"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
- SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection [See DOSAGE AND ADMINISTRATION, Use In Specific Populations and Clinical Studies].
The following points should be considered when initiating treatment with SOVALDI:
- Monotherapy of SOVALDI is not recommended for treatment of CHC.
- Treatment regimen and duration are dependent on both viral genotype and patient population [See DOSAGE AND ADMINISTRATION].
- Treatment response varies based on baseline host and viral factors [See Use in Specific Populations and Clinical Studies].
DOSAGE AND ADMINISTRATION
Recommended Dose In Adults
The recommended dose of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [See CLINICAL PHARMACOLOGY].
SOVALDI should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC in adults. The recommended regimen and treatment duration for SOVALDI combination therapy is provided in Table 1.
Table 1 : Recommended Regimens and Treatment Duration
for SOVALDI Combination Therapy in HCV Mono-infected and HCV/HIV-1 Co-infected
|Patients with genotype 1 or 4 CHC||SOVALDI + peginterferon alfaa + ribavirinb||12 weeks|
|Patients with genotype 2 CHC||SOVALDI + ribavirinb||12 weeks|
|Patients with genotype 3 CHC||SOVALDI + ribavirinb||24 weeks|
|a See peginterferon alfa prescribing
information for dosing recommendation for patients with genotype 1 or 4 CHC.
b Dose of ribavirin is weight-based ( < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg). The daily dose of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤ 50 mL/min) require ribavirin dose reduction; refer to ribavirin prescribing information.
SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen [See Use In Specific Populations and Clinical Studies]. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.
Patients with Hepatocellular Carcinoma Awaiting Liver Transplantation
SOVALDI in combination with ribavirin is recommended for up to 48 weeks or until the time of liver transplantation, whichever occurs first, to prevent post-transplant HCV reinfection [See Use in Specific Populations].
Dose reduction of SOVALDI is not recommended.
Genotype 1 and 4
If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.
Genotype 2 and 3
If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Table 2 provides guidelines for dose modifications and discontinuation based on the patient's hemoglobin concentration and cardiac status.
Table 2 : Ribavirin Dose Modification Guideline for
Coadministration with SOVALDI
|Laboratory Values||Reduce Ribavirin Dose to 600 mg/daya If:||Discontinue Ribavirin If:b|
|Hemoglobin in patients with no cardiac disease||< 10 g/dL||< 8.5 g/dL|
|Hemoglobin in patients with history of stable cardiac disease||≥ 2 g/dL decrease in hemoglobin during any 4 week treatment period||< 12 g/dL despite 4 weeks at reduced dose|
|a The daily dose of ribavirin is administered
orally in two divided doses with food.
b Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that ribavirin be increased to the original assigned dose (1000 mg to 1200 mg daily).
Discontinuation Of Dosing
If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued.
Severe Renal Impairment And End Stage Renal Disease
No dose recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m² ) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [See Use In Specific Populations and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
SOVALDI is available as a yellow colored, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “7977” on the other side. Each tablet contains 400 mg sofosbuvir.
Storage And Handling
SOVALDI tablets are yellow, capsule-shaped, film-coated tablets containing 400 mg sofosbuvir debossed with “GSI” on one side and “7977” on the other side. Each bottle contains 28 tablets (NDC 61958-1501-1), a silica gel desiccant, polyester coil and is closed with a child-resistant closure.
Store at room temperature below 30 °C (86 °F).
- Dispense only in original container
- Do not use if seal over bottle opening is broken or missing
Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404. Issued: March 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/6/2015
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