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- Ledipasvir + Sofosbuvir
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Ledipasvir + Sofosbuvir
Subsidy Information and Financing Scheme
No
Drug Guidance
Yes
Post-marketing information
No
Summary of Biologics
No
Active ingredients: Ledipasvir | Sofosbuvir
General information
Subsidy Information and Financing Scheme
Not Applicable
Drug Guidance for Subsidy
01/10/2020 Direct-acting antiviral agents for treating genotype 1 chronic hepatitis C
The Ministry of Health’s Drug Advisory Committee has recommended:
Sofosbuvir 400 mg/velpatasvir 100 mg tablet for treating genotype 1 chronic hepatitis C infection in treatment-naïve, or pegylated interferon plus ribavirin (PR)-experienced, or NS3/4A protease inhibitor (boceprevir, simeprevir, telaprevir)-experienced adults.
Glecaprevir 100 mg/pibrentasvir 40 mg tablet for treating genotype 1 chronic hepatitis C infection in treatment-naïve, or pegylated interferon plus ribavirin (with or without sofosbuvir)-experienced, or sofosbuvir plus ribavirin-experienced adults.
Sofosbuvir/velpatasvir and glecaprevir/pibrentasvir should be used in line with the recommended treatment regimens listed in the Annex.
Sofosbuvir/velpatasvir and glecaprevir/pibrentasvir should be prescribed by a specialist physician (gastroenterologist, hepatologist, or infectious disease specialist) with experience in the treatment of hepatitis C.
The supplier of sofosbuvir/velpatasvir will provide retreatment with sofosbuvir/velpatasvir/voxilaprevir to patients who fail to achieve a sustained virological response with sofosbuvir/velpatasvir through their No Cure No Pay program, at no additional cost.
Subsidy status
[R] Sofosbuvir 400mg/velpatasvir 100 mg tablet and glecaprevir 100 mg/pibrentasvir 40 mg tablet are recommended for inclusion on the Medication Assistance Fund (MAF), for the abovementioned indications.
[NR] MAF assistance does not apply to other direct-acting antivirals (asunaprevir, ombitasvir/paritaprevir/ritonavir+dasabuvir, sofosbuvir/ledipasvir, elbasvir/grazoprevir and daclatasvir).
01/10/2020 Direct-acting antiviral agents for treating genotype 2 to 6 chronic hepatitis C
The Ministry of Health’s Drug Advisory Committee has recommended:
Sofosbuvir 400 mg/velpatasvir 100 mg tablet for treating genotype 2, 3, 4, 5, or 6 chronic hepatitis C infection in treatment-naïve, or pegylated interferon plus ribavirin (PR)-experienced or NS3/4A protease inhibitor (boceprevir, simeprevir, telaprevir)-experienced adults; and
Glecaprevir 100 mg/pibrentasvir 40 mg tablet for treating genotype 2, 3, 4, 5, or 6 chronic hepatitis C infection in treatment-naïve, or pegylated interferon plus ribavirin (with or without sofosbuvir)-experienced, or sofosbuvir plus ribavirin-experienced adults.
Sofosbuvir/velpatasvir and glecaprevir/pibrentasvir should be used in line with the recommended treatment regimens listed in the Annex.
Sofosbuvir/velpatasvir and glecaprevir/pibrentasvir should be prescribed by a specialist physician (gastroenterologist, hepatologist, or infectious disease specialist) with experience in treating hepatitis C.
The supplier of sofosbuvir/velpatasvir will provide retreatment with sofosbuvir/velpatasvir/voxilaprevir to patients who fail to achieve a sustained virological response with sofosbuvir/velpatasvir through their No Cure No Pay program, at no additional cost.
Subsidy status
[R] Sofosbuvir 400 mg/velpatasvir 100 mg tablet and glecaprevir 100 mg/pibrentasvir 40 mg tablet are recommended for inclusion on the Medication Assistance Fund (MAF), for the abovementioned indications.
[NR] MAF assistance does not apply to other direct-acting antivirals (sofosbuvir, sofosbuvir/velpatasvir/voxilaprevir, sofosbuvir+daclatasvir, sofosbuvir/ledipasvir and elbasvir/grazoprevir).
Legend
This section displays recommendation from the MOH Drug Advisory Committee for subsidy and appropriate use of the drug as extracted from the Agency for Care Effectiveness (ACE) Drug Guidances. As this website is updated monthly, please refer to the ACE website for the most updated information.
Legend list
Indicator | Legend |
|---|---|
R | Recommended for subsidy |
NR | Not recommended for subsidy |
General Availability in Public Healthcare Institution
Note:
General availability information reflected is based on the Public Healthcare Institutions’ (PHI) formulary on what is commonly used for treating their patient population and may or may not be available for patients not under the care of that institution. It does not reflect the PHI’s actual inventory availability and is subjected to change. Please consult the Public Hospitals or Polyclinics for details on availability and supply restrictions/considerations. General availability is not tied to any brand unless otherwise stated.
Users are to consult the respective PHIs for actual inventory availability and supply restrictions/consideration
Drug availability
Formulation | Public Healthcare Institution |
|---|---|
Tablet, Film Coated, Ledipasvir 90 mg + Sofosbuvir 400 mg |
|
Registered Product(s) Information
Clinical and product info
Clinical info | Product Info |
|---|---|
Information under the Indication, Dosage and Contraindication sections are extracted from the relevant Package Insert/Patient Information Leaflet of the product available on HSA Infosearch. For more information, please refer to the product's Package Insert/ Patient Information Leaflet available on HSA Infosearch. The information provided is for informational purposes only, and is not exhaustive. The information provided is not a substitute for professional medical advice. Please consult a qualified healthcare provider for any medical advice. | Information available here are product details as registered with the HSA. As this website is updated monthly, please refer to HSA Infosearch for the most updated product information. |