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FDA requests data on daclatasvir in combination with other agents

November 26, 2014

The FDA issued a complete response letter to Bristol-Myers Squibb in response to its new drug application for daclatasvir, an NS5A complex inhibitor.

The FDA is requesting additional data for the drug’s treatment of hepatitis C virus in combination with other antiviral agents, as the original new drug application focused on a daclatasvir-asunaprevir combination. Bristol-Myers Squibb withdrew the new drug application for asunaprevir, an NS3/4A protease inhibitor, in October.

Meeting News Coverage

Post-transplant sofosbuvir/simeprevir regimen effective, well tolerated

November 26, 2014
BOSTON — An all-oral antiviral regimen of sofosbuvir and simeprevir was associated with high sustained virologic response regardless of the addition of ribavirin…
In the Journals

HBV vaccine provides lasting protection to HCWs, with no booster needed

November 25, 2014
When vaccinated against hepatitis B virus as adults, health care workers appeared to receive robust and long-lasting vaccine protection, according to researchers from…
Eric Lawitz Meeting News Coverage

Top HCV studies presented at The Liver Meeting

November 25, 2014
Healio.com/Hepatology has compiled a list of the latest, most relevant research on hepatitis C virus infection, presented recently at The Liver Meeting in Boston.
CME
HCV Consults: Volume 1, Number 2

HCV Consults: Volume 1, Number 2

This activity is supported by educational grants from AbbVie and Genentech.

Approved interferon-free therapy has already become entrenched among clinicians for patients with HCV genotypes 2 and…
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Meeting News Coverage Video
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Early liver transplantation could improve survival rates for patients with alcoholic hepatitis

November 17, 2014
BOSTON — Ibrahim A. Hanouneh, MD, hepatologist at Cleveland Clinic, discussed results of a study that compared…
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CME
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CRITICAL ISSUES IN HBV: Considerations in Optimizing HBV Treatment

This activity is supported by an educational grant from Gilead Sciences Medical Affairs.

Hepatitis B virus (HBV) infection is a global epidemic with a worldwide burden. Physicians must address the importance…
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FDA News

FDA requests data on daclatasvir in combination with other agents

November 26, 2014
The FDA issued a complete response letter to Bristol-Myers Squibb in response to its new drug application for daclatasvir, an NS5A complex…
Meeting News Coverage

Post-transplant sofosbuvir/simeprevir regimen effective, well tolerated

November 26, 2014
BOSTON — An all-oral antiviral regimen of sofosbuvir and simeprevir was associated with high sustained virologic response regardless of the…
In the Journals

HBV vaccine provides lasting protection to HCWs, with no booster needed

November 25, 2014
When vaccinated against hepatitis B virus as adults, health care workers appeared to receive robust and long-lasting vaccine protection, according…
Eric Lawitz Meeting News Coverage

Top HCV studies presented at The Liver Meeting

November 25, 2014
Healio.com/Hepatology has compiled a list of the latest, most relevant research on hepatitis C virus infection, presented recently at The Liver…
Meeting News Coverage

Birth cohort screening more accurate in detecting HCV vs. standard method

November 25, 2014
BOSTON — Hepatitis C virus screening among a birth cohort was five times more effective in identifying people with current or previous…
Meeting News Coverage

'Real life' experience with sofosbuvir-based regimens after transplant shows promise

November 25, 2014
BOSTON — On-treatment response using sofosbuvir as the backbone of treatment for recurrent hepatitis C virus after liver transplantation…
HBV/HCV in mothers led to increased risk for neurological outcomes in infants In the Journals

HBV/HCV in mothers led to increased risk for neurological outcomes in infants

November 24, 2014
Hepatitis B and hepatitis C virus infections in mothers were associated with an increased risk for neonatal neurological outcomes in infants…
Meeting News Coverage

TURQUOISE-II: Demographics, viral factors did not predict SVR after 3D regimen

November 21, 2014
BOSTON — Sustained virologic response rates after treatment with an all-oral regimen of coformulated ABT-450 boosted with ritonavir, ombitasvir…

EMA panel recommends approval of DAA regimen for patients with HCV

November 21, 2014
The European Committee for Medicinal Products for Human Use, or CHMP, granted a positive opinion for the recommendation of Viekirax plus Exviera…

Commission approves ledipasvir/sofosbuvir combo for marketing in EU

November 20, 2014
The European Commission granted marketing authorization to Gilead Sciences for its once-daily single tablet regimen of Harvoni for the treatment of…
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