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: VIEKIRA PAK Therapy
Foreword
In December 2014, The Food and Drug Administration (FDA)
approved the combination of VIEKIRA PAK with and without ribavirin
to treat hepatitis C genotype 1a and 1b including people with HIV and
hepatitis C coinfection and people with compensated cirrhosis. The
information is taken from the Highlights of Prescribing Information
issued by the FDA.
Medications:
• Ombitasvir
• Paritaprevir/ritonavir
• Dasabuvir
Note: Brand Name: VIEKIRA PAK
• With and without ribavirin
VIEKIRA PAK comes in a packet of pills that is taken twice daily. If
ribavirin is prescribed (see below) it is also taken twice daily.
Written by: Alan Franciscus,
Editor-in-Chief
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]
Food Requirements:
• VIEKIRA PAK and ribavirin are taken with food.
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.
Side Effects:
• The most common side effects were fatigue, nausea, pruritus (itching),
skin reactions, insomnia, and general weakness.
This information is provided
by the Hepatitis C Support Project a
nonprofit organization for
HCV education, support and advocacy
Treatment discontinuations:
• The treatment discontinue rates in the phase 3 clinical trials was less
than 1%.
HCSP • VERSION 1 • January 2015
Reprint permission is
granted and encouraged
with credit to the
Hepatitis C Support Project.
1
© 2015 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: VIEKIRA PAK Therapy
VIEKIRA PAK combination by subtype and treatment duration:
Patient Population
Treatment*
Duration
Genotype 1a, without
cirrhosis
VIEKIRA PAK + ribavirin
12 weeks
Genotype 1a, with cirrhosis
VIEKIRA PAK + ribavirin
24 weeks**
Genotype 1b, without cirrhosis
VIEKIRA PAK
12 weeks
Genotype 1b, with cirrhosis
VIEKIRA PAK + ribavirin
12 weeks
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1
infection.
**VIEKIRA PAK administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history [See
Clinical Studies (14.3 in Food and Drug Administration Highlights of Prescribing Information) ].
Sustained Virological Response Rates:
Phase 3 Studies – Genotype 1 – ABT-450/r, ombitasvir, dasabuvir – with and
without ribavirin
Study
name/
Treatment
Period
Cure Rates
Genotype
1a
Cure Rates
Genotype
1b
96%
95%
98%
96%
96%
97%
Ribavirin
Y/N
TX Naïve/
Experienced
Number of
Patients
Cure
Rates
Overall
YES
naïve
473
yes
experienced
297
12 weeks
yes
naïve
210
100%
12 weeks
no
naïve
209
99%
12 weeks
yes
naïve
100
97%
12 weeks
no
naïve
205
90%
12 weeks
yes
both
208
92%
89%
94%
24 weeks
yes
both
172
96%
99%
100%
SAPPHIRE-1
12 weeks
SAPPHIRE-II
12 weeks
PEARL-III
PEARL-IV
TURQUOISE-II
HCSP • VERSION 1 • January 2015
2
© 2015 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: VIEKIRA PAK Therapy
Additional Information
• No dose adjustments were needed for patients 65
yo and over. There were no differences in safety
or effectiveness between these subjects and
younger subjects.
• VIEKIRA PAK can be used in patients with
mild to moderate hepatitis impairment
(compensated cirrhosis), but not in patients with
decompensated cirrhosis.
• No dose adjustments are needed for mild,
moderate or severe renal (kidney) impairment.
Pregnancy
VIEKIRA PAK is pregnancy category B: There
are no adequate and well controlled studies with
VIEKIRA PAK in pregnant women. Because animal
reproduction studies are not always predictive of
human response, VIEKIRA PAK should be used
during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
Ribavirin therapy should not be started unless
a report of a negative pregnancy test has been
obtained immediately prior to planned initiation
of therapy. Extreme care must be taken to avoid
pregnancy in female patients and in female partners
of male patients. Patients should be instructed to use
at least two forms of effective contraception during
treatment and for 6 months after treatment has been
stopped. Pregnancy testing should occur monthly
during ribavirin therapy and for 6 months after
therapy has stopped
Drug-Drug Interactions
VIEKIRA PAK should not be taken with certain
medications. See the Full Prescribing Information.
Related publications:
• VIEKIRA PAK Full Prescribing Information
http://www.hcvadvocate.org/hepatitis/factsheets_pdf/viekirapak_pi.pdf
• Sovaldi (sofosbuvir) Full Prescribing Information – (includes genotypes
2, 3 & 4)
http://www.hcvadvocate.org/hepatitis/factsheets_pdf/sovaldi_pi.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
HCSP • VERSION 1 • January 2015
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© 2015 Hepatitis C Support Project