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Hepatitis C

EASL 2014: Sofosbuvir + Ledipasvir Is Safe and Effective for Relapsers and Hard-to-Treat Hep C Patients

A coformulation of sofosbuvir and ledipasvir successfully treated a variety of difficult-to-treat patient populations including people with hepatitis C virus (HCV) genotype 3, patients with decompensated cirrhosis, and people who were not cured with previous sofosbuvir-containing therapy, according to a series of studies presented at the 49thEASL International Liver Congress (EASL 2014) this week in London.

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EASL 2014: 88% of Previous Relapsers Cured with Simeprevir Triple Therapy

Almost 90% of European patients who had relapsed after previous treatment with pegylated interferon and ribavirin were cured of hepatitis C after 24 weeks of treatment with the protease inhibitor simeprevir (Olysio) combined with pegylated interferon/ribavirin, according to a presentation Thursday at the 49th EASL International Liver Congress (EASL 2014) in London.

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FDA Grants Priority Review for Gilead's Sofosbuvir + Ledipasvir Coformulation

The U.S. Food and Drug Administration (FDA) has agreed to expedited review of Gilead Science's sofosbuvir plus ledipasvir coformulation for treatment of chronic hepatitis C, putting the combination pill on track for an approval decision by mid-October, the company recently announced.

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EASL 2014: Sofosbuvir + Ledipasvir Produces Early Cure for 100% of HIV/HCV Coinfected Patients

Treatment for 12 weeks with a coformulation of sofosbuvir plus ledipasvir led to sustained response for all HIV/HCV coinfected individuals with genotype 1 hepatitis C followed for 12 weeks post-treatment, according to interim findings from the ERADICATE study presented at the 49thEASL International Liver Congress (EASL 2014) this week in London.

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APASL: Simeprevir Matches Telaprevir in Phase 3 Study, Gets Positive European Regulatory Opinion

The new hepatitis C virus (HCV) protease inhibitor simeprevir has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorization in the European Union, Janssen R&D announced this week. The recommendation was based on findings from a set of Phase 3 trials, some of which were presented at the Asian Pacific Association for the Study of the Liver (APASL) conference this month in Brisbane.

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EASL 2014: WHO Recommends Global Use of Newest Hepatitis C Drugs, Urges Price Reductions

The World Health Organization has issued global treatment guidelines for hepatitis C, strongly recommending the use of the new direct-acting antivirals sofosbuvir (Sovaldi) with ribavirin for HCV genotypes 1, 2, 3, and 4, or simeprevir (Olysio) with pegylated interferon interferon and ribavirin for genotype 1 infection. The WHO guidelines were released to coincide with the 49th International Liver Congress this week in London. New guidelines from the European Association for the Study of the Liver (EASL) will be released on Saturday.

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Advances in Hepatitis C Treatment: the Future Is Now [VIDEO]

As effective direct-acting antiviral drugs to treat hepatitis C come into widespread use and interferon-free therapy becomes a reality, patients, providers, and payers are now grappling with issues such as who should receive treatment and how to pay for the new medications.

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Bristol-Myers Squibb Requests FDA Approval of Daclatasvir and Asunaprevir

Bristol-Myers Squibb has submitted New Drug Applications asking the U.S. Food and Drug Administration (FDA) to approve its experimental hepatitis C virus (HCV) NS5A inhibitor daclatasvir and HCV protease inhibitor asunaprevir, the company announced this week.

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CROI 2014: Interferon-free BMS Combo Cures 90% of Genotype 1 Hepatitis C

An all-oral regimen of daclatasvir, asunaprevir, and BMS-791325 -- without interferon or ribavirin -- led to sustained response in approximately 90% of previously untreated hepatitis C patients, most with hard-to-treat genotype 1a, according to a study presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI 2014) this month in Boston.

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