April 15, 2016, Barcelona, Spain: Data from a Phase 2 clinical trial show that an investigational injectable treatment known as RG-101 in combination with a four week course of oral direct-acting antiviral (DAA) treatment was well tolerated and resulted in high virologic response rates post-treatment among Hepatitis C (HCV) infected patients with genotypes 1 and 4, who had not been treated previously.
The findings, presented today at The International Liver Congress™ 2016 in Barcelona, Spain are an interim analysis, with ongoing research to assess virologic response over a 48 week follow-up period to further assess the safety and efficacy of a four week treatment course.
The investigational treatment, RG-101 works on microRNA-122, which the virus uses to replicate. Drugs that interfere with miR-122 could inhibit HCV replication, acting earlier in the viral lifecycle than currently approved HCV protease, polymerase or NS5A inhibitors.1 The current standard of care treatment in HCV consists of eight-12 weeks of DAA oral agents.2
"These early results indicate the potential for RG-101 with oral DAA combination therapy to provide an effective Hepatitis C regimen for patients with a short treatment course of just four weeks," said Dr Mihaly Makara from the Buda Hepatology Centre, Budapest, Hungary, and lead study author. "We very much hope the long-term, 48-week follow-up data follows the same trend."
This international study enrolled 79 patients with chronic HCV, genotype 1 or 4 who had not previously received treatment. Each patient received a 2mg/kg injection of RG-101 on Day one, with a four week course of oral DAAs (either ledipasvir/sofosbuvir, simeprevir, or daclatasvir), following by a second 2mg/kg injection of RG-101 on Day 29. The mean baseline viral load among patients was 5.805 IU/mL.
Interim analysis showed that 97.4% (37/38) and 100% (14/14) of patients at eight and 12 weeks respectiviely had a high virologic response. This was determined by assessing HCV levels 'below the lower limit of quantification' (<12 IU/mL), using the Abbot RealTimeHCV Assay, a consolidated HCV viral load and HCV genotype testing method.3
The combination therapy was generally well tolerated, with the majority of side effects reported being mild in nature, including headache and fatigue, reported in 11.4% of patients.
"It is encouraging to see a potential treatment combination on the horizon that could limit treatment duration for patients," said Professor Tom Hemming Karlsen, EASL Vice Secretary. "We will be eagerly awaiting the 48 week follow-up data."
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
General session 2 and awards 1, Hall 6.0
Friday 15 April, 08:30 - 10:30
Presenter: Mihaly Makara, Hungary
Abstract: GS08, RG-101 in Combination with 4 Weeks of Oral Direct Acting Antiviral Therapy Achieves High Virologic Response Rates in Treatment Naïve Genotype 1 and 4 Chronic Hepatitis C Patients: Interim Results from a Randomised, Multi-Center, Phase 2 Study
Author disclosures of interest
Investigator in clinical trials supported by Novartis, Bristol-Myers Squibb, Janssen-Cilag, AbbVie, Roche, Boehringer-Ingelhiem, Merck Sharp & Dohme and Regulus. He has received lectures and consultant fees from Janssen-Cilag, AbbVie, Roche, Boehringer-Ingelhiem, Merck Sharp & Dohme, and Gilead
1 World Hepatitis Alliance. MiR-122 inhibitor RG-101 suppresses hepatitis C virus with a single dose. Available from: http://www.worldhepatitisalliance.org/latest-news/infohep/3036058/mir-122-inhibitor-rg-101-suppresses-hepatitis-c-virus-single-dose. Last accessed: March 2016.
2 EASL. EASL Recommendations on Treatment of Hepatitis C 2015. Available from: http://www.easl.eu/medias/cpg/HEPC-2015/Full-report.pdf. Last accessed: March 2016.
3 Abbott Molecular. Abbott RealTime HCV. Available from: https://www.abbottmolecular.com/products/realtime-hcv.html. Last accessed: March 2016.