April 16, 2016, Barcelona, Spain: A pilot study presented today found that all patients with acute HCV who were treated with a direct-acting antiviral treatment over a ‘short-duration’ of six weeks had undetectable HCV after a 12 week follow-up. The investigator-initiated study, presented at The International Liver CongressTM in Barcelona, Spain, demonstrated that the combination of sofosbuvir and ledipasvir for only six weeks is sufficient to treat patients with acute HCV.
Those infected with HCV usually develop acute Hepatitis C, which spontaneously clears in 10 to 50% of infected persons. Early diagnosis of HCV infection is rare and the disease may go unnoticed until patients have already developed serious liver damage.1 Sofosbuvir and ledipasvir is one possible regimen for treatment of patients with chronic HCV. Sustained virologic response (SVR) is greater than 95% with a 12-week course of this treatment.2
"Given the high cost of sofosbuvir and ledipasvir, and the associated side effects that occur during treatment, we set out to assess whether shortened treatment duration could be an effective option for acute Hepatitis C patients," said Katja Deterding from Hannover Medical School, Germany and study author. "Our research demonstrates that not only is the combination of sofosbuvir and ledipasvir safe, well tolerated and effective in acute HCV genotype 1 patients who have severe liver disease with very high liver enzymes, but a shorter treatment duration does not appear to hinder efficacy," confirmed Professor Heiner Wedemeyer, the senior author of this study.
The German pilot study, performed by the German HepNet Study-House included 20 patients. Risk factors of HCV infection among the study members included; sexual transmission (n=11), medical procedures/needle stick injury (n=5), drug use (n=1), and nail treatment complications (n=1). The causes were unspecified for the remaining two patients.
All 20 patients completed six weeks of sofosbuvir and ledipasvir without ribavirin. At the 12 week follow up, all 20 patients had undetectable HCV and achieved SVR (100%). Fatigue was the most frequent side effect reported by study members (30%).
"These exciting findings open up short and cost-effective treatment options that could prevent the spread of HCV in high risk populations," said Professor Frank Tacke, EASL Governing Board member. "We look forward to seeing this pilot study extended so the findings can be validated and then hopefully used as a tool to change clinical practice for the better."
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™ takes place from April 13 - 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.
Since EASL's foundation in 1966, this not-for-profit organisation 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, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
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Onsite location reference
Late-breaker session, Hall 8.0
Saturday 16 April, 16:00 - 18:00
Presenter: Katja Deterding, Germany
Abstract: LB08, Six Weeks of Sofosbuvir/Ledipasvir (SOF/LDV) are Sufficient to Treat Acute Hepatitis C Virus Genotype 1 Monoinfection: The Hepnet Acute HCV IV Study
Author disclosures of interest
K. Deterding: Travel grants and lecture fees: AbbVie, MSD/Merck, Gilead, BMS
H. Wedemeyer: Grants received from AbbVie, Abbott, BMS, Gilead, Merck/Schering-Plough. Consultant for AbbVie, Abbott, BMS, Gilead, Merck/Schering-Plough. Sponsored lectures (national and international) for AbbVie, Abbott, BMS, Gilead, Merck/Schering-Plough
1 US National Library of Medicine National Institutes of Health. Treating viral hepatitis C: efficacy, side effects, and complications. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1860034/. Last accessed: March 2016.
2 Hepatitis C online. Ledipasvir-Sofosbuvir (Harvoni). Available from: http://www.hepatitisc.uw.edu/page/treatment/drugs/ledipasvir-sofosbuvir. Last accessed: March 2016.