Top Infectious Disease News of the Week—October 21, 2018

#5: Global HIV Vaccine Enterprise Releases 5-Year Strategy to Develop HIV Vaccine

As HIV research continues to move forward the question prevails—how close are we to an HIV vaccine?

Now, the Global HIV Vaccine Enterprise (Enterprise), hosted by the International AIDS Society (IAS) is laying out a strategic plan to try to answer that question, as announced today, October 22, 2018, at the opening of HIV Research for Prevention in Madrid, Spain.

IAS has released a 5-year strategic plan with an overarching goal of using the support of global stakeholders to achieve the vision of a safe and effective HIV vaccine that is globally available.

Read more about the 5-year strategy to develop an HIV vaccine.

#4: FDA Approves Expanded Use of Afluria Quadrivalent Influenza Vaccine

The US Food and Drug Administration (FDA) has issued an extended approval for the quadrivalent formulation of the AFLURIA influenza vaccine, in individuals 6 months of age and older. The vaccine, produced by Seqirus, was first approved in the United States in August 2016 for adults 18 and older. The extended approval is also applicable to the trivalent form of the vaccine.

“As we enter a new flu season, we are reminded of the enormous impact that influenza can have on public health,” said Gregg Sylvester MD, Vice President of Medical Affairs at Seqirus in the announcement. “Having another option to fight this disease can translate to saved lives and fewer flu-related hospitalizations this season and going forward.”

The quadrivalent vaccine is designed to protect against 2 influenza A strain viruses and 2 influenza B strain viruses. It is an inactivated vaccine which is available in single-dose, pre-filled syringes as well as multi-dose vials. The vaccine is available in the United States for the 2018-2019 influenza season.

Read more about the Afluria quadrivalent influenza vaccine.

#3: Benefits of Baloxavir Marboxil for the Treatment of Influenza

Mike Ison, MD, MS, professor at Northwestern University Feinberg School of Medicine, discusses the key takeaways from the CAPSTONE-2 phase 3 trial evaluating baloxavir marboxil for the treatment of patients with influenza.

Interview transcript (modified slightly for readability):

"I think the most important takehomes [from the study] are threefold. One that antiviral therapy, including baloxavir, reduces the incidence of complications in patients with high risk for complications infected with influenza. Two, it shows the baloxavir, a new class of drugs, is both safe and effective in the treatment of influenza. And then the third critical finding is that there is a much more rapid clearance of virus with those patients who are treated with baloxavir.”

Watch the rest of the interview clip with Dr. Ison on baloxavir marboxil.

#2: FDA Approves Baloxavir Marboxil to Treat Uncomplicated Influenza

The US Food and Drug Administration (USDA) has announced the approval of baloxavir marboxil (Xofluza) for the treatment of acute uncomplicated influenza. The approval is indicated for patients 12 years of age and older who have been experiencing flu symptoms for less than 48 hours. This approval marks the first new antiviral flu treatment with a novel mechanism of action in nearly 20 years.

Baloxavir marboxil is a single-dose oral medication that targets the influenza virus by inhibiting the cap-dependent endonuclease protein which is essential for the replication of the virus.

At ID Week 2018, Mike Ison, MD, MS, professor at Northwestern University Feinberg School of Medicine and an investigator on the CAPSTONE-2 study which evaluated baloxavir marboxil in comparison to oseltamivir, sat down with Contagion^® to discuss the unique nature of the medication (see video).

Read more about baloxavir marboxil for the treatment of uncomplicated influenza.

#1: A New Way to Measure Success When It Comes to HIV Suppression

It’s become clearer to the scientific community that focuses on HIV that time is of the essence when pursuing treatment. Studies have demonstrated that individuals who are diagnosed with HIV and are linked to early care and treatment often achieve lower levels of viral suppression and experience fewer complications from the disease. Beginning antiretroviral treatment (ART) as soon as possible after diagnosis, therefore, is recommended.

But how many newly diagnosed individuals actually begin ART regimens and see a quick lowering of their viral levels? Right now, the commonly used indicators of progress in HIV therapy don’t measure that information. The US National HIV/AIDS Strategy (NHAS), a government plan that keeps tabs on how we manage HIV in this country, offers several indicators that provide a snapshot of our success.

For people with diagnosed HIV, the process indicator is the percentage that receives medical care for the disease; the goal is for 90% of all of those with HIV to be receiving care by 2020. The outcome indicator is the percentage of those living with HIV who achieve viral suppression; the goal is for 80% of those in this group to be suppressed by 2020. For newly diagnosed individuals, the single process indicator is the percentage that immediately enters HIV medical care (within 4 weeks of diagnosis), with a goal of 85% of newly diagnosed individuals entering care by 2020. There is no outcome indicator, however, for newly diagnosed individuals.

A team at the New York City Department of Health recently completed a study of more than 27,500 individuals—most of them men—who were newly diagnosed with HIV over a 10-year period from early 2007 to late 2016. The subjects’ information had been given to the New York City Department of Mental Health and Hygiene.

The study tracked the patients for 3 months after diagnosis to learn how many were able to reach a viral load of fewer than 200 copies/mL in that time period. From 2007 to 2016, the percentage of individuals who saw their viral load drop to 200 copies/mL or less within 3 months rose from 9% to 37%, with a particular upward trajectory from 2012 to 2016.

Read more about the new way to measure success in HIV suppression.