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news.US-based biopharmaceutical firm Gilead Sciences has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Harvoni (ledipasvir 90mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat chronic hepatitis C genotype 1 infection in adults.
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Approved under the trade name Sovaldi in March, Harvoni is a combination of the NS5A inhibitor ledipasvir and the nucleotide analog polymerase inhibitor sofosbuvir.
The drug 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.
National Center for Global Health and Medicine The Research Center for Hepatitis and Immunology professor Masashi Mizokami said: "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."
The approval is based on data from the Phase III clinical trial GS-US-337-0113 conducted in 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).
Out of the 318 patients enrolled in the trial, 34% were ages 65 years or older and 23% had cirrhosis.
Among patients receiving 12 weeks of ledipasvir/sofosbuvir without ribavirin, 100% of treatment-naïve and 100% of treatment-experienced patients achieved sustained virologic response 12 weeks after completing therapy (SVR12)
Gilead Research and Development executive vice-president and chief scientific officer Norbert Bischofberger said: "Harvoni is a safe, simple and well-tolerated treatment. With cure rates of up to 100% and without the need for interferon or ribavirin, it offers genotype 1-infected patients a high likelihood of cure.
"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."
The US Food and Drug Administration has also approved Harvoni based on data from three Phase III trials ION-1, ION-2 and ION-3, which evaluated eight, 12 or 24 weeks of ledipasvir/sofosbuvir among genotype 1 HCV patients.
Image: Harvoni Product Photo. Photo: courtesy of Gilead.