Talal’s Hepatitis C Therapies Study Wins BTC Clinical Research Award

The award honors outstanding accomplishments in clinical research by University at Buffalo or Roswell Park Comprehensive Cancer Center investigators published in major journals.

“The Clinical Research Achievement Awards competition is a way to identify and recognize major advances resulting from the region’s investment in research to benefit the health and welfare of our community,” says Anne B. Curtis, MD, SUNY Distinguished Professor, Charles and Mary Bauer Professor and chair of the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences.

Curtis serves on the board of UB’s Clinical and Translational Science Institute (CTSI), the sponsor of the awards program, and she chaired the Clinical Research Achievement Awards Committee.

“We wanted to recognize the accomplishments of UB and Roswell researchers who are pushing at the forefront of clinical research and helping to translate basic scientific discoveries into practical, viable therapeutics," says Timothy F. Murphy, MD, senior associate dean for clinical and translational research, SUNY Distinguished Professor of medicine and director of the CTSI.

Talal is an expert in diagnosing and treating liver disease, including hepatitis C virus (HCV), especially in hard-to-treat populations.

He is principal investigator on a $7 million Patient-Centered Outcomes Research Institute award to study innovations that he has helped develop to treat liver disease, especially HCV, in people with substance use disorders.

These innovations include telehealth approaches to treat HCV among patients in methadone treatment clinics and also include the co-administration of methadone and the direct acting antiviral (DAAs) medications used to treat HCV. This study is currently being conducted at 12 sites throughout New York State.

The BTC award recognizes Talal for a paper titled “Hepatic Pharmacokinetics and Pharmacodynamics With Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir Treatment and Variable Ribavirin Dosage,” published in the Journal of Infectious Diseases in September 2017.

The study also offered an opportunity to provide HCV treatment to former substance users who agreed to participate and would not have otherwise received HCV treatment.

The trial was a phase 2, partially randomized, open-label, exploratory study performed at two sites. It evaluated the kinetics of viral load decline with ombitasvir/paritaprevir/ritonavir plus dasabuvir therapy in combination with variable ribavirin dosing in patients with chronic hepatitis C infection. 

Talal, the study’s first author, notes that DAAs have revolutionized the treatment of HCV infection with tremendous efficacy, but that the impact of DAAs on virus decay in the liver and blood is poorly understood.

He says it was also unknown whether the addition of a second medication, ribavirin, would change the early virus decline after starting therapy. 

“For the first time using an all-DAA regimen, we found that the virus level was higher in blood and declined more rapidly than in the liver,” Talal says.

“Also for the first time, we were able to measure liver concentrations of five DAA compounds using samples obtained by fine needle aspiration (FNA),” he adds. “Ribavirin had no effect on viral decline after addition to a DAA-based regimen.”

Results of the study:

• suggested a guide for treatment duration for DAA-treated patients
• observed that ribavirin had no effect on early viral decline after addition to a DAA-based regimen
• provided data on the utility of FNA liver sampling for drug concentration measurements, of use for future studies
• fostered development of the academic health center by promoting research collaborations with international (University of Paris) and industrial partners
• promoted community engagement through active subject recruitment via community gastroenterology practices

Other authors on the study from UB are:

• Barbara M. Bauer, research technician at the Clinical and Translational Science Institute
• Gene D. Morse, PharmD, SUNY Distinguished Professor of pharmacy practice in the School of Pharmacy and Pharmaceutical Sciences
• Andrew J. Ocque, research scientist in the Department of Pharmacy Practice in the School of Pharmacy and Pharmaceutical Sciences
• Richard M. Rejman, clinical research associate in the Clinical Research Office

Additional authors are from:

• Abbott Diagnostics
• AbbVie Inc.
• Roivant Sciences Inc.
• University of Paris