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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
Ooh La La: France Negotiates a Steep Discount for Sovaldi From Gilead

The fixed price reduced the cost by about 27%, and so a 12-week regimen will now be priced at $51,400, instead of $71,100. This makes this the “lowest price in Europe,” according to the Economic Committee for Health Products. There is also stipulation that rebates will be made in the event of “treatment failure,” according to a statement from the agency.

Published
21 November 2014
From
Wall Street Journal
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
Practical steps to eliminating hepatitis C: a consensus for London

The aim of this document is to reinforce the need for urgent leadership from the Department of Health, PHE and NHS England and concerted action from Local Authorities, Health and Wellbeing Boards, Clinical Commissioning Groups (CCGs) and service providers to improve hepatitis C testing and treatment services in London for people with a history of using drugs – the group most affected by chronic hepatitis C – in order to find and treat significantly more people affected by the disease.

Published
17 November 2014
From
London Joint Working Group on Substance Use and Hepatitis C
Interim Revision of Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

This interim revision of the Guidelines includes a revised section on Hepatitis C Virus (HCV)/HIV Coinfection, with emphasis on considerations for use of antiretroviral (ARV) drugs in patients who also receive treatment for HCV infection. A new table (Table 12) provides clinicians with guidance on the concomitant use of HCV drugs and ARV drugs, with a focus on potential pharmacokinetic drug interactions. The Panel refers clinicians to http://www.hcvguidelines.org for guidance on the diagnosis and treatment of HCV infections.

Published
17 November 2014
From
AidsInfo
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
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