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Hepatitis C

Simeprevir as Effective, Better Tolerated than Telaprevir in HCV Triple Therapy

The recently approved next-generation hepatitis C virus (HCV) protease inhibitor simeprevir (Olysio) produced sustained virological response rates similar to those of telaprevir (Incivek or Incivo) when combined with pegylated interferon and ribavirin, but with fewer side effects, researchers reported at theViral Hepatitis Congress taking place this week in Frankfurt.

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FDA Approves Harvoni, Gilead's Sofosbuvir/Ledipasvir Combo Pill for Hepatitis C

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On October 10, the U.S. Food and Drug Administration (FDA) approved a new once-daily combination pill for the treatment of genotype 1 chronic hepatitis C containing Gilead Sciences' HCV nucleotide polymerase inhibitor sofosbuvir (Sovaldi) plus ledipasvir, the first approved HCV NS5A inhibitor.

Sofosbuvir + Ribavirin To Be Studied in Children and Adolescents with Hepatitis C

A Phase 2 clinical trial is now underway to evaluate sofosbuvir (Sovaldi) plus ribavirin for children and adolescents, ages 3-17 years, with hepatitis C virus genotypes 2 or 3. Another study will follow to test the forthcoming sofosbuvir/ledipasir coformulation in pediatric patients.

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BMS Withdraws FDA Application for Hepatitis C Drug Asunaprevir

Bristol-Myers Squibb unexpectedly announced this week that it will no longer seek U.S. Food and Drug Administration (FDA) approval for its experimental hepatitis C virus (HCV) protease inhibitor asunaprevir, despite promising results in clinical trials to date.

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ICAAC 2014: Telaprevir and Boceprevir Have Limited Efficacy in Real-world Use

Hepatitis C treatment using the first-generation HCV protease inhibitors telaprevir (Incivek or Incivo) or boceprevir (Victrelis) cured only 71% of people with easier-to-treat HCV genotypes 1b, falling to 47% for those with genotype 1a, researchers reported at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy this month in Washington, DC.

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HCV Genotype 3, Hispanic Ethnicity Linked to Higher Risk of Cirrhosis, Liver Cancer

People with hepatitis C virus (HCV) genotype 3 are more likely to progress to liver cirrhosis and hepatocellular carcinoma (HCC) compared to people with other genotypes, according to a recent report. A related study found that people of Hispanic/Latino ethnicity are also more likely to develop advanced liver disease.

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Gilead Announces Generic Licensing Agreements for Hepatitis C Drug Sofosbuvir

Gilead Sciences announced this week that it has granted a license to 7 generic drug companies in India to produce cheaper versions of its groundbreaking hepatitis C polymerase inhibitor sofosbuvir (Sovaldi) and its forthcoming sofosbuvir/ledipasvir coformulation for use in more than 90 developing countries.

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Trio of Broadly Neutralizing Antibodies Interfere with Hepatitis C Virus Infection

Three broadly neutralizing antibodies delivered by a viral vector blocked hepatitis C virus (HCV) infection of hepatocytes (liver cells) in a laboratory culture model and appeared to cure infection in modified mice carrying human liver tissue, researchers reported in the September 17 edition of Science Translational Medicine.

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Simeprevir Label Adds Interactions with Transplant Rejection Drugs

The U.S. Food and Drug Administration recently approved revisions to the product label information for Janssen's new hepatitis C protease inhibitor simeprevir (Olysio), noting drug interactions with cyclosporine and tacrolimus, which are used to prevent organ rejection after a transplant.

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