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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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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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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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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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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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