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Fast Advance in Hepatitis C Care Prompts EMA to Revise Clinical Trial Guideline

EMA has proposed changes to its guideline on clinical trials of direct acting antiviral hepatitis C drugs. The revisions are intended to ensure the guideline reflects the dramatic changes that have happened in the hepatitis C sector since Gilead introduced its blockbuster Sovaldi (sofosbuvir).

Published
17 July 2016
From
Regulatory Affairs Professionals Society
Treatment Action Group: Pipeline Report 2016

Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.

Published
15 July 2016
From
Treatment Action Group
Complete clearance of hepatitis B is rare - especially in women and people of Asian descent

Researchers at several different US sites have found that less than one-third of 1% of patients infected with hepatitis B virus (HBV) get rid of the virus per year, and overall, only 1.2% of patients finally get rid of it.

Published
12 July 2016
From
Eurekalert Inf Dis
Incidence of liver cancer is increasing in people with HIV/HCV co-infection

Incidence of liver cancer is increasing among people with HIV co-infection, an international team of investigators report in the online edition of Clinical Infectious Diseases. Researchers from

Published
12 July 2016
By
Michael Carter
European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.

Published
08 July 2016
From
Gilead press release
Viral hepatitis 'kills as many as Aids or TB'

Viral hepatitis is one of the leading causes of death and disability across the globe, killing as many people as Aids or TB, research published in the Lancet suggests.

Published
07 July 2016
From
BBC Health
FDA places RG-101 for HCV on clinical hold

The FDA has verbally notified Regulus Therapeutics that its investigational new drug RG-101 for the treatment of chronic hepatitis C virus infection has been placed on clinical hold after a second patient reported a serious adverse event, according to a news release.

Published
05 July 2016
From
Healio
HIV-to-HIV Organ Transplants Moving Forward

Multicenter study preparing for launch, pilot studies already begun

Published
04 July 2016
From
MedPage Today
FDA Approves Gilead's Epclusa Combo Pill for All Hepatitis C Genotypes

On June 28 the U.S. Food and Drug Administration (FDA) approved Gilead Sciences Epclusa, a new once-daily combination pill containing sofosbuvir and velpatasvir, for the treatment of adults with hepatitis C virus (HCV) genotypes 1 through 6 -- the first approved oral pangenotypic regimen. While it is more effective against more types of HCV, Epclusa will cost less than most earlier interferon-free direct-acting antiviral regimens.

Published
04 July 2016
From
HIVandHepatitis.com
Vaccination could have important role in control of UK HCV epidemic among people who inject drugs

A vaccine, even with low efficacy, could lead to meaningful reductions in the incidence and prevalence of hepatitis C virus (HCV) among people who inject drugs (PWID),

Published
30 June 2016
By
Michael Carter

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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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