Updates from the FDA

In May, the FDA approved the first ZIKV diagnostic test to be commercially available in the U.S. Marketed by InBios International, the test detects Zika virus antibodies in a patient’s blood.  At present, the test is approved only for patients who may be infected with Zika virus, not for screening blood donors.

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Fighting Pediatric Hepatitis C

Drug approval extended to children 12–18

There’s a new treatment option for pediatric patients with hepatitis C: The FDA has approved the antiviral drug Mavyret (glecaprevir-pibrentasvir) for children as young as 12.There’s a new treatment option for pediatric patients with hepatitis C: The FDA has approved the antiviral drug Mavyret (glecaprevir-pibrentasvir) for children as young as 12.

Liver Killer

Hepatitis C is a transmissible, blood-borne viral liver infection that can lead to progressive chronic liver disease or liver cancer. Although most often spread by sharing needles, the hepatitis C virus (HCV) can also be transmitted from mother to fetus during pregnancy. The CDC estimates that there may be as many as 46,000 HCV-infected children in the United States.

Back in August 2017, the FDA approved a promising new antiviral medication for treating HCV: tablets of glecaprevir and pibrentasvir, marketed by AbbVie Inc. under the trade name Mavyret. Clinical trials suggest that a full course of Mavyret can completely cure all genotypes of HCV in patients with no or mild cirrhosis.

Although the 2017 approval included only adult patients, the FDA has now extended that approval to include children 12 years or older weighing at least 99 pounds.

Not for Everyone

As with many medications, Mavyret has some contraindications, in particular for those who also have (or have had) hepatitis B. You can learn more about glecaprevir-pibrentasvir in the treatments section of the Hepatitis C Online webpage maintained by the University of Washington at www.hepatitisc.uw.edu.

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New Treatment for Hospital-Acquired Infections

Drug approved for HABP and VABP

There’s a new tool for fighting hospital-acquired infections: The FDA recently approved the medication Zerbaxa to treat healthcare-associated bacterial pneumonia.

Zerbaxa Approval

If you’ve worked in the ICU, you may be all too familiar with the risks of ventilator-associated bacterial pneumonia (VABP). By some estimates, as many as 27 percent of patients on mechanical ventilators suffer VABP, with typical mortality rates of 10 percent or more. The danger is particularly acute with antibiotic-resistant infections, which are harder to treat.

In June, the FDA granted approval for a new treatment for VABP and other hospital-acquired bacterial pneumonias in adult patients: Zerbaxa, a drug manufactured by Merck that was previously approved for treating complicated intra-abdominal and urinary tract infections.

“Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients,” says FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “New therapies to treat these infections are important to meet patient needs because of increased antimicrobial resistance.”

No Substitute for Hand Hygiene

Although the FDA says Zerbaxa is as safe and effective as existing treatments, the drug still requires careful stewardship to avoid developing resistant bacterial strains. Zerbaxa is also contraindicated in renally impaired patients and can cause severe diarrhea. Ultimately, preventing VABP infections is still just as important as fighting them.

“Nurses are the first line of defense in preventing bacterial colonization of the oropharynx and gastrointestinal tract,” wrote Beth Augustyn, RN, MSN, ACNP, CCRN, in an oft-cited study in the journal Critical Care Nurse, noting that “meticulous” hand hygiene by nurses and other clinicians is a vital step in avoiding cross-contamination and reducing infection risk.

In this Article: FDA, Pediatrics, Vaccination