The
Aurum Institute and its partners, as part of the IMPAACT4TB project, have announced
that five high-burden TB countries will roll out a new, shorter drug regimen
(known as 3HP) to prevent TB.
Countries
that will initially provide the new regimen with funding from Unitaid, U.S.
PEPFAR and the Global Fund include Cambodia, Ethiopia, Kenya, Malawi, South
Africa and Zimbabwe. More than 120,000 patient courses of 3HP will be delivered
by the project to 12 countries in 2020. An additional 1 million patient courses
are expected to reach low- and middle-income countries by the end of the year,
through the combined support of Unitaid, Global Fund, the Stop TB Partnership’s
Global Drug Facility (GDF) and PEPFAR.
“Effective
TB prevention will be a game-changer in the global fight to eliminate tuberculosis,”
said Robert Matiru, director of programmes at Unitaid. “This new, shorter
regimen, which has until now been unaffordable, offers a great opportunity to
turn the tide against TB and protect those who are at highest risk. Preventing
this deadly, airborne disease is even more important at a time when the entire
world fights to control the threat of COVID-19 and where health systems are
being stretched beyond their limits.”
TB
remains the world’s deadliest infectious disease. In 2018 alone, 10 million
people fell ill from the disease which killed around 1.5 million people, over
95% of whom were living in low- and middle-income countries. TB can lie dormant
for decades before it strikes; this is called “latent TB.” People with latent
infection—almost a quarter of the globe—have no symptoms, are not contagious
and most of them don’t know they are infected. If left untreated, latent
infection can develop into active TB, the form of TB that makes people sick and
is capable of being transmitted from one person to another.
“This
is an exciting new step in the fight to end TB, as it is safer, shortens the
duration of preventive therapy and provides more options for those at highest
risk of developing active TB,” said Dr Tereza Kasaeva, Director of the Global
TB programme at WHO. “WHO, through its regional and country offices, is
committed to support scale-up of TB preventive treatment in countries to
achieve the UN HLM targets. These countries will pave the way for 3HP rollout
in other TB high burden countries.”
During
this first phase, 3HP will first be given to those at highest risk of
progressing from TB infection to TB disease, notably people living with HIV
(PLHIV) and children under the age of five. People living with HIV are 20 to 37
times more likely to move from latent to active TB than those without HIV
infection. Often, their infection goes unnoticed until it’s too late, and as a
result people being successfully treated for HIV are now dying from TB.
At
the UN High-Level Meeting on TB in 2018, world leaders committed to providing
TB preventive therapy to at least 30 million people, including 6 million people
living with HIV, by 2022, 4 million children under 5 years and 20 million
household contacts.
“Children
up to five years of age are at highest risk of progressing from TB infection to
disease, yet only about 25% of those who are eligible for it start TB
preventive therapy,” said Dr Matteo Zignol, Unit Head a.i., TB prevention,
diagnosis, treatment, care and innovation, WHO Global TB Programme. “The
scale-up of 3HP among these vulnerable populations will go a long way towards
not only saving lives, but also reducing the overall burden of TB disease.”
In
October 2019, Unitaid, the Global Fund and Sanofi announced a new price
agreement for rifapentine (Priftin®), which drastically discounted the price of
3HP. The agreement with Sanofi lowered a patient treatment course of Priftin®
from $45 to $15 (a 66% discount). The discounted price was made available to
the public sectors of low-income countries, lower-middle income countries and
upper-middle income countries with a high burden of TB and TB/HIV.
“As
of 2018, only 65 countries reported initiating 1.8 million people living with
HIV and around 350,000 children under the age on TB preventive therapy—well
below the targets set at the UN High-Level Meeting on TB which took place in
September 2018,” said Gavin Churchyard, founder and CEO of the Aurum Institute.
“Until recently, price remained a key barrier to scale-up of short course
regimens such as 3HP. Now that this barrier has been removed, it’s time to get
serious about preventing TB, particularly during the SARS-CoV2 pandemic, as
there is some evidence to suggest that active TB may worsen the clinical
outcome of Covid19 disease.”
“Unitaid
is committed to establishing a healthy market for TB preventive therapy, in
line with the political commitments made at the UN high-level meeting on TB,”
said Philippe Duneton, Unitaid Executive Director a.i. “Moving forward, we
intend to support the entry of at least one more generic supplier of the FDC,
as well as other rifapentine-based formulations, including for children.”
“This
is only the first step, and in the coming months the Aurum Institute and its
IMPAACT4TB partners will be working to roll out 3HP to all 12 of its project
countries, which represent almost 50% of the global TB burden,” said Karin
Kanewske Turner, Director of the IMPAACT4TB Project, from the Aurum
Institute.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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