AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C

NORTH CHICAGO, Ill., Dec. 19, 2016 -- (Healthcare Sales &Marketing Network) -- AbbVie (ABBV), a global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company'... Biopharmaceuticals, FDA AbbVie, Glecaprevir, Pibrentasvir, Hepatitis C virus
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news

Related Links:

This study evaluated the time-dependent association of RTP concentrations in erythrocytes, RBV-induced toxicity, and virological response to RBV treatment for hepatitis C. Methods: A total of 28 Japanese patients with CHC were treated with RBV/peg-interferon/simeprevir or RBV/sofosbuvir and were genotyped for ITPA variants (rs1127354 and rs7270101). We measured RTP concentrations in erythrocytes in a total of 76 samples collected at 4, 8, and 12 weeks from the initiation of treatment. Results: The ITPA rs1127354 variant was found in 7 patients. This was associated with significantly higher RTP concentrations in eryth...
Source: Therapeutic Drug Monitoring - Category: Drugs & Pharmacology Tags: Original Article Source Type: research
Antibiotic-resistant Neisseria gonorrhea is an international threat. Find out what you know about current first-line treatment in just a few minutes.
Source: ConsultantLive - Category: Internal Medicine Authors: Tags: Hepatitis C Source Type: news
Conditions:   Hepatitis C;   Hepatitis C, Chronic;   Chronic Hepatitis C;   Hepatitis C Virus Infection;   HCV Infection Interventions:   Drug: AT-527;   Drug: Daclatasvir Sponsor:   Atea Pharmaceuticals, Inc. Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Antibiotic-resistant Neisseria gonorrhea is an international threat. Find out what you know about current first-line treatment in just a few minutes.
Source: ConsultantLive - Category: Internal Medicine Authors: Tags: Hepatitis C Source Type: news
The objective of this study was to estimate the frequency of HCV clearance and identify correlates of vira...
Source: BMC Infectious Diseases - Category: Infectious Diseases Authors: Tags: Research article Source Type: research
People who inject drugs (PWID) are disproportionally affected by the hepatitis C virus (HCV) infection. In the Netherlands, active HCV transmission in PWID has practically been halted but uptake of HCV testing...
Source: Harm Reduction Journal - Category: Drugs & Pharmacology Authors: Tags: Research Source Type: research
This is so far the first meta ‐analysis about TM6SF2 polymorphisms and chronic liver disease. Our pooled analyses suggested that rs58542926 polymorphism was significantly associated with chronic liver disease in both Asians and Caucasians. Future investigations are warranted to explore potential roles of other TM6SF2 polymorph isms in the development of chronic liver disease. AbstractBackgroundSome genetic association studies tried to investigate potential associations of transmembrane 6 superfamily member 2 (TM6SF2) polymorphisms with chronic liver disease. However, the results of these studies were not consistent. Thus...
Source: Molecular Genetics & Genomic Medicine - Category: Genetics & Stem Cells Authors: Tags: ORIGINAL ARTICLE Source Type: research
ConclusionsThis study shows that eradication of HCV by DAAs will result in a parallel decrease in IR and improve clinical outcomes in patients with established T2DM.
Source: Diabetes and Metabolic Syndrome: Clinical Research and Reviews - Category: Endocrinology Source Type: research
Authors: An J, Lee JS, Sharpsten L, Wilson AK, Cao F, Tran JN Abstract Objective: To describe pill burden before and after hepatitis C virus (HCV) treatment initiation among patients newly treated for HCV infection, and to evaluate the association between HCV pill burden and gaps in HCV therapy. Methods: This was a retrospective administrative claims study of patients treated with direct-acting antivirals (DAAs) for HCV from 01 November 2013 - 31 July 2016. HCV pill burden was defined as the pill count per day for the index HCV regimen. Mean overall pill burden (HCV medications plus non-HCV medications) was calcula...
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research
Authors: Goh OQ, Colby DJ, Pinyakorn S, Sacdalan C, Kroon E, Chan P, Chomchey N, Kanaprach R, Prueksakaew P, Suttichom D, Trichavaroj R, Spudich S, Robb ML, Phanuphak P, Phanuphak N, Ananworanich J, RV254/SEARCH 010 Study Group Abstract INTRODUCTION: Dolutegravir (DTG) is recommended as part of first-line antiretroviral therapy (ART) for people living with HIV(PLHIV). We sought to determine the rate of adverse events (AEs) and discontinuations among Thais treated during acute HIV infection (AHI) and switched to DTG-based regimens. METHODS: Thai participants in the SEARCH010/RV254 cohort who initiated ART during...
Source: Journal of the International AIDS Society - Category: Infectious Diseases Tags: J Int AIDS Soc Source Type: research
More News: Food and Drug Administration (FDA) | Hepatitis | Hepatitis C | Marketing | New Drug Applications | Pharmaceuticals