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New and experimental hepatitis C treatment news

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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
Biotech’s Hard Bargain

Investors love drug companies in part because they often have tremendous pricing power. Drugs designed to fight rare diseases routinely cost two or three hundred thousand dollars; cancer drugs often cost a hundred grand. But the signs of a backlash are clear.

Published
24 April 2014
From
The New Yorker
Three-drug AbbVie combination safe and highly effective in treatment of post-transplant hepatitis C recurrence

A three-drug combination of direct-acting antivirals developed by AbbVie cured hepatitis C genotype 1 infection in 96% of transplant recipients with recurrent hepatitis C in a small

Published
23 April 2014
By
Keith Alcorn
AbbVie Submits New Drug Application to U.S. FDA for its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C

AbbVie (NYSE: ABBV) submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May.

Published
23 April 2014
From
AbbVie press release

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