FDA ACCEPT NDA For VIEKIRA PAK

AbbVie  a global biopharmaceutical company, announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the United States for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is not for people with decompensated cirrhosis.

The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily with a meal, with or without twice-daily RBV, potentially offering another important treatment option for people living with GT1 HCV. The NDA filing is supported by data from two bioavailability studies. Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.

The Centers for Disease Control and Prevention (CDC) estimates that in the United States, approximately 2.7 million people are chronically infected with HCV. Genotype 1 is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases. Hepatitis C is inflammation of the liver caused by an infection with HCV. It is transmitted when an infected person's blood enters the bloodstream of an uninfected person. There are six major HCV genotypes (GT1-6). Presently, there is no vaccine for HCV infection.

AbbVie Announces Phase 2 Studies ABT-493

AbbVie announced data from the SURVEYOR studies of its investigational HCV regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment (SVR₁₂) in non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. After 12 weeks of treatment, SVR₁₂ rates achieved were 97-100 percent in genotype 1 (GT1), 96-100 percent in genotype 2 (GT2) and 83-94 percent in genotype 3 (GT3) patients.These data are being presented at The Liver Meeting^® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. 

Separately, in a late-breaking presentation of the SURVEYOR-I study, data show non-cirrhotic GT1 chronic HCV patients who received a shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved a SVR₁₂ rate of 97 percent.

^{SURVEYOR-I and SURVEYOR-II are ongoing Phase 2 clinical studies that evaluate the safety and efficacy of ABT-493 and ABT-530, with or without ribavirin (RBV), for 8 to 12 weeks. These data presented at AASLD include non-cirrhotic patients with GT1, GT2 and GT3 chronic HCV infection. Data in additional patient populations (genotypes 4-6) will be presented at future meetings.} 

Roche expands cobas 4800 System menu

Roche announced the commercial availability of the cobas HIV-1, HCV and HCV Genotyping (GT) assays in countries accepting the CE mark. These new molecular diagnostic assays increase the available menu on the cobas 4800 System, further improving efficiency and flexibility that allows laboratories to deliver results for rapid clinical decisions.

The new virology assays offer the latest generation of performance with dual target technology for HIV-1 and dual probe technology for HCV. All of the new virology assays can run simultaneously on the cobas 4800 System, with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System now has a menu of 12 high medical value IVD assays, making it the ideal solution for a highly efficient laboratory.

The assays launched today will be followed in the coming months by the cobas HBV Test, which will complete the portfolio of viral load monitoring and genotyping assays for the cobas 4800 System.