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Gilead submits sNDA for Truvada for reducing the risk of acquiring HIV

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Gilead Sciences Truvada

Gilead Sciences has submitted an sNDA application for the approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the US.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP. The application is based on the results of two large placebo-controlled trials of Truvada as PrEP, sponsored by the National Institutes of Health (NIH) and the University of Washington.

The first trial providing data to support the Truvada sNDA is a Phase III, randomised, double-blind, placebo-controlled trial known as the Pre-Exposure Prophylaxis Initiative (iPrEx), which was sponsored by the NIH and conducted among 2,499 high-risk HIV-negative adult homosexuals in the US and countries in Africa, Asia and South America. Results from the trial, published in the New England Journal of Medicine in November 2010, showed that once-daily use of Truvada for PrEP reduced the risk of acquiring HIV overall by 44 per cent compared with placebo and by up to 73 per cent among men who reported taking the drug consistently (defined as at least 90 per cent of days). Among men who took the drug consistently enough to have detectable drug in their body, the risk was reduced by more than 90 per cent.

The Truvada sNDA submission is also supported by data from Partners PrEP, a Phase III, randomised, double-blind, placebo-controlled trial conducted among 4,758 heterosexual couples in Kenya and Uganda, in which one partner was infected with HIV and the other was not. The trial, sponsored by the University of Washington, showed that once-daily use of oral Truvada by the HIV-negative participants reduced their risk of acquiring HIV by 73 per cent compared with placebo.

Additional supportive data come from two studies sponsored by the Centers for Disease Control (CDC). The first trial, known as TDF2, was a Phase III, randomised, double-blind, placebo-controlled trial conducted in Botswana among 1,200 HIV-negative heterosexual men and women. Participants taking once-daily oral Truvada for PrEP had 63 per cent fewer HIV infections compared with those receiving placebo. The second trial, known as CDC 4323, was a Phase II, randomised, placebo-controlled, double-blind study of homosexual men in the US primarily designed to assess the safety, adherence and acceptability of PrEP.

Although full details are not yet available, another separate Phase III study of Truvada for PrEP known as FEM-PrEP was stopped in April 2011 based on a recommendation by the study’s Independent Data Monitoring Committee that the trial would not be able to establish the efficacy of Truvada among HIV-negative women in sub-Saharan Africa. The reason for this outcome is not yet understood and a complete detailed analysis of the data is currently under way.

In all studies, side-effects included nausea, weight loss and serum creatinine elevations. The incidence of side effects was consistent with Truvada’s safety and tolerability profile when used as HIV treatment, which is supported by more than 1.8 million years of patient use. Overall, there have been more than 4.4 million patient years of experience with tenofovir-containing regimens. Three cases of resistance to emtricitabine were reported in the iPrEx trial among participants who tested negative for HIV infection by serology at enrollment, but were later found to have been infected with HIV prior to enrolment using a different assay. Two of these cases occurred in the active drug arm, and one case occurred in the placebo arm.

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Diagnostics Focus – Ambulatory Blood Pressure

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Ambulatory blood pressure may “best predict brain disease and cognitive decline”

Ambulatory blood pressure – not the doctor’s office blood pressure – can best predict the progression of small vessel brain disease and the decline of cognitive function in older people, according to a new study in Circulation: Journal of the American Heart Association. Ambulatory blood pressure is measured by monitoring blood pressure at regular intervals using a special recording device under normal living and working conditions. Clinical or in-office blood pressure is taken in a healthcare provider’s office. The National Institutes of Health funded the study.

According to Dr William B White, senior author of the study and professor of hypertension and clinical pharmacology in the Calhoun Cardiology Center at the University of Connecticut School of Medicine in Farmington, the study showed for the first time in an older population that blood pressure measured over a 24-hour period was associated with the progression of vascular brain disease, whereas the typical office blood pressure was not. To determine the effect blood pressure had on the progression of brain disease, researchers examined the change in blood pressure and volume of white matter hyperintensities (WMH) in the brain at baseline and after two years.

WMH are a sign of small vessel brain damage that can be detected using an MRI. In addition to looking for WMH, researchers measured cognitive ability and physical mobility over the two-year time period. Previous studies by the authors and other researchers have shown that increased WMH is associated with cognitive decline. A worsening in ambulatory blood pressure was associated with an increase in WMH and a decrease in cognitive and mobility functions. If medical professionals target average ambulatory blood pressure, it could reduce the progression of small vessel brain disease, researchers stated.

The two-year study included 72 patients – average age 82. For the group, there were no major changes in body weight, clinical or ambulatory blood pressure during the study, and only three patients had severe medical problems, including the development of stroke, heart failure or valvular disease. Researchers found no relationship between clinical blood pressure and WMH; the average volume of WMH, when adjusted for age and “bad” LDL cholesterol, increased significantly over two years from 13.9mL to 20.5mL; and three of the four mobility measures and all of the cognitive measures were significantly related to WMH volume at two years.

The results of this cohort study mean that for older people who aim to stay as functional as possible during advancing age, their blood pressure averaged out of the office, rather than in the office, might be the most important to target and treat.

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Medica 2011

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In the Medical Technology Blog today’s post is and article taken from Espicom’s business publication Drug Delivery Insight, provided by DDI’s editor, Sophie Bracken, please read on…

A new international pharma company has been launched, the result of a three-year Anglo/Russian project by London, UK’s Celtic Pharma. The company, Pro Bono Bio, has big growth targets that, if attained, could to allow it to combine global pharma expertise from within the UK together with international capital and funding from the Russian Corporation of Nanotechnologies (RUSNANO).

Pro Bono Bio has decided on a clear humanitarian approach to its business, namely that its products will be priced in different geographic areas based on the region’s ability to pay. Backed by company’s shareholders, the business model includes the provision of free drug donations to Africa, based product sales at normal prices in the Western European pharma market.

The UK’s Prime Minister, David Cameron believes that the Pro Bono project is “a great example of UK/Russia collaboration at the cutting edge of R&D, demonstrating how British business can work together with their Russian counterparts to expand into new areas, creating jobs and prosperity in the UK”.

As well as keeping busy with its humanitarian focus, Pro Bono has released its first prescription medicine in the UK known as Flexiseq. The latter is a nanotechnology-based osteoarthritis treatment, and the first in a pipeline of products under development. The company has plans to roll out a further two more products in the UK – Exoseq and Possoseq – over the coming months. The products are designed for the treatment of inflammatory skin disorders, including psoriasis and eczema. Like Flexiseq, they are based on Pro Bono’s Sequessome technology, which physically absorbs and removes chemicals that are a key component in the pain and inflammation cascade. Sequessomes were invented and developed by Pro Bono with the help of external partners, and the technology is protected by a number of worldwide patents.

Other products that Pro Bono has in the pipeline include blood factors for the treatment of haemophilia, and novel antibiotics for the treatment of serious infections like C. difficile, MRSA and tuberculosis. Pro Bono has big plans to develop and market these products by exploiting its management team’s so-called “Big Pharma” experience – expertise from the likes of the company’s CEO, John Mayo.

First off, Pro Bono will focus on marketing Flexiseq and other Sequessome Technology-based products in Western, Central and Eastern Europe as well as the CIS. The company’s commercial and manufacturing model is based on collaborations with specialist service partners. The outsourced sales model will eventually be bolstered by selective full ownership of the salesforce in certain territories. Also, products will initially be sourced from European and Russian manufacturers’ approved facilities.

In the mid-term, Pro Bono will support the plans by building  – with RUSNANO’s support – a state-of-the-art pharma plant close to Moscow, with a further plant in the UK, in order to comply with EU regulations.

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Diagnostics Focus in The Medical Technology Blog this week – Scientists call for UK medical centres to adopt pulse oximetry test for identifying heart defects in newborns

The largest UK investigation into screening newborns for congenital heart defects has found that pulse oximetry is able to identify babies with life-threatening congenital heart defects, a major cause of infant mortality in the developed world. Researchers from the University of Birmingham and Birmingham Women’s Hospital have published data from the study, called PulseOx, in The Lancet medical journal.

More than 20,000 mothers and babies from throughout the West Midlands took part in the trial. Midwives used pulse oximetry to measure oxygen levels in newborns’ blood via a small sensor placed on the skin of hands or feet. Babies with low oxygen levels soon after birth may be at increased risk of heart defects. Current screening for heart defects involves ultrasound before delivery and routinely examining all newborns in the first 24 hours after birth. However, these examinations often miss babies with serious heart defects. PulseOx is carried out as an additional test on the postnatal ward, before discharge from hospital.

In six maternity units in the UK, asymptomatic newborn babies (gestation >34 weeks) were screened with pulse oximetry before discharge. Infants who did not achieve predetermined oxygen saturation thresholds underwent echocardiography. All other infants were followed up to 12 months of age by use of regional and national registries and clinical follow-up. The main outcome was the sensitivity and specificity of pulse oximetry for detection of critical congenital heart defects (causing death or requiring invasive intervention before 28 days) or major congenital heart disease (causing death or requiring invasive intervention within 12 months of age).

Out of the 20,055 newborn babies that were screened, 53 had major congenital heart disease (24 critical), a prevalence of 2·6 per 1,000 live births. Analyses were done on all babies for whom a pulse oximetry reading was obtained. Babies who failed the PulseOx test were given a heart ultrasound. Of 195 babies with an abnormal result following the test, 26 had a major congenital heart defect and a further 46 had other important problems which required urgent treatment brought to attention by the test.

Lead investigator Dr Andrew Ewer says that sufficient evidence exists for all babies to be routinely tested using pulse oximetry and, in conjunction with other tests, could help identify cases of critical congenital heart defects that go undetected with antenatal ultrasonography. Funding for the UK study was provided by the National Institute for Health Research Health Technology Assessment programme.

Thanks to Sophie Sanderson, editor of Diagnostics Focus for providing this article.



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Hi all, apologies for the lack of posts this week, but i’m carrying out some much needed back-office installations and cleaning to the blog. Bear with me please i’ll be posting again very soon.

Thanks, Paul.



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