The largest clinical trial of anti-retroviral therapy (ART) for people with HIV infection ever run in Africa has found that regular laboratory tests offer little additional clinical benefit to populations when compared to careful clinical monitoring.

The results suggest that many more people with HIV in Africa could be treated for the same amount of money as is currently spent if lab tests are not routinely used to monitor the effects of ART.

The evidence from the Development of Anti-drugpricegrabber.com/96/buy_retrovir/”>Retrovir al Therapy in Africa (DART) clinical trial will be of value to low income or resource poor countries that are prioritising ART access over investment in expensive laboratory facilities.

The DART trial aimed to find out whether the lab-based strategies used to deliver ART to people with HIV infection in resource rich countries were essential in Africa, where around 4 million people still need ART urgently and resources are limited.

The DART team believes governments and policymakers, as well as people living with HIV/AIDS, can now be confident that ART can be delivered safely and effectively by trained and supervised health workers in remote communities where routine laboratory services are not available.

In all, 3,316 people who had not previously had ART took part in the DART trial. All had severe or advanced HIV infection and had been assessed for ART eligibility using clinical staging and laboratory tests including CD4 cell count (a measure of how well the body’s immune system, which is damaged by HIV, is working). The trial began six years ago when treatment for people with HIV was just starting to become more widely available in Uganda and Zimbabwe.

DART participants were randomly allocated to one of two groups. People in the first group received ART and their doctor was given the results of blood tests done every three months to check for drug side-effects and measure their CD4 cell count. People in the second group had the same ART and the same blood tests done, but their doctors did not see CD4 count results and only saw the results of safety tests if they were seriously abnormal. People in both groups received free medical care and free diagnostic tests for episodes of illness throughout the trial.

The results show that 90% of people in the first group were still alive after five years compared to 87% of people in the second group, a difference of only 3 percentage points. Over the five years data was collected, 78% of people in the first group survived and had developed no new AIDS-related illnesses, compared with 72% in the second group. These differences only became apparent from the third year of ART. The research team believes this may be a result of the participants in the lab-monitoring group switching to a different combination of ART earlier than those in the second group. No difference in the occurrence of side effects caused by ART was found between the two groups.

Irrespective of group, the survival rate in the DART trial is amongst the best reported from any trial, ART programme or study in Africa. Historical comparisons, based on data from follow-up of similar patients in Uganda who did not have access to ART make it clear that few of the DART trial participants would have been alive after five years without ART.

DART co- principal investigator Professor Peter Mugyenyi of the Joint Clinical Research Centre in Uganda said:

”It is estimated that two-thirds of people who need treatment for HIV in Africa currently don’t have access to antiretroviral therapy. Thanks to DART, Governments now have evidence that expensive blood tests aren’t needed routinely for HIV treatment to be successful and safe. It also means that treatment could be delivered locally as long as health care workers have the right training, support and supervision. This could make a huge difference to people who live in remote areas that are many days’ walk from the nearest hospital or laboratory.”

DART was sponsored and funded by the UK Medical Research Council. Further funding was provided by the UK Department for International Development and the Rockefeller Foundation. Antiretroviral drugs given to trial participants were donated by GlaxoSmithKline , Gilead Sciences, Abbott Laboratories and Boehringer Ingelheim. These pharmaceutical companies also provided funding for some of the sub-studies that were part of the DART trial.

Scientists and health care workers from Africa and the UK collaborated closely to run the trial. Healthcare and research centres in Uganda were the Joint Clinical Research Centre, Kampala, the Infectious Diseases Institute at Mulago Hospital, Kampala and the MRC/Uganda Virus Research Institute Uganda Research Unit on AIDS, Entebbe. In Zimbabwe, researchers were based at the University of Zimbabwe Medical School Clinical Research Centre, Harare. The MRC Clinical Trials Unit in London provided overall coordination and the secretariat was provided by the International HIV Clinical Trials Research Management Office at Imperial College London.

DART co-principal investigator Professor James Hakim of the University of Zimbabwe Medical School Clinical Research Centre in Harare explains the impact the DART results could have for people with HIV who don’t have access to a clinic with lab facilities:

”The health economists in the DART team who have analysed the trial data have concluded that a third more people could be successfully treated for HIV in Africa if expensive lab tests weren’t used routinely. DART has shown that giving ART without these routine tests is safe and effective and suggests how the limited funding available could be used most effectively as by treating more people the number of deaths and disease related to HIV infection can be reduced. The challenge now is for policy-makers to widen availability of ART.”

Co-principal investigator Professor Charles Gilks of Imperial College London and now UNAIDS, noted that:

“DART has been a landmark trial in Africa in many ways, not only in the numbers involved and its length, but for the way the patient communities were involved and engaged. For example, the strong partnerships developed with the pharmaceutical industry in a trial that was looking at treatment strategies, rather than comparing one product with another, and the exceptional participation, survival and low loss to follow-up that we achieved. The results provide compelling evidence for planners and policy-makers that, until universal access is achieved, the priority should be getting untreated patients on to ART, provided by well-trained and well-supported health workers who can deliver high quality clinical care.”

Co-principal investigator Professor Diana Gibb of the MRC Clinical Trials Unit in London said:

”The survival of people who took part in the trial was remarkable; without treatment only about 10% of HIV-infected African people like those in DART would be expected to survive for five years. In DART, 87% of those receiving treatment without routine blood test monitoring were still alive and well after five years, only 3 percentage points less than in the group that had routine blood test monitoring. For health policy-makers in Africa, DART provides evidence that more people could be treated for the same amount of money by not using routine laboratory tests. This would substantially reduce the number of people dying with serious disease due to HIV infection.”

Commenting on the DART trial MRC Chief Executive Sir Leszek Borysiewicz said:

”The DART trial is an example of how working in partnership can deliver excellent results by sharing expertise and resources. Along the way, this collaboration between publically-funded researchers and industry has also helped to develop research capacity in Africa.”

International Development Minister, Mike Foster of DfID said:

“It’s absolutely clear that anti-retroviral treatment saves lives - but the cost of accompanying laboratory tests significantly reduces the number of people that this treatment can reach. The DART trial, for which DFID provided £2.5m in funding, shows that this life saving treatment can still be safely provided without this additional cost.”

“Crucially, the money saved from paying for these tests could enable more people to safely receive treatment, including those who for whatever reason are unable to travel to the laboratories. Such a step would be an important move towards our ultimate aim of achieving universal access to treatment for HIV/AIDS by 2010.”

The results of the DART trial were presented at the International AIDS Society (IAS) Conference 2009 in Cape Town on the 21 July.

Notes

Abstract titles: Impact of routine laboratory monitoring over 5 years after antiretroviral therapy (ART) initiation on clinical disease progression of HIV-infected African adults: the Dart Trial final results and Cost Effectiveness Analysis of Routine Laboratory or Clinically Driven Strategy Monitoring Anti-Retrovir al Therapy in Uganda and Zimbabwe.

As the DART trial centres are key centres for ART treatment, most patients are staying at the same clinical centre for their ongoing clinical care, unless for practical reasons they wish to be transferred (e.g. to a health centre nearer to where they live).

All participants will continue to receive ART free of charge and most will stay on the same regimen they were taking at the end of the study. All the information from the trial, including all their CD4 results have been summarised for each participant at the end of the trial and shared with the participants and their health carers. Some participants will have the opportunity to enrol in other ART studies if they wish to.

The main DART trial closed on 31 December 2008. Two additional sub-studies are ongoing that will continue to August/September 2009.

The Ministries of Health in Uganda and in Zimbabwe have been informed of the results and a meeting for trial participants is scheduled to be held immediately after the IAS conference.

About Imperial College London

Consistently rated amongst the world’s best universities, Imperial College London is a science-based institution with a reputation for excellence in teaching and research that attracts 13,000 students and 6,000 staff of the highest international quality.

Innovative research at the College explores the interface between science, medicine, engineering and business, delivering practical solutions that improve quality of life and the environment - underpinned by a dynamic enterprise culture.

Since its foundation in 1907, Imperial’s contributions to society have included the discovery of penicillin, the development of holography and the foundations of fibre optics. This commitment to the application of research for the benefit of all continues today, with current focuses including interdisciplinary collaborations to improve health in the UK and globally, tackle climate change and develop clean and sustainable sources of energy.
Website: http://www.imperial.ac.uk

About The Department for International Development

The Department for International Development (DFID) is the part of the UK government that manages Britain’s aid to poor countries and works to get rid of extreme poverty. It works in 150 countries and has 2,600 staff, half of whom work abroad. In 2007/08, DFID spent £5.3 billion on aid to poorer countries and its budget will increase to £7.9 billion by 2010/11. By 2013, the government has pledged to increase DFID’s aid to the equivalent of 0.7% of the UK’s gross national income, from 0.36% in 2007/08. DFID works with governments of developing countries, charities, businesses and international bodies, including the World Bank, the UN agencies and the European Commission, with the aim of reaching the Millennium Development Goals (MDGs) - international targets agreed by the United Nations (UN) to halve world poverty by 2015.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.For more information please visit http://www.boehringer-ingelheim.com

Source
Medical Research Council

The NPA is asking for the RPSGB retention fee to be held at the present level, given the financial pressures on pharmacy businesses, many of which pay retention fees for their staff.

Margaret Peycke, NPA External Relations Manager said:

“The justification to charge RPSGB members more is unclear, especially as such a large increase in fees (40%) was made in 2008, the declared purpose of which was to provide the RPSGB with the resources to create the regulatory and professional leadership bodies. In such circumstances, an uplift to fees in the region of 2.2% is inappropriate.”

“NPA members already coping with a challenging economic environment are not in a position to comfortably absorb such increases, bearing in mind that many employers fund their employee pharmacist and technician retention fees. The NPA has recently surveyed its members and over 80% highlighted the current burden of costs on their pharmacy business.”

In addition the fee set by the RPSGB is a fee which will be divided between the new regulatory body (GPhC) and the new professional leadership body (PLB) after the split which is due to occur in April 2010. The document does not indicate how the fees will be apportioned between the bodies or make mention of the fact that existing members of RPSGB who do not wish to join the new PLB do not have to and will be entitled to a refund on the unused element of the fees apportioned to the PLB.

Source
National Pharmacy Association

The National Pharmacy Association and Allergy UK provided free allergy screening to the public at Hampton Court Palace Flower Show from 7-12 July. Over 7,000 members of the public picked up information on community pharmacy allergy screening or asked for advice and 75 allergy screenings were carried out.

Jules Payne, Deputy Chief Executive, Allergy UK said: “Allergy UK has done a lot of shows over the years and, without a doubt, this was the best show we have ever done. A lot of the people we spoke to clearly had very real allergic/intolerant problems. Even though people were out for a nice day out, it proved added value to them. People were also picking up the information for their friends and family.”

Stephen Foster, Community Pharmacist (Pierremont Pharmacy, Broadstairs, Kent) said: “Allergy screening was very well received by the public at Hampton Court and the event has proved to be a successful way of raising the profile of the service. I would like to see pharmacy engaged with more events like this in the future.”

John Turk, Chief Executive, National Pharmacy Association said: “Hampton Court Palace Flower Show gave us the opportunity to engage with the public about community pharmacy allergy screening on our members behalf. The community pharmacy service has been running just about year so we wanted an event to showcase the service where we could put into practice what pharmacy is all about - speaking with the public face to face.”

“The Show has proved that there is clearly a demand for allergy screening at primary care level. The feedback, from those who talked to us at Hampton Court, was that community pharmacy is the right place to help people with their allergies.”

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The National Pharmacy Association