San Antonio Medicine December 2015

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UTHSCSA DEAN’S MESSAGE prove upon currently available treatments and allows for an expedited review process. Because of this status, the new DAA cocktail was approved by the FDA earlier this summer. After decades of little progress and low cure rates in hepatitis C treatment, more significant advances were made in the mid-1990s with cure rates in the 40 to 50 percent range, but much lower for the group with diseased livers. Interferon was a major part of those treatments and it brought an entire range of flu-like side effects such as muscle aches, fever, rashes, as well as other serious symptoms including reduction in brain function, possible thyroid dysfunction, other autoimmune difficulties and even bone marrow suppression. These side effects were dangerous for patients, especially those facing advanced cirrhosis and other issues. Progress increased in the late 1990s through the early 2000s; a time of rapid growth and advancement as DAAs were discovered and cure rates began to climb. Boceprevir, the first FDA approved DAA, came onto the market in 2011. In use with interferon, it nearly doubled the cure rates to the 75 percent range; however it also carried all the interferon related side effects. It was within the past few years that researchers began leaving out the interferon and adding the other DAAs after they saw virus counts in chimpanzees (the only other animal that can get hepatitis) were greatly reduced. This led to proofof-concept studies, safety studies and other key measures for an FDA approval track. Recent treatments have been so effective that the FDA actually allowed the terminology “cure” to be used in approval applications. Because of recurrences in the virus, they previously would not allow the word to be used. Thanks to the new research, we have also seen advancement in the accepted definition of the word “cure.” Currently, a cure for hepatitis C is defined as a “sustained virologic response” – no detectable virus in the bloodstream of the patient – three to six months post treatment. Unlike HIV or hepatitis B, which can become part of our genome and hence “non curable,” we know hepatitis C cannot sustain itself unless it constantly replicates.

Benefits of higher cure rates There are many direct and indirect benefits to these new cure rates of hepatitis C. There will be less cirrhosis, which means there will be less liver cancer and lower mortality. Fewer cancers means there is a potential increase in organ availability for people who need transplants for other reasons. This all contributes to a tremendous societal benefit that not only will reduce the financial burden in Texas and other areas, but also significantly improves the lives of all involved in the equation. The patient benefits, of course, but the large circle

of caregivers – especially family members who must spend a significant amount of time and money caring for and dealing with these patients – are now relieved of that burden. It all adds up to a very positive effect on the lives and economies of people on a micro scale as well as on a greater scale for the entire country. With these excellent cure rates, Dr. Poordad and other researchers have shifted their focus to the five to seven percent of patients whose virus resists the treatment. Dr. Poordad is also turning his attention back to FLD, which is becoming more pressing thanks to the cure rate for hepatitis C. Fatty liver disease is not just an obesity problem. Fat metabolism in the liver is very complex, with many metabolic transporters and enzymes that are genetically determined and are problematic for many patients who suffer with FLD. Non-alcoholic steatohepatitis (NASH) is liver inflammation and damage caused by a buildup of fat in the liver. It is part of a group of conditions called non-alcoholic fatty liver disease. We see hepatitislike damage from the inflammation but it does not manifest in every patient as FLD. As well, some patients progress to cirrhosis and cancer and some do not. There is a great deal to be discovered, especially in the Hispanic population which is more prone to NASH and FLD. Dr. Poordad served as the co-director of liver transplantation at Johns Hopkins and chief of hepatology and liver transplantation at Cedars-Sinai Medical Center in Los Angeles prior to his arrival here. Dr. Lawitz was a specialist in gastroenterology and hepatology at Brooke Army Medical Center and founded the very successful Alamo Medical Research Center before both joined forces to form the TLI. Besides working at the TLI, Dr. Poordad teaches medical students, residents and fellows and rotates on the liver transplant team at University Hospital System. Along with Dr. Lawitz and others within the School of Medicine, they are part of a team that is not just working on the issues that affect Central and South Texas, but is making unprecedented progress in the fight against these and other diseases. All the best, Francisco González-Scarano, MD Dean, School of Medicine Vice President for Medical Affairs Professor of Neurology John P. Howe, III, MD, Distinguished Chair in Health Policy The University of Texas Health Science Center at San Antonio scarano@uthscsa.edu visit us at www.bcms.org

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