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Bulevirtide Demonstrates Efficacy, Safety for Hepatitis D Treatment


For patients who have chronic hepatitis Delta (HDV), which is the most severe form of viral hepatitis, the infection can often come with poor prognosis and high rates of mortality. And combined with the possible coinfections such as hepatitis B (HBV) and HIV, disease management can be extremely difficult.

“What we know is hepatitis delta prevalence in people living with HIV is actually higher than in people who do not have HIV,” Anu Osinusi, MD, vice president, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead, said. “And so because of the common routes of transmissions of these diseases, HIV, hepatitis B, and hepatitis Delta, people who have triple infections, what we also know from the data is that there is a higher rate of liver-related outcomes such as developing cirrhosis, decompensated liver disease, liver cancer…larger rates of the need for liver transplantation and overall death, compared to individuals who just have hepatitis B or hepatitis D.”

With the potential severity of chronic hepatitis D and the coinfections and limited treatment options, there is an unmet need for therapies. Bulevirtide (Hepcludex, Gilead) is a first-in-class entry inhibitor that was approved in the European Union for chronic HDV infection in HDV RNA positive adult patients with compensated liver disease. The therapy is an investigational treatment in the United States.

“What bulevirtide does is it essentially binds to and then inactivates the NTCP receptor, which then has the goal of preventing new infections in the hepatocytes, and then inhibits the propagation of hepatitis Delta itself,” Osinusi said.

At last week’s Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, CO, data was presented on bulevirtide in regards to those with chronic hepatitis D and also included results on 2 patients who had HIV, hepatitis B, and hepatitis D.

Study Parameters and Results
In this study, 150 participants with chronic hepatitis D were randomized (1:1:1) into 3 arms including Arm A, which was no active anti-HDV treatment for 48 weeks, followed by bulevirtide 10mg/d for 96 weeks (n=51), and Arms B or C: immediate treatment with bulevirtide at 2 mg/d (n=49) or 10 mg/d (n=50), respectively, each for 144 weeks, with follow-up of 96 weeks after end of treatment. Efficacy was measured by combined (undetectable HDV RNA or ≥2 log10 IU/mL decline from BL and ALT normalization), virologic and biochemical response rates.

“At week 96, 39% to 56% of patients responded with substantially reduced levels of HDV RNA and with normal levels of the liver enzyme alanine aminotransferase, a key marker of liver health. Through 2 years of treatment, bulevirtide was safe and well tolerated,” the study authors wrote.

Osinusi explained that for some participants it may have taken longer time to see a therapeutic benefit.

“Even in the patient participants who didn’t have a virologic response at week 24, over time, many of those participants actually go on to have this improved response at week 96,” she said.

For the 2 individual patients in the subset who had HBV/HDV, they also saw a benefit. “At week 96, both patients achieved a combined response (virologic and ALT normalization) as well as improvements in HBV DNA, platelet levels, and liver stiffness measurements,” the investigators wrote. “Neither patient required changes to their anti-HIV regimen nor did they experience serious [adverse events] AEs related to [bulevirtide] BLV.”

Contagion spoke to Osinusi who offered further insights on the study and the therapy.

Reference
Wedemeyer H, Aleman S, Brunetto M, et al. Efficacy and Safety of Bulevirtide 2 mg or 10 mg for 96 Weeks in Chronic Hepatitis Delta, Including in 2 Patients With HIV/Hepatitis B Virus/Hepatitis Delta Virus. Poster #735 presented at CROI 2024. March 3-6, 2023. Denver, CO.



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Pesto Baked Chicken Thighs – Minimalist Baker Recipes

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Golden brown pesto baked chicken thighs in a cast iron skillet

Sometimes we post what we’re eating on Instagram and you want the recipe right away. Waiting for good things is hard, but you’ve proved you can do hard things. The wait for our pesto baked chicken thighs is finally over, and we have a feeling the recipe will be on repeat in your kitchens!

This garlicky, herby dish comes together in just 20 minutes and pairs well with just about anything, including salads, pasta, potatoes, and roasted veggies. Let’s make it!

Boneless skinless chicken thighs, pesto, olive oil, dried Italian herbs, red pepper flakes, salt, garlic powder, and black pepper

These EASY pesto baked chicken thighs begin with seasoning the chicken with garlic powder, dried Italian herbs, salt, pepper, red pepper flakes, and PESTO! The mixture is savory and salty with a little herbiness and a kick of heat.

Mixing pesto, dried Italian herbs, red pepper flakes, and chicken thighs in a bowl

Next, we sear the chicken in a cast iron skillet to create a golden brown exterior that seals in its juiciness. Another 5-10 more minutes in the oven and it’s cooked through. Letting it rest for an additional 5 minutes out of the oven allows the meat to reabsorb its juices, leaving you with tender, perfectly cooked chicken!

Golden brown chicken thighs in a cast iron skillet

We hope you LOVE this pesto chicken! It’s:

Herby
Garlicky
A little spicy
Savory
Juicy on the inside
Golden on the outside
& SO versatile!

This dish is a great staple entrée to have in your rotation because it pairs well with almost anything! It’s delicious with roasted veggies (potatoes, eggplant, and/or asparagus), pesto pasta salad, green salads, and so much more.

More Easy, Satisfying Entrées

If you try this recipe, let us know! Leave a comment, rate it, and don’t forget to tag a photo @minimalistbaker on Instagram. Cheers, friends!

Pesto pasta swirled on a fork next to a pesto chicken thigh and roasted vegetables

Prep Time 5 minutes

Cook Time 15 minutes

Total Time 20 minutes

Servings 4 (Chicken thighs)

Course Entrée

Cuisine Dairy-Free, Gluten-Free

Freezer Friendly No

Does it keep? 2-3 Days

Prevent your screen from going dark

  • 4 (~6 oz. each) boneless, skinless chicken thighs (organic, pasture-raised when possible // four thighs are ~1 ½ lbs // bone in, skin on also work)
  • 1 tsp garlic powder
  • 2 tsp dried Italian herb blend (or dried oregano + basil)
  • 1/4 tsp sea salt
  • 1/2 tsp black pepper
  • 1/2 tsp red pepper flakes (omit/reduce for less heat)
  • 3-4 Tbsp basil pesto (store-bought* or homemade // dairy-free as needed)
  • 2 tsp olive oil (use less for skin-on chicken thighs)
  • Preheat oven to 375 degrees F (190 C) and set out a large cast iron skillet (10-12 inch).
  • To a mixing bowl, add the chicken thighs, garlic powder, dried Italian herbs, salt, pepper, red pepper flakes, and pesto. Mix well until evenly coated, adding 1 Tbsp more pesto if using homemade (it’s not usually as concentrated in flavor).

  • Heat the cast iron skillet over medium-high heat. Add oil and wait 1 minute for it to get hot. Add chicken thighs (skin side down if using skin-on) and cook until golden brown on the underside, about 3-4 minutes. Then flip and cook for 2-3 minutes more.

  • Once browned on both sides, carefully transfer the skillet to the oven (using an oven mitt) and bake until the internal temperature reads 170F / 76C (make sure to insert into the center and not hit bone for an accurate reading) — about 5-10 minutes, depending on the size of your chicken thighs.

  • Remove from the oven and let rest in the pan for ~5 minutes before serving.

  • Best when fresh, though leftovers will keep covered in the refrigerator for up to 2-3 days. Reheat in the oven or microwave until hot. Not freezer friendly.

*Store-bought dairy-free pestos we’ve tried and enjoy: Gotham Greens Vegan Pesto, Le Grand Garden Pesto, and Trader Joe’s Vegan Kale, Cashew & Basil Pesto.
*We prefer searing on the stovetop before baking for best flavor and texture. Cooking on the stovetop only doesn’t work as well because the exterior is prone to burning before the chicken is cooked through.
*If you want to bake only and skip searing on the stovetop, you can place the seasoned chicken thighs on a foil or parchment-lined baking sheet sprayed/rubbed with oil. Bake at 425 F / 218 C for 20-30 minutes, flipping halfway through, until the internal temperature reads 170 F / 76C (make sure to insert into the center for an accurate reading). They don’t get as crispy but are still delicious!
*Loosely adapted from our Pesto “Parmesan” Turkey Meatballs.
*Nutrition information is a rough estimate calculated with boneless skinless thighs and the lesser amounts where ranges are provided.

Serving: 1 serving Calories: 248 Carbohydrates: 2.4 g Protein: 35 g Fat: 11 g Saturated Fat: 2.1 g Polyunsaturated Fat: 2.1 g Monounsaturated Fat: 5.4 g Trans Fat: 0 g Cholesterol: 144 mg Sodium: 366 mg Potassium: 503 mg Fiber: 0.9 g Sugar: 0.2 g Vitamin A: 123 IU Vitamin C: 2.5 mg Calcium: 26 mg Iron: 2.3 mg





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Are They Right for You?


March 11, 2024 – At-home medical diagnostic testing has exploded in recent years. NASDAQ reports that the market for at-home testing has reached a staggering $45.6 billion and will continue to grow at a rate of over 10% per year up to 2031. 

COVID-19 testing may have gotten the ball rolling, but new home tests for a variety of conditions are becoming widely available. Do-it-yourself genetic tests for everything from thyroid disease, to sexually transmitted diseases (STDs), to heart disease, and more are cutting-edge options, as are inflammation-detecting tests that may spot early signs of conditions like Alzheimer’s

Convenience is a major advantage when it comes to at-home testing, also sometimes called direct-to-consumer testing Those who think they may have sleep apnea, for example, but don’t want to endure the discomfort of a night in the hospital for a sleep study, have the option of an at-home evaluation – plus they can get fitted for a CPAP machine if needed.

While accessible, the evaluation is not foolproof, warned Brooke G. Judd, MD, an assistant professor of medicine and assistant professor of psychiatry at Dartmouth College’s Geisel School of Medicine. 

“Although these devices report a number of metrics, including sleep time, sleep stages, and blood oxygen levels, it is important to understand that the algorithms for these metrics change quickly, and are still only providing estimates rather than accurate values,” said Judd, who is also the medical director of sleep medicine at Dartmouth Hitchcock Medical Center in Lebanon, NH. 

There are other drawbacks to direct-to-consumer tests. New research from the University of Pennsylvania found that companies that make at-home tests don’t guarantee the same privacy rules a doctor’s visit automatically provides, and these tests often require the consumer to take on the responsibility of accuracy. 

Read on for more must-knows about at-home medical testing, so you can decide if it’s right for you. 

Are At-Home Tests Safe? 

Yes – so long as the test has been approved by the FDA. 

“When it comes to a true direct-to-consumer test, the FDA has always really emphasized safety,” said Mark Fendrick, MD, a professor of internal medicine, professor of health management and policy, and director of the Center for Value-Based Insurance Design at the University of Michigan in Ann Arbor. “These tests are incredibly well-studied.”

How Do You Take an At-Home Medical Test? 

An at-home test works much like those you’re used to getting at your doctor’s office. 

Typically, the process is:

  • A consumer buys a test at a store or online.
  • A DNA sample is collected – either saliva, urine, or blood – using the test kit instructions.
  • The sample is mailed off to the company that makes the test. The sample is analyzed for certain genetic evidence that indicates a specific medical condition.
  • Results then are sent to the consumer, usually through a secure web portal. Sometimes, the results are simply positive or negative; sometimes, a medical professional is available to interpret and discuss the results. 

Specific Tests and How They Work 

Sleep Apnea 

Harvard Medical School estimates that 60% to 70% of these studies are now done using home evaluations. The sleep apnea test approved by the FDA, WatchPAT, is a disposable test that works by attaching finger and/or chest probes, rather than using a more complex head sensor system in traditional on-site sleep studies. You speak with a doctor through a telemedicine chat who approves you for the device. Then you use the device at home and send your sleep data to the company. Your data gets doctor-reviewed, and you’re sent a report with recommendations, including, potentially, for the CPAP machine. Research has shown that the WatchPAT has a positive predictive sleep apnea rate of 79% to 96%. Its accuracy for predicting a negative diagnosis of the condition is reported at 96%. It costs about $190 and is typically covered by insurance.

Inflammation 

Inflammation home tests are sold under many brand names and range in price from about $25 to $100. Most of the time, the test involves a finger prick , and the blood sample is then mailed to these tests’ makers.

 EmpowerDX offers one popular option. It sells a home test that measures C-reactive protein in the blood, which can indicate a range of health conditions. The company stresses the usefulness specifically of this test to find out if inflammation has activated your immune system. Some of these kits, such as a popular model from Everlywell, also measure vitamin D levels, to find out if they’re sufficient to activate your immune system. 

The most significant test of this kind is made by Quest Diagnostics and was introduced to the market last summer as an early diagnostic tool for Alzheimer’s. It’s a blood test that measures beta-amyloid protein, which is a major indicator of the condition. 

Sexually Transmitted Diseases, Including HIV

STD testing kits are available for about $100 through brands like CVS and commonly involve sending in urine samples. It usually takes about 5 to 16 days to get results back. 

Hyperthyroidism and Hypothyroidism

Thyroid at-home blood test kits are offered by many companies, including Paloma Health. To ensure best accuracy, consumers should choose a kit that’s CLIA- and CAP-certified. You send in your sample and get digital results within a few days. 

Waiting for Results 

Waiting for the results of your at-home test can be nerve-wracking.

“I call it ‘screening purgatory,'” said Fendrick. “Is it really worthwhile for people to perhaps receive life-changing test results if they don’t have family, friends, or a support system to turn to?”

In deciding if you can handle the wait, he offered a suggestion. 

“Before you start the test, think about what you might do if the result is positive OR negative.” If the condition you’re testing for is potentially serious, it might be better to receive in-person testing by a health care provider. This will get you results quickly, and you can access fast, professional medical advice. 

Ensuring Accurate Results 

In short: There isn’t 100% certainty, even with tests that have good accuracy rates. 

“All medical tests have the potential to be inaccurate,” said Mary T. Gover, MD, an assistant professor of medicine at Albert Einstein College of Medicine and an internist with Montefiore Einstein Advanced Care in Bronx, NY. “There can either be a false positive or a false negative.”

A study from the University of Minnesota points out that direct-to-consumer testing can be unclear in terms of follow-up, too. The good news is, most people who take these tests do understand the importance of reporting this information to their doctors. The University of Michigan’s National Poll on Healthy Aging found that almost 50% of the people in the survey, ages 40 to 80, had used an at-home test. And 90% of those who’d bought a test for cancer brought their results to their health care provider, as did 55% of those who tested themselves for an infection. 

If you get a positive test result, call your doctor right away to get retested, so the results can be confirmed. If your home test is proven accurate, your doctor can start any treatment that you need. And sometimes, you’ll find that you actually don’t have a condition or disease after all.

“There has been research done in populations of patients who have gotten a false positive diagnosis of a condition, but actually turned out not to have that condition,” said Gover. “These patients reported having increased concern about that condition afterward. They didn’t have it, but emotionally, they felt like they had it.”

If this happens to you, talk about your feelings with your doctor. Getting a “debrief” as soon as you can may help you avoid this type of emotional impact. 

The bottom line: At-home tests can be a convenient and useful step in the process of getting a confirmed medical diagnosis. But for those who are truly concerned about a potentially serious health problem, it’s probably best to leave the testing to your doctor. Expert care and advice is always the best way to stay as safe and healthy as possible. 



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The Role of Vaccine Efficacy Impacting 2023-24 Influenza


In the US, the efficacy of influenza vaccines changes annually, influenced by the alignment between the strains targeted by the vaccine and those circulating. Evaluating the vaccine effectiveness (VE), and how well it protects against the flu, is vital for developing public health measures to reduce the impact of the flu. Preliminary estimates of the vaccine’s effectiveness for the 2023-24 season show that it lowers the risk of medically attended flu virus infections for children and adults. The Centers for Disease Control and Prevention (CDC) advises that everyone in these groups who has not yet received their vaccine this season should do so, especially as the flu remains prevalent in local communities.

When analyzing VE by influenza type, VE against influenza A varied from 46% to 59% for children and adolescents, and from 27% to 46% for adults. In contrast, VE against influenza B was significantly greater, with pediatric patients in outpatient settings experiencing a range from 64% to 89%, and adults in diverse settings seeing a range from 60% to 78%. This method provides estimates of VE against influenza virus infection requiring medical attention. The research revealed that the VE differed across age groups, settings, and types of the virus for children and adolescents aged 6 months to 17 years.

The VE in preventing flu-related outpatient visits was estimated to range from 59% to 67%, and in preventing flu-related hospitalizations varied from 52% to 61%. For adults aged 18 and older, the vaccine’s effectiveness in reducing outpatient visits due to influenza ranged from 33% to 49%, and its effectiveness against hospitalizations was between 41% and 44%.

3 Key Takeaways

  1. The effectiveness of the influenza vaccine varies annually and is influenced by how well the vaccine strains match the circulating virus strains.
  2. The data suggest that the flu vaccine, particularly the QIV-HD, is associated with a significant reduction in hospitalizations for pneumonia or influenza and all-cause hospitalizations compared to the QIV-SD.
  3. The lower vaccination coverage observed in the current season compared to previous seasons and before the COVID-19 pandemic underscores the challenge of achieving sufficient vaccination rates to maximize public health benefits.

“Influenza vaccination coverage in the United States has been lower this season than in the previous season and lower than coverage before the COVID-19 pandemic. In the current analyses, fewer than one-half of test-negative control patients had received influenza vaccine in all VE networks and among enrollees of most age groups,” according to the CDC. “The public health benefit of annual influenza vaccination depends on both vaccine effectiveness and vaccination coverage.”1

To estimate the interim VE for the flu season, researchers employed a test-negative case-control study method, leveraging data from four VE networks. This approach involved assessing the vaccination status of patients aged 6 months and older who sought medical attention for acute respiratory illnesses, comparing their influenza test results, and determining if they were positive or negative for the virus.

Limitations begin with the small sample sizes preventing the estimation of VE for certain age groups and environments. Despite adjustments for potential confounders, the risk of unmeasured confounding factors, such as underlying health conditions or previous vaccination history, remains. Additionally, the possibility of misclassification of vaccination status exists, particularly when vaccination data is self-reported or when the vaccine was administered outside the healthcare system. For these analyses, individuals who received one or more doses of the 2023–24 flu vaccine were classified as vaccinated.

Based on a recent report from Contagion, the vaccine was associated with lower incidence rates of hospitalizations for pneumonia or influenza and all-cause hospitalizations compared with QIV-SD with trends evident independent of influenza circulation levels. The exploratory results suggest a number needed to treat of 65 (95% CI 35-840) persons with QIV-HD compared to QIV-SD to prevent 1 additional all-cause hospitalization per season.2

The study involved 12,477 participants, those who received QIV-HD had only 10 events of hospitalizations for pneumonia or influenza compared to those who received QIV-SD with 33 events. The risk of such hospitalizations was 70% lower with QIV-HD. The total number of hospitalizations for any reason was also lower in the QIV-HD group, with 647 events compared to 742 events in the QIV-SD group, indicating a 13% reduction.

“Effectiveness estimates for all significantly reduced outcomes (hospitalizations for pneumonia or influenza, all-cause hospitalizations, and all-cause death) consistently favored QIV-HD in our temporal analysis,” according to the investigators. “The observed effectiveness even before active influenza transmission during the study season may point to beneficial immunomodulatory effects of vaccination independent of the prevention of overt influenza infection.”2

All in all, research shows the importance of flu vaccines, comparing QIV-HD and QIV-SD, in reducing severe flu outcomes and hospitalizations. Early data for the 2023-24 flu season emphasizes their role in public health by preventing serious cases and promoting widespread vaccination to combat the flu’s unpredictability. The CDC focuses on boosting vaccination rates for both personal and community health benefits.

References

  1. CDC. Interim Estimates of 2023–24 Seasonal Influenza Vaccine Effectiveness — United States. Published February 29, 2024. Accessed March 6, 2024. https://www.cdc.gov/mmwr/volumes/73/wr/mm7308a3.htm?s_cid=mm7308a3_w
  2. Abene S. High-Dose Influenza Vaccine (QIV-HD) Shows Promise Results in Reducing Hospitalizations. Contagion. Published February 12, 2024. Accessed March 6, 2024. https://www.contagionlive.com/view/high-dose-influenza-vaccine-shows-promise-results-in-reducing-hospitalizations



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Garlic Parmesan Baked Potato Wedges

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Baked parmesan garlic potato wedges are so incredibly easy and have the best savory flavor! These crispy wedges are roasted to perfection and guaranteed to be a huge hit. Grab your favorite dipping sauce and enjoy!

These baked potato wedges are always a hit with my family. We love them even more with some homemade dipping sauces! Try mumbo sauce, Cane’s sauce, or comeback sauce!

Baked Parmesan Garlic Potato Wedges served with ketchup.

Garlic Parmesan Baked Potato Wedges

Craving some crispy, cheesy goodness? Look no further than these garlic parmesan baked potato wedges! They’re one of my go-to appetizers, and I know once you give them a try, you’ll love them just as much.

They’re so easy to make too! Just toss some potato wedges with olive oil, garlic powder, Italian seasoning, and Parmesan cheese, then bake until golden brown. They’re the perfect side dish for any meal, or a delicious snack on their own. So grab your favorite dipping sauce- ketchup, fry sauce, anything you like! They’re sure to satisfy your cravings for a salty snack and leave you reaching for another.

Ingredient List

Just a few simple ingredients here to give your potato wedges the best possible flavor and texture! Measurements for each ingredient are in the recipe card at the end of the post.

  • Russet Potatoes: These are the potatoes you want for wedges – big and starchy for the best crisp. Yukon potatoes are another type of starchy, buttery potato that would work well.
  • Olive Oil: Coats the wedges and helps them get nice and golden brown.
  • Garlic Powder: For a punch of savory flavor! You can also go bold and use fresh minced garlic instead.
  • Italian Seasoning: A mix of herbs like oregano and basil to help infuse flavor.
  • Parmesan Cheese: Melty, salty cheese that makes the baked potato wedges taste so good.
  • Salt and Pepper: Simple seasonings to make all the other flavors pop! Add as much or as little as you like.
  • Fresh Parsley (Optional): Chopped for a garnish on top.

Should I Peel My Potatoes?

In this recipe for baked potato wedges I recommend not peeling the potatoes. The best part is that thick, crispy crust to enjoy after baking.

How Do You Make Baked Parmesan Garlic Potato Wedges?

These potato wedges are so no-fuss and easy to make. You get a perfectly crispy outer layer without the hassle of frying them in oil!

  1. Preheat Oven, Prepare Wedges: Preheat oven to 400 degrees Fahrenheit. Cut each potato lengthwise in half. Then cut each half into three wedges.
  2. Season: In a large bowl add the potato wedges, olive oil, garlic powder, Italian seasoning, salt and pepper.
  3. Bake: Arrange potatoes skin side down in a single layer on a 15x10x1-in. baking pan coated with cooking spray. Sprinkle with any remaining coating. Bake for 25-30 minutes until they are golden brown and crispy.
  4. Enjoy: Garnish with fresh parsley and serve with ketchup, ranch, or sauce of choice.
3-photo collage of the potato slices being prepared.

Soaking your raw potato wedges in hot water for 10 minutes before baking helps give them more of a crispy outside.

The cooked potato wedges on a baking sheet.

Dipping Sauces to Serve Your Baked Potato Wedges With

This garlic parmesan baked potato wedges are amazing on their own, but even better paired with a thick, flavorful sauce. Here are a few of my favorites!

Closeup of parmesan garlic baked potato wedges.

Storing Leftovers / Reheating

These potato wedges are best enjoyed fresh out of the oven when they’re nice and crispy. Storing them in the fridge can make them a bit soft, but if you have a lot of extras, this is definitely an option. They’ll stay good in the fridge in an airtight container for a day or two. Reheat them in the oven to revive some of the crispiness. (10 minutes at 350 degrees Fahrenheit should do the trick!) Keep in mind that the texture won’t be quite the same.

Dipping a potato wedge in ketchup.

Other Tried and True Potato Appetizers

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  • Preheat oven to 400°. Cut each potato lengthwise in half. Cut each half into three wedges.

  • In a large bowl add the potato wedges, olive oil, garlic powder, Italian seasoning, grated parmesan salt and pepper.

  • Arrange potatoes skin side down in a single layer on a 15x10x1-in. baking pan coated with cooking spray. Sprinkle with any remaining coating. Bake for 25-30 minutes until they are golden brown and crispy.

  • Garnish with fresh parsley and serve with ketchup, ranch, or sauce of choice.

Originally posted April 23, 2019
Updated on March 11, 2024

Calories: 404kcalCarbohydrates: 38gProtein: 13gFat: 23gSaturated Fat: 7gPolyunsaturated Fat: 2gMonounsaturated Fat: 13gCholesterol: 26mgSodium: 1110mgPotassium: 813mgFiber: 4gSugar: 1gVitamin A: 321IUVitamin C: 9mgCalcium: 345mgIron: 3mg

Nutrition information is automatically calculated, so should only be used as an approximation.





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Managing Treatment-Resistant Depression: One Person’s Story


When Imadé Borha graduated from Columbia University in 2015 with a master’s degree in nonfiction creative writing, she thought the last thing she’d have to worry about was finding a job. It didn’t happen. “That was around the time of the first suicide attempt,” recalls Borha, 34, now a Durham, NC-based communications professional for a nonprofit organization.

“Career instability was triggering a lot of the mental health problems I was having,” she says. “It had felt like a failure that I had to leave New York, and not having a job” was traumatic.

Borha was first diagnosed with major depressive disorder in 2012. “It was in response to suicidal behavior, and basically textbook depression,” she says. “When I had the first suicide attempt, that was when I noticed that the three meds I’d taken hadn’t helped.”

Treatment-resistant depression happens when someone with major depressive disorder hasn’t responded to at least two antidepressants taken in the right dosage for the prescribed amount of time, according to Matthew Rudorfer, MD, a psychiatrist and chief of the somatic treatments and psychopharmacology program at the National Institute of Mental Health in Potomac, MD.

“There are clearly many shades of major depression. … There is no ‘one-size-fits-all’ solution. Rather, the best clinical intervention for the person with [treatment-resistant depression] should be personalized to the individual. A major aim of ongoing research is to improve the ability to match patients with the right treatment.”

A New Diagnosis

In 2019, Borha was diagnosed with borderline personality disorder (BPD), which brings mood swings, a shaky sense of self, impulsive behavior, and trouble forming relationships.

“The symptoms of BPD include extreme, intense emotions that can be triggered by reactions like a sense of abandonment or rejection,” she says. She feels being turned down for jobs and other opportunities brought her symptoms roaring to the surface.

Amid the mental turmoil, it took a while for Borha to tease out how much anxiety drove much of her thinking and actions. “When you’re highly suicidal, you really don’t have the time to ask, ‘Do I have an anxiety problem?’ ” In time, she tried the prescription anti-anxiety med buspirone (BuSpar). It helped quiet her mind. Along with dialectical behavioral therapy, her world began to come into focus.

Dialectical behavioral therapy blends weekly talk therapy with group skills training. It zeroes in on emotions and takes a balanced approach to both accept oneself and learn ways to make helpful changes. It was first developed to treat BPD and women with suicidal tendencies, but now it’s used to treat other related problems, too.

“It helps folks like me, who have really big emotions, have skills or tools to help regulate those emotions so our lives aren’t looking like chaos every single day,” Borha says. Exercise – mainly high-intensity interval training – helps keep her centered too, she says.

Community Is Key

“I do strongly believe that building [a mental health] community is going to keep me alive, keep my suicidal behavior and self-harm low,” Borha says. At the same time, she finds it tough to build interpersonal relationships because of her fear of abandonment and rejection. “I speak a lot, but when it comes to day-to-day interaction about my current mental health, it’s hard. I need to be more vulnerable, to put myself out there, to just be honest with people.”

Borha says resistance to seeking treatment for mental or emotional conditions is deep-rooted in the Black community. “We’re dealing with a situation where historically, when Black people disclose they’re sad, they’re depressed, or they’re angry, they’ll be punished. They feel their lives can be in danger. That response echoes through their families and support systems.”

Borha says the mindset to keep problems in the family, under wraps, is loosening up a little. “Now, [Black people with mental issues] have a chance to find therapists and other resources.” But she still sees obstacles and racial bias related to care.

Through her website, DepressedWhileBlack.com, Borha tries to link her followers with therapists who’ll understand them. Right now, her Help Me Find a Therapist program is on hiatus while her team catches up on the backlog of requests.

Be Your Own Researcher

“I do think treatment-resistant depression is a huge part of the suicide crisis,” Borha says. “If we can treat people who’ve struggled with it, we can save lives.”

The antidepressant esketamine (Spravato) is the only nasal spray drug the FDA has approved specifically for treatment-resistant depression, though a range of other treatments and therapies can help and continue to be studied, Rudorfer says. Esketamine comes from ketamine. It’s a nasal spray that has to be given and monitored by a health care provider.

Borha says she’s asked her insurance to cover esketamine, but so far it’s a no-go. Meanwhile, she presses on to study and learn more about her condition.

“I would say research your symptoms, because you may [need] a different diagnosis,” she says. “Then use that research to do self-advocacy. Tell your therapist or psychiatrist what else is out there that they haven’t considered, when it comes to diagnoses.”

And, she says, “It’s OK to be wrong. … If psychiatrists can be wrong, I can be wrong. As patients, we have the right to experiment, and to fail, and to try again. We have that right.”

“Just experiment, research, and go for it,” she says. “Advocate for yourself.”



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New Method to Quantify Antibiotic For Gut Microbiome Studies


Omadacyline (Nuzyra, Paratek Pharmaceuticals) is a tetracycline-class antibiotic that was FDA approved for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). The antibiotic is also being studied for a variety of potential indications.1

Investigators from the Garey lab at the University of Houston explored omadacycline as it relates to the microbiome and potential application for its use for the healthcare-associated infection, C difficile infection (CDI). In a recent study by Garey et al, they investigated omadacycline for possible utility in this indication as compared to vancomycin, and they found omadacycline had high fecal concentrations with a distinct microbiome profile compared to those in the vancomycin group.2

They concluded that omadacycline was safe for “patients at high risk for C diff infection.”2

In addition, researchers from the Garey lab also explored finding a novel method to quantify omadacycline and its epimerization in stool. The results of this research were published in a recent issue of Journal of Chromatography B. 3

Previous research showed the ability to extract and quantify omadacycline in plasma and urine using high performance liquid chromatography (HPLC) and liquid chromatography-tandem mass spectrometry (LC-MS/MS), but there was serious limitations when it came to fecal analysis, the investigators reported. “Only a single study reported using LC-MS/MS to quantify human fecal omadacycline, however, it involved multi-step extraction and lacked validation of matrix effect, precision, and accuracy.”3

As such the team developed and validated a new method with liquid chromatography-tandem mass spectrometry (LC-MS/MS), and were able to quantify omadacycline and its epimerization in stool to facilitate microbiome studies.3

Study Methods
They had 8 healthy individuals take oral omadacycline for 10 days. The participants had stool samples collected at baseline, during therapy duration, and at follow-visits. The team extracted the antibiotic in a methanol-water-ethylenediaminetetraacetic acid (ETDA) solvent containing deuterated omadacycline as internal standard, followed by dilution. In an optimal gradient elution mode, omadacycline and its C4 epimer were separated within 5 min on reversed-phase C18 column.3

In terms of results, they were able to find a simple solution to quantify the antibiotic. “The method showed a broad working range of 0.1–200 ng/ml with a limitation of detection (LOD) of 0.03 ng/ml, little fecal matrix effect, good intra-day and inter-day accuracy (90–101 %), precision (2–15 %), and recovery rate (99–105 %),” the investigators wrote. “The method was sufficiently sensitive to quantify omadacycline in human fecal samples (n = 82) collected during a 10-day therapy course and at follow-up (day 13 and day 30) that ranged from 1 to 4785 µg/g. Further analysis revealed that ∼9 % of omadacycline was epimerized in fecal matrix control while, on average, 37.4 % was epimerized in human fecal samples.”3

“This study revealed that on average, 37.4% of omadacycline transformed to a C4 epimer form in fecal samples with a wide variability noted between samples. The mechanism of epimerization is unknown and will require further study. However, concentrations of native omadacycline well above minimum inhibitory concentration for pathogenic bacteria including C difficile were noted in all samples,” the investigators concluded.3


References

1. Fleming M. FDA Approves Omadacycline for ABSSSI and CABP. ContagionLive. October 3, 2018. Accessed March 8, 2024.
https://www.contagionlive.com/view/fda-approves-omadacycline-for-absssi-and-cabp

2. Brooks A. Omadacycline Demonstrates Safety, Possible Utility for Healthcare-Associated Infection Compared to Vancomycin.
https://www.contagionlive.com/view/omadacycline-demonstrates-safety-possible-utility-for-healthcare-associated-infection-compared-to-vancomycin

3. Hu C, Wang W, Jo J, Garey KW. Development and validation of LC-MS/MS for quantifying omadacycline from stool for gut microbiome studies. J Chromatogr B Analyt Technol Biomed Life Sci. Published online February 28, 2024. doi:10.1016/j.jchromb.2024.124057



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How Diabetes Affects The Heart


Heart disease is common in people with diabetes. In general, the risk of heart disease death and stroke is more than twice as high in people with diabetes.

While all people with diabetes have an increased chance of developing heart disease, the condition is more common in those with type 2 diabetes. In fact, heart disease is the number one cause of death among people with type 2 diabetes.

The Framingham Study was one of the first pieces of evidence to show that people with diabetes are more vulnerable to heart disease than those people who did not have diabetes. The Framingham Study looked at generations of people, including those with diabetes, to try to determine the health risk factors for developing heart disease. It showed that multiple health factors — including diabetes — could increase the possibility of developing heart disease. Aside from diabetes, other health problems associated with heart disease include high blood pressure, smoking, high cholesterol levels, and a family history of early heart disease.

The more health risk factors a person has for heart disease, the higher the chances that they will develop heart disease and even die from it. Just like anyone else, people with diabetes have an increased risk of dying from heart disease if they have more health risk factors. However, the probability of dying from heart disease is 2 to 4 times higher in a person with diabetes. So, while a person with one health risk factor, such as high blood pressure, may have a certain chance of dying from heart disease, a person with diabetes has double or even quadruple the risk of dying.

For example, one medical study found that people with diabetes who had no other health risk factors for heart disease were 5 times more likely to die of heart disease than those without. Another medical study showed that people with diabetes, no matter the number of other heart disease risk factors, were as likely to have a heart attack as someone without diabetes who has already had a heart attack.

Heart disease experts recommend that all people with diabetes have their heart disease risk factors treated as aggressively as people who have already had heart attacks.

The most common cause of heart disease in a person with diabetes is hardening of the coronary arteries or atherosclerosis, which is a buildup of cholesterol in the blood vessels that supply oxygen and nutrition to the heart.

When the cholesterol plaques can break apart or rupture, the body tries to repair the plaque rupture by sending platelets to seal it up. Because the artery is small, the platelets could block the flow of blood, not allowing for oxygen delivery and a heart attack develops. The same process can happen in all of the arteries in the body, resulting in lack of blood to the brain, causing a stroke or lack of blood to the feet, hands, or arms causing peripheral vascular disease.

Not only are people with diabetes at higher risk for heart disease, they’re also at higher risk for heart failure, a serious medical condition in which the heart is unable to pump blood adequately. This can lead to fluid build-up in the lungs that causes difficulty breathing, or fluid retention in other parts of the body (especially the legs) that causes swelling.

The symptoms of a heart attack include:

  • Shortness of breath.
  • Feeling faint.
  • Feeling dizzy.
  • Excessive and unexplained sweating.
  • Pain in the shoulders, jaw, and left arm.
  • Chest pain or pressure (especially during activity).
  • Nausea.

Remember not everyone has pain and these other classic symptoms with a heart attack. This is especially true for women.

*If you are experiencing any of these symptoms, you should call your doctor, call 911, or go to the nearest emergency room immediately.

Peripheral vascular disease has the following symptoms:

  • Cramping in your legs while walking (intermittent claudication) or hips or buttocks pain
  • Cold feet.
  • Decreased or absent pulses in the feet or legs.
  • Loss of fat under the skin of the lower parts of the legs.
  • Loss of hair on the lower parts of the legs.

There are several treatment options for heart disease in those with diabetes, depending on the severity of the heart disease, including:

  • Diet.
  • Exercise not only for weight loss, but to improve blood sugar levels, high blood pressure, cholesterol levels and to decrease abdominal fat, a risk factor of heart disease.
  • Medicines.
  • Surgery.

Peripheral vascular disease is treated by:

  • Participation in a regular walking program (45 minutes per day, followed by rest)
  • Special footwear
  • Aiming for an A1c below 7%
  • Lowering your blood pressure to less than 130/80
  • Getting your cholesterol to below 100
  • Medicines
  • Stopping smoking
  • Surgery (in some cases)

The best way to prevent heart disease is to take good care of yourself and your diabetes.



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PCR Testing Hastens Treatment of Community-Acquired Pneumonia


Patients hospitalized with suspected community-acquired pneumonia (CAP) received pathogen-targeted treatment sooner with polymerase chain reaction (PCR) testing in the emergency medicine department (EMD) than with standard-of-care microbiologic detection, in a randomized trial of this approach to enhance diagnostic stewardship.1

The investigators point out that the standard, culture-based methods to diagnose CAP are labor intensive, detect a pathogen in only 20 to 40% of patients, and are insufficient to inform early treatment decisions. This trial, they indicate, is the first to examine the relative clinical utility of “judicious,” syndromic rapid PCR pneumonia panel testing of patients presenting with suspected CAP.

“Most previous studies did not use a comprehensive syndromic PCR panel or included patients shortly after admission, potentially limiting the advantages or rapid molecular testing,” commented Harleen Grewal, MD, PhD, Department of Clinical Science, Bergen Integrated Diagnostic Stewardship Cluster, University of Bergen, Bergen, Norway, and colleagues.

“Another aspect of its novelty is the emphasis on pragmatism whereby decisions to continue, switch, or discontinue antimicrobial treatment were at the discretion of the treating physician alone,” the investigators noted.

The pragmatic, parallel-arm, single–blinded trial was conducted at a large tertiary care hospital in Bergen, Norway in 2 separate periods between September 2020 and June 2022. For the study, 374 participants were identified from patients with suspected CAP presenting to the EMD with at least 2 of the following: new or worsening cough, expectoration or dyspnea; pleuritic chest pain; radiological evidence of pneumonia; abnormalities on chest auscultation and/or percussion; or fever.

They had 187 participants randomized to the syndromic PCR testing and 187 to the standard-of-care microbiological diagnostics.The participants and the EMD clinicians were blinded to the treatment group allocation. The PCR panel applied in the ER tested orophayngeal and/or nasopharyngeal swabs for 27 bacterial and viral respiratory pathogens with 7 antimicrobial resistance genes.The standard-of-care microbiological diagnostics included blood cultures, pneumococcal urine test, and an in-house PCR test for respiratory viruses and atypical bacteria.

Grewal and colleagues found that pathogen-directed treatment was provided to 66 patients (35.3%) in the intervention group compared to 25 (13.4%) in the standard-of-care group; corresponding to a reduction in absolute risk of 21.9% (95% CI, 13.5-30.3).The median time to provision of treatment within 48 hours was 34.5 (31.6-37.3) hours in the intervention group and 43.8 (42.0-45.6) hours with standard-of-care.

The investigators note that the findings remained significant after adjustment for season.They stopped the trial earlier than planned because an ad hoc interim analysis showed substantial differences between the intervention and standard-of-care groups for both primary outcomes.

Although no significant differences in the secondary clinical outcomes were found between groups, the investigators indicate that the trial was designed principally to compare methods for facilitating timely diagnosis and targeted treatment.The intervention was associated with median 9.4 hours reduction in time without provision of pathogen-directed treatment within the first 48 hours after randomization. Outside the 48 hour period, the PCR testing in the EMD reduced the time from admission to a relevant test result by as much as 53.8 hours.

“A faster microbiological diagnosis allows for directed therapy, which has been shown in previous studies to improve outcomes, limit antibiotic overuse, and prevent antimicrobial resistance,” Grewal and colleagues observed.

Reference

Markussen DL, Serigstad S, Ritz C, et al. Diagnostic stewardship in community-acquired pneumonia with syndromic molecular testing. A randomized clinical trial. JAMA Netw Open. 2024; 7(3)e240830. doi:10.1001/jamanetworkopen.2024.0830. Accessed March 9, 2024.



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Air Fryer Ham Recipe | The Recipe Critic

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This air fryer ham is moist and flavorful with the most delicious caramelized honey glaze! It’s super easy to make and tastes so incredible, you’ll never want to cook ham any other way! Your friends and family will all be asking for the recipe!

Ham is such a great main dish for many different meals, especially for the holidays! Some of my other favorite ham recipes that you might want to try are this apricot glazed ham, this honey glazed ham or this very popular garlic honey mustard glazed ham! You can even make ham in an instant pot!

Sliced ham in an air fryer.

Ham in the Air Fryer

Cooking your ham in the air fryer starts with a large, sliced ham that is already cooked. With this recipe, we are simply adding great flavor and heating it so it retains all of its juices, and gets a crisp, caramelized outside edge that will keep you wanting bite after bite! There are a variety of ways to heat up a cooked ham, and after trying it in the air fryer, it’s become my go-to way to cook ham.

Air fryer ham has such amazing flavor, juiciness and texture, yet it is so quick and easy to make! The simple glaze can be made in a matter of minutes, then baste the ham and let the air fryer work its magic. We line the air fryer with foil, so clean-up is a breeze too! Make this ham entree into a complete meal by adding some tasty sides like mashed potatoes, glazed carrots, some green beans and don’t forget fluffy rolls! Whether you’re cooking for Easter, Mother’s Day or Christmas, you’ll have the perfect holiday spread!

Ingredients Needed

You will be shocked at how wonderful this air fryer ham recipe turns out with just 4 ingredients including the ham! Check out the recipe card at the bottom of the post for exact measurements.

  • Ham: We’re using a 3 pound sliced, boneless spiral ham that is fully cooked.
  • Butter: Melted butter gives the glaze the perfect consistency and richness.
  • Brown Sugar: An essential ingredient, so the outside of the ham gets deliciously caramelized!
  • Honey: Adds extra sweetness and an irresistible honey flavor that you will love!

How to Cook Ham in the Air Fryer

Get ready for the best ham you’ve ever tasted with just 10 minutes of prep! This insanely delicious main course will be on your table in no time. Here’s how to make the glaze and cook the ham:

  1. Make the Brown Sugar Glaze: In a small saucepan over medium heat, add the butter, brown sugar, and honey. Heat until the butter melts and the mixture comes to a simmer. Remove from heat and set aside.
  2. Add Ham to Air Fryer: Line a piece of heavy duty foil in the basket of the air fryer. Place the ham in the center of the foil then fold up the edges of the foil around the ham.
  3. Brush on Glaze: Brush some of the butter glaze over the top and around the sides of the ham. Save the rest of the glaze to baste throughout the cooking process.
  4. Cook: Cover the top of the ham with foil and cook in the air fryer at 325 degrees Fahrenheit for 20 minutes.
  5. Add More Glaze: Baste with additional glaze, recover with foil, then cook an additional 15 minutes. The ham should reach 145 degress Fahrenheit.
  6. Baste Once More: Remove the top piece of aluminum foil and glaze the ham one more time.
  7. Finish Cooking: Increase the temperature to 350 degrees Fahrenheit and brown the top of the ham for 2-3 minutes or until golden brown to your preference.
  8. Serve: Remove the ham from the air fryer basket and slice and serve.

Tips for the Perfect Ham

Here are my top tips for juicy, perfectly cooked ham that the whole family will happily devour!

  • Larger Ham: This recipe calls for a 3-pound boneless ham, if you have a larger ham, cut it into two equal pieces and cook together (as long as both fit in the air fryer).
  • Wrapping in Foil: Not only does it make for easy clean-up, but it’s important to wrap the ham in foil to keep it super moist as it cooks.
  • Fully Cooked: This recipe is only for a pre-cooked ham. Be sure the packaging on your ham says fully cooked.
  • Internal Temperature: You definitely don’t want the ham to be overcooked and dry, it is ready to remove from the air fryer when the internal temperature is 145 degrees F. 
  • Thaw it: If you have a frozen ham, then make sure to thaw it overnight in the fridge. Make sure not to start cooking it until it’s fully thawed!

Storing Leftovers

Ham makes fantastic leftovers! Use it for sandwiches or reheat it for dinner the next night. Here’s how you can store it safely.

  • In the Refrigerator: If you have leftover ham, then place it in an airtight container (or wrap it in plastic wrap and then foil) and put it in your fridge. It can last up to about 4 days! 
  • Reheating: Place the ham on a baking sheet and cover it with foil. Cook at 325 degrees for about 10 minutes or until the ham is heated through! You can also rewarm individual slices in the microwave.

Closeup of a cut ham after being cooked in the air fryer. It is surrounded by sliced carrots.

More Ham Recipes

If your family loves ham as much as mine does, you will want to try all of our favorite recipes using ham. You can’t go wrong with any of these dishes! They are all so delicious and easy to make!

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  • In a small saucepan over medium heat, add the butter, brown sugar, and honey. Heat until the butter melts and the mixture comes to a simmer. Remove from heat and set aside.

  • Line a piece of heavy duty foil in the basket of the air fryer. Place the ham in the center of the foil then fold up the edges of the foil around the ham.

  • Brush some of the butter glaze over the top and around the sides of the ham. Save the rest of the glaze to baste throughout the cooking process.

  • Cover the top of the ham with foil and cook in the air fryer at 325 degrees Fahrenheit for 20 minutes.

  • Baste with additional glaze, recover with foil, then cook an additional 15 minutes. The ham should reach 145 degress Fahrenheit.

  • Remove the top piece of aluminum foil and glaze the ham one more time.

  • Increase the temperature to 350 degrees Fahrenheit and brown the top of the ham for 2-3 minutes or until golden brown to your preference.

  • Remove the ham from the air fryer basket and slice and serve.

Serving: 1servingCalories: 743kcalCarbohydrates: 15gProtein: 49gFat: 53gSaturated Fat: 23gPolyunsaturated Fat: 5gMonounsaturated Fat: 22gTrans Fat: 1gCholesterol: 181mgSodium: 2817mgPotassium: 669mgFiber: 0.01gSugar: 15gVitamin A: 473IUVitamin C: 0.03mgCalcium: 28mgIron: 2mg

Nutrition information is automatically calculated, so should only be used as an approximation.





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