Officials Gather In Ghana To Discuss Intellectual Property Laws, Accessibility Of Low-Cost Antiretroviral, Malaria, TB Drugs

Source: MedicalNewsToday

Health officials and legal experts on Wednesday gathered for a two-day meeting in Accra, Ghana, to discuss intellectual property laws that could make antiretroviral, malaria and tuberculosis drugs available, accessible and affordable in the country, the GNA/Accra Daily Mail reports. The workshop, under the theme, "Increasing Access to Medicines in Ghana; The Role of WTO/ Trade Related Aspects of Intellectual Property Flexibilities," is being attended by representatives from local and international pharmaceutical companies, the World Health Organization, the World Trade Organization and donor organizations.Health Minister Maj. Courage Quashigah, speaking at the opening of the meeting, called on officials to make a concerted effort to reduce the burden of the three diseases. "A significant component of that effort must be to make effective drugs accessible to people at risk," he said. Elias Kavinah Sory, director-general of the Ghana Health Service, noted that many essential medicines remain too costly in relation to local buying power. Sory said essential medicines have saved lives and improved health but "only if they are available, affordable and properly used." Quashigah said that there are overwhelming disparities in access to medicines, adding that some current treatments for diseases in developing countries might soon become irrelevant because of the widespread drug resistance. William Ofori, chair of the Association of Representatives of Ethical Pharmaceutical Industries, raised concern about the inability to find new TB treatments and called for collaboration between local and multinational companies to produce quality, affordable drugs (GNA/Accra Daily Mail, 11/7).

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MDR TB crisis is focus of world TB conference; 400,000 cases in 2007

Keith Alcorn, Thursday, November 08, 2007
Aidsmap news

The growing problem of multidrug-resistant (MDR) tuberculosis threatens to derail TB control efforts unless there is greater investment in control and diagnosis, TB experts warned this week in the run-up to the 38th World Lung Health conference, which opens tomorrow in Cape Town, South Africa.

This year’s conference is taking place in South Africa in order to highlight the growing challenge of drug-resistant tuberculosis in the regions of the world most seriously affected by HIV.

Last year’s discovery of an outbreak of extensively drug-resistant TB among HIV-positive patients in the rural KwaZulu Natal town of Tugela Ferry rocked the worlds of TB and HIV treatment, and highlighted the need for greater integration of TB and HIV care.

“XDR TB is a wake-up call to ensure a better future of HIV treatment by strengthening TB control,” said Dr Haileyesus Getahun of the World Health Organization Stop TB department, speaking at a workshop on XDR and MDR-TB in the context of HIV, organised by the Treatment Action Group and the Stop TB Partnership.

The XDR outbreak has now spread to every province in South Africa, and two cases have been identified in Mozambique, Dr Lindewe Mvusi, TB director of the South African department of health, reported at the International Union Against Tuberculosis and Lung Disease African regional meeting on Wednesday. Four hundred and eighty-one cases have now been identified in South Africa, 188 in KwaZulu Natal, 157 in Eastern Cape and 64 in the Western Cape, with 281 deaths to date. Two hundred and thirty-five patients are currently receiving treatment in hospital, while 18 patients have been discharged to receive directly observed therapy in the community following conversion to a smear-negative state. Although extensively drug-resistant tuberculosis has been spotted before, notably in China, India and the Russian Federation, this is the first time it has emerged in a region where HIV prevalence is high. The consequences have been particularly bleak in people with HIV, said Dr Neel Gandhi, part of the research team that identified the Tugela Ferry outbreak. Almost all HIV-positive patients died within weeks of being examined for suspected tuberculosis, often before the results of sputum tests could confirm tuberculosis, and XDR-TB was confirmed retrospectively in many patients.

The Church of Scotland hospital in Tugela Ferry has seen little improvement in survival rates since the initial outbreak was identified in April 2006, Dr Gandhi said this week. Where has the XDR-TB outbreak come from? Although there’s little doubt that the current outbreak is due in large part to transmission from person to person, particularly in health care settings, and that proper implementation of infection control measures could greatly reduce the incidence, the initial XDR case must have developed as a result of the evolution of drug resistance in persons receiving first and second-line TB treatment. Molecular analysis of the XDR-TB strains present in Tugela Ferry patients has been able to uncover the gradual accumulation of resistance to more and more drugs.

The road to XDR-TB in KwaZulu Natal began around 1994, when patients first began to develop strains resistant to all first-line drugs. As the decade went on, these drug-resistant strains, circulating in the community, began to accumulate resistance to additional drugs used in second-line TB treatment, until by 2001 the first strain classified as extensively drug resistant is now known to have been present in a patient in KwaZulu Natal. But at the time no one knew just how much drug resistance was already present in some TB patients due to the lack of drug sensitivity testing. The critical step appears to have been presumptive treatment of patients who had failed first-line TB therapy, using a standard regimen of second-line drugs.

Why should it have emerged in KwaZulu Natal? Probably because the province has consistently had the lowest TB cure rate in South Africa; just 45% of patients who commenced TB treatment were pronounced cured in 2006, compared with just over 70% in the Western Cape province. A national drug sensitivity survey carried out in 2001/2002 showed that although the highest prevalence of MDR-TB per capita occurred in the northern provinces of Mpumalanga and Limpopo, the largest numbers of cases of multi-drug resistance were found in KwaZulu Natal and the Western Cape. In addition, KwaZulu Natal has the highest HIV prevalence in South Africa, in excess of 30% in many communities, compared with levels closer to 10% in the Western Cape. HIV-positive people are particularly vulnerable to TB, and likely to have a faster and more virulent course of MDR-TB. All these factors explain why KZN was the site of emergence, but what’s still unclear is whether the outbreak spread across the country from the province, or whether greater vigilance coupled with drug sensitivity testing uncovered a phenomenon that was emerging simultaneously in every province of South Africa.

Other countries in Africa have reason to be concerned about the potential for home-grown outbreaks of XDR-TB. The World Health Organization estimates that alongside South Africa, Nigeria and Ethiopia are the hotspots for MDR-TB in Africa, followed by Tanzania, Malawi, Zambia, Rwanda, Mozambique and the Democratic Republic of Congo. Countries in southern and central Africa are currently investigating whether XDR-TB is present, but surveillance will be hampered by the severe shortage of drug sensitivity testing. Few laboratories are equipped to do it, the equipment is expensive and trained staff are thin on the ground. For most countries, the likelihood that XDR-TB is present will be present is governed by the extent to which patients already have access to second-line TB treatment. Second-line TB treatment is expensive ($1500 - $4000 for a course of treatment), it’s hugely labour intensive and requires hospital beds to be set aside for six to eight months until the patients achieves conversion to smear-negative. Just under 40% of TB programmes in Africa and Asia currently include MDR TB treatment as part of their routine activities, says Dr Haileyesus Getahun of WHO. The WHO and Stop TB Partnership has set a target for the expansion of MDR-TB treatment from 30,000 patients worldwide in 2007 to 1.6 million in 2015. The target is based on the estimated number of patients who fail TB treatment and develop drug resistance to components of the first-line regimen.

Unless efforts to control MDR-TB succeed, said Dr Mario Raviglione, director of WHO’s Stop TB department, “MDR-TB will replace the drug-susceptible strain as the dominant strain. There are countries in the former Soviet Union already approaching 15 – 20% [of new TB cases MDR] today.” But, says Dr Rhehab Chimzizi of Malawi’s National TB Programme, “What is slowing us [in MDR response] is laboratory capacity. We have one lab to do drug sensitivity testing and sputum culture for a country of 12.8 million people!” Until countries can carry out drug sensitivity testing, their requests for free or subsidised second-line drugs are likely to be turned down by WHO’s Green Light Committee, which approves requests for second-line TB drugs based on the capacity of a country to preserve the efficacy of those drugs. Currently, drug sensitivity testing is not only expensive but slow. It can take five to six weeks to establish whether a TB isolate is resistant to rifampicin or isoniazid, or both, often leading to presumptive treatment with an inappropriate combination of drugs that can serve to increase the level of drug resistance. Tests of a new method of diagnosing isoniazid and rifampicin resistance without the need for culturing TB bacteria are currently underway in southern Africa, and if successful, could lead to the approval of a new diagnostic method by WHO within a year.

This would have the potential to speed up MDR treatment, if the investment in laboratory standards takes place now. But, as Dr Mario Raviglione points out, unless donors begin to invest in combating the MDR-TB crisis now, we will fall further and further behind in the fight against MDR-TB. Earlier this year WHO and the Stop TB Partnership issued a call for $2.15 billion to back an extensive plan to combat MDR and XDR TB. So far, he says, there is a funding gap of close to half a billion dollars in 2007, despite the fact that more than 400,000 MDR-TB cases are expected to be diagnosed this year alone. More on MDR and MDR-TB Further reporting on MDR and XDR-TB, including new models of community-based treatment, will appear during the coming week from the 38th World Lung Health conference in Cape Town at http://www.aidsmap.com/

HIV treatment 'failing' in Africa

BBC News, Tuesday, 16 October 2007

More than a third of patients on HIV medication in sub-Saharan Africa die or discontinue their treatment within two years of starting it, a survey shows.

The study found that many were too late taking up anti-retroviral (ARV) drugs, while for some it was impractical to travel to distant clinics.

The US researchers also found evidence that in cases where patients had to pay for ARVs, some stopped treatment. But it showed success rates vary depending on the programme and country.

Daily stress
Details of the study by the Boston University School of Public Health are published online by the Public Library of Science.

The researchers looked at antiretroviral programmes for HIV patients in 13 sub-Saharan countries. They found that two years on from the commencement of treatment, only 61.6% of all patients were still receiving medication. The researchers say there are many reasons for the fall-out rate. Many patients were too late in taking up ARVs in the first place and died within a few months of commencing treatment. Other patients dropped out because of problems with accessing the drugs - they may live some distance, for example, from the clinic which provided the medication.

There was also evidence, the researchers say, of patients discontinuing treatment because of the cost of the drugs in those cases where patients were charged for their ARVs.
Boston University's Dr Christopher Gill says in many cases, taking the ARVs may take a back seat to more pressing daily needs. "Receiving the drug itself is a major investment of a patient's time, so if you live 8 km from the nearest clinic and have to go there once a month and you don't have a ready means of transport it's a huge investment of your own time," he told the BBC.
"And if you're feeling well and you're worried about other things in terms of finding enough to eat or maintaining a job or finding a job I suppose if you were feeling well you might be tempted to see treatment as being a second-order priority.

Poverty
For the director of the Association of People with Aids in Kenya, poverty, a lack of education and an element of stigma are all part of the problem. "If people are not well educated on how to take the drugs, then some patients fall out, and if they do fall out then they develop resistance," Roland Gomol Lenya told the BBC. "We find some people also suffer from stigma: in some workplaces, people are not able to carry their ARVs and take their ARVs freely at workplaces.
"I think there are also the issues of poverty, and the people who administer ARVs should also look at the poverty element, because sometimes because of poverty people are not able to access the centres. "The centres are normally far away from where people live, and that has been a problem." The study shows that retention rates between individual ARV programmes vary widely across Africa. One programme in South Africa retained as many as 85% of their patients after two years while another in Uganda retained only 46% of patients after the same period of time.

Study Finds HIV Infection Rate in Ethiopia Rose By 26 Percent

The rate of the number of people tested for HIV/Aids in Ethiopia since February-August 2007 and found to be positive showed 26 % increase; compared to similar test conducted from November, 2006 -January 2007, a report compiled in September, 2007 disclosed.

The report entitled Millennium Aids Campaign Ethiopia (MAC-E) prepared FHAPCO (M&E Department) states the plans and actual performances carried out on HIV council ling and testing, ART treatments and the momentum for the continuation of the campaign to the third phase where the first two are already completed.

According to the report, in the first phase of the campaign that lasted from Nov 2006-Jan2007, 705,619 people were tested for HIV/AIDS and 37,943(5.4%) were found to be positive.
In the second phase, out of the 982,452 people tested, 70,470 were found to be positive (7.3%), according to the report, which showed a 26% increase by the end of August 2007.

The two major objectives of the campaign in the first phase were testing 320,000 people and enrolling 22,000 new patients to ART service; and more than double were tested. The ART plan for new patients fell short of the set target 11,582 but nevertheless a substantial increase from the previous trend, the report states.

In phase II of the campaign, though it was planned to test and council 1.8 million individuals over the seven months period, 982,452 were actually tested (53%) and 31,359 new individuals started ART (77%) from the 40, 710 planned to initiate.

In a round table discussion prepared yesterday at Internews meeting room, Dr. Yibeltal Assefa, health program officer at HAPCO discussed about the plan for the third phase of the program and the comprehensive Universal Access Program (UAP) set for 2010. He said, "three million test kits are prepared for the new year which will render by far better testing and counseling services than the past years." Sensitization, social mobilization and community conversation are also the major areas of emphasis given in the third phase, according to the officer. In the (UAP), it is planned to achieve to have one health center one test post in each woreda o f the country, Dr. Yibeltal indicated.

Daily Monitor (Addis Ababa)NEWS

Posted to the web 8 October 2007

By Endale Assefa

'Dawn of Hope' in Ethiopia

'Dawn of Hope' in Ethiopia (World Bank News)
June 12, 2007 - In 2000, while finishing a university degree in plant sciences and then working as an agronomist, Sileshi Betelei suffered two serious bouts of illness and found out he had HIV. Counseling helped him find the courage to tell his family, and they were very supportive. He believes their positive attitude stemmed from their understanding that anyone can get HIV.

He returned to work and continued to live a normal life, until 2001 when his CD4 (T-cell) count dropped to a dangerously low level, and he became extremely weak. Though Sileshi wanted to start on antiretroviral medications, he could not afford the drugs then available in Ethiopia. He refers to this period of his life as “the disaster time.”

A year later, Sileshi learned about Dawn of Hope – a local nongovernmental organization in Ethiopia that supports people infected and affected by HIV. He decided to join them, and work on the advocacy campaign to get public provision of free anti-retroviral treatment (ART). During this period he received drugs for opportunistic infections through Dawn of Hope – financed by the Ethiopia MAP. This enabled him to manage his health well enough to keep going, and to get married. His wife is also HIV-positive.

As an activist, Sileshi and others lobbied the government as well as officials from UNAIDS and the Global Fund to Fight AIDS, Tuberculosis and Malaria. In 2004 Ethiopia’s ART program was launched, with money from the Global Fund.

After 18 months on treatment, Sileshi’s CD4 count improved and he felt strong enough to start a second university degree in management. Seeing a future for themselves, Sileshi and his wife began a family. Today, Sileshi is a leader in the Ethiopian AIDS community, representing people living with HIV on the National AIDS Council and the National AIDS Committee Management Board. He is also the proud father of an 18 month-old son, who is HIV-negative, thanks to treatment to prevent transmission from mother-to-child. While it is access to free antiretroviral drugs that is keeping him and his wife healthy today, Sileshi says that they and many other Ethiopians with the virus would not have survived if not for the free drugs to fight opportunistic infections, financed by the World Bank’s Multi-Sectoral AIDS Program.

“The MAP made a big difference in people’s lives,” Sileshi says. “Before treatment, people were dying of opportunistic infections. The MAP enabled us to arrive at the era of antiretroviral treatment.”. He also points out that counseling and home-based care provided through the MAP were essential. “Without counseling, there is no positive living, there is no hope.”

Cadila launches drug production

By Andualem Sisay
Capital

Addis Ababa, Ethiopia - A new 100 mln birr medicine factory, Cadila Pharmaceuticals Limited, which is operating in 43 countries throughout the world, has begun production in Akaki-Kaliti sub city.

The factory is an Indo-Ethiopian joint venture with local company ALMETA Impex and Indian parent company Cadila Pharmaceuticals, with the expatriates holding the majority shares. According to Mr. Nalini Nayak, Marketing Manager of Cadila, the factory will be the first of its kind in East Africa, when it will soon be qualified by the United States Food and Drug Administration (US FDA).
Cadila India has recently qualified to the World health Organization (WHO) Good Management Practice (GMP). "Ethiopia has a very good potential market, which is not yet explored," said Mr.Nayak. Besides, we are happy to work in Ethiopia; where there is a strict drug regulation. It is difficult to find such an atmosphere in other African countries," he said.
Nearly 200 employees have begun operations at CADILA Pharmaceuticals. Anti biotics, anti-malarias, anti-acids, anti-fungal and multivitamins are the medicines that the company is currently producing. Anti-tuberculosis and anti-AIDS drugs are also being planed for production.
In addition to local demand, CADILA Pharmaceuticals will also export its products to neighboring markets such as Kenya, Sudan, Uganda and Djibouti.
Sunshine, Addis, Bethlehem, Pharmacur and Epharm Pharmaceuticals are the existing factories engaged in medicine production. The opening of CADILA Pharmaceuticals will raise the number of medicine factories to six.

Latest & Newest HIV Medication: Prezista for Ethiopia

Aspen signs HIV med deal

Wednesday, April 04, 2007

Tibotec Pharmaceuticals Ltd. Of Ireland on Wednesday announced that it has signed a royalty-free, non-exclusive license agreement with the South African company Aspen Pharmacare.
According to a press release from the two companies, Aspen will register, package and distribute the protease inhibitor PREZISTA (darunavir, DRV) in sub-Saharan Africa.

Source: Health24.com