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THIBELA TB MAIN RESULTS RELEASED AT CROI
8 March 2012 |
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The long awaited main results from the Thibela TB study into Isoniazid Preventive Therapy in Gold Miners were publically released at the Conference on Retroviruses and Opportunistic Infections on March 8, 2012 in Seattle, Washington, USA.
The study showed a definitive reduction in tuberculosis incidence in individuals who took IPT, albeit that the protective effect seemed to dissipate rapidly after treatment was stopped. Prof Churchyard, principal investigator of Thibela TB said "The Thibela TB study aimed to reduce the burden of TB in the mines using a radical approach of community-wide TB preventive therapy. The Thibela TB study provided clear evidence that community-wide TB preventive therapy did not improve TB control at a population level even though it was effective in reducing the risk of TB among individuals taking TB preventive therapy." This result, whilst disappointing, was nonetheless an important scientific finding in the combat against this ancient and deadly disease.
Reacting to the study results, Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership, said "The study appears to show that, for people who are at a high-risk of developing active TB, taking IPT on a daily basis can have significant benefits. The promise of a cheap, effective and well targeted solution in a sector which is considered the tip of the spear in terms of TB in Africa is very exciting."
Some key news pieces on the results include:
For a copy of the media release at the conference click here.
To view the full presentations with slides given at the conference please reference the links below:
For further information contact Dr Dave Clark at the Aurum Institute on +27 10 590 1301.
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SOUTH AFRICA CONDUCTS TRIALS FOR SHORTER TB TREATMENT
30 March 2012 |
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South African researchers said Friday they were conducting medical trials to shorten the duration of tuberculosis treatment to make it easier for patients to complete the full regimen.
"Fighting tuberculosis is going to require new strategies. The ongoing trial aimed at reducing the treatment period from six to four months is one of the new strategies of fighting the disease," said Gavin Churchyard, chief executive of Aurum Institute, an independent medical research body.
"South Africa has the highest burden of TB infections (in the world), therefore it is important to position ourselves in the forefront of new research to help stop the disease," he said.
The trials are conducted at the TB Research Centre, based at a public hospital in Tembisa township east of Johannesburg, one of the areas with the highest infection rates.
Aurum has also partnered with the French pharmaceutical firm Sanofi to increase research capacity in various TB initiatives.
"No organisation can work alone to make a meaningful contribution towards eliminating the disease," said Christopher Viehbacher, chief executive of Sanofi.
"The long period of treatment has been identified as one of the reasons for poor adherence, resulting in drug resistant TB strains, which are more expensive to treat," he said.
This month, TB Alliance in Washington unveiled plans for the first clinical tests of a new treatment regimen for tuberculosis that could shorten treatment times to four months in both patients with TB and some forms of drug-resistant TB.
Many TB patients fail to complete treatment because they cannot tolerate the difficult side effects of the medications or cannot adhere to the long-term treatment, according to the TB Alliance.
This leads to drug resistant forms of the disease, or even extensively drug-resistant TB known as XDR-TB.
A total of 8.8 million people worldwide fell ill with the contagious lung disease in 2010 and around 1.4 million died, according to the World Health Organization (WHO).
Aurum acknowledges France24 as the source of this article
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SOUTH AFRICA: NEW REPORTS CHART PROGRESS - AND COSTS - IN HIV FIGHt
27 February 2012 |
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JOHANNESBURG, 27 February, 27 (PLUSNEWS) - Mothers, babies and newly diagnosed HIV patients are receiving more of the services they need but progress comes at a cost, according to a new report that predicts a funding shortfall for HIV treatment in South Africa.
On 23 February, the Health Systems Trust released the latest versions of its annual District Health Barometer and South African Health Review.
Although in its sixth year of publication, this year's barometer is the first to include data on early infant HIV testing for babies born to HIV-positive mothers and shows that about half of all babies born to HIV-positive mothers are now being tested for the virus at six weeks of age, an important step to ensuring they access the early HIV treatment recommended for all children younger than one under national guidelines. In 2009, only about a quarter of such babies were being tested using the sensitive polymerase chain reaction - tests that confirm whether HIV-exposed infants are HIV-positive.
The report also found that almost all pregnant women are now tested for HIV, which has helped lower mother-to-child HIV transmission to below 4 percent in the country.
The latest barometer is also the first to include data on tuberculosis (TB) screening among newly diagnosed HIV patients. In 2008, only about a third of new HIV patients were screened for TB; in 2011 about 70 percent were checked.
People who have both HIV and carry latent TB are up to 30 times more likely to develop active TB as their HIV-negative peers and TB remains the leading cause of death in South Africa and among people living with HIV worldwide.
Funding shortage
The HST also launched the South African Health Review, an independent review of the public health sector funded by the South African government. While the report notes that HIV/AIDS spending has increased substantially since 2007, it predicts the country will need up to US$5.3 billion extra every year to sustain its HIV/AIDS response, particularly treatment.
The review notes that this year alone the government will spend about $3.1 million on HIV and AIDS; less than a fourth of this comes from donors such as the Global Fund to Fight AIDS, TB and Malaria or the US President's Emergency Plan for AIDS Relief (PEPFAR).
The South African government already shoulders about 80 percent of its HIV treatment costs domestically and authors of the review predict that treatment will be the main driver of the escalating costs of the country's HIV/AIDS response.
In late 2009, the World Health Organization revised its HIV treatment guidelines to recommend that people living with HIV start treatment sooner, at CD4 counts - a measure of the immune system's strength - of 350 or below. Since then, South Africa has gradually fallen into line, first extending earlier treatment to at-risk groups, such as pregnant women and TB patients in 2010 and finally to all patients in 2011. While activists bemoaned the wait, policy-makers argued they had to make sure the country, which shoulders about 80 percent of its treatment costs domestically, could afford it.
As of March 2011, about 1.5 million people were on ARVs in South Africa. The review expects that number to rise to about three million by 2015.
Aurum acknowledges PlusNews as the source of this article
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GLOBAL FUND MONIES FINALLY RELEASED
22 February 2012 |
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Cape Town - More than seven months overdue, the Global Fund to fight AIDS, Tuberculosis and Malaria grant will finally be released to key South African AIDS organizations that have been struggling to survive. Some were on the verge of shutting down.
The Global Fund released US$7,106,426.91 to the South African National Treasury on 6 February, the same day seven of the grant's sub-recipients delivered an open letter to Minister of Health, Aaron Motsoaledi, pleading for intervention to bring the Fund's "life-threatening delays" to an end.
Signed by the�Treatment Action Campaign (TAC) and six other sub-recipients of the Fund's Round 6 HIV grant to South Africa, the letter warned of imminent closure of vital community-response programmes across South Africa, a country with one of the world's highest HIV burdens.
The payment, of which US$2,722,555 will be released this week to the sub-recipients, represents about half the total owed by the Global Fund to these community organizations for July-December 2011. It covers human resources only and no programmatic costs.
Funding crisis
The Fund cancelled its Round 11 funding last November after a funding crisis and allegations of corruption, and early this year executive director, Michel Kazatchkine, resigned. The new general manager, Gabriel Jaramillo, is expected to spearhead a reform process.
The South African sub-recipients of Round 6 funding would like to see some change. "Almost every tranche has been late since the beginning," said TAC treasurer Nathan Geffen. He said that when the July 2011 tranche failed to appear, TAC was initially unsurprised. However, as weeks and then months passed, the situation became untenable.
The blame game
"What has become patently clear is that the Global Fund systems are so complex that neither the Fund nor its principal recipient, the Department of Health, is able to manage the system properly," Geffen told IRIN/Plus News.
Organizations such as TAC, which deliver services on the ground, are not funded directly by the Global Fund. Instead it contracts with a single principal recipient, the health department, encouraging organizations from different sectors to work together.
In theory, this system should simplify administration. But with multiple organizations trying to meet complex reporting requirements, the result appears to have been additional complications that TAC says the health department is not adequately equipped to administer.
Complications
According to the�Global Fund Observer (an independent newsletter on the Global Fund produced by Aidspan), the situation was further complicated by the South African Country Coordinating Mechanism's (the implementing body for the grants, made up of government and local stakeholder organizations, including TAC) desire to consolidate the Round 6 grant with its Round 9 and new Round 10 funding, all of which would then be managed by the health department.
Thus the department and Fund embarked on implementing a "singe-stream-of-funding" negotiation, a process that took longer than expected and was not finalized until 15 December 2011.
"Yesterday, in a formal meeting, the Global Fund people admitted that the main reason for the delay was the attempt to consolidate the round 6, 9, and 10 grants into a single system," Geffen told IRIN/Plus News.
The Fund acknowledges that the single stream funding did slow the grant disbursement, but maintains the fault lay with the grantees. "The Single-Stream-of-Funding grant was delayed as the grant documents did not contain information requested by the Global Fund," Fund spokesperson Marcela Rojo told IRIN/Plus News by email.
Meanwhile, Minister Motsoaledi, who acts as chair of the Country Coordinating Mechanism, told IRIN/Plus News he was not "very sure" if the funding stream was the reason. "We are looking at what [caused] the delay, and we tried to correct everything that could have been wrong," Motsoaledi said.
David Garmaise, a senior analyst at Aidspan, told IRIN/Plus News that most people working on Global Fund programmes agreed that single stream funding was preferable, but that in practice, it was not easy to realize. "The Global Fund, as the agency pushing for this change, has a responsibility to ensure that the transition is handled smoothly, and that care, treatment, prevention and other services are not disrupted in the process," Garmaise said.
Under pressure
Regardless of who is at fault, services in South Africa have been disrupted, and the reality on the ground is grim. Nearly all the sub-recipients have dug deep into reserve funds. Furthermore, the ability to plan activities has been hamstrung.
One of the casualties of the delayed funds has been Soul City, an organization that uses mass media for public health. Soul City's HIV prevention radio programme, broadcast in nine languages across the country, has been scrapped for the time being. "It means that we're not reaching poorer, more rural people in their own languages.
There's a whole range of things we're having to do away with," said programme director Sue Goldstein.
Jack Lewis, director of the Community Media Trust (CMT), a fellow Round 6 sub-recipient, is concerned that the ultimate result of the collapse of programmes like Soul City's and CMT's own popular "edu-tainment" offerings, as well as major programmes such as TAC's treatment literacy campaign, will mean reversing gains in reducing new infections and increasing ART adherence.
"If all these programmes were to collapse, there's no doubt in my mind that there would be a negative impact on the reduction in new infections, which is the holy grail of HIV programmes. We'd also see a worsening of adherence. The need to maintain adherence through motivation versus policing is a vital component of these programmes, so you'd expect to see more problems with that, which means more people have to go on second-line treatment, which is more expensive and adds the possibility of the passing on of the resistant virus," Lewis said.
Meanwhile, the sub-recipients still do not know when they can expect the balance owed from 2011, or 2012's first payment. "I don't see any light at the end of the tunnel. After the meeting [with the Global Fund], we are feeling as hopeless as when we entered," said Geffen.
The Fund maintains that now that single stream funding is in place, recipients will see some change. "The Global Fund is working with the [primary recipient] to improve the quality of grant documents so that the disbursement processes can go more smoothly in the future," said Rojo.
Aurum acknowledges PlusNews as the source of this article
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THE AURUM KLERKSDORP LAB TEAM WINS THE MTN AWARD FOR THE BEST LAB IN THE MTN NETWORK
26 October 2011 |
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The Klerksdorp Laboratory has three staff members, Laboratory Manager, Laboratory Co-ordinator and Laboratory Technician.
The laboratory strives to be the most efficient lab, by adhering to high quality standards and meeting required deadlines. Laboratory staff are committed and dedicated to their work and go beyond the call of duty and teamwork being the most important aspect of the laboratory.
MTN 003 referred to as VOICE is a very challenging research project; research laboratory staff members are expected to work long hours.
With this project, stored samples are requested by the MTN Network laboratory for Regular Quality control and shipping purposes. Immediately when the request is received, the staff prepares samples and quality control is conducted to ensure that the correct samples are shipped. Once all shipping processes are completed, a designated courier is notified the intension to ship. This is normally carried out within 48hours of the initial request.
Because of the teams responsiveness they have been recognized by MTN as the most outstanding laboratory in responding to the sample requests.
Well done again on this wonderful achievement and for displaying the Aurum values of innovation, respect, teamwork, integrity and excellence in all you do.
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HONORARY LIFE MEMBERSHIP OF THE SOCIETY OF MEDICAL LABORATORY TECHNOLOGISTS AWARDED TO KENNETH REGINALD CLARKE
16 September 2011 |
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Ken was awarded Honorary Life Membership of the Society of Medical Laboratory Technologists at the recent Laboratory Medicine Congress in recognition of his contribution and services to the Society and to the profession of Medical Technology.
Award presentation
Certificate
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AURUM ON SAFM
July 2011 |
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Aurum Institute on the SAFm Radio on the monthly Aurum update.
Download audio file
Aurum acknowledges SAfm as the source of this Podcast
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ISONIAZID PROPHYLAXIS NOT LINKED WITH TB DISEASE-FREE SURVIVAL IN PEDIATRIC PATIENTS WITH HIV
11 July 2011 |
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Despite access to antiretroviral therapy and isoniazid prophylaxis, the burden of tuberculosis remained high among HIV-infected children in South Africa, and survival rates were relatively unaffected, according to a study published online this week.
Shabir A. Madhi, MD, PhD, of the University of the Witwatersrand in Johannesburg, South Africa, and colleagues randomly assigned 548 children with HIV and 804 infants who did not have the virus to isoniazid prophylaxis or a placebo for 96 weeks.
Nearly 99% of the children with HIV had access to ART and isoniazid prophylaxis, but there was no differences in the subsequent incident of TB or death, which occurred in "52 children in the isoniazid group and 53 in the placebo group (P=.93)."
The researchers reported similar trends among children who did not have HIV, with like rates of TB infection, TB disease or death between the isoniazid group (39 children) and the placebo group (45 children; P=.44).
The researchers reported that TB rates were 121 cases per 1,000 child-years in the group of children with HIV vs. 41 per 1,000 child-years in the group of children who did not have HIV.
Madhi and colleagues said their study findings may be limited because increased access to ART may have affected the epidemiology of TB in their study cohort, and increased research is needed into the epidemiology of TB.
"These findings underscore the need to explore alternative options for the prevention and management of TB in HIV-exposed children," they said.
In an accompanying editorial, Edward Nardell, MD, of the division of global health equity at Brigham and Women�s Hospital, and Gavin Churchyard, MD, of Harvard Medical School, called for better diagnosis and control of TB to boost survival rates.
"The risk of TB in young children... points to the need for better control of transmission in the community and in congregate settings, such as clinics, hospitals and prisons," they wrote. "This can best be achieved by intensified case finding, rapid diagnosis and prompt institution of effective therapy - fully supervised and based on rapid drug-susceptibility testing."
Disclosure: The study was funded by the NIH and Secure the Future, which is sponsored by Bristol-Myers Squibb.
Aurum acknowledges Pediatric Supersite as the source of this article
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SHORT REGIMEN EFFECTIVE FOR LATENT TB IN HIV PATIENTS
Michael Smith, 6 July 2011 |
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Short, intense treatment for latent tuberculosis may be the wave of the future for people also infected with HIV, researchers reported.
In a randomized controlled trial, two short, three-month regimens prevented active TB just as well as the standard six-month course of daily isoniazid (Nydrazid, Tubizid), according to Richard Chaisson, MD, of the Johns Hopkins University School of Medicine, and colleagues.
A fourth approach � daily isoniazid for up to six years � had similar outcomes, Chaisson and colleagues reported in the July 7 issue of the New England Journal of Medicine.
Disappointingly, however, a separate study in the journal found that using isoniazid to prevent TB in children had no effect, whether they were HIV-positive or not.
Taken together, the studies suggest that a cycle of continuing transmission and reinfection is likely to make large benefits from prevention strategies "elusive," according to Edward Nardell, MD, of Harvard Medical School, and Gavin Churchyard, MD, PhD, of the London School of Hygiene and Tropical Medicine.
In an accompanying editorial, Nardell and Churchyard argued that transmission and reinfection is a fundamental and not fully appreciated obstacle to effective TB prevention in high-prevalence settings.
Better control of transmission "can best be achieved by intensified case finding, rapid diagnosis, and prompt institution of effective therapy," they wrote.
In particular, new technology now allows a diagnosis within hours, which should speed up the treatment process, always assuming, they noted, "that treatment programs are in place."
Chaisson and colleagues, however, argued that shorter, easier-to-use regimens may have an impact, even if the rates of disease in this study were equivalent.
"Simpler regimens will substantially increase the number of people receiving therapy," Chaisson said in a statement.
In their study, Chaisson and colleagues enrolled 1,148 South Africans who had HIV and a positive tuberculin skin test in one of four treatment arms:
- Weekly rifapentine (Priftin) and isoniazid (both at 900 mg) for 12 weeks
- Rifampin (Rifadin, Rimactane) and isoniazid (600 and 900 mg) twice a week for 12 weeks
- Isoniazid daily at 300 mg for up to six years
- Or standard therapy with isoniazid at 300 mg a day for six months � the control group
Patients in the study could not be on antiretroviral therapy because the rifamycins � rifapentine and rifampin � break down protease inhibitors in the liver, making them less effective as HIV treatment. However, other types of anti-HIV drugs are compatible with the rifamycins, the researchers noted.
Patients in the trial were adults, with a median age of 30, and had an average CD4-positive T-cell count of 484 per cubic millimeter. The primary outcome of the trial was tuberculosis-free survival.
After a median follow-up of about four years, with slight differences among the arms, the researchers found the incidence of active TB was not significantly different regardless of therapeutic strategy.
Specifically, the rate of active TB per 100 person-years was:
- 3.1 in the rifapentine-isoniazid group
- 2.9 in the rifampin-isoniazid group
- 2.7 in the continuous-isoniazid group
- And 3.6 in the control group.
Adverse events in the three experimental arms were also not significantly different from those seen in the control arm, Chaisson and colleagues reported.
The study in children randomly assigned 548 HIV-positive and 804 HIV-negative infants � ages 91 to 120 days -- to isoniazid at 10 to 20 mg per kilogram of body weight per day or to a matching placebo for 96 weeks, according to Shabir Madhi, MD, PhD, of the Respiratory and Meningeal Pathogens Research Unit in Bertsham, South Africa, and colleagues.
The primary outcome of the study was active TB and death in HIV-infected children and latent TB infection, active TB, and death in HIV-uninfected children within 96 to 108 weeks of randomization, Madhi and colleagues reported.
Most of the HIV-positive children � some 98.9% -- started antiretroviral therapy during the study, they reported. All children were given the bacille Calmette-Gu�rin vaccine against TB within 30 days of birth.
Isoniazid has been shown to prevent progression to active TB in children who were in contact with people with infectious tuberculosis, the researchers noted, but it has not been tested as pre-exposure prophylaxis.
Disappointingly, it did not appear to work, Madhi and colleagues reported:
- In the HIV-positive children, TB disease or death occurred in 52 children in the isoniazid group and 53 in the placebo group. The difference -- 19% versus 19.3% -- was not significant.
- Among HIV-uninfected children, 39 children in the isoniazid group and 45 in the placebo group met the combined endpoint of TB infection, TB disease, or death. The difference � 10% versus 11% -- was again not significant.
- The incidence of TB was 121 cases per 1,000 child-years among the HIV-positive children, compared with 41 per 1,000 child-years in the HIV-uninfected children. The 95% confidence intervals did not overlap.
- There were no significant differences in clinical or severe laboratory toxic effects.
Aurum acknowledges MedPage Today as the source of this article
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