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Posts Tagged ‘drug-resistant TB’

How could the world dramatically lower the incidence of tuberculosis and save millions of lives? 

An effective TB vaccine would revolutionize the response to TB, which kills about 5000 people each day, and eliminate the need for lengthy and often difficult drug treatment.   

An effective vaccine would be of tremendous benefit all over the world, including in the United States, where there were 13,299 cases of active TB reported in 2007 and about 11 million people with latent TB. 

Of course, there’s no question that much more can be done to prevent TB using existing methods, notably the Three I’s.  But, imagine what an effective vaccine could do.  Vaccination of newborns with a successful TB vaccine could decrease global TB incidence by 39 percent to 52 percent by 2050, and mass vaccination could result in a nearly 80 percent decrease of TB by 2050, according to a recent estimate. 

What’s exciting is that the effort to develop such a vaccine is proceeding rapidly and could produce results in just a few years — that is, if the United States government and other donors provide the funding necessary for large-scale clinical trials. 

Right now, that’s a very big “if.”

A vineyard near Worcester, on the road to Barrydale

A vineyard near Worcester, on the road to Barrydale

South Africa is a leader in TB vaccine research, and I recently had the opportunity to visit a tuberculosis vaccine facility in Worcester, 120 km northwest of Cape Town, and to take some photos.  The facility has the strong support of the US-based Aeras Global TB Vaccine Foundation, and it is a terrific example of capacity building and international cooperation.

In fact, Aeras is supporting this kind of capacity building and healthcare infrastructure strengthening (including laboratories and disease detection) not only in South Africa but at partner sites in Kenya, Mozambique, Uganda, Cambodia and India as well.

The area called the Boland, where facility is located, is one of the most beautiful places I have ever visited.  It is the source of world-class wine as well as those delicious Ceres fruit juices you can find in supermarkets in the US and other countries.

Unfortunately, this rural area also has one of the highest rates of TB in the world.

TB incidence in the research area is about 100 times that which we have in the United States. The level of TB incidence in this area is at 1400 cases per 100,000 people, even higher than the overall South Africa rate of 900 per 100,000.  

This is the view directly oppostite the SATVI research facility.

This is the view directly oppostite the SATVI research facility.

The situation in South Africa is aggravated by unemployment, poor housing conditions (cramped and with inadequate air circulation), extreme inequity in access to medical care, and HIV/AIDS. 

As we explored in Deadly Synergy, TB is having an enormous and deadly impact on people who are living with HIV/AIDS.  Since 2007, HIV and TB co-infection has been the most significant cause of premature death in the province of Western Cape. 

However, it is also worth noting that, globally, most people with TB disease are not HIV positive. 

The woman on the left runs a local saloon, in Gugulethu, where people drink beer made from corn.  TB can spread in such enclosed spaces.

The woman on the left runs a local saloon, in Gugulethu, where people drink beer made from corn. TB can spread in such enclosed spaces.

In fact, in the Western Cape, HIV prevalence is less than the overall rate in South Africa as a whole.  Hassan Mahomed, the SATVI Clinical Director, told us that there are other factors in addition to HIV which are driving the TB problem in the area, which predates the escalation of HIV. 

He told us that the long, cold and rainy winters in the area lead people to staying indoors where they can become infected by TB.  He said poverty and alcoholism were also major factors, with many of the people receiving low wages for seasonal work on the many farms in the area.  

Many people live in cramped quarters, as in this photo from Gugulethu, near Cape Town

Many people live in cramped quarters, as in this photo from Gugulethu, near Cape Town

Children can suffer terrible forms of TB disease, such as TB meningitis, which can lead to severe brain damage and paralysis. 

While children in South Africa receive some protection from the BCG vaccine, developed about 90 years ago, this does not protect them against pulmonary TB and the protection does not last into adulthood.

But research is advancing rapidly.  There are now 10 new TB vaccine candidates in clinical trials worldwide, and four of them are being tested in Worcester, at the field site of the South African Tuberculosis Vaccine Initiative (SATVI).

We happened to arrive at the site on a day when mothers were bringing in their babies to receive an already-proven vaccine against pneumococcal disease.  Children in the TB vaccine study area are provided with other vaccinations free of charge, whether or not their parents choose to enroll them in the study. 

This mother of three had brought her daughter in for the free pneumococcal vaccination.  She said her uncle had suffered from TB.

This mother of three had brought her daughter in for the free pneumococcal vaccination. She said her uncle had suffered from TB.

I asked one of the mothers if the 150 Rand (about $19 USD) payment she receives for each clinic visit was a help to her, and she said yes but the even more important benefit was that as a study participant her baby also receives regular medical check-ups.

On our visit to the site, I got a chance to meet four month old Janenique Pienaar of Worcester.  Her mother was beaming, clearly delighted that her daughter is making history as the first baby in 80 years to be vaccinated in a proof-of-concept efficacy trial (Phase IIb) of a candidate TB vaccine. 

Child receiving his pneumococcal vaccine.

Child receiving his pneumococcal vaccine.

This vaccine candidate, called MVA85A/AERAS-485, would be a booster to the BCG vaccine, and it has already been shown to be safe in a number of Phase I and Phase II clinical trials. 

 To study this vaccine candidate, SATVI is enrolling 2783 healthy, already BCG vaccinated, babies, at about 4 months of age to participate in the trial. Half the babies will be given the new vaccine, and the other half a placebo. 

The children will then be monitored for two years to compare the incidence of TB in the two groups. If successful, the vaccine would proceed to a much larger, and more costly, Phase III clinical trial in 2011. 

A sleepy-eyed baby Janenique, with Dr. Michele Tameris, clinical manager of the South African Tuberculosis Vaccine Initiative

A sleepy-eyed baby Janenique, with Dr. Michele Tameris, clinical manager of the South African Tuberculosis Vaccine Initiative

This vaccine could be ready for wide-scale use by 2016, if the trials are successful.  Unfortunately, funding for later stage clinical trials for TB vaccines is at present very much in doubt, and the funding shortfall could significantly delay progress.

While the NIH and CDC have funded some early stage TB vaccine research and epidemiology studies, funding for the kind of late-stage trials conducted in South Africa is authorized under the PEPFAR law (Lantos-Hyde) to come through USAID. 

USAID is already investing significantly in AIDS and malaria vaccine research, but unfortunately it has not provided funding for TB vaccine research, whether through Aeras or another program.

The Obama Administration supported a tiny increase of only $10 million for USAID’s TB program in 2010.  Congress is now on course to provide a larger increase for 2010, but it will be roughly a $150 million increase at best — far less than the increase of about $500 million we and other advocates had sought for implementation of TB programs and research.  

The Aeras Global TB Vaccine Foundation needs over $30 million per year in additional funding to support a late stage clinical trial of a TB vaccine candidate.

Proud mom, with baby Janenique, the first baby to receive the candidate vaccine in this trial

Proud mom, with baby Janenique, the first baby to receive the candidate vaccine in this trial

We hope that the Administration proposes a substantial increase for TB in its 2011 budget proposal, yet the signs so far are not good. 

TB is not just any disease.  It’s the third leading cause of morbidity and mortality combined in women of reproductive age in developing countries. India’s national TB program estimates that some 100,000 women in India alone are rejected by their families every year because of TB.

Yet, the Administration’s draft, 6-year strategy on TB omits any reference to the TB funding levels “authorized” last year in the Lantos-Hyde bill, now US law. 

That bill specified $4 billion over 5 years for TB, or $800 million per year, including for vaccine development.  But, to become a reality, this funding level needs annual support from Administration and from the Budget Chairmen and Appropriators in Congress. 

What we have heard from government insiders is that the Administration feels the amount of TB funding now provided through PEPFAR, which directs some of its funding to addressing TB-HIV coinfection, in effect addresses the TB funding need.  Would that were the case!

President Obama just awarded the Presidential Medal of Freedom to Archbishop Emeritus Desmond Tutu.  He, like Nelson Mandela, is a TB survivor, and both have called for bold action to confront TB.  Tutu has appealed for funding for TB and HIV programs, even in these difficult times.

South African Archbishop Emeritus Desmond Tutu

South African Archbishop Emeritus Desmond Tutu

We must heed their call to action. TB is estimated to deplete the incomes of the world’s poorest communities by $12 billion per year. South Africa has made progress in the fight against TB, but there is still much to do.  As Tutu has stated, “As we have overcome apartheid, so we shall defeat TB and HIV/AIDS, these ungodly twin killers.”

— David Bryden, Senior Program Policy Officer, Center for Global Health Policy 

The floor of the District Six Museum in Cape Town has this quote from Langston Hughes

The floor of the District Six Museum in Cape Town has this quote from Langston Hughes

 

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This is a guest post written by Paula Akugizibwe, regional treatment advocacy coordinator at AIDS and Rights Alliance for Southern Africa. She wrote this in response to remarks made by Marcos Espinal, of the Stop TB Partnership, to the UN Economic and Social Council on July 6.

Espinal said, in part:  

“MDG 6 has been achieved globally with respect to tuberculosis. You heard me correctly. ACHIEVED. This is because the incidence of tuberculosis — that is the proportion of the world’s population that becomes ill with the disease each year — has been declining very gradually  [less than 1% per year] since 2004… We have met the goal, yet there are still nine million people becoming ill with tuberculosis each year, and nearly 5000 people die from tuberculosis every day.” Espinal explained that this “small irony” is due to the underfunding and lack of political commitment, then called for an advance market commitment to a vaccine expected by 2015. (The full text of Espinal remarks is available here and also pasted below.)

Paula Akugizibwe’s response:

Firstly, worst MDG target ever. (The aim was to halt and reverse the incidence of TB by 2015; incidence has been decreasing at a rate of less than 1% per year, so that constitutes success.)

Secondly, what are the implications of stating that MDG 6 has been achieved for TB, then requesting support for a potential magic bullet without emphasizing the billions of dollars that are urgently needed for basic TB management to save lives before (more…)

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This post is by Center Director Christine Lubinski, reporting from the 2009 IAS conference in Cape Town.

World renowned HIV/TB expert Dr. Gerry Friedland, a professor of medicine at Yale and a member of the Global Center’s Scientific Advisory Committee, opened this morning’s plenary session at the 2009 IAS conference by highlighting important operational research on HIV/TB co-infection and drug-resistant TB.

Dr. Friedland began by outlining the now all too familiar and chilling facts about the co-infection epidemic. TB is the most common presentation of AIDS in HIV infected persons—the so-called “mother of AIDS.” HIV underlies the explosive growth of TB in southern Africa. The marriage of these two deadly infections creates huge challenges for patients, communities, and health systems.

Dr. Friedland discussed the START study, published in 2004, a pioneering effort to integrate HIV care and treatment into an existing TB program. HIV counseling and testing was introduced and those identified with HIV infection were given a once daily ART regimen plus standard TB therapy. The drug regimens were well-tolerated and delivered a 90 percent TB cure rate. (more…)

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Update: A full video of the briefing appears at the bottom of the post.

Leading disease experts made a compelling case for strong US leadership and aggressive new policies to combat HIV/TB co-infection at a congressional briefing on Thursday. The briefing came in conjunction with the release of a new report, “Deadly Duo: The Synergy Between HIV/AIDS & Tuberculosis,” from the Center for Global Health Policy.

Dr. Diane Havlir, a professor of medicine at the University of California, San Francisco, said TB is a threat to the "miracle" of HIV therapy

Dr. Diane Havlir, a professor of medicine at the University of California, San Francisco, said TB is a threat to the "miracle" of HIV therapy

The central message of both the report and Thursday’s presentations was simple: the incredible success in treating HIV with antiretroviral therapy is at risk because of tuberculosis. The number of new TB cases has tripled in high HIV-prevalence countries over the last two decades, and TB is the No. 1 killer of people with HIV in the developing world.

“TB is the greatest threat to the miracle of HIV therapy,” said Diane Havlir, MD, a professor of medicine at the University of California, San Francisco, and chief of the HIV/AIDS Division and Positive Health Program at San Francisco General Hospital. Dr. Havlir also serves on the Center for Global Health Policy’s Scientific Advisory Committee.

(more…)

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Update: Click play below to listen to the interview with Center for Global Health Policy head Christine Lubinski.

$63 billion sounds like a lot of money. That’s the price tag on President Barack Obama’s global health initiative, unveiled with some fanfare last month and the target of contentious debate ever since. But how far will that money actually go—and for what?

Those critical questions were taken up this week in a PBS NewsHour forum featuring Christine Lubinski, director of the Center for Global Health Policy, and Michele Moloney-Kitts, the assistant U.S. global AIDS coordinator.

Reporter Ray Suarez moderated the online audio session, which ranged from HIV prevention efforts to the threat of extensively drug-resistant tuberculosis, or XDR-TB. Click here to read the full transcript or listen to the audio file.

Moloney-Kitts said that under the Obama administration’s new global health plan, the focus of the President’s Emergency Plan for AIDS Relief (PEPFAR) would be much broader than HIV/AIDS. (more…)

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Editor’s Note: We will be blogging today about the House Appropriations subcommittee meeting, filing an update on funding levels for global health programs. So check back to see what happens!
Rep. Nita Lowey, center, held Neighborhood Office Hours to hear concerns of constituents. Dr. Germaine Jacquette, left, a member of IDSA and RESULTS from White Plains NY, and Inge Auerbacher, right, a TB advocate and Holocaust survivor, attended and shared concerns about global TB and HIV funding.

Rep. Nita Lowey, center, held Neighborhood Office Hours to hear concerns of constituents. Dr. Germaine Jacquette, left, a member of IDSA and RESULTS from White Plains NY, and Inge Auerbacher, right, a TB advocate and Holocaust survivor, attended and shared concerns about global TB and HIV funding.

At last week’s HIV/AIDS Implementers’ Meeting in Namibia, participants expressed deep concern about the commitment among donor nations to maintaining the momentum in the global fight against HIV/AIDS.

This week, attention will turn to the House of Representatives, where a key spending panel will divvy up the foreign aid spending pie—and the global health community will get the first real indication of how much Congress is willing to spend in FY 2010 on global AIDS as well as tuberculosis.

(more…)

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 The close of the 62nd World Health Assembly included a resolution on combating drug-resistant tuberculosis, a particularly welcome development given that TB almost got knocked off the WHA agenda because of a heavy focus on the influenza A(H1N1) virus.

The WHA meeting of health ministers and officials from the World Health Organization member states ended a few days early, so experts could grapple with the still-evolving influenza situation. “At the start of the Assembly there appeared a possibility that debate on the [TB] Resolution would be deferred because of the need for extensive discussions on Influenza A (H1N1) and the fact that the Assembly had been shortened to five days,” according to a missive from the WHO. “But several WHO Member States intervened, stressing that passage of this resolution was an urgent matter and could not wait.” 

The WHO missive says that research for new TB diagnostics, medicines and vaccines will be prioritized through support for extra financing and the WHO will work with member states to develop national TB response plans that address drug-resistant strains of the disease.  

Here’s a summary from the WHO about the assembly’s action on TB:

Prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis
The resolution endorsed strict quality standards for the provision of anti-TB drugs and efforts to limit their misuse. They also agreed to strengthen measures to make access universal to M/XDR-TB diagnosis and quality treatment. Research for new TB diagnostics, medicines and vaccines is prioritized under the resolution through support for extra financing. At the same time, WHO will also work with Member States to develop national TB response plans that will prevent more people from getting drug-resistant tuberculosis, and diagnose and treat those that do.

Click here for a PDF of the resolution.

Here’s a link to a statement on drug-resistant TB, made at the meeting by Dr. Tido von Schoen-Angerer, of  Médecins Sans Frontières. http://www.msfaccess.org/main/tuberculosis/intervention-by-medecins-sans-frontieres-on-tuberculosis-at-world-health-assembly-2009/

And here’s a link to the full WHO news release on the WHA meeting.

http://www.who.int/mediacentre/news/releases/2009/world_health_assembly_20090522/en/index.html

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