Back Hepatitis C

Hepatitis C

Interferon-free Daclatasvir + Asunaprevir Approved in Japan for Hepatitis C

Bristol-Myers Squibb's all-oral dual regimen of daclatasvir (Daklinza) plus asunaprevir (Sunvepra) has been approved for the treatment of chronic hepatitis C in Japan, where most people are infected with HCV genotype 1b, the company announced this week.

alt

Survey Finds Most Primary Care Providers Unaware of New Hepatitis C Drugs

Nearly 75% of primary care physicians are unfamiliar with the most recently approved direct-acting antiviral drugs for hepatitis C, and about two-thirds are unaware of even the first-generation antivirals available since 2011, according to a recent survey by Decision Resources Group.

alt

AbbVie's 3D Hepatitis C Combo Gets Priority Review in U.S. and Europe

AbbVie's all-oral 3-drug combination regimen for genotype 1 chronic hepatitis C has been granted priority review status by the U.S. Food and Drug Administration (FDA), putting it on track for approval by the end of the year. In related news, the company announced last week that Marketing Authorization Applications for the 3D regimen have been validated and are under accelerated assessment by the European Medicines Agency (EMA), with a decision expected in early 2015.

alt

Studies Look at Hepatitis C Care Cascade and Healthcare Utilization

Half of people with hepatitis C in the U.S. are aware of their infection, but fewer than 10% have been successfully treated and achieved sustained virological response (SVR), according to a meta-analysis published July 2 in the open-access journal PLoS ONE. Despite these gaps in testing, care, and treatment, hepatitis C accounts for a substantial share of healthcare utilization, especially among baby boomers, a related study found.

alt

Sofosbuvir/Ledipasvir Cures 100% of Genotype 1 Hepatitis C Patients in Japanese Study

All treatment-naive and previously treated participants using a combination pill containing Gilead Science's hepatitis C virus (HCV) polymerase inhibitor sofosbuvir (Sovaldi) and NS5A inhibitor ledipasvir, without ribavirin, for 12 weeks achieved sustained virological response in a Phase 3 study in Japan, where most hepatitis C patients have HCV genotype 1b.

alt

Boehringer Ingelheim Discontinues Faldaprevir, Halts HCV Drug Development

Boehringer Ingelheim has announced that it will discontinue development of its investigational hepatitis C virus (HCV) protease inhibitor faldaprevir, will withdraw pending approval requests, and will not proceed with further work in this area due to rapid changes in the hepatitis C treatment environment.

alt

Daclatasvir + Asunaprevir Is Highly Effective Against Hepatitis C Genotype 1b

An all-oral combination of daclatasvir plus asunaprevir, without pegylated interferon or ribavirin, cured 87% of genotype 1b patients who were ineligible for or could not tolerate interferon and 81% of prior non-responders in a Japanese study published in the June 2014 edition of Hepatology.

alt

European Regulators Give Positive Opinion on Daclatasvir for Hepatitis C

Bristol-Myers Squibb announced this week that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of its hepatitis C virus (HCV) NS5A inhibitor daclatasvir, which has been given the brand name Daklinza.

alt

HCV Drug Development: Merck Acquires Idenix, FDA Lifts Sovaprevir Hold

Merck this week announced that it will purchase Idenix, a specialty biopharmaceutical company developing several hepatitis C virus (HCV) drug candidates. In related news, Achillion announced that the U.S. Food and Drug Administration (FDA) has lifted a clinical hold on one of its drugs and a clinical trial of another is now underway.

alt