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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, with or without ribavirin, for the treatment of chronic hepatitis C genotype 1 and 4 infection, according to a press release.

The Viekirax (omitasvir/paritaprevir/ritonavir, AbbVie) and exviera (dasabuvir, AbbVie) combination was looked upon favorably based on data from multiple phase 3 studies — SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II. The CHMP’s recommendation will be addressed by the European Commission, which has the authority to approve the drug for the European Union. More than 2,300 patients have been included in the studies with the direct-acting antiviral regimen, and the treatment has been generally well tolerated.

In the Journals

HIV, STIs prevalent among male sex workers in Mexico City

November 21, 2014
HIV and other sexually transmitted infections were common among Mexican male sex workers, according to recent data. Omar Galárraga, PhD, of Brown University…
Adam Hersh In the Journals

Black children more likely to receive narrow-spectrum antibiotics for otitis media

November 21, 2014
Black children diagnosed with otitis media during an ambulatory care visit were more likely to receive guideline-recommended narrow-spectrum antibiotics than nonblack…
In the Journals

Vector-borne, zoonotic diseases pose threat to soldiers in Afghanistan

November 21, 2014
Southern Afghanistan faces a potential reemergence of vector-borne and zoonotic diseases endemic to the region, possibly posing public health threats to military…

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 adults with chronic…
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HCV Consults: Volume 1, Number 3

HCV Consults: Volume 1, Number 3

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

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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
J490 Challenges in HIV Screening

Challenges in HIV Screening and Prophylaxis: PrEP’ing for the Future

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

A substantial proportion of Americans with HIV remain undiagnosed and suboptimally treated. Failure to follow…
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