Cure in sight for Hep C patients
The outlook for the sickest hepatitis C patients—those with advanced cirrhosis or those who have had a liver transplant but the virus has returned—has historically been bleak.
But researchers say that could change now that the U.S. Food and Drug Administration has cleared the way for expedited drug development and review of an investigational combination of drugs that shows promise for healing these patients.
The FDA has granted amended Breakthrough Therapy Designation for an oral regimen of daclatasvir and sofosbuvir taken with ribavirin for the treatment of patients with the genotype 1 strain of hepatitis C.
The decision was based on early results of the ALLY-1 clinical trial.
Fred Poordad, M.D., the principal investigator of the study, has been researching cures for hepatitis C for 20 years.
“We have had a lot of success recently with new oral medications for various groups of patients, but it’s exciting to see a cure in sight for patients who have the bleakest outlook,” said Dr. Poordad, clinical professor of medicine at the Health Science Center and vice president of academic and clinical affairs at the Texas Liver Institute. “We are refining treatments for different groups and I would say that in the next few years, we should be able to treat most genotypes very successfully.
“This is a very promising time for hepatitis C patients.”
The Phase III study evaluated a 12-week oral regimen of daclatasvir and sofosbuvir taken once a day with ribavirin. Results showed an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C, and 83 percent for patients with advanced cirrhosis. The study’s primary endpoints also were reached, with 95 percent of post-transplant genotype 1 patients and 82 percent of genotype 1 patents with advanced cirrhosis being cured 12 weeks after treatment.
Earlier this year, the FDA had planned to withdraw the Breakthrough Therapy Designation for the regimen because of the availability of other medicines that were more successful for other genotypes. But based on the early data from the ALLY-1 trial, the FDA amended its original decision and opted to continue expedited development of this treatment for the subgroup of patients studied in ALLY-1.
The FDA is continuing its new drug application review of the daclatasvir-sofosbuvir regimen for the treatment of genotype 3 hepatitis C.
Don’t drink, ever, if pregnant
Prenatal exposure to alcohol is the leading preventable cause of birth defects and intellectual and neurodevelopmental disabilities in children, according to a clinical report co-authored by Janet F. Williams, M.D., FAAP, professor of pediatrics in the School of Medicine.
No amount of alcohol should be considered safe to drink at any time during pregnancy, states the report from the American Academy of Pediatrics.
The range of effects that can occur in someone whose mother drank alcohol during pregnancy is called fetal alcohol spectrum disorders, and includes neurocognitive and behavioral problems. The effects of prenatal alcohol exposure are lifelong, but early recognition, diagnosis and therapy for any condition can improve a child’s health.
A lack of uniformly accepted diagnostic criteria for fetal alcohol-related disorders has critically limited efforts to lessen the impact of fetal alcohol spectrum disorders, said Dr. Williams.
“Even though fetal alcohol spectrum disorders are the most commonly identifiable causes of developmental delays and intellectual disabilities, they remain significantly under-recognized,” said Dr. Williams.
Prenatal alcohol exposure is a frequent cause of structural or functional effects on the brain, heart, bones and spine, kidneys, vision and hearing. It is associated with a higher incidence of attention deficit hyperactivity disorder and specific learning disabilities such as difficulties with math and language, visual-spatial functioning, impaired impulse control, information processing, memory skills, problem solving, abstract reasoning and auditory comprehension.
Even when a pregnant woman’s consumption was limited to one alcoholic drink per day—such as a 1.5-ounce shot of distilled liquor, 5 ounces of wine or 12 ounces of beer—there is increased risk of infant growth retardation, a recent study found. Yet 8 percent of women surveyed said they continued to drink during pregnancy.
Drinking during the first trimester, compared to no drinking, results in 12 times the odds of giving birth to a child with fetal alcohol spectrum disorders. First- and second-trimester drinking increased the odds 61 times, and women who drank during all trimesters increased the likelihood of fetal alcohol spectrum disorders odds by a factor of 65.
“The research suggests that the smartest choice for women who are pregnant is to just abstain from alcohol completely,” Dr. Williams said.
Chronic complication in diabetics explained
Most patients with longstanding Type 1 diabetes have chronic gastrointestinal symptoms that significantly reduce their quality of life. And now researchers have a better understanding of why this happens.
These complications, called diabetic enteropathy, include the delayed emptying of food, irritable bowel syndrome, abdominal distension and fecal incontinence. The cause was previously unknown.
Intestinal tissues from diabetic patients and healthy people were compared in a study co-authored by Franco Folli, M.D., Ph.D., professor of medicine in the Diabetes Division of the School of Medicine. The studies were carried out by researchers at Boston Children’s Hospital and Harvard Medical School and San Raffaele Hospital in Milan, Italy, led by Paolo Fiorina, M.D., Ph.D.
“In patients with Type 1 diabetes, the cell lining of the intestine was damaged,” Dr. Folli said. “The stem cells that maintain this lining, called colonic stem cells, were altered. The culprit is found in a protein called insulin-like growth factor binding protein 3, which is produced in the liver and in higher amounts in Type 1 diabetes. It binds to a receptor protein on colonic stem cells, causing their death and, in turn, damaging the intestinal lining.”
The team also experimented with a biopharmaceutical that blocks circulating levels of the protein. Studies in diabetic mice show that the drug can reverse the colon damage.
“This has the potential to result in a new treatment for this chronic complication of longstanding Type 1 diabetes,” Dr. Folli said.
The findings were published in Cell Stem Cell.
Intolerant to chemicals? It could affect your children too.
Mothers with chemical intolerances are two to three times more likely than other women to have a child with autism spectrum disorder or attention deficit hyperactivity disorder, a new study shows.
The medical study, led by primary author Lynne P. Heilbrun, M.P.H., autism research coordinator for the Department of Family and Community Medicine, was published in The Journal of the American Board of Family Medicine.
People who are chemically intolerant often have serious reactions to common chemicals, and some become too sick carry out routine functions. Chemical intolerance affects about 10 to 30 percent of the U.S. population. Developmental disorders such as autism and attention deficit disorder affect 1 in 6 children in the United States.
The study was based on maternal responses to the Quick Environmental Exposure and Sensitivity Inventory, or QEESI, a 50-question survey used by physicians worldwide to diagnose chemical intolerance.
“We are most concerned about how vulnerable the children with ADHD and autism were to environmental exposures,” said Heilbrun. “Mothers reported that their children were significantly more sensitive to everyday exposures such as engine exhaust, gasoline, smoke, fragrances and cleaners than their neurotypical peers.”
The children reportedly also were more sensitive to adverse effects from infections, medications, chemicals, foods and allergens. They were more likely to have had nausea, headaches, dizziness or trouble breathing when exposed to smoke, nail polish remover, engine exhaust, gasoline, air fresheners or cleaning agents.
“Physicians have the opportunity right now to become proactive in helping mothers protect their children from neurological disorders plaguing U.S. families,” Heilbrun said, urging doctors to use QEESI to assess patients for potential chemical intolerances.
The authors also recommended all mothers and pregnant women avoid potentially harmful chemicals such as pesticides, solvents, combustion products, and chemicals used during construction and remodeling.
UT Dentistry has new home
Its technology is considered ultra-modern. It is energy efficient. And within its 198,000 square feet, patients will receive the latest evidence-based care in a dozen specialties, and can be treated with anything from braces and dental implants to crowns and root canals.
At a total cost of $96.5 million, the Center for Oral Health Care & Research officially opened its doors in September. Located at 8210 Floyd Curl, it sits across from the Medical Arts & Research Center and features 12 specialty clinics and 400 pre-doctoral and specialty operatories.
There is a dental surgery operating room and overnight recovery area built to hospital specifications, and extra-large monitors are prominent in all exam and surgical areas to offer patients and practitioners a better view of dental images. Dental chairs offer digital lighting and the most current examination equipment.
“The new Center for Oral Health Care & Research allows our faculty, residents and students to provide care in a technologically advanced setting that is second to none,” said William L. Henrich, M.D., MACP, president of the Health Science Center. “It enables our School of Dentistry to lead the way technologically and sustain our top-tier reputation in education, research and patient care.”
The first two floors are for faculty-led care of patients in various specialties of oral health. The third and fourth floors are used for general dentistry, including clinical training for third- and fourth-year dental and dental hygiene students who provide care to the public at a reduced rate.
School of Dentistry Dean William Dodge, D.D.S., said the new facility helps UT Dentistry fulfill its unique role as the academic dental practice for South Texas.
“This beautiful, energy efficient and technologically advanced clinic is only our second clinical home since the school began in 1970,” Dr. Dodge said. “What a step up.”
Growth spurt
Regents approve millions in HSC construction
A new Health Science Center clinic will be constructed in north San Antonio.
The UT System Board of Regents in August approved $19.5 million for the construction of the multiservices center, which will be located on Interstate 10 West near Ralph Fair Road. It will expand teaching venues for students and trainees, enhance clinical research and make UT Medicine, the academic medical practice of the School of Medicine, available to more people.
The 18,000-square-foot facility will include exam rooms, conference rooms, offices for physicians, waiting rooms and a full-service imaging center with MRI, CT scan and general X-ray facilities.
“This clinic will be located in a high-growth area with a demonstrated need for both quality primary care and subspecialty medical services,” said William L. Henrich, M.D., MACP, president of the Health Science Center.
It is part of a clinical transformation plan that includes expanding and diversifying services of UT Medicine throughout San Antonio beyond the primary outpatient practice site, the Medical Arts & Research Center in the South Texas Medical Center. That facility is also slated to undergo a major clinical expansion this year.
The regents also approved $15 million to purchase and improve the Medical Centre Plaza building at 8431 Fredericksburg Road. The building will provide an additional 100,000 gross square feet of space to accommodate primarily administrative staff. The university had been leasing space in the building since 2006.
“The purchase will not only provide space for necessary expansion, but it will also generate cost savings of approximately $2 million a year,” Dr. Henrich said.
Tuition revenue bonds will be used to renovate other university buildings, many more than 40 years old. Updates will affect electrical, mechanical and plumbing systems, as well as security and safety, Dr. Henrich said.
Advanced degree now offered in respiratory care
Millions of Americans suffer from cardiopulmonary disease and need specialized care from a respiratory therapist.
The Health Science Center is meeting the need with a new master of science degree in respiratory care. The two-year program began this fall and is open to current respiratory therapists and students with no prior health care experience.
“More than 34 million people have asthma in the United States, approximately 13 million suffer from chronic obstructive pulmonary disease, or COPD, which is the third leading cause of death in America,” said David C. Shelledy, Ph.D., RRT, FAARC, dean of the School of Health Professions. “Because of underdiagnosis, we believe the actual number of those suffering from COPD is closer to 24 million.”
Respiratory care, also known as respiratory therapy, is the allied health profession that provides care to patients with cardiopulmonary disease. A respiratory therapist cares for patients of various ages, from newborns to the elderly. Common illnesses include asthma, emphysema, COPD, pneumonia, cystic fibrosis and respiratory distress syndrome.
The new degree was created because of the complexity of the care needed by these patients, Dr. Shelledy said.
“The master’s degree will prepare individuals to provide specialized care and to serve as the clinical leaders in the field, especially in the acute care setting in intensive care units,” he said.
It will be only one of four such degrees in the country.
Alzheimer’s institute to open this year amid flurry of support
A comprehensive care center for Alzheimer’s disease and other neurological disorders will open at the Health Science Center in 2016, fueled by millions in donations gathered in less than two years.
Over $41 million has been secured in cash and endowment support to launch South Texas’ first Institute for Alzheimer and Neurodegenerative Diseases, located in the Medical Arts & Research Center.
Of that, $735,000 was collected at the 2015 President’s Gala, themed “An Evening of Service.” Proceeds from the Sept. 26 event established the Bartell and Mollie Zachry Endowment for Alzheimer Research and Patient Care, in recognition of the gala’s honorees, Bartell and Mollie Zachry.
“They have made and continue to make exemplary contributions to San Antonio, to education and to the welfare of our entire community,” said Health Science Center President William L. Henrich, M.D., MACP. “They are our city’s finest examples of integrity and kindness and they embody, in all respects, service.”
The Health Science Center must play an active role in tackling Alzheimer’s and other neurodegenerative diseases, Dr. Henrich told the more than 1,000 gala attendees. That mission is something the community has rallied behind, offering unprecedented support for the project in record time, he added.
“As one of America’s leading academic health centers, we must serve our community’s health-related needs,” he said. “The time is now to focus on new discoveries, treatments and auxiliary services to help those suffering from the ravages of Alzheimer’s disease and related disorders.”
The institute is designed to be a comprehensive care center and will feature expert diagnostics; physician specialists in Alzheimer’s, Parkinson’s and other diseases; support programs for caregivers; and access to clinical trials of new therapies.
By 2025, the number of Americans age 65 and older with Alzheimer’s disease is expected to reach 7.1 million, a 40 percent increase from today. In Texas, the number of residents with the disease is projected to increase 48.5 percent. Texas ranks third in the nation in the estimated number of Alzheimer’s cases and second in the number of deaths attributable to the disease, behind California and Florida.
“There are many reasons to be concerned about this illness,” Dr. Henrich said, citing “its unrelenting cruelty in robbing a person of memory and faculty, the toll it takes on families and caregivers, its devastating effects on the economy and our collective sense of futility in trying to arrest its insidious lethal aggression.”
There are also personal reasons. A little more than a year before his death, Glenn Biggs, the university’s founding Development Board chairman, approached Dr. Henrich and Long School of Medicine Dean Francisco González-Scarano, M.D., about his diagnosis of Alzheimer’s.
“He came to us seeking guidance on where to go and what to do for his advancing condition,” Dr. Henrich said. “So you can understand our frustration in not being able to provide him answers that pointed him to a comprehensive care center or, even better, being able to assure him that prevention was available that could make a difference. After he left that day, Francisco and I pledged ourselves to this singular purpose.
“Glenn Biggs was the inspiration for our vision to establish the Institute for Alzheimer and Neurodegenerative Diseases, and we are committed to the promise we made to him and so many other families to see this vision achieved.”
Dr. Henrich said he will ask the UT Board of Regents for approval to name the center in his honor.
Biggs’ wife, Ann, was the gala’s honorary chair. In a video tribute to her husband, who died in May, she spoke of the hope he carried with him that someday a cure would be found.
“He wanted to help others,” she said. “This was his dream, and he would be so pleased. He took great pride in doing what he could to help the Health Science Center in all the years he had. It’s my pleasure to do what I can to carry on his wishes.
“Don’t give up hope. Something good is going to come.”
Gifts and pledges of $1 million or more
- Anonymous
- Baptist Health Foundation
- The Greehey Family Foundation
- J.M.R. Barker Foundation
- Robert J. Kleberg, Jr. and Helen C. Kleberg Foundation
- Klesse Foundation
- Kronkosky Charitable Foundation
- Keith and Pat Vigeon Orme
- Valero Energy Foundation
- Anonymous
Gifts boost pediatric transplant program
Transplant surgeon Francisco G. Cigarroa, M.D., believes children who need life-saving organ transplants deserve care that is both high quality and accessible. Three recent gifts to the pediatric transplant program at San Antonio’s University Transplant Center will help create a National Center for Excellence in pediatric liver transplantation, grow an already renowned pediatric kidney transplant program and improve access to services for patients along the Texas-Mexico border.
Particularly transformative, Dr. Cigarroa said, is a $2 million gift from Carlos and Malú Alvarez to create the Carlos and Malú Alvarez Distinguished University Chair in Pediatric Transplant Surgery. Dr. Cigarroa, the inaugural recipient of the chair, specializes in adult and pediatric kidney and liver transplant surgery and is surgical director of the pediatric transplant program at the University Transplant Center. The center is a partnership between University Health System and the Health Science Center.
The Alvarez Distinguished University Chair will advance both the clinical and research missions of the program, he said.
Two-thousand children are among the more than 120,000 people in the U.S. waiting for an organ transplant. In Texas, nearly 200 of the 11,500 people waiting to receive an organ transplant are children.
Providing much-needed support to parents as they deal with their child’s illness also contributes to better outcomes for pediatric transplant patients, Dr. Cigarroa said.
Dr. Cigarroa created the first civilian pediatric liver transplant program in San Antonio after joining the Health Science Center in 1995. He continued performing transplants as president of the Health Science Center from 2000 to 2009. The pediatric liver transplant program was eventually put on hold while Dr. Cigarroa served as chancellor of The University of Texas System from 2009 to 2014.
“I’ve always felt very strongly that San Antonio needs to provide a center of excellence for transplanting these very sick children who otherwise would die, and at the same time being very sensitive to preserving the family unit, making sure there is adequate support to not only take care of their child, but to take care of their family and themselves,” he said. “This gift from Carlos and Malú Alvarez will save lives for children, and especially children in South Texas and along the Texas-Mexico border.”
A $125,000 gift from Robert Oliver established the Robert Oliver Pediatric Transplant Program Endowment to support outreach and education in San Antonio and surrounding communities and to help build a life-saving pediatric transplant program of excellence.
“We serve the South Texas community, and we want every family to know about this program,” Dr. Cigarroa said. “Robert Oliver’s gift is critical in helping us do this important outreach.”
A gift of $100,000 from Col. Robert E. Kelso and Betty Kelso will help establish outreach clinics in South Texas communities so that patients and their families will face fewer challenges in accessing care, he added.
“[The gift will] help us revitalize this critically important program for children who need a transplant to survive,” Dr. Cigarroa said.
“It’s wonderful when you have very passionate people like Carlos and Malú Alvarez, Robert and Betty Kelso, and Robert Oliver, who want to support excellence and want to be a part of something that actually impacts quality of life. What is more powerful than saving a baby’s life through the miracle of transplantation?”
All of the gifts will enable the program to recruit and retain faculty for the transplant team and sustain the program for years to come.
“When we transplant a child, we have to think that this is for a lifetime,” Dr. Cigarroa said. “Once you start taking care of a child, you are committed for life. You have basically inherited another family member, and that is a joy.”
Liver cancer research receives multi-year funding
The Clayton Foundation for Research is supporting, for up to five years, the development of a biorepository and new strategies for treating hepatocellular carcinoma (HCC), which is the most common liver cancer in adults. The gift provides $300,000 in research support each year.
The research team is interested in learning why the morbidity and mortality of HCC is higher in Hispanics in South Texas than in Hispanics from elsewhere in Texas and the U.S., as well as in other ethnic groups, said Francisco G. Cigarroa, M.D., professor of surgery at the Health Science Center. Dr. Cigarroa directs the research project with LuZhe Sun, Ph.D., professor in the Department of Cellular and Structural Biology.
“The mortality of this tumor is extremely high,” Dr. Cigarroa said, adding that researchers are already interpreting project data from DNA and RNA sequencing.
The Houston-based foundation also is supporting the ongoing heart attack and stroke prevention research of Marc D. Feldman, M.D., professor of medicine and engineering. The foundation’s original five-year gift totaling $1.5 million in 2011 was renewed and increased in 2015, with an option to continue year to year after 2016.
The Clayton Foundation seeks to invest in scientists who are key leaders in medicine and have a vision to advance biomedical discovery that has far-reaching benefits to humanity.