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LONDON, [9th March 2012] – Today, the National Institute for Health and Clinical Excellence (NICE) in the UK has issued a Final Appraisal Determination (FAD) recommending the use of 'Victrelis'® (boceprevir) in combination with peginterferon alfa and ribavirin ('dual therapy') as an option for the treatment of genotype 1 chronic hepatitis C (CHC) in adults with compensated liver disease, who are previously untreated or in whom previous treatment has failed. 1A
The FAD for boceprevir is the first for any direct acting anti-viral treatment for CHC genotype 1 infection and concludes that the drug "represents a cost-effective use of NHS resources." 1B The FAD provides the final conclusions of the NICE Appraisal Committee and will form the guidance to the National Health Service (NHS) in England and Wales, which is expected to be published in April. The announcement follows an accelerated assessment of boceprevir by NICE, and means that with its availability, the likelihood of an individual clearing the virus will be higher than if treated with dual therapy alone.
Charles Gore, Chief Executive, The Hepatitis C Trust, commented "The new drugs for chronic hepatitis C genotype 1 are a step change for treatment, but can only make a difference if patients and physicians have access to them. NICE play a critical role in allowing access by evaluating the clinical and cost-effectiveness of new drugs, and they have shown that the benefits of these treatments clearly outweigh their financial cost.
For too long, only the minority of people who have hepatitis C have been diagnosed, and only a fraction of those people treated. Recent advances in hepatitis C management are bringing us closer to the vision that hepatitis C can be eradicated in the UK. This decision represents an important opportunity to help prevent further deaths caused by this disease."
The Committee recognised "the demands that living with genotype 1 chronic hepatitis C places on patients and concluded that treatments which enable patients to achieve a sustained virological response and which consequently help to reduce HCV transmission are of significant importance."1C
When a NICE technology appraisal recommends use of a drug or treatment, or other technology, the NHS must usually provide funding and resources for it within 3 months of the final guidance being published.1E
Professor Graham Foster, Professor of Hepatology, Barts and The London School of Medicine and Dentistry, commented "The new generation of drugs for patients with genotype 1 hepatitis C have shown very clearly that they can dramatically increase the proportion of patients who are able to clear the viral infection. In the first technology appraisal of these drugs, NICE has reviewed the clinical and cost-effectiveness of boceprevir and given a positive recommendation. It will now be important to ensure that patients have easy access to the high quality care that they need to give them the best chance of clearing the virus."
NICE based their recommendation on clinical trials, which showed that the addition of boceprevir to standard therapy for those who had failed previous treatment, almost tripled (x2.8) the number of patients clearing the virus (achieving sustained virologic response, SVR) compared to standard therapy alone from 21% (17/80) to 59% (95/162).2 In previously untreated patients, the addition of boceprevir nearly doubled (x1.7) the number of patients clearing the virus compared to standard therapy alone from 38% (137/363) to 63% (233/368).2
Boceprevir is a direct acting antiviral agent which interferes with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme.2 This is in comparison to dual therapy which boosts the immune system to elicit a response. Treatment has a manageable side effect and tolerability profile with a similar discontinuation rate due to adverse events compared to dual therapy alone.3,4 In clinical trials the most common adverse events were fatigue, headache, nausea, anaemia, and dysgeusia (a metallic taste).2 Anaemia was observed in 49% of subjects treated with boceprevir as part of triple therapy, compared with 29% of subjects treated with standard therapy alone.2
Source : MSD
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