Download Genotype 1: Sovaldi (Sofosbuvir)Triple Therapy

www.hcvadvocate.org
a series of fact sheets written by experts in the field of liver disease
HCSP FACT SHEET
• H C V T RE AT ME N T: FD A-APPRO VE D MED I C ATI O NS•
Genotype 1: Sovaldi (Sofosbuvir)
Triple Therapy
Written by: Alan Franciscus, Editor-in-Chief
Foreword
In December 2013, the Food and Drug Administration (FDA) approved
the combination of sofosbuvir—brand name Sovaldi, plus pegylated
interferon and ribavirin (PEG/RBV) to treat hepatitis C (HCV) genotype
1. This fact sheet will discuss the basics of the therapy for treatment of
HCV genotype 1. For more detailed information please see the Sovaldi
(sofosbuvir) Package Insert. The FDA approval was based on the
NEUTRINO study except where otherwise noted.
Overall the cure rates were 89% and were somewhat comparable between
patients that are usually considered the ‘easiest’ to treatment and those who are
the most ‘difficult’ to treat (see below).
Medications and Dose:
• Sofosbuvir (brand name Sovaldi) a HCV polymerase inhibitor. Sovaldi is a
400 mg pill taken once-a-day.
• Pegylated interferon (PEG) is injected under the skin once-a-week.
• Ribavirin (pill) taken twice daily. The dose of ribavirin is based on body
weight (<75kg = 1000mg; ≥ 1000kg = 1200mg).
Dose Modification:
• The recommendation is that Sovaldi should not be dose reduced. If
medications used with Sovaldi are discontinued—Sovaldi should also be
discontinued.
Food Requirements:
• Sovaldi – no food requirements
• Ribavirin – taken with food.
• Pegylated interferon – no food requirement
HCSP • VERSION 1 • December 2013
HCSP FACT SHEET
A publication of the
Hepatitis C Support Project
EXECUTIVE DIRECTOR,
EDITOR-IN-CHIEF,
HCSP PUBLICATIONS
Alan Franciscus
DESIGN
Leslie Hoex,
Blue Kangaroo Design
PRODUCTION
C.D. Mazoff, PhD
CONTACT
INFORMATION
Hepatitis C Support Project
PO Box 15144
Sacramento, CA 95813
[email protected]
The information in this fact sheet is
designed to help you understand and
manage HCV and is not intended as
medical advice. All persons with HCV
should consult a medical practitioner
for diagnosis and treatment of HCV.
This information is provided
by the Hepatitis C Support Project a
nonprofit organization for
HCV education, support and advocacy
Reprint permission is
granted and encouraged
with credit to the
Hepatitis C Support Project.
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© 2013 Hepatitis C Support Project
HCSP FACT SHEET
• HCV T REAT MENT: F DA- APPROVED M EDIC ATI ON S •
a series of fact sheets written by experts in the field of liver disease
Genotype 1: Sovaldi (Sofosbuvir) Triple Therapy
Length of Treatment:
• 12 weeks
Sustained Virological Results (SVR- 12
weeks post treatment)/ Cure Rate
• Treatment Naïve: 89% overall
♦ ♦ Genotype 1a = 92%
♦ ♦ Genotype 1b = 82%
• Cirrhosis/No Cirrhosis
♦ ♦ No cirrhosis = 92%
♦ ♦ Cirrhosis = 80%
• Race
♦ ♦ Black = 87%*
♦ ♦ Non-black = 91%
*17% of trial participants were Black
• Side effects
♦ ♦ The usual PEG/RBV side effects—fatigue,
headache, nausea, insomnia and anemia.
• Treatment Discontinuation
♦ ♦ The number of patients who discontinued
treatment due to side effects was 2% for
those who received Sovaldi, PEG/RBV for
12 weeks
• The NEUTRINO clinical trial only included
treatment naïve patients. The patients in
the study who had negative predictors of
treatment response—Metavir F3/F4 (severe
fibrosis/compensated cirrhosis), high viral
load (> 800,000 IU/mL) and an IL28B non C/C
genotype—achieved a 71% (37 of 52 patients)
cure rate.
HCSP • VERSION 1 • December 2013
Additional indications
• Sovaldi plus PEG/RBV is also approved to treat
HCV in people coinfected with HIV.
• The patients in the trial who were over 65 yo
had similar cure rates as those under 65 yo—
no dose adjustments were needed.
• No Sovaldi dose adjustment for people with
mild-to-moderate kidney impairment
• No Sovaldi dose adjustment for people
with liver impairment, but people with
decompensated were not studied in the clinical
trials
• People with liver cancer pre-transplant can be
treated with sofosbuvir/ribavirin
Pregnancy
The prior cautions and warnings of PEG/RBV
also apply to the triple combination of Sovaldi,
PEG/RBV. The use of ribavirin can cause birth
defects. Women must have a negative pregnancy
test prior to therapy and partners must use at
least 2 effective non-hormonal methods of birth
control. A woman must have monthly pregnancy
tests.
Drug-Drug Interactions
Sovaldi should not be taken with certain
medications such as HIV medications,
antimycobacterials and anticonvulsants. Sovaldi
should not be taken with the herb—St. John’s
wort. (See the complete list in the Highlights of
Prescribing Information)
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© 2013 Hepatitis C Support Project
HCSP FACT SHEET
• HCV T REAT MENT: F DA- APPROVED M EDIC ATI ON S •
a series of fact sheets written by experts in the field of liver disease
Genotype 1: Sovaldi (Sofosbuvir) Triple Therapy
Related publications:
• Olysio (simeprevir) Package Insert
www.hcvadvocate.org/hepatitis/factsheets_pdf/Olysio_pi.pdf
• Sovaldi (sofosbuvir) Package Insert
www.hcvadvocate.org/hepatitis/factsheets_pdf/sovaldi_pi.pdf
• Patient Assistance Programs
www.hcvadvocate.org/hepatitis/factsheets_pdf/Patient_Assistance.pdf
For more information
• American Association for the
Study of LIver Diseases
www.aasld.org
• Food and Drug Administration
(FDA):
www.fda.gov
• Centers for Disease Control
and Prevention
www.cdc.gov
• Mayo Clinic
www.mayoclinic.com
Visit our websites to learn more about
viral hepatitis:
www.hcvadvocate.org • www.hbvadvocate.org
www.hepatitistattoos.org
HCSP • VERSION 1 • December 2013
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© 2013 Hepatitis C Support Project