosbuvir with ribavirin regimens for treatment of genotype 2 or 3 patients only. This recommendation is based on evidence that Epclusa offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for genotype 3 infections. Treatment regimens for sofosbuvir (Sovaldi) for genotype 2: - Treatment-naive or treatment-experienced genotype 2 Approved regimen: 12 weeks in combination with ribavirin (Ibavyr) Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program. Coverage limit: LU Authorization Period: 12 Weeks. Reason for Use code 487 In combination with ribavirin (Ibavyr) for treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 3; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) as the preferred therapeutic option over sofosbuvir with ribavirin regimens for treatment of genotype 2 or 3 patients only. This recommendation is based on evidence that Epclusa offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for genotype 3 infections. Treatment regimens for sofosbuvir (Sovaldi) for genotype 3: - Treatment-naive or treatment-experienced without cirrhosis, or with compensated cirrhosis (2), or with decompensated cirrhosis (2), or post-liver transplant Approved regimen: 24 weeks in combination with ribavirin (Ibavyr). Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program. Coverage limit: LU Authorization Period: 24 Weeks. Coverage limit: 1. Treatment-experienced are those who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor. 2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Score 5 to 6]) and decompensated cirrhosis (Child-Turcotte-Pugh B or C [i.e. Score 7 or above]) may be considered. 3. Combination therapy with Zepatier (elbasvir/grazoprevir) will not be considered for funding. 4. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.
No interchangeable product listed in the Ontario extract
Sovaldi · DIN 02418355 Manufacturer: Gilead Sciences Canada, Inc.; listing date 2017-02-28 Health Canada: Marketed since 2014-01-06 · brand SOVALDI · ATC J05AP08 SOFOSBUVIR · form Tablet · route Oral · ingredients SOFOSBUVIR 400 MG · company Gilead sciences canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Sovaldi: Formulary list price $654.7619/unit (unit not stated in source; not the patient's cost)

Ministry pays: $654.7619 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90293 · Verify on the e-Formulary ↗ (DIN 02418355)

Source record
DIN 02418355: Sovaldi Raw flags: sec12=Y, sec3=Y Item: 081800369; group id 109; item number 0191; lccId 00277; manufacturer id GIL Source form: Tab; strength: 400mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $654.7619; ministry $654.7619 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02418355 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90293
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (08:18 Antivirals) and how they are covered

Matched class: 08:18 Antivirals

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ABACAVIR & LAMIVUDINE & ZIDOVUDINE, ABACAVIR SULFATE, ABACAVIR SULFATE & LAMIVUDINE, BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE, CABOTEGRAVIR, CABOTEGRAVIR & RILPIVIRINE, COBICISTAT & ELVITEGRAVIR & EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE, DARUNAVIR & COBICISTAT, DARUNAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE, DELAVIRDINE MESYLATE, DOLUTEGRAVIR, DOLUTEGRAVIR & ABACAVIR & LAMIVUDINE, DOLUTEGRAVIR & RILPIVIRINE, DOLUTEGRAVIR SODIUM/LAMIVUDINE, DORAVIRINE, DORAVIRINE/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ/TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE, ELVITEGRAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE, EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR ALAFENAMIDE HEMIFUMARATE, EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR DISOPROXIL, EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE, ETRAVIRINE, FOSAMPRENAVIR CALCIUM, GANCICLOVIR SODIUM, LAMIVUDINE & ZIDOVUDINE, LOPINAVIR & RITONAVIR, MARAVIROC, NELFINAVIR MESYLATE, RALTEGRAVIR POTASSIUM, RILPIVIRINE HYDROCHLORIDE, RITONAVIR Some products covered without a code (check the product listing): ACYCLOVIR, ATAZANAVIR SULFATE, DARUNAVIR, EFAVIRENZ, LAMIVUDINE, NEVIRAPINE, VALACYCLOVIR 08:18 Antivirals

GLECAPREVIR & PIBRENTASVIR

· 1 products · Limited Use, codes 550, 551, 552 · strengths: 100mg & 40mg · Tab

LEDIPASVIR & SOFOSBUVIR

· 1 products · Limited Use, codes 482, 483, 484 · strengths: 90mg & 400mg · Tab

SOFOSBUVIR & VELPATASVIR

· 1 products · Limited Use, codes 488 · strengths: 400mg & 100mg · Tab

SOFOSBUVIR & VELPATASVIR & VOXILAPREVIR

· 1 products · Limited Use, codes 524 · strengths: 400mg & 100mg & 100mg · Tab

ABACAVIR & LAMIVUDINE & ZIDOVUDINE

· 2 products · General benefit · strengths: 300mg & 150mg & 300mg · Tab

ABACAVIR SULFATE

· 4 products · General benefit · strengths: 20mg/mL, 300mg · O/L, Tab

ABACAVIR SULFATE & LAMIVUDINE

· 7 products · General benefit · strengths: 600mg & 300mg · Tab

ACYCLOVIR

· 15 products · Listed, not a benefit (2), General benefit (13) · strengths: 200mg, 400mg, 800mg · Tab

ATAZANAVIR SULFATE

· 12 products · General benefit (8), Off-Formulary Interchangeable, not an ODB benefit (4) · strengths: 150mg, 200mg, 300mg · Cap

BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE

· 1 products · General benefit · strengths: 50mg & 200mg & 25mg · Tab

CABOTEGRAVIR

· 3 products · General benefit · strengths: 200mg/mL, 30mg · Inj Sol-ER Susp 3mL Vial Kit Pk, Tab

CABOTEGRAVIR & RILPIVIRINE

· 2 products · General benefit · strengths: 200mg/mL & 300mg/mL · Inj Sol-2mL Kit, Inj Sol-3mL Kit Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 08:18 and 42 more
Full class listing Related classes: 08:08 Anthelmintics, 08:12 Antibiotics, 08:14 Antifungals, 08:16 Antitubercular Agents, 08:20 Plasmodicides (Antimalarials), 08:24 Sulfonamides, 08:30 Antiprotozoals, 08:32 Trichomonacides, 08:36 Urinary Anti-Infectives, 08:40 Miscellaneous Anti-Infectives Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 INDICATIONS SOVALDI is indicated for the treatment of genotype 1, 2, 3, or 4 chronic hepatitis C virus (CHC) infection as a component of a combination antiviral treatment regimen. The following points should be considered when initiating treatment with SOVALDI:  SOVALDI must not be administered as monotherapy (see 7 WARNINGS AND PRECAUTIONS, General).  Treatment regimen and duration are dependent on both viral genotype and patient population (see 4 DOSAGE AND ADMINISTRATION).  Treatment response varies based on baseline host and viral factors. Patients Awaiting Liver Transplantation Efficacy with SOVALDI + ribavirin (RBV) regimen has been established in patients with HCV genotype 1, 2, 3 or 4 infection awaiting liver transplantation with hepatocellular carcinoma (HCC) meeting Milan criteria (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS). Patients Co-infected with Human Immunodeficiency Virus (HIV-1) Efficacy with SOVALDI + RBV regimen has been established in treatment-naïve CHC patients with HCV genotype 1 and in CHC patients with HCV genotype 2 or 3 regardless of treatment experience. Clinical data is not ava… https://pdf.hres.ca/dpd_pm/00061948.PDF PM date: June 21, 2021 Source product: SOVALDI; DIN 02418355; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.