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| Prof Benson Edagwa designed the required modifications of the new product |
A
US-based Kenyan scientist has unveiled the world's first antiretroviral (ARV)
drug to be taken once-a-year.
Professor Benson Edagwa and his
colleagues at the University of Nebraska Medical Center modified an existing
ARV drug - cabotegravir - to enable the body to absorb and release it slowly
from tissues over 12 months.
“This occurs for extended time
periods, and in laboratory and animal testing, up to a year,” said Edagwa, who
designed and produced the required modifications of the new product.
The new formulation will be given
as an injection once a year.
The breakthrough was reported on
Monday in Nature
Materials, a leading peer-reviewed biomedical research journal.
The
discovery means people living with HIV will not have to take drugs daily, as it
is the case at the moment.
The
new pill, according to the scientists, could also act as a vaccine for healthy
people who take it and have unprotected sex.
It's
however, not a cure for HIV/Aids.
Edagwa,
a former Moi University chemistry student, co-developed the new formulation
with Professor Howard Gendelman, a virologist and chairman of the Department of
Pharmacology and Experimental Neuroscience at UNMC.
Edagwa, who comes from Vihiga, works
as an assistant professor in the department.
The two scientists have tested the new drug on mice and non-human
primates and found it safe and effective.
"To date, no adverse side effects have been demonstrated in any of
the animal testing models," the University of Nebraska Medical School said
in a statement.
ARVs are well-proven to suppress HIV if taken consistently by infected
people. This means the new product can act both as a vaccine for negative
people and treatment for those already infected.
"Human testing has not begun, but the development necessary to
achieve this goal is ongoing with the assistance of scientists from the Clinton
Health Access Initiative," UNMC said.
The university said they have also begun collecting requirements necessary
to obtain US Food and Drug Administration approval to eventually enter the
market.
Researchers in Kenya called the development a breakthrough.
Leading HIV researcher Peter Cherutich welcomed the good news. He
said it could take nearly five years before the product enters the
market.
"It will have to be shown in humans that it would achieve durable
viral suppression for a year and, of course, supply chains and production lines
will have to be established so we are looking at three to five years before availability,"
Dr Cherutich told the Star.
He was the principal investigator
of the recent Kenya Population-based HIV
Impact Assessment survey.
Cherutich predicted the product
would be well-received in Africa and would reduce healthcare costs.
"Clinic
visits will be reduced, leaving health providers to provide other essential
services like immunisations and also the patients would have more time for
other economic activities. Supply chain would be easier and predictable and
most likely cheaper," he said.
HIV
used to be a death sentence in the 1990s, but it is currently a chronic
condition kept in check by daily pills.
Kenya has the fourth-largest HIV
epidemic in the world with 1.5 million people living with HIV in 2019.
The
virus is spreading fastest among the youth, who also report the highest levels
of non-adherence to the rigorous daily pill schedule.
The
new product has the potential to eliminate complications that arise from
missing doses.
“This
pharmaceutical development has the potential to not only treat but also prevent
viral transmission,” said Gendelman, who designed the pharmacological testing.
“This may certainly be a therapeutic milestone.”
Edagwa
and Gendelman also credited a large team of scientists within the department
for work on the project, including instructor Aditya Bade and graduate student
Tanmay Kulkarni.
Head
of the Kenya Treatment Access Movement James Kamau said: "This is
groundbreaking and will take away the daily pill burden."
Kamau
was, however, concerned that once-a-year ARV would erode other gains like viral
load monitoring which are carried out routinely when patients go to pick their
ARVs.
"The
question is: Why would we jump to a once-a-year ARV when we haven't gotten a
once a month one?"
Nelson
Otuoma, head of Nephak, a network of people living with HIV, also welcomed the
development.
"It's
good progress although it may take time before it's available in Kenya,"
he said.
The cabotegravir drug or CAB was originally
developed by ViiV Healthcare, a pharmaceutical subsidiary of GlaxoSmithKline
that specialises in the development of therapies for HIV infection.
Edagwa
and Gendelman created the
year-long-acting medicine by chemically converting cabotegravir into
a nanocrystal and allowing the body’s own enzymes to slowly convert the
modified drug into an active form that can be slowly released from tissue
stores.
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