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Transcript of Sovaldi® (Sofosbuvir)
concomitant ribavirin or peginterferon alfa in women who are or may become pregnant and in men with pregnant female partners
monotherapy or dose reduction of sofosbuvir is not recommended
report suspected adverse reactions to the US Food and Drug Administration (Medwatch)
birth defects and/or fetal death may occur with ribavirin use
obtain a negative pregnancy test immediately before ribavirin initiation
avoid pregnancy during therapy
use 2 non-hormonal forms of contraception during therapy and for at least 6 months after therapy is completed
routine monitoring recommended
Clinical Trials in Subjects with Genotype 1 or 4 CHC
Response Rates in Study NEUTRINO (N=327)
Clinical Trials in Subjects with Genotype 2 or 3 CHC
Response Rates in Study FISSION (N=256)
Response Rates in Study POSITRON (N=207)
Response Rates in Study FUSION
12 weeks, N=103
16 weeks, N=98
Response Rates in Study VALENCE
Genotype 2, N=73
Genotype 3, N=250
Treatment of Chronic
Nucleotide Analog NS5B Polymerase Inhibitor
Tmax, Oral: 0.5 to 2 hours
Effects of food: no effect on Cmax or AUC
Protein binding: 61% to 65%
GS-461203 (major): active
GS-331007 (major): inactive
Dialyzable: Yes (hemodialysis)
Elimination Half Life
Side Effects/Adverse Reactions
may result in decreased exposure to and loss of efficacy of sofosbuvir
potent P-gp inducers – St. John’s wort (Hypericum perforatum), rifabutin, rifampin, and rifapentine
Anticonvulsants – carbamazepine, phenytoin, phenobarbital, and oxcarbazepine
HIV Protease Inhibitors– tipranavir and ritonavir
Gastrointestinal: Diarrhea (12% )
Hematologic: Anemia (less than 1% to 23% )
Neurologic: Headache (24% to 44%), Insomnia (15% to 29% )
Other: Fatigue (30% to 59% )
usual dose: 400mg by mouth once daily
Hepatitis C, chronic, Genotype 1, 2, 3, or 4, as a component of a combination antiviral treatment regimen - Liver carcinoma, awaiting liver transplantation: 400 mg ORALLY once daily for up to 48 weeks or until transplantation; give in combination with ribavirin
Hepatitis C, chronic, Genotype 1 interferon ineligible, as a component of a combination antiviral treatment regimen: 400 mg ORALLY once daily for 24 weeks; give in combination with ribavirin
Hepatitis C, chronic, Genotype 1 or 4, as a component of a combination antiviral treatment regimen: 400 mg ORALLY once daily for 12 weeks; give in combination with peginterferon alfa and ribavirin
Hepatitis C, chronic, Genotype 2 as a component of a combination antiviral treatment regimen: 400 mg ORALLY once daily for 12 weeks; give in combination with ribavirin
Hepatitis C, chronic, Genotype 3 as a component of a combination antiviral treatment regimen: 400 mg ORALLY once daily for 24 weeks; give in combination with ribavirin
Oral Tablet: 400 mg
a yellow colored, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “7977” on the other side
at room temperature below 86°F (30°C)
Dispense only in original container
monotherapy not recommended
administer in combination with peginterferon alfa and/or ribavirin
may take with or without food
Pregnancy Category X
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination.
not known whether Sovaldi and its metabolites are present in human breast milk
Safety and effectiveness of Sovaldi in children less than 18 years of age have not been established
No dose adjustment of Sovaldi is warranted in geriatric patients
Gilead Sciences, Inc. (2013, Dec. 6). News Release. Retrieved Feb. 25, 2014, from Gilead.com: http://investors.gilead.com/External.File?t=2&item=g7rqBLVLuv81UAmrh20Mp+/J9Zc53tEbemTTi7yIvqa7WOhHwdT64tjvkABi8HIbBXSDLBoC4aaX7D6SvcYUpg==
Gilead Sciences, Inc. (n.d.). Sovaldi Package Insert. Retrieved Feb. 25, 2014, from Gilead.com: http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf
MicroMedex. (n.d.). RED BOOK Online. Truven Health Analytics Inc.
Micromedex. (n.d.). Sofosbuvir Product Details. (Truven Health Analytics Inc.) Retrieved February 25, 2014, from Red Book Online: http://0-www.micromedexsolutions.com.library.acaweb.org/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/A32619/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/64F0B6/ND_PG/evidencexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/ev
Advise male and female patients of reproductive potential to use at least 2 adequate forms (nonhormonal methods) of contraception during treatment and for at least 6 months posttreatment. Advise female patients and female partners of male patients that monthly pregnancy tests are required.
Side effects may include fatigue, headache, nausea, insomnia, decreased appetite, or diarrhea.
Counsel patient to take recommended regimen on regular schedule, and the dose must not be reduced.
Advise patient drug must not be used alone and must be used in combination with ribavirin or in combination with peginterferon alfa and ribavirin.
Advise patient that there are multiple significant drug-drug interactions for this drug. Consult healthcare professional prior to new drug use (including over-the-counter and herbal drugs).
If a dose is missed, it may be taken later in the day and advise the patient to resume the regular dosing schedule on the next day. Do not exceed more than 400 mg daily.
Questions ? ? ? ?