Arvophillia Case Study

The document introduces new treatment guidelines for severe arvophillia in the Republic of Zachistan. Two clinical trials demonstrated that the new drug Clairadol has lower mortality rates and fewer side effects than the current standard treatment, Huffstatin. Based on these trials, the WHO now recommends Clairadol as the preferred treatment globally. However, Zachistan has not yet updated its treatment guidelines. CHAI is working with Zachistan's Ministry of Health to advocate adopting the WHO's Clairadol recommendation based on the strong evidence from the clinical trials.

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Arvophillia Case Study

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Mickelson Joseph Vil

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REPUBLIC OF ZACHISTAN -

INTRODUCING NEW TREATMENT GUIDELINES FOR SEVERE ARVOPHILLIA

Disease Overview

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.

This exercise is confidential and proprietary. Please do not share with others.
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 NEEDAN study. 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 Mortality using Mortality Benefit from

Huffstatin Clairadol Clairadol*
Adults 22% 15% 7%
(>14 years old))
Children 10.9% 8.5% 2.4%
(<14 years old)
*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
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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.

The relevant details and figures are provided in the appendix.

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Appendix

Epidemiological Profile of Republic of Zachistan

Total Population 34,619,949

Diagnosed arvophillia cases in total population 27%
Severe arvophillia among diagnosed cases 5%

Age wise distribution of severe arvophillia population

Age Category Percent of severe arvophillia population Average Weight (kg)

< 3 years 70% 10

3 - 5 years 8% 16

5 - 9 years 2% 23

9 - 14 years 6% 38

> 14 years 14% 62

Treatment Protocol for Huffstatin and Clairadol

ITEM HUFFSTATIN CLAIRADOL

Dosing
Ampoule/ Vial Sharing* NO NO
Unit size 300 mg Ampoule 60 mg Vial
Loading Dose**(mg/kg body weight) 20 2.4
Maintenance Dose*** (mg/kg body 10 2.4
weight)
Number of loading doses 1 1
Number of maintenance doses 9 4
Dextrose required 1ml/mg 5ml/vial
Consumables used/patient
Syringes 10 6
Needles 10 6
Cannulas 3 1
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IV Giving Sets 3 1
*No vial/ampoule sharing means these cannot be shared across doses or across patients. For
example if a dose requires 2.5 vials, it means 3 vials will be used since the unused portion will
be discarded.
**Loading dose: An initial (usually higher) dose of treatment given to get an effective drug
concentration in the body
***Maintenance dose: Follow up doses given for the complete treatment

Price List

ITEM BASIC UNIT UNIT COST (USD)

Huffstatin 300mg Ampoule 0.16
Clairadol 60mg Vial 1.2
Dextrose 500ml Bottle 0.5
Cannula Piece 0.23
IV Giving set Piece 0.17
Syringe Piece 0.05
Needles Piece 0.17

This exercise is confidential and proprietary. Please do not share with others.