Top Infectious Disease News of the Week—May 12, 2019

#5: New Deal Makes PrEP Accessible for the Uninsured—But Will It Help?: Public Health Watch

These days, when a government official takes to Twitter, the world spins off its axis.

Or at least it seems that way.

However, a tweet posted on May 9^th by US Department of Health and Human Services (HHS) Secretary Alex Azar has drawn all too little attention in the media. Indeed, Azar used the social media platform to announce that drug manufacturer Gilead Sciences had reached an agreement with the Trump administration to donate HIV pre-exposure prophylaxis (PrEP) medication for as many as 200,000 patients each year between now and 2030.

According to Azar, the drug supplies will be earmarked for those “who are at risk for HIV and who are uninsured,” particularly those residing in states and regions identified as “priority areas” as part of President Donald Trump’s plan (and goal) to end the epidemic in the US, as outlined in his State of the Union address in February. However, not everyone is so sure about the true merits of the deal.

Read about PrEP for uninsured Americans.

#4: Are Certain Clinical Characteristics Associated with Severe C Diff Infections?

The US Centers for Disease Control and Prevention has classified Clostridium difficile (C diff) infections as an urgent threat to public health, yet it can be difficult for clinicians to classify the severity of infection. Similarly, lack of data leaves gaps in knowledge about if a correlation exists between severity, C diff treatment, and clinical outcomes.

In order to determine characteristics that can be used to classify C diff disease severity, a team of investigators from the University of Mississippi and University of Cincinnati collaborated on a study. The findings of their research, which set out to determine differences in the clinical characteristics between complicated and uncomplicated C diff infections were presented in a poster session at the Making a Difference in Infectious Diseases 2019 (MAD-ID) annual meeting.

In an exclusive interview at the meeting, Contagion® spoke with the poster presenter, Jaime Wagner, PharmD, a clinical assistant professor in the Department of Pharmacy Practice at the University of Mississippi, about the research (see video).

Read about clinical characteristics of severe C diff and watch the interview with Dr. Wagner.

#3: NIAID to Give $41.6 Million in Funding for Development of STI Vaccines

With an increase in the rate of reported sexually transmitted infections (STIs) in the United States, the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) has announced a program of more than $41 million dollars to fund research into vaccines for syphilis, gonorrhea, and chlamydia.

The recent NIAID announcement details the establishment of 4 multi-institutional cooperative research centers (CRCs), which over the next 5 years are each set to develop at least 1 vaccine candidate to prevent infections from syphilis, gonorrhea, and chlamydia. In an interview with Contagion^®, NIAID Director Anthony S. Fauci, MD, explained that the growing rate of STIs in the United States coupled with scientific advances have made now the appropriate time for such much-needed vaccines, though much remains to be understood about the rise in STIs.

“It’s multifactorial. Certainly we are better at diagnosis as well as surveillance, so the real increase that we’re seeing is probably that we’re picking up more cases, but there are probably some other factors,” explained Fauci, noting that the increase in STIs may be linked to the opioid epidemic as well as an increase in unprotected sex, suboptimal sexual health education, and the use of PrEP to prevent HIV resulting in more sex without condoms.

Read more about funding for the development of STI vaccines.

#2: Ryan K. Shields, PharmD, MS: T2Candida's Place in Rational Antifungal Management

Segment Description: Ryan K. Shields, PharmD, MS, associate professor of medicine at the University of Pittsburgh and Contagion®'s Multidrug-Resistant Infections Section Editor, discusses his research presented at MAD-ID 2019 on T2Candida's place in rational antifungal management.

Interview transcript (modified slightly for readability):

Ryan K. Shields, PharmD, MS: This year at MAD-ID 2019 I presented research on behalf of a larger team about our ways we’ve incorporated T2Candida into diagnostic management in our medical ICU. T2Candida is a new diagnostic test that’s really important because it detects candida directly from whole blood samples within 3 to 5 hours. Comparatively, it takes 2 to 3 days to diagnose candidemia in blood cultures, which we know delays antifungal therapy for patients. So we view T2 as a way to find patients with candidiasis where we can initiate earlier antifungals and we hope to be able to improve their outcomes with that.

Watch the interview with Dr. Shields here.

#1: Is Antibiotic Development Now the Road Less Traveled?

Although attention has been focused on the use of genetically modified bacteriophages to fight a highly resistant infection in a young girl, the antibiotic pipeline is not just drying up…but dying. This isn’t news though; in fact, we’ve known about it for a while. It’s been decades since a novel antibiotic hit the market and, as antimicrobial resistance surges, the treatment options are becoming increasingly scarce.

Recent attention has been focused on the bankruptcy of the biotech company Achaogen. It’s likely you haven’t even heard of them, let alone know that they filed for bankruptcy a few weeks ago. The reason this bankruptcy is worrisome is that Achaogen’s antibiotic, plazomicin, was actually approved by the US Food and Drug Administration in June 2018 and, despite its efficacy against multidrug-resistant Enterobacteriaceae, it failed to keep the company afloat. The cost-prohibitive nature of antimicrobial research and development is all but ensuring that the pipeline for development is drying up. Not only does the Achaogen bankruptcy highlight the costly nature of antimicrobial development, but it’s even more worrisome that a company that was solely focused on such efforts couldn’t stay in business even with the financial push and support from the National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA), and the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) .

Pew Charitable Trusts notes that more than 90% of antibacterial products currently in development are by small companies and of these companies, more than 60% have no other pharmaceutical products on the market, meaning they’re solely focused on antibiotics. In most cases, it’s expected that bringing a new drug to market will take 10-15 years and cost approximately $1 billion. Antimicrobial resistance expert Maryn McKenna recently wrote that “it’s time to talk about other, more controversial enticements to get more antibiotics on the market. These so-called ‘pull’ incentives (the alternative to push) don’t pay R&D costs up front; instead, they reward R&D done well.

Read about antibiotic development.