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New and experimental hepatitis C treatment news

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FDA declines to approve Bristol-Myers hepatitis drug

Bristol-Myers said the FDA has asked it for data involving use of daclatasvir with other drugs, and that the company is in discussions with the agency about the scope of the required information.

Published
27 November 2014
From
Reuters
"Promising" results in Oxford trials of Hepatitis C vaccine

A new vaccine developed by researchers at the University of Oxford has generated a strong immune response against the Hepatitis C virus in human volunteers. The vaccine is the first Hepatitis C inoculation to reach this stage of clinical trials, and the results have been promising. The 15 healthy human volunteers who took part in the phase 1 safety trial all responded positively.The study found that after the second, booster inoculation, all 15 volunteers had large, broad and sustained T cells responses.

Published
26 November 2014
From
Cherwell
CHMP Grants Positive Opinions of AbbVie’s VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) for the Treatment of Chronic Hepatitis C in Europe

Major regulatory milestone achieved toward approval in the European Union; final decision from the European Commission expected in the first quarter of 2015.

Published
21 November 2014
From
AbbVie press release
NHS asks Nice to delay ground-breaking hepatitis C drug

Nice is due to finish its final assessment of sofosbuvir in January. It is usual for them to give the NHS three months to find the money or put staff – if needed – in place. NHS England is thought to have asked them to delay this by six months.

Published
19 November 2014
From
Channel 4 News (blog)
European Commission Grants Marketing Authorization for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir)

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir (LDV) with the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved by the European Commission under the tradename Sovaldi® in January 2014.

Published
19 November 2014
From
Gilead press release
New HCV drugs pass muster in real world

Clinical trials for some of the new direct-acting agents against hepatitis C (HCV) have yielded some impressive efficacy numbers. But how well do the drugs stack up in the real world?

Published
11 November 2014
From
MedPage Today
New pill that can cure hepatitis C approved for patients in Scotland

Daclatasvir is an oral once-daily pill, used in combination with other medicinal products, to treat adult patients with chronic hepatitis C. The decision makes Scotland the first country in Europe to adopt positive guidance for daclatasvir and means it will be routinely available to eligible patients through the Scottish NHS.

Published
11 November 2014
From
STV
Merck’s four-week treatment for hepatitis C misses the mark

In disappointing news for Merck, the drug maker released results of an interim study showing a triple combination treatment – which includes two of its own compounds and the big-selling Sovaldi medication from Gilead Sciences – came up short.

Published
11 November 2014
From
Wall Street Journal
Phase 3 UNITY Trials Demonstrate High Cure Rates for Investigational, All-Oral Daclatasvir TRIO Fixed-Dose Combination in Genotype 1 Hepatitis C Patients, Including Those with Cirrhosis

Daclatasvir TRIO achieves 98% cure rate in treatment-naïve and 93% cure rate in treatment-experienced genotype 1 patients with cirrhosis when used with ribavirin, as shown in UNITY 2. 12-week, all-oral treatment halves current regimen duration for hard-to-manage treatment-experienced genotype 1 patients with cirrhosis. Fixed-dose regimen also demonstrates 91% SVR rates in non-cirrhotic genotype 1 patients without requiring use of ribavirin

Published
10 November 2014
From
Bristol-Myers Squibb press release
ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients

Daclatasvir+sofosbuvir regimen achieves SVR12 in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 patients. ALLY-3 is the first Phase 3 study of an all-oral, ribavirin-free treatment regimen for genotype 3 HCV patients with a 12-week treatment duration

Published
10 November 2014
From
Bristol-Myers Squibb press release
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