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Medical [Medical] Baloxavir Marboxil, New Anti -Flu Agent
2019.02.28 10:15
February 28, 2019
Antiviral Agents Compared for Treatment of Influenza
Da Hee Han, Pharm D
A total of 22 randomized controlled trials were identified and included in the analysis
In otherwise healthy patients, influenza treatment with baloxavir marboxil was found to be comparable, and on some efficacy measures, superior to neuraminidase inhibitors, according to a network meta-analysis published inCurrent Medical Research and Opinion.
For this investigation, a total of 22 randomized controlled trials were identified and included in the analysis to compare the safety and efficacy of baloxavir with other antivirals. Results showed that treatment with baloxavir was associated with significantly shorter time to alleviation of all symptoms vs zanamivir (difference in median time 19.96 hours, 95% CI, [3.23, 39.07]). In addition, “the time to cessation of viral shedding was significantly shorter for baloxavir than zanamivir and oseltamivir (47.00 hours; 95% CI [28.18, 73.86] and 56.03 hours [33.74, 87.86], respectively),” the authors reported.
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Moreover, baloxavir demonstrated a greater mean decline in virus titer from baseline to 24 hours compared with the other agents (zanamivir, oseltamivir and peramivir). The authors noted that other differences in efficacy outcomes were not found to be statistically significant.
Regarding safety, no significant differences were observed between baloxavir and other antivirals except a lower incidence of total drug-related adverse events associated with baloxavir vs oseltamivir and laninamivir.
Baloxavir marboxil (Xofluza; Genentech), a polymerase acidic (PA) endonuclease inhibitor, is currently approved as a single-dose regimen to treat acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.
For more information visit tandfonline.com.
Comment 3
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A brand-new drug to shorten the duration of the flu—baloxavir marboxil (Xofluza)—just received approval from the Food and Drug Administration.
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“With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “This novel drug provides an important, additional treatment option.”
The drug should be available for purchase within the next few weeks, in time for most of the flu season, according to a spokesman for Genentech, the company that distributes Xofluza in the U.S.
As flu season ramps up, here are answers to several key questions you might be asking about this new drug.
How Well Does It Work?
The data from clinical trials suggest that Xofluza, approved for most healthy people over age 12, works about as well as oseltamivir (Tamiflu and generic)—the most commonly used flu treatment currently available—at reducing the length of a flu illness. Overall, both appear to cut the time people have flu symptoms from a little over three days to a little over two days.
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What’s Different About Xofluza?
Similar to Tamiflu, it needs to be taken within 48 hours of developing symptoms to be effective. And for Xofluza, the sooner the better: In one clinical trial, published in September in the New England Journal of Medicine (NEJM), people who took the drug within 24 hours of getting sick had symptoms for less time than those who took it between 24 and 48 hours after developing flu symptoms.
Side effects appear to be similar to those of Tamiflu. In the NEJM study, about 20 percent of participants who received Xofluza experienced some mild side effects, including diarrhea, bronchitis, nausea, and sinusitis. The rates of these side effects were about the same for study subjects who received either Tamiflu or a placebo.
However, Xofluza requires only one dose. (The size of the dose depends on your weight.) A course of Tamiflu entails multiple doses over several days.
And preliminary evidence suggests that Xofluza might be effective against strains of flu that have developed resistance to Tamiflu, though this has yet to be confirmed in clinical studies.
While Xofluza is approved only for healthy people 12 and older, Tamiflu can be used in children as young as two weeks. Tamiflu is also approved for pregnant women: Currently, Genentech advises women to let their doctor know if they are pregnant, planning to become pregnant, or breastfeeding—before using Xofluza.
And unlike Tamiflu, Xofluza should be taken only by people with an “uncomplicated” flu bug, meaning it’s not for those who have become seriously ill from the viral infection. Clinical trial data didn’t show how well the drug would work for people who are hospitalized from flu, for instance.
How Much Will It Cost?
According to Genentech, Xofluza’s retail price will be $150. But the company is providing coupons to reduce the cost of the drug, available here. If your health insurer covers the drug, the coupon could reduce your cost to as little as $30; otherwise, the coupon could cut your out-of-pocket price to $90.
Do I Still Need a Flu Shot?
Yes. Preventing the flu altogether is always preferable to catching the bug and treating it with an antiviral, according to the FDA. Although the flu vaccine isn’t perfect, it’s the most effective step you can take to keep yourself healthy this winter.
And you should get the vaccine as soon as you can—it takes about two weeks for the shot’s protection to take full effect.
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INFLUENZA VACCINE COMPARISONS (2018−2019 SEASON) Storage and Handling • Store refrigerated at 2–8°C (36–46°F)
• Do not freeze; discard if product has been frozen
• Protect from light
• Do not use influenza vaccine beyond the expiration date printed on the label
• Once the stopper of the multi-dose vial has been pierced, the vial must be discarded within 28 days
Brand Indicated
AgeRoute Allergies1 Mercury content
(mcg Hg/0.5mL)How Supplied NOTES Key: IM = intramuscular; ID = intradermal; IN = intranasal
IM: For adults and older children, the recommended site of IM administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommendations on Immunization.
1Persons with a history of egg allergy may receive any licensed, recommended influenza vaccine appropriate for recipient’s age and health status. Those who report having had reactions to egg involving symptoms other than urticaria (hives), or who required epinephrine or another emergency medical intervention, should be vaccinated in an inpatient or outpatient medical setting, under the supervision of a healthcare provider who is able to recognize and manage severe allergic reactions.
2May be administered by needle/syringe (≥5yrs) or PharmaJet Stratis Needle-Free Injection System (18–64yrs only).
Immunization providers should review FDA-approved prescribing information for 2018–2019 influenza vaccines for the most updated information, including (but not limited to) indications, contraindications, and precautions. Table listing reflects vaccines expected to be available during the 2018–2019 influenza season. This information is subject to change. For information on individual vaccines, see the product entries, contact the manufacturer, or call the National Immunization Hotline at (800) 232-4636.
REFERENCES Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2018–2019 Influenza Season. MMWR Recomm Rep. 2018;67(No. RR-3):1–20. https://www.cdc.gov/mmwr/volumes/67/rr/rr6703a1.htm
(Rev. 9/2018)
INACTIVATED INFLUENZA VACCINE, TRIVALENT (IIV3), STANDARD DOSE Afluria ≥5yrs IM egg protein, neomycin, polymyxin 0 0.5mL single-dose prefilled syringe 24.5 5mL multi-dose vial2 INACTIVATED INFLUENZA VACCINE, TRIVALENT (IIV3), HIGH DOSE Fluzone High-Dose ≥65yrs IM egg protein 0 0.5mL single-dose prefilled syringe INACTIVATED INFLUENZA VACCINE, TRIVALENT, ADJUVANTED (AIIV3) Fluad ≥65yrs IM egg protein, neomycin, kanamycin 0 0.5mL single-dose prefilled syringe INACTIVATED INFLUENZA VACCINE, QUADRIVALENT (IIV4), STANDARD DOSE Afluria Quadrivalent ≥5yrs IM egg protein, neomycin, polymyxin 0 0.5mL single-dose prefilled syringe 24.5 5mL multi-dose vial2 Fluarix Quadrivalent ≥6mos IM egg protein 0 0.5mL single-dose prefilled syringe FluLaval Quadrivalent ≥6mos IM egg protein 0 0.5mL single-dose prefilled syringe <25 5mL multi-dose vial Fluzone Quadrivalent 6–35mos IM egg protein 0 0.25mL single-dose prefilled syringe ≥6mos 25 5mL multi-dose vial ≥3yrs 0 0.5mL single-dose prefilled syringe, 0.5 mL single-dose vial INACTIVATED INFLUENZA VACCINE, QUADRIVALENT, CELL-CULTURE-BASED (CCIIV4) Flucelvax Quadrivalent ≥4yrs IM 0 0.5mL single-dose prefilled syringe 25 5mL multi-dose vial LIVE, ATTENUATED INFLUENZA VACCINE, QUADRIVALENT (LAIV4) FluMist Quadrivalent 2–49yrs IN egg protein, gelatin, arginine, gentamicin 0 0.2mL single-dose prefilled nasal spray RECOMBINANT INFLUENZA VACCINE, QUADRIVALENT (RIV4) Flublok Quadrivalent ≥18yrs IM 0 0.5mL single-dose prefilled syringe This article originally appeared on MPR
Baloxavir marboxil (trade name Xofluza) is an antiviral medication for treatment of influenza A and influenza BFDA-approved in October 2018 and given as a single dose by mouth. It may reduce the duration of flu symptoms by about a day. It was developed by Shionogi Co., a Japanese pharmaceutical company, and Roche AG.[1]