Top Infectious Disease News of the Week—April 28, 2019

#5: Mayvret Approved to Treat Hepatitis C in Children

The US Food and Drug Administration (FDA) has announced the approval of AbbVie Inc.'s Mavyret (glecaprevir and pibrentasvir) for the treatment of all 6 genotypes of hepatitis C virus (HCV) in pediatric patients aged 12 to 17 years. The tablets were approved to treat adults 18 years and older in 2017.

HCV, which consists of liver inflammation, can lead to reduced liver function and liver failure. The overall risk of HCV is elevated for children who are born to mothers who have HCV and current estimates indicate that 23,000 to 46,000 children in the United States have HCV.

According to dosing information that was released with the announcement of the approval, the agent should be administered to adult or pediatric patients 12 years and older, or weighing at least 99 pounds, who are infected with any of 6 identified HCV genotypes either without cirrhosis or with compensated cirrhosis.

Read about the FDA approval of Mayvret for pediatric HCV.

#4: Opioid Use Disorder Should Be Thought of Like an Infectious Disease, Experts Say

Opioid use disorder (OUD) is not an infectious disease, but a new paper from the National Institutes of Health (NIH) and the University of Maryland argues that ID specialists need to start considering themselves as a first line of treatment against the disorder.

“The infectious diseases and [substance-use disorder] communities have important, overlapping, and optimally synergistic roles in addressing this crisis,” Anthony Fauci, MD, director of the NIH’s National Institute of Allergy and Infectious Diseases, and co-authors wrote this month in The Journal of Infectious Disease.

The opioid crisis remains a major public health concern, with some 47,000 people dying from overdoses of opioid-containing drugs in 2017 alone. Many people who become addicted to opioid painkillers begin with a prescription for oral medication. However, as the addiction worsens, some individuals turn to injecting prescribed or illegal opioids, a practice that often correlates with risky behaviors, including needle-sharing and unsafe sexual activities, all leading to an increased risk of infectious diseases.

Read about thinking of OUD as an infectious disease.

#3: Are Frontline Hospitals Ready for a Patient With Ebola?

Just how well prepared are frontline hospitals for high-consequence pathogens like Ebola? It’s likely you won’t be happy with the answer that is included in a new article from Health Security, which details an evaluation of a multi-hospital system and identifies gaps in their biopreparedness.

Following the Dallas Ebola cluster in 2014, the US Department of Health and Human Services (HHS) created a tiered hospital approach to manage Ebola preparedness. When the first patient in Dallas was identified, hospitals around the United States rushed to acquire the necessary personal protective equipment (PPE), train staff, and identify and correct gaps in their admitting processes to avoid missing symptoms of highly contagious diseases such as Ebola.

From travel screening questions in electronic medical records to special Ebola treatment teams, it was a time of extreme effort and fatigue for health workers. To reduce the burden on the US health care system, HHS created a regional approach that involve 3 tiers—frontline hospitals were expected to identify, isolate, and hold a patient for 12-24 hours; assessment hospitals were tasked with receiving, isolating, and providing laboratory efforts while holding the patient for up to 96 hours; Ebola treatment centers were designated to receive and isolate Ebola patients, and provide care for a minimum of 7 days, while sustaining enough staff and supplies to care for Ebola patients for weeks.

Read about if frontline hospitals are ready to treat a patient with Ebola.

#2: FDA Issues Complete Response Letter to Nabriva for Contepo

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Nabriva Therapeutics for intravenous fosfomycin (Contepo) for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

According to a press release, the CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the New Drug Application. Nabriva plans to request a “Type A” meeting to discuss the FDA’s findings. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of Contepo.

“We will be working with the FDA in the coming weeks to gain a full understanding of the FDA’s comments, with the goal of bringing this important treatment to patients as quickly as possible,” Ted Schroeder, CEO of Nabriva Therapeutics, said in a statement.

Read about the CRL issued to Nabriva for Contepo.

#1: US Flu Activity Falls Below Baseline After Longest Flu Season in a Decade

Although the current influenza season in the United States has been milder than 2017-2018, the US Centers for Disease Control and Prevention (CDC) says a second wave of the virus made this season the longest in a decade.

The good news is that during influenza season week 16 ending on April 20, 2019, the proportion of outpatient visits for influenza-like illness (ILI) fell to 2.1%, the first time in 21 weeks that the rate was not at or above the national baseline of 2.2%. According to the CDC’s weekly FluView report, influenza activity continues to decrease following a second wave of flu illnesses that began in February when influenza A(H3N2) viruses started to predominate. Prior to this year, the longest recent flu season was in 2014-2015 and lasted 20 weeks, and although this season was longer, last season was more severe and led to nearly 80,000 deaths.

Through April 20^th, the CDC estimates that there have been as many as 42.4 million flu illnesses, 630,000 hospitalizations, and 59,500 flu-related deaths this season. In week 16 the CDC also reported 5 influenza-associated pediatric deaths, bringing this season’s total to 96. The 2017-2018 flu season saw 186 pediatric flu deaths in the US, the most since the 2009-2010 flu season, which saw 288 pediatric flu deaths.

In more pediatric flu news, a new study published in Open Forum Infectious Diseases by investigators in Austria has found that repetitive influenza infections in consecutive flu seasons occurred quite frequently in children and adolescents, predominantly in young children. The study builds on prior research about how influenza infections in the first decade of life may help build long-lasting immune memory and protection in subsequent years after an infection against similar influenza virus types or subtypes.

The study included a retrospective analysis of 2308 laboratory-confirmed influenza cases in children and adolescents during the flu seasons from 2014-2015 to 2017-2018. Investigators found that in the 2015-2016 flu season, nearly 12% of patients also had an influenza infection during the previous season; in 2016-2017, more than 14% had at least 1 infection during the prior 2 flu seasons; and in 2017-2018, more than 18% had 1 or more infections during the 3 previous seasons. Of the patients, 29 had 3 or 4 infections during these seasons, and 38 children had 2 influenza episodes within the same season. Most of the repeat infections occurred in children aged 3 to 8 years.

Read about the current status of US flu activity.