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The Liver Meeting
Boston MA
November 2016
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RG-101 + DAAs - New Combination Therapy Could Cure Hepatitis C With Only 4 Weeks of Treatment
New HCV Drug RG-101.....http://www.natap.org/2016/HCV/012516_03.htm
Regulus Reports Clinical Hold of RG-101.....
RG-101 Interim Analysis Shows 97% Response at 8 Week Follow-Up......http://www.natap.org/2016/HCV/021916_04.htm

New Combination Therapy Could Cure Hepatitis C With Only 4 Weeks of Treatment News provided by
American Association for the Study of Liver Diseases (AASLD)
Nov 11, 2016, 08:00 ET
BOSTON, Nov. 11, 2016 /PRNewswire/ -- Two injections of RG-101, in combination with a four-week course of direct-acting antiviral (DAA) therapy, has been shown to clear hepatitis C in patients at both 12 and 24 weeks after treatment in the majority of patients, according to research presented this week at The Liver Meeting® - held by the American Association for the Study of Liver Diseases.
Hepatitis C (HCV) is a liver disease commonly spread through blood. In recent years, DAA treatment has changed the prognosis of this disease from chronic to curable, and the current standard of care for HCV consists of eight to 24 weeks of oral DAA therapy. RG-101 is a newly developed therapy, delivered through injection that specifically targets the microNRA in the liver that is essential for HCV to continue to replicate (or stay active) in a person's body. Researchers recently assessed the safety and effectiveness of just a four-week treatment of combining RG-101 with oral DAA therapy in people with HCV genotypes one and four.
"Research today focuses on shorter therapies with high efficacy and good safety, explains Mihály Makara, MD; consultant, Hepatology Center of Buda in Budapest, Hungary, and an investigator in the study. "In previous studies, eight weeks seemed to be a limit. RG101 has a pharmacokinetic profile that provides a unique opportunity for shorter treatment." Dr. Makara's team enrolled 79 participants in their study. The participant's average age was around 45 years, and 54 percent of participants were women. Each participant was placed into one of three DAA treatment groups (with consideration for ensuring people with various disease characteristics were evenly distributed): ledipasvir/sofobuvivr (group one), simeprevir (group two) or daclatasivr (group three), and received these medications along with a 2 mg/kg injection of RG-101 at days one and 29 in the study.
At the beginning of the study, the average viral load (a measurement of HCV in the body) was 638,000 IU/Ml. Seventy-seven percent of participants had genotype one, and the majority (86 percent) had stage zero-to-one fibrosis (scarring of the liver). Dr. Makara's team noted the combination therapy was well tolerated, and most side effects of the treatment were mild-to-moderate. Additionally, no one stopped taking the combination therapy due to side effects.
One hundred percent of participants in the group one, 96 percent in group two, and 92 percent in group three showed undetectable levels of HCV after 12 weeks post treatment. After 24 weeks post treatment 29 patients were available for follow up. Among these patients, 100 percent in group one, 80 percent in group two, and 89 percent in group three were free from HCV.
"This study showed promising results that curing chronic hepatitis C infection is possible with a very short course of treatment," says Dr. Makara of the findings.
Dr. Makara will present these findings at AASLD's press conference in Room 313 at John B. Hynes Veterans Memorial Convention Center in Boston on Saturday, November 12 at 4pm. The study entitled "RG-101 in Combination with 4 Weeks of Oral Direct Acting Antiviral Therapy Achieves High SVR Rates in Treatment Naďve Genotype 1 and 4 Chronic Hepatitis C Patients" will be presented by Gabor Horvath, MD on Sunday, November 13 at 5:15pm in the Auditorium and Balcony. The corresponding abstract (number 111) can be found in the journal, Hepatology - Special Issue: The 67th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting 2016.
About the AASLD
AASLD is a medical subspecialty society representing clinicians and researchers in liver disease. The work of our members has laid the foundation for the development of drugs used to treat patients with viral hepatitis. Access to care and support of liver disease research are at the center of AASLD's advocacy efforts.
AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists and has grown to an international society responsible for all aspects of hepatology.
Press releases and additional information about AASLD are available online at www.aasld.org.
Media Contact: Erin Meadows Phone: 404-803-2857 On-site Phone: 617-954-2956 Email: emeadows@aasld.org
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SOURCE American Association for the Study of Liver Diseases (AASLD)