by Becky Debens,
SCRIP World Pharmaceutical News
UK, 08 Apr 2009 - Drug-resistant tuberculosis is a "time-bomb" waiting to explode into a global epidemic, World Health Organization director-general Dr Margaret Chan warned last week.
Speaking at the WHO's ministerial meeting for high TB burden countries in Beijing, China, on preventing the spread of multi- and extensively drug-resistant TB (M/XDR-TB), Dr Chan said the "potentially explosive situation" meant new plans of action were urgently required in TB-endemic countries.
The meeting, attended by ministers and representatives from 27 high-burden countries, including China, Ethiopia, India, Nigeria, Russia, Pakistan, South Africa and Ukraine, discussed the threat of drug-resistant TB and studied actions to prevent and manage the disease.
by Katie McQue,
SCRIP World Pharmaceutical News
UK, 20 Apr 2009 - Multiple drug-resistant tuberculosis is rife in the former Soviet Union and parts of Southeast Asia, and efforts to fight resistance are inadequate, a study partly funded by Lilly of the worldwide prevalence of drug-resistant tuberculosis has revealed.
The report, published online in The Lancet on April 16th, found the highest resistant rate in Azerbaijan, with 22.3% of new treatment-naïve TB cases classified as multiple drug resistant (MDR).
Moldovia's MDR rates were the second highest, at 19.4%, followed by Ukraine, with a rate of 16%. Countries in the Americas, western and central Europe and Africa reported the lowest prevalence of MDR TB.
The epidemiology survey was conducted by the World Health Organisation's Global Project on Anti-tuberculosis Resistance, which gathered data from more than 90,000 patients in 83 countries between 2002 and 2007. Where possible, data for HIV status and resistance to second line drugs were also obtained.
"The countries of the former Soviet Union are facing a serious and widespread epidemic with the highest prevalence of MDR tuberculosis ever reported in 13 years of data collection. Almost half of all tuberculosis cases in countries of the former Soviet Union are resistant to at least one drug and one in five cases are MDR," said study author Dr Abigail Wright of the WHO. "In this region, MDR-tuberculosis cases have more extensive resistance patterns and the highest rate of XDR (extensively drug-resistant) tuberculosis."
The study called for anti-tuberculosis efforts to be accelerated and backed by strong political commitment in order to quash the growing epidemic.
"Outliers were identified in all regions, suggesting a prevalence of MDR tuberculosis is linked to the performance of national tuberculosis control programmes," added Dr Wright.
In 2000, the WHO implemented a directly observed therapy short course (DOTS); however, a WHO study published shortly after found that the strategy would not control multiple drug resistance in countries with widespread resistance.
DOTS consists of the administration of short-course chemotherapy regimens with first-line drugs under direct observation. New cases of TB receive an initial phase of treatment with four drugs (isoniazid, rifampicin, pyrazinamide and streptomycin or ethambutol) for two months under strict direct observation, followed by a continuation phase with rifampicin and isoniazid for four months.
"We know how to prevent the emergence of drug resistance: consistent use of good, basic tuberculosis control. The bad news is that this measure is not being done in affected countries," said Dr Martien Borgdorff, executive director of the KNVC Tuberculosis foundation, in The Lancet's commentary article.
"This drug-resistant epidemic is being tackled with antiquated and inadequate diagnostics, drugs, and vaccines. Fortunately, progress is being made: rapid diagnostic tests are in late stages of development, three drug candidates with new mechanisms of action have recently shown positive results in trials, and six vaccines will be in human trials by the end of the year," Dr Borgdoff continued.
Potential antibiotics in the clinic include Bayer's moxifloxacin, with Phase III results expected next year. The drug is already approved for various skin and respiratory infections.
Tibotec is developing novel adenosome triphosphate (ATP) synthase inhibitor, diarylquinoline (TMC-207), which promisingly displayed bactericidal activity of a similar magnitude to rifampicin and isoniazid in Phase II. The company says an NDA filing is expected by 2010.
The Japanese firm Otsuka also has a Phase II candidate, OPC-67683 – an oral mycolic acid synthesis inhibitor (scripnews.com, December 1st, 2006). The US FDA awarded it orphan status for pulmonary tuberculosis in 2007.
Montreal, 15 Sep 2009 - Tuberculosis is a global threat that affects more than 10 million people each year. Working with colleagues in the United States and France, Dr. Dick Menzies of the Research Institute of the McGill University Health Centre (RI-MUHC) has placed current tuberculosis treatment guidelines under the microscope in a new study. The team's conclusions, published today in two separate articles in the journal PLoS Medicine, recommend that the World Health Organization (WHO) must review and adjust its guidelines for fighting the disease.
"Our first study is a systematic review and meta-analysis of 57 studies, involving more than 20,000 patients from around the world," says Dr. Menzies. "It demonstrates that the treatment period should be extended for people affected by the active form of tuberculosis for the first time. Specifically, the study recommends that these patients should be treated with Rifampin for six months, instead of two months; the additional four months will help maximize the medication's effectiveness."
In the second article, the researchers assess guidelines for patients who have been treated but not cured. "Currently, these patients receive a cocktail of drugs over the course of eight months, which can result in drug resistance and a failure to cure in up to 45 per cent of cases," says Dr. Menzies. "More studies are needed to determine the optimal strategy. However, we believe that it is essential – indeed, of critical importance – to thoroughly review these guidelines."
"Our challenge as researchers is to put into place the most effective strategies for the treatment of tuberculosis, to determine the optimal length for courses of treatment so as to avoid relapse, and to formulate more effective combinations of drugs in order to avoid drug resistance," Dr. Menzies adds. The two studies will allow the WHO to review and update its directives for the treatment of tuberculosis, thereby benefiting the global community.
Dr. Dick Menzies is the Director of Respiratory Medicine at the MUHC and a researcher in the Respiratory Health Axis and Health Outcomes Axis at the Research Institute of the MUHC. He is also a Full Professor in the Departments of Medicine and Epidemiology, Biostatistics & Occupational Health in the Faculty of Medicine of McGill University.
This article was co-authored by Dr. Dick Menzies, Dr. Andrea Benedetti, Dr. Anita Paydar, Dr. Ian Martin and Dr. Madhukar Pai from the RI-MUHC, Dr. Sarah Royce from the University of California at San Francisco, San Francisco, USA, Dr. Andrew Vernon from the Centres for Disease Control and Prevention, Atlanta, USA Dr. Christian Lienhardt from the International Union against Tuberculosis and Lung Diseases and Institut de Recherche pour le Développement, Paris, France and Dr. William Burman, from the Denver Public Health, Denver, Colorado, USA
This study was funded by the World Health Organization (WHO). The Canadian Institutes of Health Research and the Fonds de la recherche en santé du Québec (FRSQ) provided salary support for some authors.
Guangzhou, 06 Jan 2010 - China, saddled with the world's second largest tuberculosis burden after India, is fighting an uphill battle against drug-resistant forms of the disease which will only drain the country's health budget.
Drug-resistant TB, far more expensive to treat, emerges when patients fail to follow treatment regimens and take substandard drugs or stop treatment too early.
Liu Zhongwu, a stonecutter working in southern China, for example, stopped taking his TB medication midway through a standard six-month course in 2007 because it was too costly.
"Even though one or two drugs were free, I had to pay 500 yuan ($73) a month for other drugs (to reduce side effects) and the side effects were bad, I suffered terrible gastric pain and had to stop work, I didn't even have energy to walk," said Liu.
It is precisely this sort of behavior that health experts are trying to stop because if the TB bacteria is not fully eliminated, it can mutate, resurge later and become resistant to the small arsenal of drugs that can fight the disease.
China has 4.5 million TB cases currently; and each year 1.4 million people fall ill with the disease. TB killed 160,000 people in China in 2008, according to the World Health Organization.
TB killed 1.8 million people across the world in 2008, or a person every 20 seconds. It is not only a scourge in poor countries but also in the West, where it has flared anew in the last 20 years because of AIDS, which weakens the immune system.
TB is also a big drain on China's health budget because of a high incidence of people with a drug-resistant strain of the disease, which is a lot harder and more expensive to treat.
In such cases, patients need to take drugs for up to two years and the worst type of TB, for which there is no cure, kills one out of every two patients.
"If there are more drug-resistant cases, the cost of TB treatment will rise by a lot, that's for sure. With drug resistance, we can't use first-line drugs and other drugs cost a lot more," said Lin Yan, director of the China office of the non-profit International Union Against TB and Lung Disease.
"When these patients infect others, the others will get drug-resistant TB. That increases the cost of treating that person and increases the chances of him not recovering."
Regular TB costs 1,000 yuan to treat in China but drug-resistant TB ranges from 100,000 to 300,000 yuan per person, said Zhong Qiu of China's TB Expert Consultative Committee.
China ranks second in the world with 112,000 drug-resistant TB cases in 2007, after India with 131,000. Russia has 43,000 cases, while South Africa has 16,000 and Bangladesh 15,000.
China spent $225 million on tackling TB in 2008, up from $98 million in 2002, according to WHO. These figures do not take into account what patients pay out of their pockets, typically between 47 and 62 percent of their hospital bills.
Drug-resistant TB made up 27.8 percent of all TB cases in China in 2000 versus five percent in advanced countries.
"There are many reasons for China's drug-resistant TB problem. Patients stop taking drugs when they feel better, maybe after a month. Some have no money for drugs if the treatment is not free and they don't even know this is a serious disease," said Lin.
"Some are so afraid of stigma they don't see a doctor, they just buy drugs over the counter."
IGNORANCE, POVERTY, STIGMA
TB affects mostly poor people, who typically live in places where healthcare is not easily accessible. Many patients pay not only for treatment but also transportation, and any chronic, long-term disease can bankrupt entire families.
Li Jiachuen, 45, quickly ran out of money and had to borrow from relatives and friends after he was diagnosed with TB.
"I don't take drugs now. I don't even have money to pay off my 20,000 yuan debt. I spent thousands of yuan on diagnosis and treatment and even more on transportation," Li said.
WHO recommends all TB treatment be free because the disease is a public health threat.
But in China, diagnosis and treatment is only free in specialist TB outpatient clinics. General hospitals, which have been self-financing since the 1990s, impose charges.
"TB is a political problem because it is infectious. It has societal impact, it is a threat to public health ... free treatment is very important," said Zhong, who also heads the Anti-TB Research Institute in China's southern Guangdong province.
The world's only TB vaccine is 100 years old and there has been no new TB drug for more than 40 years. But the resurgence of TB due to AIDS has forced the West back into TB research in the last 20 years and a string of experimental drugs and vaccines are now in the pipeline.
Chinese scientists are working on a new class of TB drugs based on an old drug called clofazimine, used in the past to treat leprosy, said Ann Ginsberg, chief medical officer of the TB Alliance, a US-based non-profit scientific group that pulls together partners to develop new TB drugs.
"They (scientists) found a very promising lead compound and we hope within the next six months ... it will come into formal pre-clinical development and get the formal animal and non human studies that are required to convince the regulators it can go onto people," said Ginsberg.
The implementation of the US$ 56 billion Plan will result in:
ICN supports the Global Plan and encourages people to read the document. You can find the full text on http://www.who.int/tb/en/You can find more information on the Global To Stop TB 2006-15 on http://www.stoptb.org/globalplan/
The Stop TB Strategy and the WHO Report 2006 Global Tuberculosis Control: surveillance, planning, financing can be downloaded on http://www.who.int/tb/publications/2006/en/index.html
Developed by the Tuberculosis Coalition for Technical Assistance (TBCTA) with funding from the United States Agency for International Development (USAID), the ISTC describe a widely accepted level of care that all practitioners, public and private, should seek to achieve in managing patients who have, or are suspected of having, tuberculosis. The Standards are intended to facilitate the effective engagement of all care providers in delivering high-quality care for patients of all ages.
The TB Guidelines is available in the six following languages :
TB GUIDELINES for Nurses in the Care and Control of Tuberculosis and Multi-drug Resistant Tuberculosis, 2nd Edition
DIRECTIVES RELATIVES À LA TUBERCULOSE à l’intention des infirmières chargées du traitement et du contrôle de la tuberculose et de la tuberculose multirésistante, seconde édition
DIRECTRICES SOBRE LA TUBERCULOSIS para las enfermeras de cuidadosy lucha contra la tuberculosisy la tuberculosis multirresistente, 2ª Edición
LINHAS DE ORIENTAÇÃO para enfermeiros no cuidado e controlo da tuberculose e da tuberculose multirresistente, 2ª Edição
Руководящие принципы TБ контроля Для медсестер в системе противотуберкулезного контроля и ухода за больными туберкулезом и туберкулезом с множественной лекарственной устойчивостью, второе издание
Five Nurses Win the Newly Launched ICN/Lilly Award for Work in Tuberculosis and Multi–drug Resistant TB.
Eleven Nurses Win the 2nd ICN/Lilly Award for Work in Tuberculosis and Multi–drug Resistant TB
On the occasion of World TB Day, the International Council of Nurses (ICN), in partnership with Eli Lilly and Company, conferred special awards to nurses working on the ground in fighting the scourge of tuberculosis (TB) and multi-drug resistant TB. The 2008 award recipients come from six TB affected countries: Kenya, Lesotho, Malawi, the Russian Federation, South Africa and Swaziland.