Kenya to roll out child-friendly tuberculosis medicines nationwide
NAIROBI – Kenya’s National Tuberculosis, Leprosy and Lung Disease Program (NTLD-Program) announced today that it will roll out child-friendly tuberculosis (TB) medicines across the country from 1 October.
From that date, all children diagnosed in Kenya with TB will be treated using formulations that are affordable, palatable, and simple to administer at the correct doses.
TB medicines specially adapted for children have been available since 2015, as a result of the Unitaid-funded STEP-TB project. In 2013 Unitaid committed 16.72 million dollars towards the implementation of the STEP-TB project, which brought together TB Alliance, and other partners to develop the first formulations of TB medicines that meets dosage guidelines set by the World Health Organization (WHO) in 2010. Going forward, Unitaid has identified a new Area for Intervention that looks at scaling-up use of the improved Paediatric TB treatment in countries.
On World TB Day this year the Kenyan Ministry of Health launched the MulikaTB!MalizaTB! campaign – (Swahili for “Shed the light on TB, End TB”) – to raise awareness of the disease, which remains a public health challenge in the country. With 250 cases per 100,000 citizens in 2014, Kenya continues to appear on the WHO list of high TB burden countries.
Now, NTLD-Program is building on the MulikaTB!MalizaTB! campaign to bring childhood TB to the forefront of the Kenyan response. The aim is to improve the diagnosis and treatment of childhood TB by raising awareness of the issue among health workers and cares givers; to promote the use of child-friendly formulations; and to create sustained public engagement about childhood TB in Kenya through talks and social media campaigns for health workers, care givers and the general public.
The NTLD-Program is training government health workers to diagnose TB in children and to dispense the new medicines where needed. Improved methods of collecting sputum, and the use of GeneXpert machines where available are helping the diagnostic effort. Health workers will also offer Isoniazid Preventive Therapy (IPT) to any child under five years of age who has been exposed to TB.
According to the WHO, at least 1 million children become ill with TB each year and 140,000 children die of this curable disease. The Unitaid-funded formulations launched across Kenya this week are set to change that.
Lesotho: First patients enrolled in revolutionary tuberculosis project
Originally published on Partners In Health’s website.
Dr. KJ Seung is something of a tuberculosis maverick.
He has worked at Partners In Health since 2001, when—fresh out of residency in internal medicine—he went to Peru to battle TB, which was devastating poor families living in shantytowns near Lima. He made sure patients got proper care despite out-of-touch policies that considered drug-resistant TB patients too difficult to treat.
He’s currently doing the same in North Korea, which is experiencing a surge of multidrug-resistant tuberculosis.
Seung now co-leads a project aimed at revolutionizing treatment for multidrug-resistant tuberculosis. endTB, a UNITAID-funded initiative that started in 2015, is implemented by Partners In Health, Médecins Sans Frontières (MSF), and Interactive Research and Development (IRD). It’s bringing new drugs and treatment regimens to 15 countries with among the highest rates of multidrug-resistant tuberculosis in the world. PIH is responsible for implementing the program in six of them: Lesotho, Kazakhstan, Peru, North Korea, Ethiopia, and Nepal.
Seung, who appeared in Boston’s “Top Docs of 2015,” traveled to Lesotho recently, where the first patients have just been enrolled. He explains the endTB program and where we’re headed.
You’ve worked on many TB projects throughout your career. How significant is this one?
Bedaquiline and delamanid are the first new TB drugs in 40 years. There hasn’t been any real TB drug development for a very long time. And it’s really only because of drug-resistant tuberculosis and our old drugs not working that there has been more research. So this is exciting for everybody who works in TB. These drugs look really effective and could potentially change treatment for millions of people per year.
Then there’s the scope of it. Certainly, PIH has never done anything like this before. We’re trying to enroll a lot of patients on treatment with these drugs—patients who are very difficult to treat because they’re infected with highly-resistant strains. They can’t be treated in any other way.
There’s a really strong research component, too. We’re partnering with MSF and IRD for the first time. So there’s a lot of very exciting aspects to this project.
Is ENDTB replacing what a pharmaceutical company would normally do in clinical trials?
No. The drugs we are using have already been developed and tested by pharmaceutical companies. Our project is stepping in where pharmaceutical companies traditionally have problems, because it’s a disease that requires treatment with a combination of drugs.
A good example is HIV. It’s really hard to do a clinical trial of a multidrug regimen if the drugs are made by different companies that may not want to cooperate with each other. With Hepatitis C now, there’s some of that going on.
So we’re stepping in at a stage of development where there are inherent difficulties.
On to Lesotho. Where are we with the project?
We have enrolled 17 patients so far, just a small portion of the 150 we expect to enroll in Lesotho and the 2,600 that will be enrolled in all 15 countries. But a lot of these patients are very difficult to treat. Some of them have been in treatment for years without being cured and are well-known to our medical team. We want to make sure everything is going OK.
To use these drugs the way the World Health Organization recommends requires close monitoring for any potential side effects.
For example, one of the things that has to be done [for each patient] is an electrocardiogram, a record of the heart rhythm. This is not something we had to do with other TB drugs. We need to teach our staff how to use an EKG machine and make sure we have all the proper supplies there.
What will the clinical trial involve?
This is where we’re testing completely novel regimens—new combinations of drugs, much shorter regimens.
In the standard WHO regimen, you’re taking five or six drugs that include an intramuscular injection for eight months. Nobody wants to get an injection every day for eight months, and it has some nasty side effects. So that gets stopped after eight months, and you take the rest of the drugs for another 12 months. The rest of the drugs are mostly old and have a lot of nasty side effects of their own. So it’s a very difficult regimen for patients to follow.
In this new clinical trial, patients will be randomized to regimens that are only nine months long, with no injection.
What is the greatest challenge you’ve come up against in Lesotho?
Honestly, the greatest challenge so far has been getting the new drugs. The project started April 1, but we didn’t actually have any drugs in Lesotho until October. And we only have one of them—bedaquiline. We still don’t have delamanid. But we’re closer now, and we’re going to start shipping that, too.
I think it’s been very challenging for everybody—from the manufacturer who has to scale up production, to the distributor, the Global Drug Facility. It’s a new drug, and they’re getting orders from all over the place.
Are we making progress with the project as a whole?
Yes, we have drugs in almost all PIH sites. We started treating patients in four out of six countries—Lesotho, North Korea, Kazakhstan, and Peru—and are close to starting in the other two. And we’ve had some really good discussions with Ministries of Health in these countries.
The Lesotho government has been really receptive. Patients have been really interested. That just shows we need to work harder and overcome all of these challenges and get these drugs out there.
Jump ahead to February 2017. Where would you like to be in a year?
We want to have a really good comfort level with the drugs—meaning all of our doctors and nurses understanding how to use, monitor, and prescribe them.
We’d like to have data about patients improving clinically, and certainly any data on unexpected side effects that haven’t been found in previous trials.
We want everybody in our countries, including governments, to be really comfortable with the drugs and planning to use them in the future.
Thematic Narrative for Reproductive, Maternal, Newborn and Child Health (RMNCH)
First patients start ENDTB programme in Peru
Originally published on Partners In Health’s website.
Carmen Contreras has seen tuberculosis patients at their worst. They have endured daily injections and swallowed fistfuls of pills for years. As reward for their diligence, some have lost their hearing and their minds as side effects of the toxic medication. One 19-year-old patient she knew, depressed and bone-tired from his years-long struggle, attempted suicide.
At times, it made fighting TB seem like a hopeless endeavor. Until now.
For the first time in 50 years, two new drugs are available to patients battling the most trenchant forms of the disease, known as multidrug-resistant and extensively drug resistant tuberculosis, or MDR- and XDR-TB. Bedaquiline and Delamanid have been used sparingly so far, but their results border on miraculous. So far, patients say they breathe better. They gain weight. And those who tested positive for TB for years have seen their results flip after a couple months of treatment.
Contreras, director of intervention projects with Socios En Salud, as Partners In Health is known in Peru, knows the promise these new drugs hold for her patients.
“When you see with your own eyes how people suffer,” she says, “your happiness is greater when they recover.”
TB is not pretty. And it’s definitely not a disease that only troubled past generations. The World Health Organization named it the most deadly infectious disease after it surpassed HIV in 2014, when it caused 1.5 million deaths worldwide compared to HIV’s 1.2 million. Perhaps most alarming, experts have seen a dramatic increase of new infections that are drug-resistant—some 480,000 in 2014 alone—and therefore harder to cure.
PIH has a long history of combatting MDR-TB, especially in Peru. In the mid-1990s, staff discovered that the first, and usually most effective, line of antibiotics were not helping many of their patients in the slums around the capital of Lima. So they began treating patients with harder to access second-line antibiotics and assigning each a community health worker, who ushered them through care.
The change was immediate and remarkable. Patients who had been treated for years with no relief returned to full health. PIH in Peru has since treated more than 10,500 people for MDR-TB with cure rates of greater than 75 percent—some of the highest in the world. In response, the WHO revised its treatment protocol for MDR-TB in recognition of PIH and other organizations’ innovative approach.
With new TB drugs on the market, PIH could again provide a worldwide example for effective, compassionate care—this time for XDR-TB patients too. As the lead of a groundbreaking program called endTB, PIH is working with nongovernmental organizations Médecins sans Frontières and Interactive Research & Development to offer new treatment regimens that include Bedaquiline and Delamanid to more than 3,000 people across 15 of the most TB-plagued countries—including Peru, Lesotho, and Kazakhstan—over a four-year period. UNITAID is funding the global effort, which launched in April 2015.
Ultimately, endTB partners hope the new drugs will prove to be safer and more effective than other second-line medications, and thus allow treatment periods to be cut in half.
LAUNCHING ENDTB
Peru is one such testing ground. There, PIH is collaborating with the Ministry of Health to include nearly 600 patients in endTB. Of this total, 420 patients will follow the WHO-approved two-year treatment regimen, which entails daily injections for 12 months and a cocktail of pills that will now include one or both of the new drugs. Starting in November, an additional 150 patients will be enrolled in a clinical trial that includes the new drugs, but eliminates injections and shortens patients’ treatment period.
Since both groups will receive the new drugs, ideally both will get better. But success in the clinical trial group would prove that drug-resistant TB patients no longer have to endure daily injections and could take medication for less time—a double-coup for clinicians and patients battling the disease.
Peru staff began contacting the first endTB participants in March, but only after overcoming logistical hurdles. National officials had to be reassured that the new drugs were not more toxic than the current course of treatment. The government then had to formally register and license Bedaquiline and Delamanid. And PIH’s TB team had to figure out how to source and import the new drugs, which are not yet mass-produced. In fact, the team is still awaiting its first order of Delamanid.
Then there is the challenge of locating patients. Peru’s National Committee on Evaluation and Treatment combs through a list of TB patients on a monthly basis to determine eligibility for endTB. If their medical records show long, unsuccessful treatment periods, they become top contenders. Most patients live in and around Lima. Those who don’t are brought to the capital, and PIH finds them and any accompanying family members a place to stay for the long haul ahead.
Once patients agree to participate, they visit their closest health center and meet with a clinician and a PIH health professional, who helps them through treatment. Their first trip is often to the hospital for a day of exams and lab work. Some TB medications have caused deafness and cardiac problems, so patients meet with an otologist and cardiologist for base assessments. Once all results are in, doctors prescribe patients medications that will most effectively combat their specific strain of TB. PIH and its endTB partners source some of these drugs, others are provided by Peru’s Ministry of Health.
The PIH pharmacy receives all the medications, including Bedaquiline and the soon-to-arrive Delamanid, which staff members painstakingly divide into patients’ daily morning and afternoon dosages. Field technicians visit their patients in the morning and at night to ensure they take their drugs. They also note patients’ general health and record adverse reactions, such as anxiety, hearing loss, cramps, and neuropathy.
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SLOW, STEADY PROGRESS
Lourdes Cruzado, PIH’s endTB field coordinator in Peru, says her staff has enrolled 27 participants so far. These men and women, who range in age from 19 to 56, are the sickest of the sick and often dealing with multiple issues. Nine suffer from drug addiction, six from depression. Two are in prison. Another is diabetic, and still another is HIV-positive. Two extremely sick patients, who simply didn’t have much fight left in them after battling the disease for years, died shortly after starting the regimen.
PIH staff help in every way possible. They get them access to mental health counseling and—especially for those coming from rural parts of Peru—connect them with food and transportation to and from doctors’ appointments. They ensure the homes of Lima-based patients are secure and have proper ventilation to control infection. They work to earn the trust of patients who have endured years of unsuccessful, and often debilitating, treatment. And they go along on appointments at health centers, where local staff aren’t always welcoming.
“In some cases, they have told us that patients shouldn’t come, that they could get other people sick,” Cruzado says.
Cynthia Dueňas, an endTB field technician, remembers meeting one patient, whom she greeted with a hug and kiss on the cheek. Seconds later, she noticed the woman was crying and asked what was wrong. “’All this time,’” the woman told her, “’people don’t come close to me and they don’t hug me that way unless they know me.’”
Cruzado tells patients that they will come out ahead of this and be okay. “You truly feel the most sincere hug,” she says. “It’s as if they take refuge in you, they trust you, and those words help them.”
Although endTB was launched in Peru just two months ago, PIH staff already see improvements among their growing group of patients. They have gained weight. They say they feel better, calmer. And they smile more often. Some patients’ sputum samples have even tested negative for TB.
“One of the patients told me, ‘I feel like running!’” Contreras says with a laugh. “I told her, ‘Hold on, please. Don’t do it yet. Very soon, you will.’”
Dueňas understands why patients might have a hard time curbing their enthusiasm about the new drugs available to them now through endTB. “They’ve spent years battling the disease and can’t beat it,” she says. “For them, it’s a leap of faith that this medication is going to save them.”
Unitaid celebrates 10 years of innovation in global health
Ministers of Health from more than 30 countries gathered with national ambassadors and UNITAID partners in Geneva, Switzerland, on 22 May 2016 to celebrate 10 years of UNITAID’s work.
They discussed the organisation’s successes as well as challenges for the future. The ministers also shared ideas about their national policies for HIV, malaria and tuberculosis.
Health ministers and diplomats gathered at Hotel President Wilson in Geneva to celebrate UNITAID’s 10 years of innovation in global health (Video: François Glatz for UNITAID):
Dr Raymonde Goudou Coffie, the Ivorian Minister of Health and the Fight against HIV/AIDS, congratulated UNITAID on work that has helped West Africa, praised its innovative financing model, and urged the organisation to continue to innovate to beat the three diseases. “Now is the time to act, to research and to put vaccines in place,” she said. “The fight continues.” Ivory Coast is using mobile technology to deliver health services, setting a good example for many African countries.
Dr Peter Kumpalume, the Minister for Health of Malawi, listed the top innovations that he would like to see for healthcare in his country. “If we could find a means of eliminating malaria quickly and cheaply, that would be number one,” he said. “Number two would be a test-kit for tuberculosis which is as quick as the Rapid Diagnostic Tests for malaria we currently have.” Kumpalume added that innovation was needed for shorter TB treatments.
Jim O’Neill of the Review on Antimicrobial Resistance called for the reform of our use of antibiotics, warning against using them “like sweets”. He called for banning the use of antibiotics in agriculture, reminding us that 70 % of antibiotics prescribed in the US are for animals. Lord O’Neill also said that the world needs state-of-the-art diagnostics to prevent unnecessary use of antibiotics.
After O’Neill’s presentation on Antimicrobial Resistance, UNITAID chair Philippe Douste-Blazy took the stage to speak of UNITAID’s success over 10 years.
Brazilian minister Celso Amorim, who will soon take over as UNITAID chair from Philippe Douste-Blazy, was there.
Unitaid launches global initiative to prevent tuberculosis
Unitaid announced a new initiative to support global efforts to end tuberculosis by 2035 by seeking to bring preventive treatments to people most likely to develop the disease.
Unitaid is calling for innovative proposals to make new, shorter preventive treatment regimens more easily available to those who could benefit most. The proposals that show most promise will be recommended for funding.
Unitaid’s efforts could reduce the number of cases in countries most affected by tuberculosis, which claims 1.5 million lives every year.
An estimated one-third of the world’s total population has latent tuberculosis, a non-infectious and asymptomatic stage of the disease. Of these, about 15 percent develop active tuberculosis during their lifetime. Children under the age of five and people living with HIV are at much higher risk of developing active tuberculosis – and are more likely to die from it.
People living with HIV, for example, are up to 37 times more likely to develop active tuberculosis following initial infection with the disease. One in every three HIV deaths occurs due to tuberculosis.
“Prevention of tuberculosis offers a golden opportunity to accelerate progress in ending tuberculosis,” said Philippe Douste-Blazy, Chair, Unitaid. “Emerging tools may make it possible for the first time to scale up preventive therapy in countries with high burdens of tuberculosis.”
“Latent tuberculosis is very widespread in Korea and in response my country introduced a program of aggressive treatment in 2011,” said Kwon Jun-Wook, Director General, Public Health Policy Senior Deputy Director, Ministry of Health and Welfare, Republic of Korea. “We therefore welcome Unitaid’s initiative to bring preventive therapy to those who are greatest risk of developing active tuberculosis in resource-limited settings.”
Current treatment requires patients to take pills daily for between 6 and 36 months. Even though this treatment can reduce the risk of tuberculosis dramatically, very few people living with HIV currently have access to it. The long duration and sometimes severe side effects can make adherence difficult. Shorter treatment regimens that are currently under development can reduce treatment to 12 weeks.
“Our goal is to create much-needed market demand by addressing specific challenges, including availability and affordability of the shorter treatment regimens,” said Lelio Marmora, Executive Director, Unitaid.
“Unitaid’s decision to invest in preventive treatment for TB marks a big step forward in our efforts to end TB,” said Dr Mario Raviglione, Director of the World Health Organization’s Global TB Programme. “Unitaid’s funding will drive the development of much-needed innovative tools for TB prevention. This could save millions of lives.”
Unitaid’s investment in tuberculosis prevention is an important part of the global response, and complements existing efforts to diagnose and treat tuberculosis.
- Communiqués de presse en français: Unitaid lance une initiative mondiale pour le traitement préventif de la tuberculose
Unitaid welcomes WHO endorsement of shorter treatment for multidrug-resistant TB
Geneva – UNITAID welcomes new WHO guidelines recommending shorter treatment regimens in specific cases of multidrug-resistant tuberculosis that will cut the length and cost of existing treatment by more than half.
The newly recommended regimen can be completed in 9-12 months at a cost of less than $1,000 per patient. It is expected to make it easier for patients to adhere to treatment, potentially reducing deaths from the disease. It will also make it possible to treat more people with existing resources.
Existing treatment regimens make it necessary for patients to take more than 14,000 pills over a period of up to two years and to receive injections for the first 8 months of treatment. WHO’s new guidelines make treatment easier for patients who are not resistant to the most important drugs used to treat multidrug-resistant tuberculosis. Treatment regimens under development may be able to eliminate injections all together in the future and to replace them with tablets.
WHO is also urging researchers to complete clinical trials in order to strengthen the evidence base supporting use of shorter regimens.
“WHO’s recommendations are a significant step forward in recognizing the need for shorter, less expensive treatment options,” said Lelio Marmora, Executive Director, UNITAID. “We remain commited to our search for better, simpler treatments – including options that eliminate the injectable component – to tackle the growing threat posed by drug-resistant tuberculosis.”
UNITAID’s funding has strengthened the capacity to use a WHO-recommended diagnostic test to identify eligible patients for the shorter treatment. The Expand TB project has shaped the market for a novel diagnostic technique with 103 newly-established or upgraded reference laboratories.
In addition, a $60 million UNITAID investment is speeding access to shorter, less toxic and more effective treatments for multi-drug resistant TB, using the first new drugs developed in almost 50 years: bedaquilline and delamanid.
Tuberculosis is overtaking HIV as the deadliest infection in the world. With over 480,000 cases of multidrug-resistant tuberculosis, growing resistance threatens to undo past gains if it is not checked.