AbbVie's VIEKIRA PAK Approval & AASLD 2014
In this month’s HCV Drugs we have news on AbbVie’s
drug approval of their HCV drugs, and, yes, more coverage from the
American Association for the Study of Liver Diseases (AASLD). In
Lucinda’s Snapshots column this month, information on Janssen’s AASLD
presentations is included.
On December 19, 2014 the Food and Drug
Administration (FDA) approved AbbVie’s 3D combination—VIEKIRA PAK—to
treat HCV genotype 1 patients. On December 23, 2014, the 3D
combination was approved by Health Canada as HOLKIRA PAK. AbbVie
conducted phase 3 trials in about 2,300 patients and the cure rates
were over 90%. Included in the FDA label was information about HIV/HCV
coinfection and liver transplantation treatment results. For more
information, visit our website for new VIEKIRA PAK fact sheets, FDA
Approved Prescribing Information and detailed information from their
phase 3 studies included in past issues of our HCV Advocate monthly and
GS-5816 is a new
investigational NS5A inhibitor being developed by Gilead. It has
activity across all genotypes (pan-genotypic). In the current studies,
it is being combined with sofosbuvir (polymerase inhibitor) with and
Safety and Efficacy of Treatment with
Sofosbuvir plus GS-5816 With and Without Ribavirin for 8 or 12 Weeks in
Treatment-Naïve Patients with Genotype 1-6 HCV Infection—T Tran et al.
Summary: The combination of sofosbuvir plus GS-5816 without ribavirin produced high cure rates in all genotypes.
Gilead continues to study
sofosbuvir in combination with other investigational compounds—in this
case with GS-5816, an NS5A inhibitor.
Part A of the
current study comprised 8 arms—all arms received sofosbuvir plus
GS-5816 at either 25 mg or 100 mg without ribavirin for 12 weeks.
Included in the study were treatment-naïve patients without cirrhosis.
There were two parts (A and B) of the study. Part A had six
treatment arms that included genotypes 1 through 6. Listed below are
the number of patients and cure rates.
Genotype 1: 55 patients: 96% to 100%
Genotype 2: 21 patients: 91% to 100%
Genotype 3: 54 patients 93%
Genotype 4: 14 patients 86% to 100%
Genotype 5: 1 patient 100%
Genotype 6: 9 patients 100%
Part B of the
study included only genotype 1 and 2 patients. There were also 8 arms
in Part B, but the genotype 1 non-cirrhotic patients received only 8
weeks of treatment at the same doses. Half of the patients in the
study received ribavirin. Genotype, number of patients and cure rates
are listed below:
The combination of sofosbuvir and
GS-5816 with and without ribavirin was safe and well-tolerated. The
most common side effects were fatigue, headache, and nausea.
The combination of sofosbuvir
(400 mg) and GS-5816 (100 mg) has been co-formulated into one pill
taken once daily. It is currently in phase 3 clinical trials to be
studied with and without ribavirin for the treatment of HCV genotype 1,
2, 3, 4, 5, and 6.
Sofosbuvir and GS-5816 has been co-formulated into 1 pill taken
once-a-day and is in phase 3 clinical trials with and without ribavirin
for a treatment duration of 12 weeks for genotype 1 through 6. Another
study being conducted in genotype 3 patients is comparing the
treatment duration of 12 vs. 24 weeks.
AASLD/ IDSA/IAS-USA Recommendations
Check out the updated HCV Guidance from the American
Association for the Study of Liver Diseases and the Infectious
Diseases Society of America that include Harvoni and VIEKERA PAK. Seven
sections of the HCV Guidance have been extensively revised based on
newly available therapies and data: Initial, Retreatment, Monitoring,
and Unique Populations (HIV/HCV Coinfection, Cirrhosis, Post-Liver
Transplantation, and Renal Impairment).
Labels: AASLD/IDSA/IAS–USA Guidelines, sofosbuvir and GS-5816, Viekira Pak