• Nigeria to begin study on pre-exposure
prophylaxis in Nnewi, Calabar, Jos • NACA
roundtable calls for nationwide introduction
of novel drug
prophylaxis in Nnewi, Calabar, Jos • NACA
roundtable calls for nationwide introduction
of novel drug
A new study has found that 100 per cent of
participants taking Human Immuno-deficiency
Virus (HIV)/Acquired Immune Deficiency
Syndrome (AIDS) prevention pill remained
infection free.
The study conducted at Kaiser Permanente in
San Francisco, United States (U.S.) involved
more than 600 high-risk individuals, most of
whom were men who have sex with men.
These individuals were healthy at the time of
enrollment and were put on a daily regimen
of a blue pill called Truvada as a pre-
exposure prophylaxis (PrEP).
Lead author Jonathan Volk, a physician and
epidemiologist at Kaiser Permanente San
Francisco Medical Center, described the
study as “the first to extend the
understanding of the use of PrEP in a real-
world setting and suggests that the treatment
may prevent new HIV infections even in a
high-risk setting.”
The U.S. Centers for Disease Control and
Prevention (CDC) says that PrEP has been
shown to reduce the risk of HIV infection by
up to 92 percent when taken consistently but
is much less effective when taken
inconsistently. In one key study, called
PROUD that included men who have sex with
men in Britain, the risk was reduced by 86
percent.
In this study, 100 percent of the participants
remained HIV-free. That’s right, not a single
person in the study, published in Clinical
Infectious Diseases, became infected while
on the drug during the study period that
included 2.5 years of observation.
“Tremendously good news,” University of
California-San Francisco researchers Kimberly
A. Koester and Robert M. Grant (one of
Time’s most influential people of 2012 for
his work in AIDS) said of the results in a
commentary accompanying the publication of
the study.
Not long after the Food and Drug
Administration first approved the drug for
preventive HIV use in 2012, the Los Angeles-
based AIDS Healthcare Foundation derided it
as a “party drug” and warned that high-risk
individuals would use it instead of condoms
— raising the risk of transmission of other
sexually transmitted diseases. #Truvadawhore
went viral. But as more studies have come
out showing how well it appears to protect
against HIV, many of those critics appear to
be turning around.
Koester and Grant emphasized that despite
the promising findings in the Kaiser study
many questions still remain, a number of
them practical in nature.
“What proportion of the population vulnerable
to HIV will take a pill a day to prevent it?
How will costs of the medication and clinic
visits be paid for?” they asked. “Assuming
people are willing to use PrEP and can
access PrEP, will they take the medication as
directed? Will uptake and use be higher or
lower among those at higher risk? Will people
place themselves at higher risk or HIV and
sexually transmitted infections (STIs) as a
consequence of using PrEP?”
The pair said it wasn’t clear from the study if
the reported rate of sexually transmitted
infections in the study is an increase or not
and that further investigation is needed. They
recommended that Truvada be combined with
a parallel plan to prevent other Sexually
Transmitted Infections (STIs), which may
include the use of condoms, more frequent
testing and discussions with prospective
partners.
Meanwhile, Nigeria is in a process of
commencing a study on PrEP and Treatment
as Prevention (TasP).
Nigeria is going into the study through the
National Agency for the Control of AIDS,
NACA, because of its immense positive
effects on the HIV/AIDS epidemic in the
country.
Until now, multiple studies have established
that anti-retroviral drugs could be used to
reduce the rate of infection in a population in
two different ways, known by the acronyms
PrEP and TasP.
Pre-exposure prophylaxis, or PrEP, is a
procedure for people who do not have HIV
but who are at substantial risk of contracting
the virus to prevent HIV infection by taking a
pill every day. The pill (brand name Truvada),
which contains two medicines (tenofovir and
emtricitabine) were used in combination with
other medicines to treat HIV. When someone
is exposed to HIV through sex or injection
drug use, these medicines can work to keep
the virus from establishing a permanent
infection.
Treatment as Prevention or TasP, on the other
hand, targets people who are already infected
with HIV-1, reducing their infectiousness in
the population.
Multiple studies have established that, after
about the first six months of treatment, anti-
retroviral therapy (ART) reduces HIV-1
concentrations to undetectable levels in
blood plasma and genital compartments.
Additional studies have demonstrated that
HIV transmission by an infected person is
significantly reduced when that person
adheres to ART well enough to maintain viral
suppression.
Chief Communications Officer (NACA), Toyin
Aderibigbe, said the study is not being done
to determine whether PrEP works or not as it
has long been established that PrEP actually
works when used in combination with other
methods of HIV prevention.
She said the study is however being carried
out in Nigeria to see whether it will work in
real life situations among the Nigerian
population under normal conditions. The
initial studies that showed that PrEP works
were done under well-controlled situations.
Aderigbigbe further explained: “NACA and
other key players that will participate in this
study will collect relevant data that will tell
us how these strategies will work in real life
situations. Thus the study is expected to
provide needed information on how to
implement the strategies in a large
population as part of a comprehensive public
health program aimed at preventing HIV
infection. The treatment strategy to be used
in this project will adopt both TasP and
PrEP.”
She said three sites have been selected for
the study. “They are Nnewi in Anambra State,
Calabar in Cross River State and Jos in
Plateau State. Teams for the study that will
work at various sites are being put in place,”
Aderigbigbe said.
She said some of the questions that the
study teams will be trying to answer include
the following:
What are the barriers to uptake, that is, why
would people hesitate to adopt a prevention
strategy?
What are the barriers to adherence, that is,
what would prevent a person who has started
PrEP or ART from continuing it?
What are the most cost-effective ways of
delivering, not just the drugs, but the
counseling and support needed to make the
strategies work? Should there be a separate
program? Is it better done within an
established programme?
Aderigbigbe added: “Sero-discordant couples
are couples in which one partner is HIV
positive while the other partner is HIV
negative. ART, necessary for TasP, is not
indicated for the infected partner until quite
some time after initial diagnosis. So the
study will provide an avenue for PrEP and
TasP to work together for long-term
prevention of HIV infection for a sero-
discordant couples. Throughout this period,
the uninfected partner is at elevated risk.
However, if PrEP is adopted by the uninfected
partner when the infected partner is
diagnosed, that risk is significantly reduced.
Eventually the infected partner begins ART
(TasP) and sometime later achieves viral
suppression.
“At this point PrEP can be stopped because
once the infected partner is suppressed
(undetectable levels of the virus), the risk of
transmission of HIV to the uninfected partner
is significantly reduced.”
She said the project will have three primary
goals:
•Construct a model that effectively delivers
PrEP to serodiscordant couples. Within the
context of this goal, the measure of
effectiveness will be the number of new
infections averted.
•Measure the cost effectiveness of the
model. The measure of cost effectiveness
will be cost per life-year gained and cost per
infection averted
•Estimate what would be needed to scale up
the delivery model to the national level.
“NACA understands that, given the data and
experience to be gained from the project, it
should be possible to present this to
stakeholders for consideration as part of the
policy and guidelines for the comprehensive
combination prevention programme in the
country,” she said.
Meanwhile, there are several dozen other
ongoing clinical trials worldwide using
Truvada in different populations. In South
Africa, for instance, National Institutes of
Health-funded researchers are looking at its
use in heterosexual adolescent men and
women ages 15 to 19 and in Australia the
government is looking at people in
relationships with HIV-negative partners. The
issues they are hoping to find out more about
include the factors that can influence an
individual’s compliance with taking the pills
regularly, how effective the pill can be when
it’s not taken regularly but before and after
sex, and how to integrate education about
Truvada into regular clinic services.
A previous story stated that another study on
Truvada found that the drug prevented
infection in about 86 percent of participants.
The study, called PROUD, lowered their risk
by 86 percent.
