FDA Approves First Oral Treatment For COVID-19 In Adults
May 26, 2023 – Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the U.S. Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
“While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives,” said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research. “Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity. The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19.”
Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug requires, among other things, substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). In considering approval of a drug, the FDA conducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population.
The efficacy of Paxlovid was primarily supported by the final results of the EPIC-HR clinical trial. EPIC-HR was a randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection. Patients were adults 18 years of age and older with a prespecified risk factor for progression to severe disease or were 60 years and older regardless of prespecified chronic medical conditions. All patients had not received a COVID-19 vaccine and had not been previously infected with COVID-19. Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause through 28 days of follow-up by 86% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment. In this analysis, 977 patients received Paxlovid, and 989 patients received placebo, and among these patients, 0.9% who received Paxlovid were hospitalized due to COVID-19 or died from any cause during 28 days of follow-up compared to 6.5% of the patients who received the placebo.
Benefit of Paxlovid was observed in patients with prior immunity to the virus that causes COVID-19. Among patients in EPIC-HR who were antibody positive at trial enrollment, the risk of COVID-19-related hospitalization or death from any cause during 28 days of follow-up was 0.2% among the 490 patients treated with Paxlovid compared with 1.7% of the 479 patients receiving placebo. EPIC-SR was another clinical trial that enrolled vaccinated patients with at least one risk factor for progression to severe COVID-19. Although not statistically significant, among these vaccinated patients, there was a reduction in the risk of COVID-19 related hospitalization or death from any cause.
EPIC-HR and EPIC-SR were randomized controlled trials and provide information about COVID-19 rebound. Data from these two trials showed that rebound in SARS-CoV-2 (RNA or virus) shedding or COVID-19 symptoms occurred in a subset of patients and happened in both the patients receiving Paxlovid and the placebo. Based on the data currently available to the FDA, there is not a clear association between Paxlovid treatment and COVID-19 rebound.
Because of the importance of reducing the risk of significant drug-drug interactions with Paxlovid, the approved label and authorized Fact Sheet for Health Care Providers for the Paxlovid EUA come with a boxed warning with instructions for prescribers. Prescribers should review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines that a patient may be taking require a dose adjustment, interruption and/or additional monitoring. Prescribers should consider the benefit of Paxlovid treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed.
In conjunction with today’s approval, the FDA is providing all prescribers with important information for prescribing Paxlovid properly and safely, such as dosing instructions, potential side effects and information regarding drugs that may cause drug-drug interactions with Paxlovid. The most common side effects of taking Paxlovid include impaired sense of taste and diarrhea. Patients should discuss with their health care provider whether Paxlovid is right for them.
Dr. Deana Steeber Hired As Sulphur Springs ISD New Superintendent
May 25, 2023 – Sulphur Springs ISD School Board has officially hired Dr. Deana Steeber as the new superintendent during a special board meeting, Thursday May 25, 2023.
During this meeting board president Craig Roberts announced that the board would consider hiring Dr. Deana Steeber, and she was quickly voted in unanimously.
Board President Craig Roberts also presented to Dr. Steeber her own name plate that will sit on the board along with her as she joins the School Board.
Deana Steeber comes from Argyle Tx, previously working at Argyle ISD as assistant superintendent. Before arriving in Argyle ISD, Dr. Steeber served as a principal in Carroll ISD and Sanger ISD. She has 27 years of experience in public education and 11 as a principal at the high school, middle school and elementary levels.
Deana Steeber has worked before as a superintendent assistant and knows the inner working of the job that is superintendent. Dr. Deana Steebers husband, Dr. Robert Steeber, is the current superintendent at McAlister Oklahoma ISD.
During the meeting Dr. Deana’s parents and husband joined the members of the audience in congratulating Dr. Steeber on her new position within the school. Also during the meeting her son facetimed to congratulate his mother, causing sweet comments from the audience and member of the board.
Steeber expressed that she is very grateful for the opportunities and wishes to work well with the community as well as those within the school district.
Barrett Arrested on Sexual Abuse Warrant
May 26, 2023 – Danny Wayne Barrett, Jr was arrested by Sulphur Springs Police on Thursday this week. Barret, age 40, is charged with Continuous Sexual Abuse of a Child Under 14.
Barrett was arrested without incident at his residence south of Brashear, TX.
KSSTRadio.com publishes Sulphur Springs Police Department reports and news. The Police Department is located at 125 Davis St., Sulphur Springs, Texas. Non-emergency calls can be made to (903) 885-7602.
If you have an emergency dial 9-1-1.
The Sulphur Springs Police Department continues to serve its citizens with pride in its overall mission and will strive to provide the best possible police force in the 21st century.
If you have an emergency, dial 9-1-1
The Hopkins County Sheriff’s Office is located at 298 Rosemont Sulphur Springs, TX 75482. You can reach them for non-emergency matters at (903) 438-4040.
Ms. Hopkins County Senior Pageant Contestants
May 25, 2023 – The 2023 Ms. Hopkins County Senior Pageant is about to be underway as the 10 contestants have been named and preparation for the event can begin. These lovely contestants are as follow:
The pageant will be held June 3rd at the Civic center, located on 1200 Houston St, at 6pm.
There will be tea on June 2nd at 1 pm for contestants, former queens, judges, and all parties involved in the pageant.
Mahoney Memorial Day Homecoming
May 25, 2023 – Memorial Day Homecoming service will be held at Mahoney Cemetery and Old Mahoney Methodist Church on June 11th starting at 10:30am. During this service, reports from the Christmas 2022 “Wreaths Across America” will be discussed for their vets.
The special speaker during this event is Ridley Briggs from Mt Vernon a former USAF fighter pilot and Texas Aggie.
At noon, basket lunches will be passed out and people will be encouraged to visit and share each others food. It is also encouraged that you bring a freezer of homemade ice-cream to share!
Statement from the Board:
“As your board, we are proud of our cemetery. Do take time to visit your loved ones graves: Mowing, filling in, with fill dirt, ant control, general maintenance , etc, keeps Mahoney Cemetery one of the best in kept in the Country Cemeteries around, especially with our aging Board!”
If you are Unable to attend and wish to send a donation, make your check out to: Mahoney Cemetery (in care of) Pinky Cooper, 3240 CR 3504, SS TX. 75482.
Plans Underway for the Hopkins County Health Care Foundation’s 4th Annual Designer Handbag Bingo
Sulphur Springs, TX – The Hopkins County Health Care (HCHC) Foundation has scheduled the Designer Handbag Bingo for Thursday, August 3.
Sponsorships are available now while reserved tables for 8 will go on sale June 24, and individual tickets will be available on July 1. Last year, this event sold out in record time. “We expect tickets to go quickly, so those wishing to play will want to make their reservations as soon as they are released,” says Foundation Chair Maleta Reynolds.
There are two sponsorship levels, $2,500 and $1,500. Those two sponsorship levels include tickets for 8 players at a reserved table. Two additional sponsorships levels, $500 and $250, are for handbag sponsorships only, with no tickets. Table reservations include tickets for 8 players and cost $550. Individual tickets are $55 each.
Reynolds added, “This is a really fun evening for ladies to share with friends. But it is also an evening that makes a real difference for others in our community, as proceeds will benefit healthcare in Hopkins County.” This event is a fundraiser for the Foundation. Proceeds are used locally to support healthcare. Sponsorships are on sale now at handbagbingo23.givesmart.com. Or email [email protected] or call 903-438-4799 for a sponsorship form or more information.
Harp Arrested for Driving Stolen Vehicle
May 25, 2023 – Shreveport, LA Police notified the Hopkins County Sheriff’s Office of a stolen vehicle possibly traveling westbound on I-30. Deputies took up observation positions along I-30 and waited for the stolen Mercury to pass.
The vehicle was spotted at mile marker 131. Deputies immediately began following the sedan and attempted to perform a traffic stop.
The driver slowed, but did not pull over until traveling approximately 4 more miles. Hopkins County Deputies performed a felony take down, and assisted the driver from the car.
Thirty-nine year old HEATH JUSTIN HARP, a resident of Groves, TX, was arrested and transported to Hopkins County Jail without incident. Harp is charged with:
31.07 UNAUTH USE OF VEHICLE
If you have an emergency, dial 9-1-1
The Hopkins County Sheriff’s Office is located at 298 Rosemont Sulphur Springs, TX 75482. You can reach them for non-emergency matters at (903) 438-4040.
SSISD Healthy Summer Meals For Kids
May 25, 2023 – SSISD will be hosting a Summer Food Service Program for all children under the age of 18 years old and enrolled students with disabilities up to 21 years of age. Free breakfast and lunch will be served for all children eligible for the program.
District enrollment is not required and no application is needed.
Summer Feeding locations are:
Bowie Primary, 1400 Mockingbird Ln., from June 5 – July 6 Monday-Thursday Only, Breakfast will be 7:30-8:30, and Lunch will be from 10:45-12:30.
Sulphur Springs Middle School, 865 Wildcat Way, from June 5- June 15, Monday-Thursday only, Breakfast will be served from 7:30-8:30, and lunch will be served from 11-2.
Wildcats Head Basketball Coach Brandon Shaver Heading to Lake Travis
Wildcats Head Basketball Coach Brandon Shaver has accepted the position as Head Basketball Coach at Lake Travis High School.
Coach Shaver continued a basketball culture set forth by his predecessor Clark Cipoletta in Sulphur Springs as Head Wildcats Coach for the past two seasons.
He had a record of 59-18 overall as Wildcats Coach.
His teams captured back-to-back district championships, including an undefeated one in 2022-23.
Coach Shaver’s highlight season was this past one as the Wildcats advanced to the Regional Semifinal for the first time since 2019-20.
The Wildcats lost to Faith Family Academy, who went on to win their third state title (including second straight) in five seasons. That team ended up 31-8 and was a perfect 10-0 in district play. They were Bi-District, Area and Regional Quarterfinal winners.
The 2022-23 team also set the school record for wins at 31.
The Wildcats under Coach Shaver in his first season also advanced to Regional Quarterfinal game in 2021-22.
He served as the Pine Tree head Coach for several seasons before becoming head coach at Sulphur Springs.
Here is Coach Shaver’s post from his Facebook about the decision:
“The last 2 years at Sulphur Springs have been amazing. I’ve absolutely loved being a part of a program that won back to back district championships, made a regional tournament run, broke a few school records, and sent several young men off to play at the next level. Sulphur Springs is such a special place that has loved and supported me, my family, and the basketball program in more ways than I could ever express gratitude for.
With that being said, I have accepted the Head Coaching job at Lake Travis. I am extremely excited about this new opportunity and getting to work with one of the best 6A schools in the state of Texas. Thank you to Coach Carter and LTISD for giving me this incredible opportunity and I can’t wait to get to work on next season.”
KSST is proud to be the official Wildcat and Lady Cat Station. We broadcast Sulphur Springs ISD games year round live on radio. When allowed, we also broadcast games via our YouTube channel.
Wildcats Golf Gets 3rd at State Meet
Wildcats golf ended their season at the state meet Monday and Tuesday, May 22-23 in Kingsland, where Sulphur Springs came up big in third.
It is the first time since 2015 men’s golf has qualified for state, and the Wildcats did not disappoint.
Coach Jeremy DeLorge is very happy with his team’s results.
“This year was definitely one of full success,” the Sulphur Springs golf coach said. “The guys were super happy with how it came out.”
The Wildcats coach said to come home after medaling in the state tournament for golf is a huge accomplishment.
After day one, Sulphur Springs found themselves in second place, behind only Canyon Randall. They did end up slipping down to third place, but their efforts were still more than enough to leave the state tournament in Kingsland getting bronze.
“It was good to see that they were so hungry,” Coach DeLorge said.
Even with four of five golfers shooting in the 70’s on Monday’s day one, Coach DeLorge said his guys still were not satisfied. The men’s golf coach said that is just the golfer’s mentality.
Totals from the two day state tournament were:
- Caleb Kesting — 74/81 (155)
- Nick Burney — 74/79 (153)
- Gage Gideon — 79/74 (153)
- Luke White — 82/78 (160)
- Tatum Tran — 76/83 (159)
The lone senior on the varsity squad is Kesting, headed to ETBU, but every other member will be sophomores come fall.
Coach DeLorge said he has a group of freshmen waiting in the wings all too ready to compete for the fifth spot that will be vacated once Kesting graduates.
For now though, Sulphur Springs takes a bit of time prior to summer workouts, but Coach DeLorge said his guys are already planning their summer workouts, programs and contests to keep themselves loose over the summer.
Congratulations to Wildcats golf for not only qualifying for the state meet for the first time in almost a decade, but also finishing third leaving Kingsland with bronze hardware.
KSST is proud to be the official Wildcat and Lady Cat Station. We broadcast Sulphur Springs ISD games year round live on radio. When allowed, we also broadcast games via our YouTube channel.
