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Aurum in the news
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A MARRIAGE MADE IN HELL: HIV/TB CO-INFECTION
21 July 2010 |
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"Slow, timid, and uncoordinated." Those were the words Tony Harries, Senior Adviser to the International Union Against Tuberculosis and Lung Disease, used to describe the response to deadly HIV/TB co-infection, with its 40 percent mortality. Harries opened the session of TB and HV Management in High-Prevalence Settings Wednesday morning at the 18th International AIDS Conference.
Lucy Chesire, a TB/HIV advocate from Kenya, identified poverty and HIV infection as the two drivers of co-infection in her country. She also outlined key benefits of HIV/TB service integration: providing patients a continuum of care and services, reducing mortality and morbidity, sustaining life long enough for patients to access antiretroviral therapy (ART), and providing an opportunity to prevent TB in HIV-infected individuals by initiating Isoniazid Preventive Therapy (IPT). She noted that the failure to engage communities in the fight against HIV/TB has contributed to the double stigma associated with having both diseases. Chesire added that it was a missed opportunity to increase peer support and accelerate advocacy for better TB tools and more patient-friendly and effective programs.
MSF (or Doctors Without Borders) physician Gilles Van Cutsen offered a field perspective by highlighting elements of effective MSF HIV/TB programs in South Africa and Lesotho, where HIV and TB program integration had produced quicker and more effective identification of TB, especially the “smear-negative” and extra-pulmonary TB more common in persons with HIV. As a result, treatment for both diseases is initiated more quickly, resulting in better patient outcomes. Stronger infection control measures, including enhanced ventilation and patient education, are key to program integration. Separate HIV and TB administrative structures continue to present challenges at the clinic level with the separate and different reporting requirements from the HIV and TB programs.
Gavin Churchyard from the Arum Institute outlined recent scientific advances in TB/HIV co-infection including studies that show a clear complementary advantage for initiating IPT in HIV patients without active TB for at least 36 months, to a screening algorithm that effectively identifies TB disease in most patients. He called for the scale up of ART with IPT and TB treatment to realize the benefits of this scientific knowledge in lives saved. He also acknowledged an effective point of care diagnostic device, Cephied Genexpert, but indicated that the cost was currently prohibitive.
Kevin DeCock, director of CDC’s Office of Global Health, offered a policy perspective and said that sound policy should be based on data, but also that evidence-based policies should be seen as a human right. Not only should policy be informed by evidence, but policy should also stimulate the search for evidence.
DeCock also warned that there could be unintended negative consequences to service integration including an erosion of technical quality and capabilities and the loss of accountability. TB programs are much better on monitoring and documenting outcomes than HIV programs, and it is important that this not be eroded in integration efforts. A one-size fits all programmatic response to HIV/TB co-infection will never be appropriate given the variability in prevalence across locales. Notwithstanding the huge burden of HIV/TB co-infection in sub-Saharan Africa, most persons with TB are not HIV- infected and the integrity and quality of TB control programs must be preserved.
He identified the questions of how to use IPT and ART most effectively in the context of HIV/TB co-infection as critical field questions.
Aurum acknowledges Science Speaks: HIV & TB News as the source of this article
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SIGNATURE MAPPING TBDX(TM) DEMONSTRATES POSITIVE RESULTS
21 June 2010 |
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Guardian Technologies International, Inc. (GDTI 0.36, +0.06, +20.00%), today announced that testing of the fully automated tuberculosis (TB) detection system, Signature Mapping TBDx(TM) (SM TBDx), at the South African National Health Laboratories (NHLS) successfully validated the integrated performance of each hardware component of the automated slide management system. The integrated hardware-software TB detection solution accurately identified 100% of the TB slides processed during an abbreviated trial that was delayed due to shipping and customs issues beyond Guardian's control.
In scheduling the clinical trial Guardian was well aware of the tight timeframe, which afforded no margin of delay due to the fact that critical South African personnel were scheduled to attend a weeklong national TB conference at the conclusion of our scheduled time, as well as other logistical challenges associated with the World Cup Games. Based on SM TBDx's speed of diagnosis and strong performance, a consensus was reached by South Africa's top TB experts on a new strategy to expand the scope of the clinical trial protocols to more fully understand and empirically demonstrate the full potential of the new integrated technology. The intent is to measure and demonstrate an even greater level of routine production sensitivity that would translate into the detection of more TB scanty cases, a major area of missed diagnosis responsible for increased incidence of disease.
The urgency to complete the clinical trial of SM TBDx was further amplified by a newly announced aggressive HIV/TB population screening program of an additional 15 million citizens by June 2011, approximately 30% of the population of South Africa. To address the urgency of the situation and to avoid the potential delays of adhering to strict governmental procurement processes, decisions were reached to employ an alternative contracting vehicle to expedite deployment.
Dr Gavin Churchyard, Chairman of The Aurum Institute, states, "Signature Mapping TBDx is an exciting new technology that enhances sputum smear microscopy for TB by combining automated slide management and computer detection of the TB bacillus. This technology breakthrough provides for the first time, the opportunity to more thoroughly analyze sputum smear samples to find TB, particularly in the earlier stages of disease when the number of bacilli present on the slide are fewer and may be missed with conventional microscopy. Finding and treating patients earlier will help reduce the spread of the disease, while automating the screening process will provide fast and consistent results. TBDx holds the promise to screen large numbers of TB suspects in a cost-effective manner, find more cases of TB and to reduce the TB burden in resource poor settings."
"As South Africa prepares to expand HIV and TB screening to an additional 15 million people, the urgency to complete the trial and negotiate a business contract is that much more vital. Collectively we have agreed to a contract framework to support a maximum rollout, in a minimum amount of time," commented Dr Dave Clark, Deputy Chief Executive Officer of the Aurum Institute. "The keys to success are a government procurement vehicle that expedites the purchasing process, and securing a financial partner to fund the acquisition of the required hardware procurement. As Guardian's newly appointed Reseller/Distributor, we believe that both goals have been met and we expect to execute the financing agreements over the next two months."
The collective judgment of the interested parties was that the clinical trial protocols should be expanded beyond the current plan to include comparative data, as follows:
- human expert readers under research conditions
- human laboratory technologists reading under routine conditions
- SM TBDx (at 100 fields of view per slide, the WHO accepted guidelines)
- SM TBDx (500-1,000 fields of view per slide)
- culture (considered the gold standard)
The rationale for expanding the trials to include 500-1,000 fields of view per slide was the ability to conduct a more thorough analysis of the sputum smear and the potential implications for higher sensitivity and more rapid TB detection and verification than the six to eight weeks required for culture. Such a study is only possible because of the speed with which SM TBDx can process and diagnose a sputum slide. Every effort will be made to keep the clinical trial moving expeditiously and to mitigate potential problems such as shipping and customs delays or access to replacement hardware inventories. The parties have agreed that the TBDx trial should be moved to the United States and be conducted under independent observer validation. The selection of the independent observer, the dates to recommence the trials, and the protocols are being coordinated by the Aurum Institute and NHLS to facilitate an unbiased comprehensive trial. It is anticipated that the recommencement will begin by July 19th.
"The new clinical protocols will establish higher standards of scientific credibility that will lead to greater international acceptance of SM TBDx. Further, when combined with the procurement and funding vehicles arranged by Aurum, the enhanced clinical trial should accelerate governmental approvals, drive increased revenue, and faster rollout throughout South Africa," stated Bill Donovan, Guardian's President. "The need for SM TBDx is present and growing. We intend to make a considerable positive impact on South African TB detection beginning in 2010."
For additional information about our activities in South Africa, please click on the following link: PDF - http://www.guardiantechintl.com/pdfs/Q_A_South Africa Press Release.pdf
Please click below to hear a radio interview with Dr Dave Clark: Mp3 - http://www.guardiantechintl.com/multimedia/Aurum - June.mp3
About SM TBDx: In the first phase of clinical trials in Oct 2009, SM TBDx achieved 92% detection sensitivity and 3.75% false positive rate. The SM TBDx solution combines Guardian's highly sensitive and specific image analysis software with an automated slide loader capable of processing 200 slides without human intervention, a bar code reader, an automated microscope stage navigator to process the slide through the capture of 100 fields of view (FOV), and an auto-focus camera to digitally capture each FOV. SM TBDx Manages and synchronizes the hardware components for hands-free slide acquisition and TB detection analysis. A video of the TBDx automated solution is available at the following link: http://www.youtube.com/watch?v=IiDub_QXVTw
About Guardian Technologies International: Guardian Technologies uses high-performance imaging technologies and advanced analytics to create integrated information management products and services. Currently, the company offers products and services for use in disease detection and airport security. By automating the processing of large quantities of graphic, numeric, and textual data, Guardian allows organizations to more efficiently detect, extract, analyze or effectively act upon the information. Guardian's solutions are designed to improve the quality and speed of decision-making and enhance organizational productivity and accuracy. Founded in 2003, Guardian is publicly traded on Nasdaq as GDTI. For more information visit www.GuardianTechIntl.com
Safe Harbor statement under the Private Securities Litigation Reform Act of 1995:
Statements in this news release looking forward in time involve risks and uncertainties, including the risks associated with the effect of changing economic conditions, trends in the markets, variations in the company's cash flow, competition, celebrity programs, business development efforts, technology availability and cost of materials and other risk factors. Factors that could cause actual results to differ materially are discussed in the Company's most recent filings with the Securities and Exchange Commission.
Aurum acknowledges MarketWatch as the source of this article
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DR DAVE CLARK ON SAFM ON TBDX
15 June 2010 |
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Dr Dave Clark, Deputy CEO of the Aurum Institute represented Aurum on SAfm on TBDx Tuesday evening.
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Aurum acknowledges SAfm as the source of this Podcast
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SOUTH AFRICAN GOLD MINES A 'TB FACTORY', ACTIVIST CLAIMS
10 June 2010 |
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The gold mining sector came under heavy criticism from clinicians, ex-miners, advocacy groups and the Minister of Health for the tuberculosis crisis it faces at the recent South African TB Conference, held in Durban from 1 to 4 June 2010.
“If TB/HIV is a snake in Southern Africa, we know that its head is in South Africa in the mines. We are exporting TB and HIV throughout the region,” stated the South African Minister of Health, Dr Aaron Motsoaledi during the conference’s opening plenary.
Paula Akugizibwe of the Aids and Rights Alliance for Southern Africa (ARASA) stressed that the mining sector, which she referred to as a ‘TB factory’, was over a century behind schedule in its response toTB.
The South African Chamber of Mines, along with medical officers from the largest mining houses, such as AngloPlatinum and Goldfields described the best practice interventions and guidelines that have been developed and implemented in the mining sector, at a symposium on TB in the mining industry hosted by the Chamber of Mines at the conference.
Why is there a TB problem in South Africa’s mines?
Mineworkers are at increased risk for developing TB as poorly ventilated conditions in the mines and hostels increase the risk of transmission. Silica dust increases the risk of developing TB. Migration back and forth between home and mine reduces the likelihood of diagnosis and increases the chance of treatment interruption and failure. Health care for mine workers is often poor and TB screening by employers is inconsistent and unverified, as outlined in a study published last week by researchers from Oxford University and the London School of Hygiene and Tropical Medicine.
Interventions by the mining sector outlined at the symposium included the production of resources which outline the responsibilities of mining houses to address TB, such as the Safety in Mines Research Advisory Committee Handbook of Occupational Health and the Department of Mineral Resources (DMR) Guidance Note for TB Control produced in 2001.
A TB Review Tool which audits TB programmes in mines has also been established.
There are also efforts to provide isoniazid preventive treatment (IPT) to all HIV-positive miners and a Dust Team to address silicosis in the gold mines has been instituted, through the Mine Industry Occupational Safety and Health (MOSH) Best Practice Adoption System which aims to facilitate widespread adoption of knowledge, technology and practice in order to improve health and safety performance in South African mines.
Additional efforts are also being made to address the risk factors that place mineworkers at increased risk for developing TB,such as phasing out the hostels where mineworkers live in overcrowded conditions. ‘Living out allowances’ to support mineworkers living outside of hostels are being paid and financial support for home ownership is being made available.
However, activists and clinicians presenting at the session questioned if these interventions were enough.
‘If we look at the response relative to the magnitude of the problem of TB and HIV in the mines, the mining industry is driving a wooden wagon of circa 1903,’ stated Akugizibwe.
In 1903, the Milner Commission set up to look into the problem of TB in the mines stated that ‘The extent to which Miners’ Phthisis [TB] prevails at the present time is so great that preventive measures are an urgent necessity.’
The South African Gold Mining Industry may well have the highest incidence of TB in the world, with cases ranging from 3000 to 7000 per 100 000 miners per year, according to the South African Department of Health Tuberculosis Strategic Plan for South Africa 2007 – 2011.
Nationally, the overall TB incidence is estimated to be 920 per 100 000 for 2008 according to the World Health Organisation, which declares it a health emergency when the TB incidence of a country is 250 per 100 000 per year.
Silicosis (an occupational disease caused by inhaling dust from gold production) is very rare in most developed countries, but is widespread among miners in South Africa and other developing countries.
The association between silicosis and tuberculosis has long been recognised. Rates for active tuberculosis in silicotic subjects are 2- to 30-fold higher than those in the same workforce without silicosis, according to a review published by Jill Murray of the National Institute for Occupational Health in South Africa. The risks of silicosis and HIV infection exponentially increase the risks of TB in gold mineworkers.
In 2003 the South African mining sector launched an initiative to eliminate silicosis and developed targets for silica dust reduction.
However, Professor Gavin Churchyard of the Aurum Institute pointed out that the elimination of silicosis would require dust levels to be at least 50% lower than the targets that have been set by the sector. According to Goldfields, there were 1778 new cases of silicosis in 2009 among the company’s employees.
Compensation
According to ARASA, the compensation system for mine workers is rife with legal and policy challenges, including the fact that miner workers get worse TB compensation than other workers. A former mine worker from Lesotho who attended the conference said that after contracting TB in 2007 he was dismissed. He has since had to make several taxing and costly trips between Maseru and Johannesburg (approximately 350km apart) in his efforts to secure the compensation to which he is legally entitled, but is yet to receive.
A 2005 audit by Deloitte found that the Compensation Fund was insolvent and that mining companies’ levies (paid by companies to the Compensation Fund due to the occupational risks for developing TB in the mining sector) would need to be substantially increased in order to cover the deficit. Over the 21-month period during which the audit was conducted, only 400 of the 28,000 (1.4%) claims submitted were paid out.
Currently, the burden of responsibility for this shortfall is being shifted between different government departments and the mining sector, and disagreements between the Chamber of Mines and the Department of Health about who should be held responsible for correcting the compensation fund’s deficit have resulted in a court case that will be heard later this year.
However, Mr. Eric Gclilitshana, the National Union of Mineworkers’ National Secretary for Health and Safety warned that the union would not support litigation against the mining houses, because experience has shown that “litigation does not benefit the ex-mine worker, as all the funds go to the lawyer’s fees”.
Lynette Mabote from ARASA expressed concern about this view, saying that “former mineworkers, whose labour built [the South African] economy, have been left to the mercy of a system that was historically designed to maximise exploitation and impunity.”
Prof. Churchyard added that greater accountability was necessary. “When deaths are caused due to mining accidents, companies are held to account. No one is held accountable for the deaths caused by TB in the mining industry. This is an unprecedented public health disaster and urgent action is needed.”
Aurum acknowledges aidsmap news as the source of this article
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AURUM TB CLINIC AT TEMBISA HOSPITAL ON TELEVISION PROGRAMME 'SHIFT'
May 2010 |
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Tuberculosis (TB) is the world’s second deadliest infectious disease, after HIV, with nearly 9.3 million new cases diagnosed worldwide in 2007. Tuberculosis is also the leading cause of death for people living with HIV/AIDS.
In Tembisa, the Aurum Institute has established a TB Research Clinic where alternative and new TB treatments that take shorter amounts of time to complete are being studied. TB usually takes 6-9 months to treat successfully and sometimes people stop their treatment early because they start feeling better. This is very dangerous though, because the TB bacterium is still present in the body and can then become resistant to the antibiotics.
The first study to be conducted at the site is called the Rifaquin study. Working with Tembisa Hospital and the Department of Health, the Aurum TB Research Clinic has enrolled 141 participants in the Rifaquin study so far.
Recently, the popular SABC1 daytime television talk show "Shift" visited the Aurum TB Research Clinic at Tembisa Hospital to learn more about TB and produce a segment for their World TB Day programme which aired on 24 March (World TB Day). A participant of the study, Ms Zandile Voyiya was very happy to speak about her experience. 'When I first came here I was very, very sick. Nobody thought I would actually live. But these people welcomed me, and I volunteered to be a part of the study. I visit every week and these people are now like family. And I am so well! I have less than a month left of treatment and I am so happy," says the vivacious Voyiya.
The Aurum Institute is an internationally-recognised, South African-led specialist research and health systems management organization with a focus on improving health in individuals and communities through innovation in TB and HIV prevention, treatment and care. Aurum is based in Johannesburg with branches in North West, Gauteng, Limpopo and Free State provinces of South Africa. It operates in collaboration with the government and other stakeholders to attract much needed funds to pursue its goal of seeing an end to TB in South Africa.
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Aurum acknowledges Isithembiso as the source of this article
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REDUCING MORTALITY WITH COTRIMOXAZOLE PREVENTIVE THERAPY AT INITIATION OF ANTIRETROVIRAL THERAPY IN SOUTH AFRICA
21 May 2010 |
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Objective: To assess the effectiveness of cotrimoxazole preventive therapy (CPT) among individuals with CD4 cell count above 200 cells/[mu]l and varying WHO clinical stages in reducing mortality during combination antiretroviral therapy (cART).
Design: A cohort study.
Methods: Using proportional hazards modeling, we compared mortality during the first 12 months after cART initiation among patients receiving CPT with patients not receiving CPT. We adjusted for clinic level confounding throughout.
Results: We included 14 097 patients starting cART between January 2003 and January 2008, 62% of whom were men, the median CD4 cell count was 132 cells/[mu]l, and 1289 died (11%). The baseline median CD4 cell count was lower (118 vs. 153 cells/[mu]l) among the 7508 patients who received CPT compared with the 6589 patients who did not. In adjusted multivariate modeling, stratifying for baseline CD4 cell count and WHO stage, CPT reduced mortality overall (hazard ratio 0.64, P < 0.001) and for all individuals with CD4 cell count below 200 cells/[mu]l or WHO clinical stage 3 or 4 conditions but did not reduce mortality for patients with both CD4 cell count above 200 cells/[mu]l and WHO clinical stage 1 or 2.
Conclusion: We demonstrated a 36% reduction in mortality extending to patients associated with CPT when used with cART that extended to patients with CD4 cell count above 350 cells/[mu]l in a setting with minimal malaria and high rates of cotrimoxazole-resistant bacteria. This provides important additional data toward efforts to increase CPT provision among all cART initiators in resource limited settings.
Aurum acknowledges AIDS: Official journal of the international AIDS society as the source of this article
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BULELANI KUWANE ON SAFM'S HEALTH MATTERS PROGRAMME
18 May 2010 |
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Deputy Director: Emthonjeni SME Programme, Bulelani Kuwane, has an interview with Karen Key - Health Matters Programme on SAfm
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Aurum acknowledges SAfm as the source of this Podcast
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BULELANI KUWANE REPRESENTING THE AURUM INSTITUTE ON "HEALTH MATTERS" ON SAFM
17 May 2010 |
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Bulelani Kuwane, Deputy Director: Emthonjeni SME Programme will be representing the Aurum Institute on:
Date: Tuesday 18th May 2010
Time: 21h05 to 22h00
Radio Station: SAfm(104 – 107fm)
Programme: Health Matters
Read Bulelani's Biosketch on the Aurum Website - http://www.auruminstitute.org/staff.php?p_id=24
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SUB-SAHARAN AFRICA NEWS IN BRIEF
5 May 2010 |
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Below is a roundup of news from or about Sub-Saharan Africa for the period 22 April - 5 May 2010
New seed institute for Nairobi
Kenya's University of Nairobi will join forces with the US-based Iowa State University to establish an African seed institute in Kenya. The institute will aim to boost food security through capacity building across the continent, where seed supply chains "are lacking or inadequate". It will also provide seed training to graduate students and support the production of improved seed varieties. The project is funded by the Alliance for a Green Revolution in Africa.
Ream more...
Guinea telecommunications industry thriving
Guinea's telecommunications industry is on the rise, with mobile phone and Internet access extending outside of the country's capital and two deals signed with London-based telecommunications company Gateway Communications. Currently mobile phone penetration is just over 20 per cent but new investments are expected to boost this figure. The country's telecommunication market is growing increasingly vibrant, said Mike van den Bergh, a CEO at Gateway.
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Climate models to predict African disease outbreaks
African and European researchers are teaming up to use climate models for predicting disease outbreaks in Ghana, Malawi and Senegal. The project - which will involve 13 institutes in the two regions, and integrate data from climate modelling and disease forecasting systems - hopes to give decision-makers sufficient time to establish intervention methods and prevent large-scale transmission of diseases such as malaria.
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South African innovation takes a leap forward
Recyclable paper calculators may one day become a reality thanks to nanotechnology research at the University of Cape Town (UCT). UCT professors have spent the last seven years investigating the use of silicon nanoparticles in ink. Research shows it might be possible to 'screen-print' semiconductors onto materials such as paper.
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Namibia government for new approach to climate change impacts
The Namibian government has announced that it will boost the Ministry of Environment's capacity to better tackle the impacts of climate change on the country. It hopes to put new structures in place to replace the ill-functioning climate change committee with a more robust approach. A one-day workshop will be organized to brief ministers on the topic and update them on developments since December's conference in Copenhagen.
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Computers for Ugandan school children
Uganda pupils in government-aided schools will begin using computers as part of a scheme to boost education quality in the country. Laptops will be provided to schools by the One Laptop per Child scheme. Rukutana Mwesigwa, the education state minister, said the computers "would increase pupils' capacity to learn quickly and sharpen their minds".
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Phase II clinical trials for TB vaccine begin
Phase II clinical trials of a candidate vaccine for tuberculosis (TB) have begun in South African HIV-infected adults. The trials are testing the safety and efficacy of the vaccine - known as AERAS-402/Crucell Ad35 - in adults affected with HIV. They are being conducted by the Aurum Institute in Klerksdorp.
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New technical manual to inform genetic mapping
A new technical manual could help researchers in developing countries understand the process behind mapping the genetic diversity of tropical trees. By understanding this process, the Nairobi based World Agroforestry Centre said, it will be easy for researchers to monitor the genetic diversity of trees found in tropical forests, which often leads to inbreeding.
Ream more...
Aurum acknowledges SciDev Net as the source of this article
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TB: NEW STUDY USES OLD APPROACH
30 April 2010, Mara Kardas-Nelson |
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Researchers from South Africa’s Aurum Institute, a health research facility, are spearheading a study to test whether widespread preventative use of the anti-tuberculosis (TB) drug, isoniazid, could dramatically reduce TB rates on a community-wide scale.
In partnership with three government departments, three major gold mining companies and mining unions, researchers from Aurum, the London School of Hygiene and Tropical Medicine (LSHTM) and Johns Hopkins University in the United States are offering isoniazid preventative treatment (IPT) to nearly 70 000 gold miners in South Africa.
Isoniazid is one of the main ingredients in first-line anti-tuberculosis drugs. IPT usually consists of a daily dose of medication for six to nine months for those vulnerable to, but not currently infected with, TB to prevent infection.
The project, called Thibela TB, is based on a study done in the 1950s among native Alaskans. During the first half of the 20th century the northern US state faced epidemic proportions of TB, with 15% of the total population infected and 90% of all children testing tuberculin positive by the age of six.
The state’s native Inuit were most affected: TB deaths within that population were the highest recorded. In response researchers developed the first community-wide IPT, or CW-IPT, administering the drug to all Inuit who did not have active TB. The results were astounding.
In just five years TB was reduced by almost 70%, with the bacterium nearly eradicated just two decades later. In South Africa IPT is primarily used for people living with HIV. It can reduce TB rates in HIV-positive people by 25%.
TB is the leading cause of death in developing countries for those living with the virus. Gavin Churchyard of the Aurum Institute proposed expanding IPT access after witnessing high rates of occupational TB among South Africa’s gold miners, who are especially susceptible to infection because of the dual epidemics of silicosis, a lung condition that results from silicosis dust released during gold mining, and HIV. While the adult HIV prevalence in South Africa sits at 18%, 30% of miners have the virus.
The impact of the two syndromes together is “multiplicative”, according to Churchyard, resulting in astronomical rates of TB: 89% of the population have latent TB and each year the disease becomes active in more than 4% of those.
Recognising the need to do something “drastic and radical” to stem the epidemic, researchers considered possible interventions.
According to Alison Grant of the LSHTM, a lead researcher on the study, a mathematical model done in 2000 “used existing data from the mines to look at what type of intervention would make a difference and [replicating the Alaska study] was the only one that really showed rapid change”.
Rather than using IPT on an individual level as is currently done, “we want to show that within a setting with HIV and high TB transmission, we can get a population level reduction of TB risk”, says Churchyard. The study breaks miners into an intervention arm and a control arm.
The control arm continues with the mine standard of care TB model, which researchers consider to be of “exceptional international standard”, while the intervention arm additionally offers IPT to any miner who does not have active TB.
Miners take IPT for nine months, with follow- ups continuing for two years to monitor preventative effects. Expectations for the programme are high.
Modelling predicted that the preventative effects would last for 10 years. Churchyard says that recent data suggests the impact could be sustained for much longer. Researchers are hoping for a 60% reduction in the burden of TB within the study’s population.
The study is now in its fourth year and final results regarding efficacy are expected some time in 2012. Preliminary results show a positive response by miners to the programme, with an uptake and retention of 80% in the last few clusters.
The programme also demonstrates the low risk of drug-resistant tuberculosis as a result of IPT, a fear that has impeded scaling up the therapy. Still, the long-term impact is far from understood. There are significant differences between the Alaskan setting of the 1950s and the South African one today.
While the former focused on TB prevention within homes, the Aurum study is broadening the population to include mines in several parts of South Africa. The Aurum study must also contend with HIV, non-existent in the 1950s, and a highly mobile population.
Recent studies have suggested that for those living with HIV, the effects of IPT may last only six months. Even if TB rates among miners were reduced, they could be infected when visiting communities not involved in the intervention.
To have a large impact, treatment may need to continue for longer or be repeated every few years and mining communities, as well as miners themselves, could need to undertake similar programmes.
Researchers hope this study will pave the way for CW-IPT that would reach the general population. There has been a request from the miners to extend the programme to their families, says Churchyard.
“They say ‘Thibela is good for us, but what about our families?’ We need to make a strong case that this works first and then we can look at expanding it. “It is our hope that it is spectacularly successful,” says Churchyard, “but at the end of the day it is a trial.”
Aurum acknowledges Mail & Guardian Online as the source of this article
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DR FAZEL RANDERA ON SAFM'S "AFTER 8 DEBATE"
29 April 2010 |
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Dr Fazel Randera of the Aurum Institute joined other panellists on SAfm’s popular “After 8 Debate” programme on 29 April, to discuss the Government’s campaign to test 15 million South Africans for HIV. Also on the panel were Thobile Mbengashe from the National Ministry of Health and a spokesperson from the Treatment Action Campaign. In the one hour programme, many calls from listeners were taken and questions fielded by the panel. The debate largely centered around the feasibility and rollout of the plan, as well as ethical and medical - related questions from callers.
Aurum acknowledges SAfm as the source of this Podcast
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DR DAVE CLARK REPRESENTED AURUM ON SAFM
20 April 2010 |
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Dr Dave Clark, Deputy CEO of the Aurum Institute represented Aurum on SAfm on the 20th April 2010.
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Aurum acknowledges SAfm as the source of this Podcast
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AERAS AND CRUCELL ANNOUNCE START OF PHASE II TB STUDY IN SOUTH AFRICA
14 April 2010 |
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Dutch biopharmaceutical company Crucell N.V. (NYSE Euronext, NASDAQ: CRXL) (SWISS: CRX) and the Aeras Global TB Vaccine Foundation today announced the start of a Phase II clinical trial of the jointly developed tuberculosis (TB) vaccine candidate AERAS-402/Crucell Ad35 in HIV infected adults.
The Phase II study is designed to test the safety and efficacy of AERAS-402/Crucell Ad35 in adults infected with HIV and will be conducted by the Aurum Institute in Klerksdorp, South Africa. All Aeras-sponsored TB vaccine candidates have been or will be tested for safety in people living with HIV. Among people living with HIV in Africa and Asia, TB is a leading cause of death. People with HIV living in countries with high TB prevalence are 20 times more likely to develop TB than those who are HIV-negative. According to the World Health Organization's (WHO) 2009 TB surveillance report, one in four TB deaths globally is HIV-related, twice as many as previously recognized. In 2007, there were an estimated 1.4 million new cases of TB among people living with HIV and 456 000 deaths. Seventy-one percent of people with TB in South Africa are co-infected with HIV.
"With the support of Crucell's innovative technologies, we are on a joint mission with Aeras to develop a next generation vaccine against TB," said Dr Jaap Goudsmit, Crucell's Chief Scientific Officer. "As there are many potential uses of the new TB vaccine, it is crucial to test the safety and immune responses in those who have been infected with HIV. That is why we are extremely pleased with the initiation of this Phase II study, an important next step towards our ambition of reducing the global burden of this fatal disease."
Enrollment of study volunteers for the first stage of the Phase II trial has started. This is the first study testing the AERAS-402/Crucell Ad35 TB vaccine candidate among this study population.
In 2004, Aeras and Crucell began jointly developing this vaccine candidate using Crucell's AdVac®vaccine technology and PER.C6® manufacturing technology. Data from all AERAS-402/Crucell Ad35 trials support the immunogenicity and acceptable safety profile of the TB vaccine candidate at all dose levels evaluated.
AERAS-402/Crucell Ad35 trials
In October 2008, the first Phase II study in adults who have had active TB started in South Africa. In this ongoing study, AERAS-402 has demonstrated an acceptable safety profile. Preliminary data indicate that the candidate vaccine induces CD8-cell immune responses in patients who have completed TB treatment.
To date, seven Phase I studies have been conducted in populations including healthy adults and infants and adult tuberculosis patients:
- A trial in healthy adults not previously immunized with Bacille Calmette-Guérin (BCG), the traditional TB vaccine, demonstrated that the candidate vaccine had an acceptable safety profile in this population.
- A South African study showed CD8 T cell immune responses that are much higher than those seen in humans in any previous TB vaccine study.
- US studies in healthy adults, focusing on the immunogenicity and safety of two boost doses after BCG priming, showed that two injections of the candidate vaccine are immunogenic, with an acceptable safety profile, when used in combination with a BCG prime, regardless of the boosting interval. This immune response is greater than that detected in the absence of BCG prime, supporting the possible utility of AERAS-402/Crucell Ad35 as a booster vaccine. BCG prime alone shows limited efficacy.
- Testing of the candidate vaccine's safety in BCG-vaccinated adults with or without latent TB has been completed in Kenya, with ongoing analysis. The vaccine had an acceptable safety profile in this study.
- A trial in South Africa is testing the safety of the candidate vaccine in infants previously vaccinated with BCG vaccine. The study is fully enrolled and dosing is ongoing. To date, the vaccine appears to have an acceptable safety profile in this study.
- Currently a US trial has started for more detailed analysis of the immune response to AERAS-402/Crucell Ad35, using a known immunogenic regimen of BCG and the candidate vaccine in healthy adults, followed by collection of large numbers of immune cells.
About Tuberculosis
Tuberculosis is the world's second deadliest infectious disease, with nearly 9.3 million new cases diagnosed in 2007. According to the WHO, an estimated 1.8 million people died from TB in 2007. One-third of the world's population has been infected with the TB bacillus and current treatment takes 6-9 months. The current TB vaccine, Bacille Calmette-Guérin (BCG), developed over 85 years ago, reduces the risk of severe forms of TB in early childhood but is not very effective in preventing pulmonary TB in adolescents and adults - the populations with the highest rates of TB disease. TB is changing and evolving, making new vaccines more crucial for controlling the pandemic. Tuberculosis is now the leading cause of death for people living with HIV/AIDS, particularly in Africa. Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) are hampering treatment and control efforts.
About AdVac® technology and Ad35
AdVac® technology is a vaccine technology developed by Crucell and is considered to play an important role in the fight against emerging and reemerging infectious diseases, and in biodefense. The technology supports the practice of inserting genetic material from the disease-causing virus or parasite into a 'vehicle' called a vector, which then delivers the immunogenic material directly to the immune system. Most vectors are based on an adenovirus, such as the virus that causes the common cold. The AdVac® technology is specifically designed to manage the problem of preexisting immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-scale production capabilities or the immunogenic properties of Ad5. AdVac® technology is based on adenoviruses that do not regularly occur in the human population, such as Ad35. In contrast to for instance Ad35 antibodies, antibodies to Ad5 are widespread among people of all ages and are known to lower the immune response to Ad5-based vaccines, thereby impairing the efficacy of these vaccines. All vaccine candidates based on AdVac® are produced using Crucell's PER.C6® production technology.
About PER.C6® technology
Crucell's PER.C6® technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines. The production scale potential of the PER.C6® cell line has been demonstrated in an unprecedented successful bioreactor run of 20,000 liters. Compared to conventional production technologies, the strengths of the PER.C6® technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions. These characteristics, combined with its ability to support the growth of both human and animal viruses, make PER.C6® technology the biopharmaceutical production technology of choice for Crucell's current and potential pharmaceutical and biotechnology partners.
About Aeras
The Aeras Global TB Vaccine Foundation is a non-profit product development partnership dedicated to the development of effective TB vaccine regimens that will prevent tuberculosis in all age groups and will be affordable, available and adopted worldwide. Aeras partners with academic, biotechnology, pharmaceutical research institutes throughout the world to ensure rapid development and ample vaccine distribution to eliminate TB. Aeras receives funding from foundations and government aid agencies and has six TB vaccine candidates in its product development pipeline. It operates from its headquarters in Rockville, Maryland, and an office in Cape Town, South Africa. For more information, please visit www.aeras.org.
About Aurum Institute
Aurum is an internationally recognized, specialist research and health systems management organization. The focus is TB and HIV prevention, treatment and care. The negative impact of the poor understanding and management of these epidemics is vast, affecting individuals, communities and economies. The recognition of the huge advantages of controlling these diseases is Aurum's motivation. Aurum has an international reputation for its work in the fields of tuberculosis, HIV/AIDS and is the recipient of research and other grants from South African and international agencies and institutions for this work. For more information, please visit www.auruminstitute.org.
About Crucell
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL) (SWISS: CRX) is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6® production technology. The Company licenses its PER.C6® technology and other technologies to the biopharmaceutical industry. Important partners and licensees include Johnson & Johnson, DSM Biologics, sanofi-aventis, Novartis, Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Argentina, China, Italy, Korea, Spain, Sweden, Switzerland, UK and the USA. The Company employs over 1200 people. For more information, please visit www.crucell.com.
Forward-looking statements
This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the US Securities and Exchange Commission on April 7, 2010, in the section entitled 'Risk Factors'. The Company prepares its financial statements under International Financial Reporting Standards (IFRS).
Aurum acknowledges marketwire as the source of this article
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WORLD TB DAY
24 March 2010 |
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Johannesburg – The South African Broadcast Corporation’s programme “SHIFT” was all about Tuberculosis (TB) this World TB Day. Aurum Institute staff members Dr Sello Mashamaite and Dr Mpho Maraisane were invited back as guests on the programme.
Dr Mpho Maraisane, Aurum Institute HIV Clinician, sat alongside Dr Martie Van Der Walt, of the TB Epidemiology and Intervention Research Unit at the Medical Research Council and Dr Dimakatso Moloi, chief director of the TB/HIV/STI Unit, Gauteng Provincial Government, in-studio. As the panel, they answered hosts’ Rhulani Baloyi and Bongani Zindela, as well as callers’ questions, about TB. There were more calls than they were able to take in the one hour programme, which indicates the topic was of great interest to the viewers. The producers gave out contact details of the panel members and interestingly on arrival back at the office from the show, no less than 5 calls had come through to Dr Maraisane’s desk; and she says, “they continue coming!”
The panel imparted a great deal of information during the hour, especially on the subjects of multi- and extreme-drug resistant TB (M-DRTB; X-DRTB), understanding how contagious TB is; how it is spread and the importance of taking the full course of treatment.
Dr Maraisane explained how powerfully HIV and TB work together, which is the reason TB and HIV care are being integrated across health care systems and programmes. And what this means to the general public. The link between the spread of pulmonary TB (TB of the lungs) and overcrowding was also highlighted.
Aurum Institute sub-investigator in the Rifaquin trial in Tembisa, Dr Sello Mashamaite, was featured on the programme in an insert produced the week before at the Aurum Institute TB Clinic at Tembisa Hospital. He explained how important it is for someone with TB symptoms to go to a Clinic and ask for a TB diagnosis, and how to go about doing this. He also introduced viewers to Perseverance Noyiya, a young lady who has been receiving treatment for TB at the Aurum Clinic at Tembisa Hospital for 5 months now. She is in fact, nearly done with her TB treatment.
Said Perseverance: “These people have treated me with open arms. They have made it so nice for me to come every week for my treatment. They have become like family to me.”
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PROFESSOR CHURCHYARD ON WORLD TB DAY
24 March 2010 |
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Johannesburg – The independent South African eTV News Channel hosted Professor Gavin Churchyard on the morning news programme to speak about TB this World TB Day.
Churchyard was optimistic that despite South African having the second highest incidence rate in the world, second only to Swaziland, the country could defeat TB.
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TB AND AIDS: UNTREATED HIV EXACTS A HIGH PRICE
23 March 2010, Margaret O'Connor |
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National treatment guidelines that take effect in South Africa on April 1 will make antiretrovirals (ARVs) available to almost 500,000 people, including HIV-positive infants, some pregnant HIV-positive women, and all TB/HIV co-infected patients.
Some 70 per cent of people treated for TB in South Africa are also HIV-positive. The introduction of earlier-stage HIV treatment should help prevent those with latent TB from developing the full-blown disease.
The push by Dr Aaron Motsoaledito, South Africa’s minister of health, to integrate TB and HIV treatment breaks with a century-old tradition of isolating TB treatment in standalone public healthcare facilities.
The pitfalls of this strategy were highlighted in 2006, when news that 52 of 53 HIV-positive patients with extreme drug resistant or XDR-TB had died while being treated at a Church of Scotland Hospital TB ward in Tugela Ferry. This tragedy fuelled fears in high-prevalence communities of only emerging from a TB hospital in a coffin and drove people with suspected cases underground.
Halting the cycle of fear and denial requires sustained public education campaigns by healthcare counsellors and treatment activists.
Stigma surrounding HIV-Aids, and to a lesser extent TB, continues to prevent affected people going to clinics for testing and treatment. However, the government’s determination to dispel the myths and misinformation about the infectious diseases that are commonplace in most poor communities has impressed activists.
“Dr Motsoaledi is leading the pace of engagement now,” says Mark Heywood, a director of the Treatment Action Campaign. The TAC is supporting the government’s drive to enrol 1.8m people in ARV programs by 2013. More than 5.5m South Africans are believed to be living with HIV-Aids and runaway rates of infection have had a grave effect on immunity to TB.
The South African Ministry of Health and the US President’s Emergency Plan for Aids Relief (Pepfar) will share financial responsibility for the drug roll-out. Existing Pepfar commitments are due to expire at the end of US President Barack Obama’s first-term in 2014.
Dr Brian Brink, a private sector representative on the ethics committee of the board of The Global Fund to Fight Aids, TB, and Malaria and medical consultant for Anglo American, the mining group says: “We’re paying the price of untreated HIV with current TB incidence rates. How we respond will determine when we turn the corner in conquering co-infection.
“Donor fatigue is apparent among the NGOs involved in HIV. They’re moving into prevention because long-term funding for treatment is too expensive.”
Civil society and business are urging government to control drug costs by pursuing generic options and forecasting drugs needs, so that pharmaceutical companies can operate in a more predictable environment.
Building management capacity across the public health care system will require massive investments in training, development, and further education. The national government says it will commit the resources. Ring-fencing budget items should ensure the money is properly allocated.
Pockets of innovation in community health care delivery provide beacons of hope.
The Western Cape Department of Health has joined with Médecins Sans Frontières to pioneer a system for streamlining HIV and TB testing, diagnosis, and treatment at 10 community clinics in Khayelitsha, a township near Cape Town.
KwaZulu Natal, the province with the highest HIV-Aids infection rate, has pioneered integrated care at the Caprisa eThekwini TB-HIV clinic in Durban and the Church of Scotland Hospital in Tugela Ferry.
These programmes are predicated on the belief that home-care with strict professional monitoring of drug treatment and contagion control procedures for families co-habitating with patients undergoing treatment has the highest chance for long-term success.
The shift in attitudes with patients taking more ownership for their drug treatment is derived from the community-care model developed for treating HIV-Aids.
The main difference in implementation is that TB patients must still take their medication in the presence of a health care worker. Directly Observed Treatment (Dot) is a cornerstone of World Health Organization guidelines.
Treatment for XDR-TB is a painful daily injection that a patient must endure for four to six months. There is widespread agreement that this should be administered in a clinical setting.
A workshop the US National Institutes of Health (NIH) held in Pretoria several weeks ago raised expectations in the clinical community that the institutes will invest in a range of TB prevention and treatment programmes that could rival their record in helping to develop 20 Aids drugs in 25 years.
Professor Gavin Churchyard, the director of the Aurum Institute, a Johannesburg-based health research organisation, says: “The NIH will devote millions, if not billions, of dollars to radically transforming the TB landscape.”
Aurum acknowledges FT.com as the source of this article
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SOUTH AFRICA: HIV TESTING AND MENTAL ILLNESS
17 March 2010 |
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As more HIV-positive people access treatment and live longer, the number of people suffering from HIV-related mental disorders is growing, but mental health remains an ethical, legal and clinical minefield, where many doctors and nurses fear to tread – and fear to test.
"We're moving away from seeing patients on their death beds towards patients who are living longer, and are being affected by mental disorders that have real impacts on their life and work," said Dr Greg Jonsson, a psychiatrist at the Luthando Psychiatric HIV Clinic at the Chris Hani Baragwanath Hospital, in Johannesburg.
Various studies have shown a higher than average prevalence of mental illness among people living with HIV. A 2005 study by South Africa's Human Sciences Research Council found that about 44 percent of the 900 HIV-positive individuals surveyed suffered from a mental disorder.
The links between HIV and mental illness are complex, but factors include the effects of the virus on the central nervous system, as well as difficulties in dealing with HIV-related stigma and discrimination.
South Africa has the world's largest ARV programme to counter an HIV prevalence rate of about 18 percent, according to UNAIDS, and about 920,000 people are on ARV treatment.
No easy choices
Doctors and nurses in clinics often find it daunting to test mental health patients for HIV. "People who are not trained in psychiatric disorders are scared of getting consent from patients with mental disorders," Jonsson told IRIN/PlusNews. "People should not assume that mentally ill or even psychotic patients are incapable of understanding [testing] and consenting."
But Jonsson added that there would be times where doctors would need to make tough calls about testing severely mentally ill patients who could not consent to HIV testing and whose families may not be approachable to consent on their behalf.
"If you can't obtain informed consent, you need to weigh up the potential harm and benefit to the patient - ask yourself whether this test is going to change your diagnoses or your treatment," he suggested to health workers at an annual symposium held by the Aurum Institute, a non-profit medical research organization.
"I think if the answer is 'yes' to either, then go for it. It is really the right of the patient to be offered effective HIV treatment," said Jonsson, who pointed out that doctors should be aware of possible interactions between mental health medications and antiretroviral (ARV) drugs.
He advised doctors to document the process and counsel patients throughout, especially about how to reduce risk, given the prevalence of substance abuse among mental health as well as HIV patients.
"Psych is hard because the 'three ticks equal this' approach doesn't really work, and that's why people are so scared of it," Jonsson told IRIN/PlusNews.
No right answers
Once a mental health patient started taking ARVs, healthcare providers would have to evaluate whether mandating a "treatment supporter" – a friend or family member to help the patient adhere to treatment - would be appropriate. Again, there may not be a right answer.
"We need to draw up protocols and put them in primary healthcare, but the problem with protocol-based system is that people don't think outside the box - with mental health patients it really is on a case-by-case basis," Jonsson told the symposium audience.
"I tell most of my patients, 'If you can get treatment support, go for it', but I don't insist on it - disclosing to a patient's family is difficult and ... at my clinic, our patients on treatment are already so stigmatized and victimized."
The Luthando Psychiatric HIV Clinic has a treatment default rate – patients who discontinue ARVs – that is the same as institutions in Johannesburg that mandate treatment supporters, Jonsson added.
Aurum acknowledges PlusNews as the source of this article
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SOUTH AFRICA: BETWEEN PATIENTS AND PREVENTION
15 March 2010 |
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New research suggests that the poor knowledge and attitudes of doctors and healthcare workers in South Africa are limiting access to preventative tuberculosis (TB) therapy.
The qualitative study by the health research non-profit, the Aurum Institute, found that many doctors and health workers shied away from prescribing isoniazid preventative therapy (IPT), in which daily doses of the antibiotic isoniazid are administered for at least six months to reduce TB risk in HIV-positive people.
The reasons most often cited by health professionals for not prescribing IPT included an inability to rule out active TB, little knowledge about IPT's benefits, and little confidence that patients would continue taking the medicine, said Dr Salome Charalambous, HIV/AIDS Programme Director at Aurum, who presented the research at the institute's annual symposium for health workers in Johannesburg.
IPT can reduce the risk of active TB in people living with HIV by about a third, according to the World Health Organization (WHO). South Africa has had national guidelines for administering IPT since 2002, but coverage has been estimated at below 1 percent. Health workers interviewed for the study also said they felt the Department of Health had not done enough to communicate the current IPT guidelines to them.
The WHO lists TB as the leading killer of people living with HIV, and South Africa has an HIV prevalence rate of about 18 percent. The country also shoulders one of the world's highest TB burdens, according to the WHO.
"It's not to say everyone must be started on IPT, but there are a whole lot of people who could benefit from IPT but are not," Charalambous told IRIN/PlusNews.
More about the professionals, less about the patients
International and national guidelines caution doctors to avoid issuing preventative TB therapy in people who have active TB. Charalambous said the difficulty in diagnosing active TB, which can hide in tissue outside of the lungs, deterred many health professionals from using IPT.
"Standard pulmonary TB is not [present in] more than 30 percent of our patients, so sputum, abscess, lymph nodes, x-rays are very often negative. I would never use [isoniazid] on my patients for this reason alone," said a doctor quoted in the study.
Other doctors were not convinced of the value of giving IPT to patients already on antiretroviral (ARV) medication. Little research has been done on the effects of IPT on patients taking ARVs, but new findings presented by Aurum at the recent 2010 Conference on Retroviruses and Opportunistic Infections showed that IPT drastically decreased mortality in newly initiated ARV patients.
Aurum's qualitative study showed that health workers' attitudes to patients influenced their willingness to prescribe IPT. "It was interesting that staff felt that patients would not understand the concept of taking medication while feeling well, but when we asked patients they didn't say taking a preventative tablet would be a problem," Charalambous commented.
The researchers recommended that the Health Department clarify the screening process and initiation requirements for IPT, and that patients be educated about treatment options for preventing TB.
Aurum acknowledges PlusNews as the source of this article
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Integrating Active Case-Finding for TB with Prevention of Mother-to-Child Transmission of HIV Services in Antenatal Clinics
5 March 2010, Celine Gounder |
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HIV and TB are the leading infectious causes of death among women of reproductive age worldwide. In South Africa is a significant cause of maternal and infant morbidity and mortality. The Perinatal HIV Research Unit (PHRU) provides counseling and testing for HIV and prevention of mother-to-child transmission (PMTCT) regimens through 13 government-run antenatal clinics in Soweto, South Africa. I hypothesized that integrating PMTCT services and active case-finding for TB among pregnant women would be a high yield intervention for detection of active pulmonary TB. In collaboration with the PHRU, I rolled out TB screening in 6 of 13 antenatal clinics in Soweto, including the antenatal clinic at Chris Hani Baragwanath Hospital. All pregnant women presenting to the antenatal clinics, regardless of their HIV status, were screened for symptoms of active pulmonary TB: cough for =2 weeks, sputum production, fevers, night sweats or weight loss. All women with any symptom of active TB were asked to cough up a single sputum specimen, which was then sent for sputum smear microscopy, mycobacterial culture and identification, and 1st line drug-susceptibility testing. Women with TB were referred for treatment at their nearest TB clinic.
Aurum acknowledges changemakers as the source of this article
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MORE EVIDENCE SUPPORTS ISONIAZID FOR TB PREVENTION IN PEOPLE WITH HIV
19 February 2010, Keith Alcorn |
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Two new studies presented this week at the 17th Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco add weight to a growing expert consensus that isoniazid preventive therapy (IPT) should be provided to people with HIV in order to reduce the risk of developing active tuberculosis (TB).
Although, as TB expert Richard Chaisson pointed out at an expert discussion on IPT prior to the conference, IPT is proven to reduce the incidence of TB in people with HIV, there are still many unanswered questions, including its effect on overall mortality, the optimum TB preventive regimen, and the effect of IPT on secondary transmission of TB in the household and among close contacts.
The studies presented this week offer new insights about the additive benefit of IPT in people taking antiretroviral drugs, and provide evidence about a potential alternative to the use of isoniazid alone.
IPT in people taking antiretroviral therapy
Dr Craig Innes of the Aurum Institute in South Africa presented results of an observational analysis of patients receiving IPT through a workplace programme in South Africa.
The study looked at the effect of IPT on mortality in a population of South African adults, predominantly male (93%), who started antiretroviral therapy (ART) between January 2004 and December 2007, comparing outcomes in those who received IPT and those who did not.
Individuals receiving health care through the Aurum programme were eligible for ART if they had a CD4 count below 250 cells/mm3 without symptoms, if they had WHO (World Health Organisation) stage 4 disease, or if they had WHO stage 3 disease with a CD4 count below 350 cells/mm3.
Isoniazid preventive therapy was recommended if a patient had no history of TB in the past three years and if current TB could be excluded, although prescription was less than universal due to fears of isoniazid resistance among some physicians if they could not exclude active TB.
The study population comprised 3258 patients who started ART, of whom 910 received IPT. The only significant differences between those who received IPT and those who did not were history of previous TB ever (2.5% vs 8.9%), WHO stage 3 or 4 disease (30% vs 50%) and haemoglobin (13.4 vs 12.9) (all differences p < 0.001).
The study showed a significantly lower mortality rate for those who received IPT: across a number of analyses, which adjusted for potential confounding factors, the risk of death was approximately halved if an individual received IPT in addition to antiretroviral therapy.
In the first analysis, which included individuals with a previous history of TB and which adjusted for age, WHO disease stage, CD4 count, haemoglobin count and year of ART commencement, the risk of death was 53% lower in those who received IPT (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.30-0.72, p<0.001).
Some patients received IPT despite guidelines indicating that they should not, and this might have diluted the effect of IPT that would be observed if the guidelines had been strictly observed. In a sensitivity analysis which excluded those with a prior history of TB, the risk of death was 54% lower, indicating no substantive effect of prior TB (HR 0.46).
Another way of looking at the question of whether, if used strictly according to guidelines, the results might turn out differently, is to exclude all patients who had symptoms associated with TB at ART commencement, no matter when they received IPT. This would tend to cast a wider net for those patients who had active TB when exposed to isoniazid, and who might therefore have shown less benefit.
In this analysis, the risk of death was 53% lower (HR 0.47, 95% CI 0.28-0.79, p = 0.05).
Only when participants were stratified according to whether they commenced IPT within three months of starting ART, or delayed IPT for more than three months, did a marginal difference emerge. Those who started IPT less than three months after ART had a 61% reduction in the risk of death, whereas those who started IPT more than three months after ART had a 46% reduction in the risk of death when compared to those who did not receive IPT.
The chief limitations of the study are its observational nature – there could have been biases in who received IPT, although the analyses controlled for known confounding factors – and the fact that causes of death were not captured in this study. It is not clear whether the effect of IPT on mortality is solely driven by a reduction in TB-related deaths, or whether protecting IPT has a wider effect.
The interaction between ART and tuberculin skin test status
The Aurum Institute study did not control for tuberculin skin test (TST) status, a test that can positively confirm that someone is latently infected with TB. In the BOTUSA IPT study, (which compared 6 and 26 months of IPT in people with HIV), previously presented at the World Lung Health conference in Cancun in December 2009, and presented again this week at CROI, TST-positive patients who received antiretroviral therapy alongside six months of isoniazid experienced a 50% reduction in the risk of developing active TB during the three-year follow-up period when compared to people who received six months of isoniazid alone.
In TST-positive people who received 36 months of isoniazid however, the additional benefit of antiretroviral therapy was marginal, reducing the likelihood of developing active TB by just 4% in comparison to the no-ART group.
In TST-negative people – those who either had no prior exposure to TB, or else hadn’t enough immune function to respond to TB antigens in the skin test – antiretroviral therapy halved the risk of developing active TB in those who received six months of isoniazid, and reduced the risk of active TB by around 45% in those who received 36 months of isoniazid when compared to isoniazid alone.
A new regimen for TB prevention?
A randomised study conducted by the Tuberculosis Research Center in Chennai, India, showed that a six-month course of isonaziad and ethambutol, another antibiotic used in TB treatment, was just as effective as a 36-month course of isoniazid in people with HIV, most of whom were not receiving antiretroviral therapy.
The Indian study was designed to test whether an alternative regimen to isoniazid alone was safe and effective in a setting where 15 to 20% of patients have isoniazid-resistant TB at diagnosis, and where rifampicin, another TB drug tested as a preventive measure, is strictly reserved for treatment of active TB in order to limit the development of resistance to the drug. The study was also deisgned to compare the feasibility of a short-course regimen of six months against a longer-term regimen that might be expected to offer greater protection against exposure to TB during the study period itself, especially in immunosuppressed people who may be at higher risk of rapid TB progression.
The study was conducted by the Tuberculosis Research Center in Chennai, and began recruiting patients for the three-year study between 2001 and 2005.
All participants had TB confirmed by sputum culture wherever possible, and the study excluded any person with HIV who had a previous history of TB.
During the study patients received a clinical review every three months to check for symptoms of TB and other health problems, and underwent chest X-ray every six months.
Participants were randomised to receive a daily regimen of isoniazid 300mg and ethambutol 800mg for six months, or 36 months of isoniazid alone, and all patients with a CD4 count below 250 cells/mm3 received cotrimoxazole. Antiretroviral therapy became available in the public sector in 2004 to patients with WHO stage 4 disease, or WHO stage 3 disease and a CD4 count below 200 cells/mm3).
The study randomised 683 patients, and 37 cases of TB occurred during the three years of follow-up, 16 of which were bacteriologically confirmed. The incidence of TB was not significantly different in the two arms of the study (2.4 cases per 100 person years in the ethambutol arm, 1.6 cases per 100 person years in the isoniazid arm), and death rates were also similar.
The low rates of TB in the study compared to the historical incidence previously measured in the Chennai cohort (6.9 cases per 100 person years) may in part be attributable to the screening by culture at baseline. Screening picked up 30 cases of active but asymptomatic TB that otherwise would have developed into incident TB cases during the trial.
In both arms, most cases of TB – and most deaths – occurred during the first 12 to 18 months of follow-up, but only three deaths were a result of TB.
Regardless of the regimen received, individuals with a baseline CD4 count had a fourfold higher incidence of TB, while TST-positive individuals (TST >5mm) had a 40% higher risk of developing TB.
Among the TB cases that were bacteriologically confirmed, six had isoniazid resistance (five in the ethambutol arm and one in the isoniazid arm).
There was no difference in the development of adverse events between the two arms: three severe events occurred in the ethambutol arm and two in the isoniazid arm, and overall the regimens were very well-tolerated. Rates of adherence were also very high, with around 93% in each arm judged to be more than 80% adherent by unannounced home visit pill counts.
Dr Swaminathan commented that the high adherence rates, the high study retention and the low rates of TB in the study may have been due to the high level of preparation and screening that patients received before entering the study. Patients in the trial received free HIV care, and for many, it may have been their first experience within the Indian health system of good-quality care and support, leading to a high level of patient loyalty to the programme, and a reluctance to be referred on for care at other centres when the trial was over.
Aurum acknowledges aidsmap news as the source of this article
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AMCLI - ASSOCIAZIONE DEI MICROBIOLOGI CLINICI ITALIANI
17 February 2010 |
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In India, a tuberculosis-endemic country, most recurrences after successful treatment of tuberculosis are due to exogenous reinfection in HIV-infected persons and endogenous reactivation in HIV-uninfected persons. Strategies for prevention and treatment of tuberculosis infection must take these findings into consideration ... Tuberculosis recurrence rates, likely due to reinfection, were much higher than incidence rates. The findings suggest heterogeneity in susceptibility, implying that a vaccine could still provide useful protection in the population and strengthening the case for secondary preventive therapy.
Allegati il primo articolo e l'editoriale; il secondo articolo può essere scaricato mediante il link.
Impact of HIV Infection on the Recurrence of Tuberculosis in South India. Sujatha Narayanan et al. The Journal of Infectious Diseases 2010;201:691–703
High Rates of Recurrence in HIV-Infected and HIV-Uninfected Patients with Tuberculosis. Judith R. Glynn et al. The Journal of Infectious Diseases 2010;201:704–711
Recurrent Tuberculosis: Relapse, Reinfection, and HIV. Richard E. Chaisson and
Gavin J. Churchyard. The Journal of Infectious Diseases 2010;201:653–655
Aurum acknowledges Amcli - Associazione dei Microbiologi Clinici Italiani as the source of this article
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LINDA-GAIL BEKKER: CONFRONTING THE TB/HIV CO-INFECTION EPIDEMIC
13 February 2010, Kelly Morris |
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As chief operating officer of the Desmond Tutu HIV Foundation and a researcher at the University of Cape Town (UCT), South Africa, award-winning scientist Linda-Gail Bekker describes herself as a “frustrated social worker”. Her research on tracking the changes in tuberculosis (TB) epidemiology within the HIV epidemic won her the 2009 Royal Society Pfizer Award. But, delivery of screening and care in hard-hit areas of Cape Town is also a passion.
Read article
Aurum acknowledges The Lancet as the source of this article
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THIBELA TB - THE PATH TOWARDS RESULTS
February 2010 |
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After nearly 5 years, the Thibela TB intervention stage of the project is drawing to a close. Starting in early 2005 with the Tau Tona mine shaft near Carletonville, the Thibela project has worked its way across 15 clusters to end with the Bambanani Mine near Welkom, in the Free State Province.
The last official study participant will take his last dose of Isoniazid (INH) in the intervention at Bambanani on the 28th of February 2010. "This is a major milestone for Thibela TB", said Dr Dave Clark, Aurum's Deputy CEO. "The team has enrolled over 30,000 participants into the program to take preventive INH, a significant achievement in the fight against TB in our country."
What has been quite remarkable at the final intervention cluster is the astounding number of volunteers for Thibela TB - over 95% of the workforce at Bambanani - evidence of a community mobilization phenomenon unheard of in clinical trials before. "I am so proud of my team in achieving this together with the people of Bambanani", said Flora Popane, Regional Project Manager for the Free State. Towards the end of this last cluster, >75% of volunteers were retained on the study, further evidence of a job well done.
Elsewhere in the study, the switch to the measurement periods of the protocol have gone well, with two shafts completing the final culture prevalence survey and several others underway or in final stage planning for primary and secondary end point measurement.
Another key component of the main part of the study has been the Electronic Data Capture system. This system has been steadily gathering enormous amounts of data from all the participants at the various sites. The main study database will also capture its last live details on the 28th February. Trisha Crawford, Thibela's Senior Data Manager, and her team have set the very ambitious task of getting to database lock by the end of March 2010 and right now, they are on track to achieving this goal. A locked database is key for investigators to begin the challenging, but pivotal task, of analyzing the data goldmine that has come from all the work so far.
"We are finally at the beginning of the end in this audacious study. I too am very proud of all this remarkable team has achieved across the various regions. We are also grateful to the thousands of mineworkers who have risen up to fight TB. We now have to finish what we have so painstakingly put together over the last few years. But I know I can count on my team to see this through to the final analysis", adds Gavin Churchyard, Thibela TB principal investigator. The study is set to publish final results early in 2012, but hopefully much interim information on lessons learned and other research questions will come from the data in the next two years.
Aurum acknowledges CREATE as the source of this newsletter
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THE JOURNAL OF INFECTIOUS DISEASES
8 February 2010, Richard E Chaisson and Gavin J Churchyard |
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The catastrophic collision of tuberculosis and human immunodeficiency virus (HIV) has yielded an extraordinary burden of suffering and death at both the individual and population levels. The convergence of these twin epidemics resulted in 1.8 million deaths due to tuberculosis disease in 2007, 24% of which were among people with HIV infection, whereas among the 2 million deaths of people with AIDS, 22% were caused by tuberculosis infection. Tuberculosis is thus the leading cause of death in people with HIV/AIDS, and HIV infection contributes to a substantial proportion of tuberculosis deaths. Interventions to control tuberculosis and HIV therefore need to take into account the unique and deadly synergy between these 2 infections.
There are many challenges that clinicians and public health programs must confront when trying to manage and prevent HIV-related tuberculosis, including prompt diagnosis, effective treatment, and successful prevention strategies. One problem that receives little attention is recurrence of tuberculosis following completion of treatment. Historically, patients properly treated with a 4-drug regimen have a very high treatment success rate and very low (2%–3%) incidence of recurrence. In HIV-infected patients, the risk of recurrent disease is higher, and previous work has demonstrated that this can be due to treatment failure, emergence of drug resistance during therapy, or reinfection with a new strain of Mycobacterium tuberculosis. Recurrence of tuberculosis after treatment among both HIVinfected and HIV-uninfected individuals is not a trivial problem. On a patient level, recurrent tuberculosis requires another round of treatment with a regimen that, in many parts of the world, is more toxic, takes longer to complete, and may, ironically, amplify drug resistance. On a public health level, recurrent tuberculosis may account for 10%–30% of all cases within some weaker tuberculosis control programs, particularly those that do not use at least 6 months of rifampin treatment, and contributes to ongoing transmission of infection to contacts of cases in the home, community, and health facilities, largely from HIV-uninfected patients.
In this issue of the Journal are 2 articles that examine the epidemiological profile of recurrent tuberculosis in populations with a high prevalence of HIV infection. Narayanan et al from India report on 2 cohorts of patients with tuberculosis who were followed up for recurrence and then underwent DNA typing of initial and recurrence M. tuberculosis isolates to distinguish exogenous reinfection from relapse. Among HIV-infected patients whose initial episode of tuberculosis was deemed cured, 14% experienced a recurrence of tuberculosis, of which just over half of infecting strains typed. Among these, 22 (88%) of 25 cases were due to reinfection with a different strain of M. tuberculosis. In a sample of HIV-uninfected patients with recurrent tuberculosis (rates of recurrence are not reported for these patients), only 9% of second episodes were due to reinfection, with the remainder being relapses of the initial infection. One possible explanation for the difference in levels of relapse among HIVuninfected patients is that many were treated with nonstandard, abbreviated regimens that included ofloxacin in a clinical trial that failed to include an appropriate control regimen; these relapsesmay simply have been the result of inadequate therapy. Importantly, one-fourth of HIV-related recurrences were with multidrug-resistant strains of M. tuberculosis, with a smaller number of resistant recurrences found among HIV-uninfected patients.
Although rates of recurrent tuberculosis cannot be compared by HIV status in this report, it is clear that recurrent disease is more common than would be expected among HIV-infected patients with tuber culosis in this Indian setting, and that almost all recurrences are due to exogenous reinfection. Narayanan et al used rigorous typing methods, with 3 independent techniques, and took great care to exclude the possibility of laboratory contamination. Although the study breaks no new ground with respect to the existence of exogenous M. tuberculosis reinfection causing disease, particularly in HIVinfected patients, it is nonetheless noteworthy for documenting the potential frequency of this phenomenon in developing countries, where recurrences are generally attributed to treatment failure due to either noncompliance or drug resistance. In this study, all of the multidrug-resistant recurrences among HIV-infected patients were reinfections, whereas both multidrug-resistant cases among HIV-uninfected patients were due to acquired or amplified resistance during treatment. These data confirmwhat has been inferred from outbreaks of multidrug and extensively drug-resistant tuberculosis among people with HIV infection in other settings: that much drug-resistant tuberculosis in HIV-infected patients is transmitted from others, rather than acquired by ineffective or insufficient therapy.
A second article in this issue of the Journal, by Glynn et al, reports on rates of recurrent tuberculosis in mine workers in South Africa. These authors followed 2 cohorts of tuberculosis patients—one with HIV infection and one without, whose illness was initially diagnosed and who underwent HIV testing in the 1990s—and determined the rates of recurrent disease that occurred at least 2 years following cure of the initial episode. The authors assumed that these late recurrences were due to reinfection rather than relapse, on the basis of previous observations, supported by the data from Narayanan et al, that almost all relapses occur in the first 2 years following treatment. Glynn et al found recurrence rates of 24.4 cases per 100 person-years at risk for initially HIV-infected miners following their index episode and 4.7 cases per 100 person-years at risk among those who were HIV-negative at the index episode. Strikingly, rates of recurrent tuberculosis were dramatically higher than incident tuberculosis rates among both HIV-infected and HIVuninfected miners. These results are consistent with those from a study of another high tuberculosis transmission setting where reinfection rates following treatment exceeded rates of incident disease.
The work of Glynn et al requires more assumptions about the source of recurrence and has less direct evidence than the study by Narayanan et al. No DNA typing was performed to confirm that recurrences were actually reinfections and not relapses; repeat HIV testing was not performed among the initially HIV-seronegative men, despite known high rates of HIV acquisition during the time of the study; and considerable attrition from the cohorts over time occurred, which could affect incidence estimates. Despite these limitations, the study demonstrates convincingly that recurrent tuberculosis is exceedingly common among miners in South Africa and is seen in both HIVinfected and HIV-uninfected men. Work by the same group and others previously documented high rates of reinfection in this setting, so it is quite credible that a large proportion of these recurrent cases were, indeed, new infections.
What can be done to reduce the frequency of recurrent tuberculosis, whether due to relapse or reinfection, in patients with and without HIV infection? In fact, quite a lot can be done, and the evidence base for a number of interventions is robust. First, ensuring completion of appropriate therapy for all patients with tuberculosis is extremely important. Although rates of treatment completion worldwide are now close to 85% for patients cared for in directly observed treatment shortcourse programs, the real completion rate when all patients are accounted for is substantially lower, particularly in Africa. Failure to complete tuberculosis treatment is associated with very high rates of recurrent disease, especially in HIV-infected patients. In addition, although 5.5% of all new tuberculosis cases worldwide have multidrug or extensively drugresistant disease, only a tiny fraction of these are actually detected and receive appropriate treatment. Improving case detection, easier access to care, improving cure rates with community-based interventions, developing new effective shorter regimens, and conducting baseline drug susceptibility testing will all reduce relapses and the evolution of drug resistance. Earlier detection of multidrugresistant tuberculosis, through use of rapid rifampin resistance assays such as line probe assays, and earlier effective treatment should also reduce recurrence due to reinfection with multidrug-resistant tuberculosis in HIV-infected patients. Because reinfection is common in HIVinfected patients in high burden settings, secondary preventive therapywithisoniazid is another strategy for reducing recurrences. One small controlled trial and one observational study have documented the effectiveness of secondary isoniazid for reducing recurrences in patients with HIV-related tuberculosis. In a nonendemic setting, the risk of recurrence among HIVinfected persons was reduced with longer duration of tuberculosis treatment.
Low CD4 cell counts are a major predictor of recurrent tuberculosis due to both relapse and reinfection in HIV-infected patients, and treatment with antiretroviral therapy decreases the likelihood of recurrence by at least 50%. Widespread use of antiretroviral therapy for all HIV-infected patients with tuberculosis is now supported by evidence from a clinical trial and from observational studies. Scaling up antiretrovirals for patients with tuberculosis will also reduce recurrent disease, as suggested by a study in Rio de Janeiro, Brazil.
A critically needed intervention to reduce reinfection tuberculosis is the implementation of infection control measures in clinical and community settings. Because patients with tuberculosis and with HIV infection congregate in the same clinic waiting rooms, offices, laboratories, and hospital wards in much of the world, ongoing transmission is a significant cause of new disease, especially drug-resistant disease, as Narayanan et al demonstrate. HIV and antiretroviral clinics in resource-poor settings have unwittingly become cauldrons of tuberculosis transmission, seriously undermining the impact of HIV therapies. The first step in reducing institutional and community transmission of M. tuberculosis infection is the detection of prevalent, undiagnosed cases and the initiation of appropriate therapy. Administrative measures to separate infectious patients from others, engineering and air flow management ranging from opening windows and doors to more sophisticated air handling techniques, and the use of personal protective equipment in more exposure-intense situations are all approaches that need to be ramped up worldwide, given the clear evidence of nosocomial transmission of tuberculosis infection among those with HIV infection.
Finally, what about vaccination as a strategy for preventing recurrent tuberculosis infections? Both Narayanan et al and Glynn et al suggest that development of a therapeutic vaccine or immunotherapy as an adjunct treatment for tuberculosis might help reduce relapse and reinfection episodes in those with exquisite susceptibility to the disease. Although this is an attractive concept in theory, the feasibility of this approach is currently quite limited. What is eminently sensible, however, is a primary vaccine for tuberculosis that prevents the development of disease in the first place. The current tuberculosis vaccine, BCG, appears to protect infants from severe forms of disease but does not prevent pulmonary tuberculosis in adults. We know from previous experience that a preventive vaccine can work, but in the case of BCG the protective effects of the vaccine most likely have become attenuated because of continuing evolution during laboratory passage. Thus, prospects for new pre- and postexposure preventive vaccines are bright. The potential for an effective primary vaccine to control initial and thus recurrent tuberculosis, especially among HIV-infected persons, is enormous. After all, the best way to ensure that patients avoid a second episode of tuberculosis is to make certain that the first episode never occurs.
Aurum acknowledges Chicago Journals as the source of this article
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"WHAT WILL IT TAKE TO CONTROL TB?"
1 February 2010, Richard Chaisson, MD |
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Dr Richard Chaisson, Professor of Medicine, Epidemiology and International Health and Director of the Center for Tuberculosis Research at the Johns Hopkins University in Baltimore, was the keynote 19 January 2010 as part of the Washington Global Health Discovery Series. His talk was on "What Will It Take To Control TB?"
Watch presentation online
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NEW TECHNOLOGY WILL REVOLUTIONISE THE WAY TB IS DIAGNOSED
14 January 2010 |
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Johannesburg – Deputy CEO of the Aurum Institute, Dr Dave Clark was interviewed live on the SABC International News programme “Health Matters” about a new way of diagnosing TB. Signature Mapping TBDx – as the technology is called, will revolutionise the way TB is diagnosed, said Clark.
TB is still being diagnose the same way it was 100 years ago. The new technology will according to Clark, increase the detection rate by 40 – 60 percent.
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DR PAUL DAVIS ON SAFM, HEALTH UPDATE
14 January 2010 |
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PROVIDER-INITIATED SYMPTOM SCREENING FOR TUBERCULOSIS IN ZIMBABWE: DIAGNOSTIC VALUE AND THE EFFECT OF HIV STATUS
1 January 2010 |
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Objective
To assess the diagnostic value of provider-initiated symptom screening for tuberculosis (TB) and how HIV status affects it.
Methods
We performed a secondary analysis of randomly selected participants in a community-based TB–HIV prevalence survey in Harare, Zimbabwe. All completed a five-symptom questionnaire and underwent sputum TB culture and HIV testing. We calculated the sensitivity, specificity, and positive and negative predictive values of various symptoms and used regression analysis to investigate the relationship between symptoms and TB disease.
Findings
We found one or more symptoms of TB in 21.2% of 1858 HIV-positive (HIV+) and 9.9% of 7121 HIV-negative (HIV-) participants (P < 0.001). TB was subsequently diagnosed in 48 HIV+ and 31 HIV- participants. TB was asymptomatic in 18 culture-positive individuals, 8 of whom (4 in each HIV status group) had positive sputum smears. Cough of any duration, weight loss and, for HIV+ participants only, drenching night sweats were independent predictors of TB. In HIV+ participants, cough of ? 2 weeks’ duration, any symptom and a positive sputum culture had sensitivities of 48%, 81% and 65%, respectively; in HIV- participants, the sensitivities were 45%, 71% and 74%, respectively. Symptoms had a similar sensitivity and specificity in HIV+ and HIV- participants, but in HIV+ participants they had a higher positive and a lower negative predictive value.
Conclusion
Even smear-positive TB may be missed by provider-initiated symptom screening, especially in HIV+ individuals. Symptom screening is useful for ruling out TB, but better TB diagnostics are urgently needed for resource-poor settings.
Aurum acknowledges The World Health Organization (WHO) as the source of this article
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