New research: Hep C treatment is safe and effective with minimal clinical monitoring

(VIENNA, Saturday 13 April 2019) Hepatitis C treatments are safe and highly curable, even when patients are not monitored in the clinic throughout the treatment period, according to new Kirby Institute research presented at the International Liver Congress™ in Vienna, Austria.

The findings from this world-first study will inform international clinical guidelines to make hepatitis C on-treatment monitoring optional, freeing up health professionals to cure larger numbers of the population, and to dedicate follow-up hours to specific individuals who require it.

“Direct-acting antiviral (DAA) therapy has transformed hepatitis C management,” said Professor Greg Dore, head of the Viral Hepatitis Clinical Research Program at the Kirby Institute. “Cure rates are above 90% with minimal side effects, and all-oral regimens as short as 8 weeks is the new standard of care. Because of these simplified regimens, we wanted to find out if reduced clinical monitoring could lead to the same patient outcomes.”

THE SMART-C study is an international randomised control trial of 380 patients with hepatitis C. Patients in the standard-of-care arm visited the clinic at weeks four and eight for pathology, dispensation of treatment drug and assessment of adverse outcomes. The intervention arm received all eight weeks of treatment drug in the first visit and received two telephone calls from the study nurse to monitor adherence and adverse effects.

“12 weeks following completion of treatment we tested all participants for hepatitis C cure. In both arms we saw cure rates higher than 90%, which is fantastic,” said Professor Dore.

While the intervention arm saw a slightly reduced cure rate (92% compared to 95%), the proportion with documented treatment failure was the same (2%). A small proportion of patients did not return for their cure test.

“What this research tells us is that many patients with hepatitis C do not need close follow-up during treatment, and this understanding will change the way that health professionals work with patients,” said Professor Dore.

“Most people with hepatitis C are highly motivated to take their medication, but for some people, such as those with major other social and health issues, including ongoing injecting drug use, this “simplified” monitoring strategy would not be appropriate.

“A less intensive monitoring schedule for those patients who do not need it, will allow more time to be dedicated to patients who do require treatment adherence support.”

The SMART-C study is sponsored by UNSW Sydney and funded by AbbVie. The results were presented at the International Liver Congress™ in Vienna.

About the Kirby Institute
The Kirby Institute at UNSW Sydney is a leading global research institute dedicated to the prevention and treatment of infectious diseases. Established in 1986 in response to the then emerging HIV epidemic, we now contribute to knowledge on a broad range of diseases, including viral hepatitis and sexually transmissible infections.

Our primary work relates to the coordination of national surveillance programs, population health and epidemiological research, clinical and behavioural research and clinical trials. Our research projects are conducted in partnership with communities most affected by epidemics. Together we implement trials of behavioural and biomedical interventions designed to prevent the spread of infectious diseases in vulnerable populations.

About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ 2019 will take place from 10–14 April 2019 at the Reed Messe Wien Congress and Exhibition Center, Vienna, Austria.

About The European Association for the Study of the Liver (EASL)
Since its foundation in 1966, this not-for-profit organization has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Date published: 
Saturday, 13 April 2019
Luci Bamford, Kirby Institute
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