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New and experimental hepatitis C treatment news

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AbbVie all-oral hepatitis C therapy gets rapid EU review

The U.S. drugmaker said on Tuesday the move by the European Medicines Agency meant that, if approved, its regimen could be available in the European Union in the first quarter of 2015. U.S. regulators have also granted the product priority review.

Published
17 June 2014
From
Reuters
NICE consults on draft guidance on the drug sofosbuvir (Sovaldi) for treating hepatitis C

In draft recommendations published today healthcare guidance body NICE is asking Gilead Sciences for more information on its product sofosbuvir (Sovaldi), for the treatment of chronic hepatitis C. “The available evidence shows that sofosbuvir is an effective treatment for chronic hepatitis C in certain patients. However, evidence is lacking for some subgroups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer.”

Published
16 June 2014
From
NICE press release
Low uptake of HCV treatment in England will lead to substantial disease burden by 2035

Only 3% of patients with chronic hepatitis C virus (HCV) are treated for their infection each year in England, according to research published in the Journal of

Published
13 June 2014
By
Michael Carter
Why Merck Just Spent $4 Billion On New Drugs For Hepatitis C

Perlmutter says that he believes Merck already had the best of two of the three drugs in the needed triple-drug combo: an NS5a inhibitor and a protease inhibitor. He expect that it may be possible to plan a combination trial of Merck’s drugs and Idenix’s lead nuke even before the deal closes.

Published
09 June 2014
From
Forbes
No critical interactions between ledipasvirsofosbuvir and certain key antiretrovirals

Ledipasvir/sofosbuvir, a fixed-dose coformulation of two direct-acting antivirals (DAAs) for HCV infection, did not have a clinically significant impact on five frequently used antiretrovirals--raltegravir, efavirenz, rilpivirine, and tenofovir/emtricitabine (TDF/FTC)--according to results of three studies in healthy volunteers.

Published
29 May 2014
From
NATAP
OLYSIO™ (simeprevir) receives marketing authorisation in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection

Simeprevir provides a new triple therapy treatment option, as well as the first ever 12-week interferon-free and ribavirin independent treatment regimen, in combination with sofosbuvir, for appropriate patients in Europe

Published
16 May 2014
From
Reuters
AbbVie Submits for EU Marketing Authorization its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Chronic Hepatitis C

Submission based on the largest Phase III program in genotype 1 (GT1) hepatitis C patients conducted to date. European Medicines Agency has granted AbbVie's request for accelerated assessment.

Published
08 May 2014
From
AbbVie press release
Sofosbuvir + ribavirin is safe and effective for HCV recurrence after liver transplantation

An interferon-free combination of sofosbuvir (Sovaldi) plus ribavirin taken for up to 24 weeks led to sustained virological response in 70% of liver transplant recipients with hepatitis C

Published
08 May 2014
By
Liz Highleyman
Janssen submits US FDA new drug application for simeprevir / sofosbuvir combination use

Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc. This regulatory submission is for the treatment of genotype 1 chronic hepatitis C (HCV) in adult treatment-naive patients with advanced fibrosis and null responders with all stages of liver fibrosis.

Published
08 May 2014
From
Janssen press release
UNITAID approves grants of $160 million, for hepatitis C, MDR-TB and malaria drugs

Breakthrough new medicines for hepatitis C and drug-resistant TB and largest-yet global programme for seasonal malaria chemoprevention to be made available for low- and middle-income countries as part of $160 million of new grants funded by UNITAID

Published
07 May 2014
From
UNITAID

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