News

Congo Declares Ebola Flare-Up over after Rapid Response

24 July 2018 (Reuters [Edward McAllister])—Democratic Republic of Congo declared an end to an Ebola outbreak after what experts hailed as a swift response to the flare-up in one of the world’s most difficult environments.

July 24 marked 42 days since the last detected case of the virus, the length of 2 incubation periods considered long enough to declare an outbreak over.

The flare-up, first detected in April, was dealt with rapidly by the World Health Organization and Congolese authorities, including the deployment of an experimental vaccine given to more than 3300 people.

Despite the deaths, the containment of this latest outbreak was considered a success, given the difficulties faced in one of the world’s most challenging environments.

The vaccine had to be kept −60 to –80 degrees Celsius in remote parts of a humid country with unreliable power supplies. Informed, signed consent was required from every person who wanted the shot, raising language and cultural barriers.

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Editorial comment: The final total is 54 cases, including 33 deaths and 21 survivors. Of interest is the report of a pregnant Liberian woman, who apparently had Ebola 13 months before and became ill after delivery of a healthy baby. She apparently transmitted Ebola to her 15-year-old son, who died, and her 8-year-old son and husband, who survived. The newborn had antibodies (presumably from the mother) and did not become ill.

FDA Approves the First Drug with an Indication for Treatment of Smallpox

13 July 2018 (FDA News Release)—The US Food and Drug Administration (FDA) today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.

“To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons. Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said FDA Commissioner Scott Gottlieb, MD. “This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher. Today’s action reflects the FDA’s commitment to ensuring that the US is prepared for any public health emergency with timely, safe, and effective medical products.”

TPOXX’s effectiveness against smallpox was established by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox and was based on measuring survival at the end of the studies. More animals treated with TPOXX lived compared to the animals treated with placebo. TPOXX was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.

The safety of TPOXX was evaluated in 359 healthy human volunteers without a smallpox infection. The most frequently reported adverse effects were headache, nausea, and abdominal pain.

The FDA granted approval of TPOXX to SIGA Technologies Inc.

TPOXX was developed in conjunction with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).

Editorial comment: Tecovirimat is administered orally. Its mechanism of action is on a major envelope protein of orthopoxviruses so as to inhibit production of extracellular virus (Grosenbach et al. NEJM 2018;379:44).

FDA Updates Warnings for Fluoroquinolone Antibiotics on Risks of Mental Health and Low Blood Sugar Adverse Reactions

10 July 2018 (FDA News Release)—The US Food and Drug Administration (FDA) today is requiring safety labeling changes for the fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances.

“The use of fluoroquinolones has a place in the treatment of serious bacterial infections—such as certain types of bacterial pneumonia—where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option. The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described in the Warnings and Precautions section of the drug labeling but differed by individual drug. The new class-wide labeling changes will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class. The mental health side effects to be included in the labeling across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium.

Additionally, the recent FDA review found instances of hypoglycemic coma where users of fluoroquinolones experienced hypoglycemia. As a result, the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.

The FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In August 2013, the agency required updates to the labeling to describe the potential for irreversible peripheral neuropathy (serious nerve damage).

In 2016, the FDA enhanced warnings about the association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system. Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, the FDA determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.

Editorial comment: According to a study (Aspinall et al. CID 2009;49:402), levofloxacin was more prone to cause dysglycemia than ciprofloxacin, which in their study was no different from azithromycin.

Iowa, Illinois Investigating Infections Linked to McDonald’s Salad

13 July 2018 (Reuters [Nivedita Balu, Alana Wise, and Maju Samuel])—The Iowa and Illinois health departments said that they were investigating cyclospora infections linked to salads at McDonald Corp’s restaurants.

McDonald’s, the world’s largest restaurant chain, said in a statement that it had been in contact with public health authorities in both states.

It said that it had voluntarily stopped selling salads at the approximately 3000 affected US restaurants until it could switch to another lettuce blend supplier.

The parasite, Cyclospora cayetanensis, typically causes watery diarrhea and frequent, sometimes explosive bowel movements. It is spread by ingesting food or water contaminated with feces and not directly from one person to another.

Several outbreaks have occurred in the United States in the past several years, especially during the summer months, that had been linked to imported fresh produce including raspberries, basil, snow peas, and lettuce.

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Editorial comment: As of 26 July 2018, a total of 286 cases have been reported in 15 states, but the cases are winding down. Of interest, a new outbreak has been reported related to Romaine lettuce sold in Walgreens, Trader Joe’s, and Kroger. The supplier is Fresh Express.

UN Says Global Fight Against AIDS is at “Precarious Point”

18 July 2018 (Reuters [Kate Kelland])—Complacency is starting to stall the fight against the global AIDS epidemic, with the pace of progress not matching what is needed, the United Nations warned.

The United Nations’ HIV/AIDS body UNAIDS said in an update report that the fight was at a “precarious point,” and although deaths were falling and treatment rates rising, rates of new HIV infections threatened to derail efforts to defeat the disease.

The report said an estimated 21.7 million of the 37 million people who have the human immunodeficiency virus (HIV) that causes AIDS were on treatment in 2017, 5 and a half times more than a decade ago.

This rapid and sustained increase in people getting treatment helped drive a 34% drop in AIDS-related deaths from 2010 to 2017. AIDS deaths in 2017 were the lowest this century, at fewer than a million people, the report said.

It also said there were now “crisis” points in preventing the spread of HIV—particularly among high-risk and vulnerable populations—and in securing sustained funding.

It said a failure to halt new infections among children was a big worry.

In 2017, 180 000 children became infected with HIV, far from the 2018 target of eliminating new HIV infections among children.

Data in the report showed that overall among adults and children worldwide, some 1.8 million people became newly infected with HIV in 2017.

Since the start of the AIDS epidemic in the 1980s, more than 77 million people have become infected with HIV. Almost half of them—35.4 million—have died of AIDS.

The report found that at the end of 2017, $21.3 billion was available for the AIDS response in low- and middle-income countries. More than half of that came from domestic funding sources rather than international donors. UNAIDS estimates that $26.2 billion will be needed to fund the AIDS fight in 2020.

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