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Antiviral Influenza Treatment Recommendations from CDC for 2015 – 2016

CDC recommendations use of Tamiflu in treatment and chemoprophylaxis of Influenza for the 2015 – 2016 season …
• Influenza antiviral prescription drugs can be used to treat influenza or to prevent influenza.
• Five licensed prescription influenza antiviral agents are available in the United States.
o Three influenza antiviral medications approved by the U.S. Food and Drug Administration (FDA) are recommended for use in the United States during the 2015-2016 influenza season: oral oseltamivir (Tamiflu®), inhaled zanamivir (Relenza®), and intravenous peramivir (Rapivab®). These drugs are chemically related antiviral medications known as neuraminidase inhibitors that have activity against both influenza A and B viruses. Tamiflu is the drug must recommended and universally used for infants, children and adolescents.
o Amantadine and rimantadine are antiviral drugs in a class of medications known as adamantanes. These medications are active against influenza A viruses, but not influenza B viruses. As in recent past seasons, there continues to be high levels of resistance (>99%) to adamantanes among influenza A (H3N2) and influenza A (H1N1) pdm09 (“2009 H1N1”) viruses. Therefore, amantadine and rimantadine are not recommended for antiviral treatment or chemoprophylaxis of currently circulating influenza A viruses.
• Antiviral resistance to oseltamivir, zanamivir, and peramivir among circulating influenza viruses is currently low, but this can change. Also, antiviral resistance can emerge during or after treatment in some patients (e.g., immunosuppressed).
o For information about antiviral drug resistance to influenza viruses and guidance on the use of influenza antiviral medications when antiviral resistance is suspected or documented this season, see Antiviral Drug-Resistance among Influenza Viruses.
o For weekly surveillance data on antiviral resistance this season, see the FluView U.S. Influenza Surveillance Report.
Tamiflu – Recommended age of use
Antiviral Agent Activity Against Influenza A and B Treatment  in Any age and for
Chemo- prophylaxis 3 months and older
Influenza Antiviral Treatment Recommendations
• Clinical trials and observational data show that early antiviral treatment can shorten the duration of fever and illness symptoms, and may reduce the risk of complications from influenza (e.g., otitis media in young children, pneumonia, and respiratory failure).
• Early treatment of hospitalized patients can reduce death.
• In hospitalized children, early antiviral treatment has been shown to shorten the duration of hospitalization.
• Clinical benefit is greatest when antiviral treatment is administered early, especially within 48 hours of influenza illness onset.
• Antiviral treatment is recommended as early as possible for any patient with confirmed or suspected influenza who:
o is hospitalized;
o has severe, complicated, or progressive illness; or
o is at higher risk for influenza complications: (below)

• children aged younger than 2 years;
• adults aged 65 years and older;
• persons with chronic pulmonary (including asthma), cardiovascular (except hypertension alone), renal, hepatic, hematological (including sickle cell disease), and metabolic disorders (including diabetes mellitus), or neurologic and neurodevelopment conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle, such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability [mental retardation], moderate to severe developmental delay, muscular dystrophy, or spinal cord injury);
• persons with immunosuppression, including that caused by medications or by HIV infection;
• women who are pregnant or postpartum (within 2 weeks after delivery);
• persons aged younger than 19 years who are receiving long-term aspirin therapy;
• American Indians/Alaska Natives;
• persons who are morbidly obese (i.e., body mass index is equal to or greater than 40); and
• residents of nursing homes and other chronic care facilities.

Treatment Considerations:
• Clinical judgment, on the basis of the patient’s disease severity and progression, age, underlying medical conditions, likelihood of influenza, and time since onset of symptoms, is important when making antiviral treatment decisions for high-risk outpatients.
When indicated, antiviral treatment should be started as soon as possible after illness onset, ideally within 48 hours of symptom onset. However, antiviral treatment might have some benefits in patients with severe, complicated or progressive illness, and in hospitalized patients when started after 48 hours of illness onset. Observational studies in hospitalized patients with influenza have reported that clinical benefit is greatest when oseltamivir is started within 48 hours of illness onset (Hsu, 2012; Louie, 2013; Muthuri, 2013). However, some studies suggest that antiviral treatment might still be beneficial in hospitalized patients when started up to 4 or 5 days after illness onset (Louie, 2012; Yu, 2011). Antiviral treatment of pregnant women (of any trimester) with influenza A (2009 H1N1) virus infection has been shown to be most beneficial in preventing respiratory failure and death when started within less than 3 days of illness onset, but still provided benefit when started 3–4 days after onset compared to 5 or more days (Siston, 2010).
• Decisions about starting antiviral treatment should not wait for laboratory confirmation of influenza (see section on Diagnostic Testing for Influenza).
• While influenza vaccination is the first and best way to prevent influenza illness, a history of influenza vaccination does not rule out the possibility of influenza virus infection in an ill patient with clinical signs and symptoms compatible with influenza.
Antiviral treatment also can be considered for any previously healthy, symptomatic outpatient, not at high risk with confirmed or suspected influenza on the basis of clinical judgment, if treatment can be initiated within 48 hours of illness onset. One randomized clinical trial in children with uncomplicated influenza demonstrated a modest reduction in duration of symptoms and virus shedding in patients initiating treatment after 48 hours; post hoc analysis suggested that treatment initiated 72 hours after illness onset reduced symptoms by one day compared with placebo (Fry, 2014).
• For outpatients with acute uncomplicated influenza, oral oseltamivir, inhaled zanamivir, or intravenous peramivir may be used for treatment. The recommended treatment course for uncomplicated influenza is two doses per day of oral oseltamivir for 5 days

Treatment Considerations for Patients Hospitalized with Suspected or Confirmed Influenza – please refer to full page article on CDC website.

Diagnostic Testing for Influenza
• Rapid Influenza Diagnostic Tests (RIDTs) can be useful to identify influenza virus infection as a cause of respiratory outbreaks in any setting. RIDTs are antigen detection tests and produce results quickly, but the results may not be accurate. A recent meta-analysis evaluating 159 studies of 26 RIDTs compared with a reference standard of either RT-PCR or viral culture reported a pooled sensitivity of 62.3% (95% CI, 57.9% to 66.6%) and pooled specificity of 98.2% (CI, 97.5% to 98.7%), although sensitivities as low as 10% were reported in individual studies, depending on characteristics such as specimen type, age of patient, and virus detected (Chartrand, 2012).
o Sensitivities were generally lower in adults (53.9% [95% CI, 47.9% to 59.8%]) than in children (66.6% [95% CI, 61.6% to 71.7%]), and lower for influenza B (52.2% [95% CI, 45.0% to 59.3%]) than influenza A (64.6% [95% CI, 59.0% to 70.1%]) (Chartrand, 2012). Sensitivities were also lower when compared with RT-PCR as the reference standard (53.9% [95% CI, 48.2% to 59.6%]) versus viral culture (72.3% [95% CI, 66.8% to 77.9%]) (Chartrand, 2012).
o In the meta-analysis, RIDTs did not perform markedly worse in the 35% of studies conducted during the 2009 H1N1 pandemic compared with performance during other influenza seasons (Chartrand, 2012). RIDT sensitivity of 58% was reported on respiratory specimens from 24 fatal cases of influenza A from the 2013-2014 season (Ayscue, 2014). Sensitivity in lower respiratory tract samples may be even lower than upper respiratory samples; in one study, RIDTs were positive in only five (25%) of 20 bronchoscopic samples in patients with severe 2009 H1N1 virus infection requiring mechanical ventilation (Blyth, 2009).
False negative results occur more commonly than false positive results. In particular, false negative test results are common during influenza season. Additionally, other antigen detection tests (e.g. immunofluorescence assays) also lack sensitivity compared to RT-PCR – a negative RIDT or immunofluorescence (e.g. direct florescent antibody staining – DFA) result does NOT exclude a diagnosis of influenza in a patient with suspected influenza.
• Other testing (i.e., RT-PCR, viral culture) is much more accurate, but can take longer to get results (several days- week).
• Rapid molecular assays are a new type of molecular influenza diagnostic test. Currently, there is only one rapid molecular assay that is FDA-approved for use in the United States.
To Minimize False RIDT Results
• Collect specimens as early in the illness as possible (ideally less than 4 days from illness onset).
• Follow manufacturer’s instructions, including acceptable specimens, and handling.
• Follow-up negative results with confirmatory tests (i.e., RT-PCR or viral culture) if a laboratory-confirmed influenza diagnosis is needed to aid in diagnosis/treatment of patient.

Information on Local Influenza Activity
• Clinicians should contact their local or state health department for information about current influenza activity. For more information about influenza activity in the United States during the influenza season, visit the Weekly U.S. Influenza Surveillance Report (FluView).

Tamiflu – Recommended Dosage and Duration of treatment and chemoprophylaxis
Treatment
(5 days) If younger than 1 yr old:
3 mg/kg/dose twice daily
If 1 yr or older, dose varies by child’s weight:
15 kg or less, the dose is 30 mg twice a day
>15 to 23 kg, the dose is 45 mg twice a day
>23 to 40 kg, the dose is 60 mg twice a day
>40 kg, the dose is 75 mg twice a day

Chemo-prophylaxis
(7 days) If child is younger than 3 months old, use of oseltamivir for chemoprophylaxis is not recommended unless situation is judged critical due to limited data in this age group.
If child is 3 months or older and younger than 1 yr old:
3 mg/kg/dose once daily
If 1 yr or older, dose varies by child’s weight:
15 kg or less, the dose is 30 mg once a day
>15 to 23 kg, the dose is 45 mg once a day
>23 to 40 kg, the dose is 60 mg once a day
>40 kg, the dose is 75 mg once a day
1 Oral oseltamivir is approved by the FDA for treatment of acute uncomplicated influenza with twice-daily dosing in persons 14 days and older, and for chemoprophylaxis with once-daily dosing in persons 1 year and older. Although not part of the FDA-approved indications, use of oral oseltamivir for treatment of influenza in infants less than 14 days old, and for chemoprophylaxis in infants 3 months to 1 year of age, is recommended by the CDC and the American Academy of Pediatrics (Committee on Infectious Diseases, 2014).
2 This is the FDA-approved oral oseltamivir treatment dose for infants 14 days and older and less than 1 year old, and provides oseltamivir exposure in children similar to that achieved by the approved dose of 75 mg orally twice daily for adults, as shown in two studies of oseltamivir pharmacokinetics in children (Kimberlin, 2013 [CASG 114], EU study WP22849, FDA Clinical Pharmacology Review). The American Academy of Pediatrics has recommended an oseltamivir treatment dose of 3.5 mg/kg orally twice daily for infants aged 9-11 months for the 2013-14 season, on the basis of data which indicated that a higher dose of 3.5 mg/kg was needed to achieve the protocol-defined targeted exposure for this cohort as defined in the CASG 114 study (Kimberlin, 2013). It is unknown whether this higher dose will improve efficacy or prevent the development of antiviral resistance. However, there is no evidence that the 3.5 mg/kg dose is harmful or causes more adverse events to infants in this age group.
Current weight-based dosing recommendations are not appropriate for premature infants
Resistance of influenza viruses to antiviral drugs can also occur spontaneously, with no known exposure to antiviral medications (Hurt, 2011; Takashita, 2013; Takashita, 2014).

About Chemoprophylaxis:
Annual influenza vaccination is the best way to prevent influenza because vaccination can be given well before influenza virus exposures occur, and can provide safe and effective immunity throughout the influenza season.
• Antiviral medications are approximately 70% to 90% effective in preventing influenza and are useful adjuncts to influenza vaccination.
• CDC does not recommend widespread or routine use of antiviral medications for chemoprophylaxis so as to limit the possibilities that antiviral resistant viruses could emerge. Indiscriminate use of chemoprophylaxis might promote resistance to antiviral medications, or reduce antiviral medication availability for treatment of persons at higher risk for influenza complications or those who are severely ill.
In general, CDC does not recommend seasonal or pre-exposure antiviral chemoprophylaxis, but antiviral medications can be considered for chemoprophylaxis in certain situations.
• The following are examples of situations where antiviral medications can be considered for chemoprophylaxis to prevent influenza:
o Prevention of influenza in persons at high risk of influenza complications during the first two weeks following vaccination after exposure to an infectious person.
o Prevention for people with severe immune deficiencies or others who might not respond to influenza vaccination, such as persons receiving immunosuppressive medications, after exposure to an infectious person.
o Prevention for people at high risk for complications from influenza who cannot receive influenza vaccine due to a contraindication after exposure to an infectious person.
o Prevention of influenza among residents of institutions, such as long-term care facilities, during influenza outbreaks in the institution. For more information, see IDSA guidelines web site[259 KB, 30 pages].
• An emphasis on close monitoring and early initiation of antiviral treatment if fever and/or respiratory symptoms develop is an alternative to chemoprophylaxis after a suspected exposure for some persons.
To be effective as chemoprophylaxis, an antiviral medication must be taken each day for the duration of potential exposure to a person with influenza and continued for 7 days after the last known exposure. For persons taking antiviral chemoprophylaxis after inactivated influenza vaccination, the recommended duration is until immunity after vaccination develops (antibody development after vaccination takes about two weeks in adults and can take longer in children depending on age and vaccination history).
Antiviral chemoprophylaxis generally is not recommended if more than 48 hours have elapsed since the first exposure to an infectious person.
• Patients receiving antiviral chemoprophylaxis should be encouraged to seek medical evaluation as soon as they develop a febrile respiratory illness that might indicate influenza.
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Adverse Events from using Anti-viral medications like Tamiflu
• When considering use of influenza antiviral medications, clinicians must consider the patient’s age, weight and renal function; presence of other medical conditions; indications for use (i.e., chemoprophylaxis or therapy); and the potential for interaction with other medications. Adverse reactions can include nausea, vomiting. There have been postmarketing reports of serious skin reactions and sporadic, transient neuropsychiatric events (self-injury or delirium; mainly reported among Japanese adolescents and adults).
• For more information on safety, effectiveness and dosing for oral oseltamivir – parents can visit CDC webpage Antiviral Drugs or consult the package inserts.
For more information, visit the Seasonal Influenza (Flu) site, or call CDC at 800-CDC-INFO (English and Spanish) or 888-232-6348 (TTY).

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