ETHIOPIAN HEALTH AND

RESEARCH INSTITUTE-EHNRI
PUBLIC HEALTH EMERGECNY MANAGEMNT-PHEM

INTERIM TREATMENT PROTOCOL

OF INFLUENZA A H1N1.

May 2009
Contents Page
I. INTRODUCTION ........................................................................................................................ 1

II. IDENTIFICATION OF CASES........................................................................................... 1

2.1 Clinical findings: ................................................................................................................ 1

2.2 Case definitions ................................................................................................................. 1

III. GROUPS AT HIGH RISK FOR COMPLICATIONS .................................................. 2

IV. TESTING OF PATIENTS FOR NOVEL INFLUENZA A (H1N1)......................... 2

V. CASE MANAGEMENT ............................................................................................................... 2

VI. CONTACT MANAGEMENT .................................................................................................. 6

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 I. INTRODUCTION

Appropriate treatment of cases is a crucial component of outbreak response and can

help to reduce morbidity and mortality and reduce disease transmission.

The new influenza A (H1N1) treatment protocol takes into consideration the shortage
of antiviral drugs, including the high incidence of underlying health conditions like
malaria, tuberculosis, malnutrition and HIV/AIDs.

The purpose of this document is to guide clinicians on how to manage the spectrum of
illnesses caused by the new influenza A H1N1. It should be noted that it may change
with increased knowledge about the disease and/or if disease patterns change and
based on availability of antiviral drugs.

II. IDENTIFICATION OF CASES

2.1 Clinical findings:

• acute febrile respiratory illness (fever >38°C) with the spectrum of disease
from influenza-like illness to pneumonia.

• Mild disease: is defined as a person with sudden onset of fever of >38 ºC and
cough or sore throat, rhinorrhea, myalgias, arthralgias, vomiting or diarrhea in
the absence of other diagnoses.

• Severe disease: Severity criteria include: Fever >38c; Dyspnoea;

Tachypnoea; Hypotension; Hypoxia; Chest X-ray abnormality.

• Complications of Influenza a (H1N1) are similar to seasonal influenza:

Exacerbation of underlying chronic medical conditions, upper and lower

respiratory tract disease, cardiac, musculoskeletal, neurologic toxic shock
syndrome, and secondary bacterial pneumonia with or without sepsis
(particularly, staph pneumonia, in the elderly and gram negative pneumonia in
the infant). Severe outcomes, including respiratory failure and death have
occasionally occurred.

2.2 Case definitions

A Suspected Case
a person with acute febrile respiratory illness : fever, cough, sore throat,
shortness of breath, difficulty in breathing or chest pains) with onset:

• within 7 days of close contact with a person who is a probable or confirmed

case of the new influenza A (H1N1) virus infection, or
• within 7 days of travel to a community internationally where there has been one
or more confirmed novel influenza A (H1N1) cases, or
• resides in a community where there are confirmed new influenza cases.

A Probable case:
an individual with an influenza test that is positive for influenza A, but is
unsubtypable by reagents used to detect seasonal influenza virus infection
OR
An individual with a clinically compatible illness or who died of an
unexplained acute respiratory illness who is considered to be
epidemiologically linked to a probable or confirmed case.
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 A Confirmed case :
an individual with laboratory confirmed new influenza A(H1N1) virus
infection by :
• real-time RT-PCR,

III. GROUPS AT HIGH RISK FOR( DEVELOPING A/H1N)

The same age and risk groups who are at higher risk for seasonal influenza
complications are considered at higher risk for novel influenza A (H1N1) complications
as there is currently, insufficient data to precisely determine who is at higher risk for
complications of novel influenza A (H1N1) virus infection

These risk groups include:

• Children younger than 2 years old. The risk for severe complications
from seasonal influenza is highest among children younger than 2
years old.
• Adults 60 years of age and older.
• Persons with the following conditions:
o Chronic pulmonary (including asthma), cardiovascular (except
hypertension), renal, hepatic, hematological (including sickle
cell disease), neurologic, neuromuscular, or metabolic
disorders (including diabetes mellitus);
o Immunosuppression, including that caused by medications or
by HIV;
o Pregnant women;
o Persons younger than 19 years of age who are receiving long-
term aspirin therapy;

IV. TESTING OF PATIENTS FOR NOVEL INFLUENZA A (H1N1)

Clinicians should test persons for the novel influenza (H1N1) virus if they have an
acute febrile respiratory illness or sepsis-like syndrome. Certain groups may have
atypical presentations including infants, elderly and immunocompromised persons.

• Priority for testing includes persons

1) with severe disease who require hospitalization or

2) and/or are at high-risk for severe disease (as listed above).

Clinicians should use their clinical judgment in addition to this guidance for deciding
when to test for novel influenza A (H1N1). Clinicians should be familiar with clinical
and epidemiological data to collection and information on specimen transport to the
national reference laboratory. (This is good it enforces what I have suggested above)

V. CASE MANAGEMENT
Clinical management of influenza A H1N1 takes into consideration severity of illness,
risk for complications and laboratory test results.

Antiviral therapy: The novel influenza (H1N1) virus is susceptible to both

oseltamivir and zanamivir. It is resistant to amantadine and rimantadine.
Recommendations for use of antivirals may change as data on antiviral effectiveness,
clinical spectrum of illness, adverse events from antiviral use, and antiviral
susceptibility data become available.

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 Antiviral recommended treatment for:

1. All hospitalised patients with confirmed new Influenza A

(H1N1)
2. Patient who are at higher risk for influenza complication
(See above)
3. All laboratory confirmed cases showing severe signs of
complication should be treated with antiviral1.

Once the decision to administer antiviral treatment is made, treatment with

oseltamivir should be initiated as soon as possible after the onset of symptoms.
Evidence for benefits from antiviral treatment is strongest when treatment is started
within 48 hours of illness onset. Recommended duration of treatment is five days.

Antiviral doses recommended for treatment of novel H1N1 influenza virus infection in
adults or children 1 year of age or older are indicated on Table 1

Oseltamivir use for children <1 year old is age-based (Table 2)

The use of Oseltamivir can be associated with seizures, confusion or abnormal

behaviour early during the course of illness, particularly among children and
adolescents. Patients taking oseltamivir should be monitored for unusual behavior
and if these signs are noted, health authorities should be contacted immediately.

Antibiotic therapy: Antibiotic chemoprophylaxis should not be used. However, when

pneumonia is present, antibiotic treatment should in general follow recommendations
from published evidence-based guidelines for community-acquired pneumonia for
example, amoxicillin or ampicillin for children.

Use of corticosteroids: There are reports of corticosteroids being used in the

treatment of suspected or confirmed cases of H1N1. Corticosteroids should not be
used routinely, but in low doses may be considered for patients with septic shock with
suspected adrenal insufficiency who require vasopressors1. Historical experience
shows that prolonged or high dose corticosteroids can result in serious adverse events
in influenza virus-infected patients, including opportunistic infection.

Special Considerations for Children: The characteristics of human infection novel

(H1N1) influenza virus are still being studied, and it is not known whether infants are
at higher risk for complications associated with novel (H1N1) influenza virus infection
compared to older children and adults.

Limited safety data on oseltamivir treatment for seasonal influenza in children less
than one year of age suggest that severe adverse events are rare. Because infants
experience high rates of morbidity and mortality from influenza, infants with novel
(H1N1) influenza virus infections may benefit from treatment using oseltamivir.

Aspirin or aspirin-containing products should not be administered to any confirmed or

suspected ill case of novel influenza H1N1 virus infection aged 18 years old and
younger due to the risk of Reye syndrome. For relief of fever, other anti-pyretic
medications such as acetaminophen or non- steroidal anti-inflammatory drugs are
recommended.

1
Agent that causes vasoconstriction and maintains or increases blood pressure e.g. norepinephrine, epinephrine
or dopamine
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 Table 1. Antiviral medication dosing recommendation for treatment or
chemoprophylaxis of New Influenza A (H1N1) infection.
Age group Treatment Chemoprohylaxis
Oseltamivir
Adult 75 – mg capsule twice per 75 mg capsule once per
day for 5 days day
Children ≥ 15 kg or less 30 mg orally twice a day 30mg once per day
12 months 15-23 kg 45 mg orally twice a day 45 mg once per day
24-40 kg 60 mg orally twice a day 60mg once per day
> 40 kg 75 mg orally twice a day 75 mg once per day
Zanamivir
< 7 years of age Consult specialist
> 7 years or adult Two 5 mg inhalations twice a day Two 5 mg inhalations once per day

Table 2. Dosing recommendations for antiviral treatment of children

younger than 1 year using Osetamivir*.
Age Recommendation treatment dose for 5 days
< 3Months 12 mg twice daily
3-5 Months 20 mg twice daily
6- 11 Months 25 mg twice daily

Table 3. Dosing recommendations for antiviral prophylaxis of children younger than 1 year
using Osetamivir.
Age Recommendation treatment dose for 5 days
< 3Months Not recommended unless situation judged critical due to
limited data on use in this age group
3-5 Months 20 mg once daily
6- 11 Months 25 mg once daily
*Healthcare providers should be aware of the lack of data on safety and dosing when considering oseltamivir
use in a seriously ill young infant with confirmed new (H1N1) influenza virus infection or who has been exposed
to a confirmed new (H1N1) influenza case, and carefully monitor infants for adverse events when oseltamivir is
used.

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Table 4.Summary of treatment considerations for clinical management of
influenza A(H1N1) virus infection
Modalities Strategies
Antibiotics In case of pneumonia, empiric treatment for community
acquired pneumonia (CAP) per published guidelines
pending microbiologic results (e.g. 2-3 days); tailored
therapy thereafter if pathogen(s) identified
Oxygen therapy Monitor oxygen saturation and maintain SaO2 over 90%
with nasal cannulae or face mask
Antiviral therapy If treatment needed, oseltamivir or zanamivir are the
(Neuraminidase choice.
Inhibitors)
NSAIDS, antipyretics Paracetamol (acetaminophen) given orally or by
suppository will generally be sufficient in most cases as an
anti-pyretic treatment. Avoid administration of salicylates
(aspirin and aspirin containing products) in children and
young adults (< 18 years old) due to risk of Reye's
syndrome
High dose steroids Moderate to High Dose Steroids are of unproven benefit
and potentially harmful (and could theoretically contribute
to prolonged viral shedding): not recommended
Infection control Whenever performing high risk aerosol-generating
procedures (e.g. bronchoscopy, any procedure involving
aspiration of respiratory tract, etc) use particular respirator
(N95), eye protection, gowns, gloves, and an airborne
precaution room, that can be naturally or mechanically
ventilated.

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VI. CONTACT MANAGEMENT

Close Contact: Close contact, for the purposes of this document, is defined as having
cared for or lived with a person who is a confirmed, probable or suspected case of novel
influenza A (H1N1), or having been in a setting where there was a high likelihood of
contact with respiratory droplets and/or body fluids of such a person.

Examples of close contact include kissing or embracing, sharing eating or drinking

utensils, physical examination, or any other contact between persons likely to
result in exposure to respiratory droplets. Close contact typically does not include
activities such as walking by an infected person or sitting across from a
symptomatic patient in a waiting room or office or airport, bus or train station,
ships, ferries or boats.

Antiviral Chemoprophylaxis for Novel (H1N1) Influenza:

• For antiviral chemoprophylaxis of novel (H1N1) influenza virus infection,
oseltamivir is recommended (Table 1). Duration of antiviral chemoprophylaxis
post-exposure is 10 days after the last known exposure to novel (H1N1)
influenza.
• The indication for post-exposure chemoprophylaxis is based upon close contact
with a person who is a confirmed case of novel influenza A (H1N1) virus
infection during the infectious period of the case.
• The infectious period is defined as one day before until 7 days after the case’s
onset of illness. If the contact occurred with a case whose illness started more
than 7 days before contact with the person under consideration for antivirals,
then chemoprophylaxis is not necessary.
• For pre-exposure chemoprophylaxis, antiviral medications should be given
during the potential exposure period and continued for 10 days after the last
known exposure to a person with novel (H1N1) influenza virus infection during
the cases infectious period. Oseltamivir can also be used for chemoprophylaxis
for children less than 1 year of age (see Children Under 1 Year of Age).
• Post exposure antiviral chemoprophylaxis with either oseltamivir or zanamivir
can be considered for the following:
o Close contacts of cases (confirmed) who are at high-risk for
complications of influenza
o Health care personnel, public health workers, or first responders who
haves had a recognized, unprotected close contact exposure to a person
with novel (H1N1) influenza virus infection (confirmed) during that
person’s infectious period.
o Pre-exposure antiviral chemoprophylaxis should only be used in limited
circumstances, and in consultation with local medical or public health
authorities. Certain persons at ongoing occupational risk for exposure
who are also at higher risk for complications of influenza (e.g., health
care personnel, public health workers, or first responders who are
working in communities with influenza A H1N1 outbreaks) should
carefully follow guidelines for appropriate personal protective equipment
or consider temporary reassignment.