– Harvoni Achieved Cure Rates (SVR12) of 100 Percent in Japanese
Phase 3 Study –
– Eliminates Need for Interferon and Ribavirin for Patients with
Genotype 1 Hepatitis C –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Japanese
Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni® (ledipasvir
90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for
the treatment of chronic hepatitis C genotype 1 infection in adults.
Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide
analog polymerase inhibitor sofosbuvir, approved by the MHLW under the
trade name Sovaldi® in March 2015. Harvoni is indicated for
the suppression of viremia in patients with genotype 1 chronic hepatitis
C virus (HCV) infection with or without compensated cirrhosis, with a
treatment duration of 12 weeks.
“Today’s approval significantly advances the standard of care for
chronic hepatitis C in Japan, as it eliminates the need for interferon
and ribavirin, which can be difficult to take and to tolerate, and
offers the majority of people with genotype 1 infection to be cured in
as little as 12 weeks with a once-daily pill,” said Professor Masashi
Mizokami, MD, PhD, The Research Center for Hepatitis and Immunology,
National Center for Global Health and Medicine, Ichikawa, Japan.
Primarily due to HCV, Japan has one of the highest rates of liver cancer
of any industrialized country. Of the more than one million people in
Japan chronically infected with HCV, 70-80 percent are infected with the
genotype 1 strain of the virus.
Harvoni’s approval in Japan is supported by data from 318
treatment-naïve and treatment-experienced Japanese patients with
genotype 1 HCV infection randomized to ledipasvir/sofosbuvir (n=157) or
ledipasvir/sofosbuvir plus ribavirin (n=161) in the Phase 3 clinical
trial GS-US-337-0113. Of the 318 patients enrolled in this study, 34
percent were ages 65 years or older and 23 percent had cirrhosis.
Among patients receiving 12 weeks of ledipasvir/sofosbuvir without
ribavirin, 100 percent (n=78/78) of treatment-naïve and 100 percent
(n=79/79) of treatment-experienced patients achieved sustained virologic
response 12 weeks after completing therapy (SVR12). Adverse events
observed with ledipasvir/sofosbuvir without ribavirin were generally
mild and included nasopharyngitis (29 percent), headache (7 percent) and
malaise (6 percent).
The approval is also supported by results from three Phase 3 studies
(ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of
ledipasvir/sofosbuvir among genotype 1 HCV patients. Trial participants
included patients from the United States, Europe and Puerto Rico who
were treatment-naïve or who had failed previous treatment, including
protease inhibitor-based regimens, and also included patients with
compensated cirrhosis. Trial participants in the ribavirin-free arms
(n=1,080) achieved SVR12 rates of 94 to 99 percent.
“Harvoni is a safe, simple and well-tolerated treatment. With cure rates
of up to 100 percent and without the need for interferon or ribavirin,
it offers genotype 1-infected patients a high likelihood of cure,” said
Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research
and Development, and Chief Scientific Officer. “We are pleased to have
partnered with the medical community in Japan to demonstrate the safety
and efficacy of two significant advances in the treatment of chronic
hepatitis C – Harvoni for genotype 1 infection and Sovaldi for genotype
2 infection, which was approved just three months ago. We look forward
to making Harvoni available in Japan as quickly as possible.”
Read complete press release here
Labels: Harvoni, Japan