HCV Protease Inhibitor Simeprevir Granted FDA Priority Review Status

On May 13, Janssen announced that its application for approval of the next-generation hepatitis C virus NS3/4A protease inhibitor simeprevir (formerly TMC435) has received priority review status from the U.S. Food and Drug Administration (FDA), giving it an estimated timeline of 6 months.

Sofosbuvir/Ledipasvir Coformulation Shows Good Early Response With or Without Ribavirin

A dual regimen of sofosbuvir (formerly GS-7977) plus ledipasvir (formerly GS-5885) for 8 or 12 weeks produced 4-week post-treatment sustained virological response (SVR4) rates of 95% to 100% for both treatment-naive and previously treated hepatitis C patients in a small Phase 2 study, according to a recent announcement from Gilead Sciences, developer of both drugs.

EASL 2013: Direct-acting Antivirals Boost Response to Pegylated Interferon/Ribavirin

For people with chronic hepatitis C who cannot wait for all-oral regimens, interferon-based therapy is still a reality. Researchers at the recent EASL International Liver Congress (EASL 2013) presented promising data showing that several experimental direct-acting antiviral agents (DAAs) can significantly improve response rates without reducing tolerability.

EASL 2013: Triple Therapy for Hepatitis C Is Effective after Liver Transplantation but Comes with Side Effects

Adding the approved HCV protease inhibitor telaprevir (Incivek or Incivo) to pegylated interferon and ribavirin can increase sustained response rates even for difficult-to-treat liver transplant recipients, but adverse events are common, researchers reported at the EASL International Liver Congress (EASL 2013) last month in Amsterdam.

EASL 2013: Anemia Is a Common Side Effect of First-generation HCV Protease Inhibitors

About half of patients taking boceprevir (Victrelis) or telaprevir (Incivek or Incivo) developed anemia and approximately one-third experienced skin rash, but sustained response rates were high in an analysis of a population representative of people with chronic hepatitis C in North America, researchers reported at the EASL International Liver Congress (EASL 2013) last month in Amsterdam.

Direct-acting Antivirals Could Dramatically Reduce Hepatitis C Transmission among IDUs

Widespread use of new direct-acting antiviral agents (DAAs) for hepatitis C could dramatically lower the rate of HCV transmission among people who inject drugs in 3 hard-hit cities, according to a math model described in the March 28, 2013, issue of Hepatology.

They assumed that interferon-free regimens would produce 90% sustained virological response (SVR) with 12 weeks of treatment and would be available by 2015 -- all "realistic scenarios" based on the latest research.

EASL 2013: ACH-3102 and Sovaprevir Show Potent Activity, High Barrier to Resistance in Early Studies

Achillion Pharmaceuticals' second-generation NS5A inhibitor ACH-3102 demonstrated potent activity against genotype 1a and 1b hepatitis C virus (HCV) and can be safely co-administered with the company's investigational protease inhibitor sovaprevir (formerly ACH-1625), according to studies presented at the EASL International Liver Congress (EASL 2013) last month in Amsterdam.

EASL 2013: Vaniprevir Boosts Interferon/Ribavirin Response Rate for Prior Non-Responders with Cirrhosis

The next-generation HCV protease inhibitor vaniprevir (MK-7009) increased post-treatment sustained response rates for previously treated genotype 1 chronic hepatitis C patients with liver cirrhosis when added to pegylated interferon plus ribavirin, researchers reported at the EASL International Liver Congress (EASL 2013) last month in Amsterdam.