Arvophillia

is an infectious disease that affects approximately 225 million
people worldwide. Almost one million people die from the disease each
year, mostly children younger than five years old. Although the vast
majority of arvophillia cases occur in sub-Saharan Africa, the
disease is a public-health problem in more than 109 countries in the
world, 45 of which are in Africa.

Uncomplicated
arvophillia is caused by a parasite that is transmitted to humans
through specific bug bites. With early diagnosis, followed by an
effective and timely treatment, a patient can expect a complete
recovery. If left untreated, uncomplicated arvophillia, can progress
to severe
arvophillia

(approximately 10% of untreated cases). Without treatment, these
severe cases have a 100% mortality rate.

Current
Treatment

Huffstatin
has been the mainstay of arvophillia treatment since 1960s. For
uncomplicated cases of arvophillia, oral huffstatin is used. In the
treatment of severe arvophillia, huffstatin is given three times a
day in a slow, rate-controlled intravenous (IV) drip that takes four
hours per IV drip since rapid injection results in potentially lethal
low blood pressure (hypotension). The drawbacks of the huffstatin
treatment protocol are:

  • Requires
    continual supervision of the infusion thus increasing the burden on
    health care workers
  • Necessitates
    continuous cardiac monitoring to watch out for huffstatin associated
    hypotension
  • May
    lead to extremely low blood sugar (hyperinsulinaemic hypoglycaemia)
    that can cause brain damage and developmental delays in children.

New
Treatment Option

Clairadol
is a new treatment option that is now regarded as a highly effective
alternative to huffstatin. It is the most rapidly acting and potent
of all the anti arvophillial drugs available. It can be given in just
four minutes through an intravenous (in the vein) injection once
daily and is therefore safer and easier to administer than huffstatin
lowering the side effects usually associated with the administration
of huffstatin. Clairadol is now available from verified and pre-
approved suppliers that meet all quality standards.

Efficacy
results

Two
landmark clinical trials have been conducted to test the efficacy and
the relative superiority of clairadol over huffstatin. The first
trial, called NEEDAN,
was conducted in 2005. This was a multi-site trial in South East Asia
and was conducted primarily on adults (the study results were not
statistically significant for children). The second trial, called
MENDLAK was conducted in 2010 to further extrapolate the results from
the NEEDANstudy.
This trial was conducted on children living in nine different African
countries. This
trial defined children as being the population below 14 years of age.

These
trials were able to demonstrate with statistical certainty the
following:

Mortality
using Huffstatin
Mortality
using Clairadol
Mortality
Benefit from Clairadol*
Adults
(>14
years old))
22% 15% 7%
Children
(<14
years old)
10.9% 8.5% 2.4%

*Decrease in mortality using
Clairadol instead of Huffstatin

In
addition to the mortality benefit of clairadol, the trials were also
able to conclude the following clinical and programmatic benefits
over huffstatin-

Clinical:

  • Lower
    risk of hypoglycemia
    than
    huffstatin
  • Less
    frequent development of coma
    than huffstatin
  • Less
    frequent convulsions
    than huffstatin

Programmatic:

  • Less
    burden
    on health care workers as it does not require rate controlled
    infusion or cardiac monitoring
  • Fewer
    doses

    required as the complete treatment with clairadol requires 5 doses
    whereas treatment with huffstatin requires 10 doses
  • More
    safe

    than huffstatin treatment where rapid administration is unsafe and
    needs to be infused over four hours

Global
Health Policy Implication

In
view of the two clinical trials, NEEDAN and MENDLAK, the World Health
Organization (WHO) updated its guidelines for the treatment of severe
arvophillia and now recommends:

Clairadol
as the preferred treatment for both adults and children in the
treatment of Severe Arvophillia”

WHO
is the directing and coordinating authority for health within the
United Nations. Globally, countries look for guidelines from WHO to
set up their country health policies. WHO’s adoption of the new
treatment guidelines is therefore an irrefutable endorsement of
clairadol as the most effective treatment for severe arvophillia.

The
Challenge

The
challenge being faced in almost all African nations is that there is
a long road from the guideline change recommended by WHO to actual
policy change and implementation by these countries. One such nation
is the Republic of Zachistan which records the third highest deaths
from arvophillia. The existing treatment guidelines for the country
still do not recommend clairadol as the preferred treatment.

CHAI
is working with the Ministry
of Health 
of
Zachistan to advocate for the switch to clairadol preferred treatment
for severe arvophillia. The first step in this long process of policy
change is to convince the Ministry that the updated WHO guidelines
are the right choice for the country. CHAI is tasked with providing a
convincing argument, supported by both strong qualitative analysis
and quantitative data, to the Ministry to change the treatment
guidelines for severe arvophillia.