February 11, 2016
Recommended Topic Related To:


"SILVER SPRING, MD ” 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"...



How Supplied


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.

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].


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

  Treatment Duration
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 Modification

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 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/6/2015

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Women's Health

Find out what women really need.