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Monday, July 11, 2016
Ledipasvir/sofosbuvir-based treatment of patients with chronic genotype-1 HCV infection and cirrhosis: results from two Phase II studies.
± ribavirin administered for 12 weeks to patients with genotype 1
hepatitis C virus (HCV) infection and compensated cirrhosis is effective
and well-tolerated. The Phase II TRILOGY-1 and TRILOGY-2 studies
investigated whether ledipasvir/sofosbuvir plus the non-nucleotide NS5B
inhibitor GS-9669 or the NS3/4A protease inhibitor vedroprevir could
reduce treatment duration and/or eliminate the need for ribavirin in
genotype 1 HCV-infected patients with compensated cirrhosis.
TRILOGY-1, 100 cirrhotic patients were randomized (1:1:1) to 8 weeks of
ledipasvir/sofosbuvir plus ribavirin, ledipasvir/sofosbuvir plus
GS-9669 250 mg or ledipasvir/sofosbuvir plus GS-9669 500 mg. In
TRILOGY-2, 46 previously treated cirrhotic patients were randomized
(1:1) to 8 weeks of ledipasvir/sofosbuvir plus vedroprevir ± ribavirin.
The co-primary endpoints were the proportion of patients with sustained
virologic response 12 weeks after treatment discontinuation (SVR12) and
both studies, most patients were male (each 65%) and white (92-96%),
infected with HCV genotype 1a (62-70%) and had IL28B non-CC genotypes
(82-87%). In total, 37-39% of patients were Hispanic or Latino. SVR12
rates were similar across treatment arms in TRILOGY-1 (82-91%) and
TRILOGY-2 (88-95%); no patient had on-treatment virologic failure. Two
serious adverse events (acute myocardial infarction and cardiomyopathy)
were reported in two patients participating in TRILOGY-1, both of whom
had pre-existing cardiac conditions. Laboratory abnormalities were
ledipasvir/sofosbuvir-based regimens were well-tolerated. To shorten
therapy and eliminate ribavirin, use of a more potent third agent or a
third agent with a different mechanism of action may be required.