The combination of sofosbuvir, velpatasvir, and GS-9857 demonstrates safety and efficacy in patients with genotype 1 hepatitis C
April 14, 2016, Barcelona, Spain: A new combination treatment for hepatitis C has potential for patients who were not cured by current treatment options. The study, presented at The International Liver CongressTM in Barcelona, Spain, demonstrated that the combination of sofosbuvir, velpatasvir and the investigational drug GS-9857 with or without ribavirin resulted in high rates of sustained virologic response 12 weeks after treatment (SVR12) in genotype 1 HCV patients who had previously received and failed treatment with direct-acting antivirals (DAAs). Overall, 98% of patients in the study achieved SVR12 with this three-drug combination in a single tablet with or without ribavirin.
Between 130 and 150 million people globally have chronic Hepatitis C virus (HCV) infection.1 It is estimated that 15 million people in the World Health Organization’s EU Region are living with Hepatitis C, representing 2% of adults.2 Worldwide, genotype 1 HCV is the most common, accounting for approximately half of all hepatitis C infections.3
“Our study set out to evaluate the safety and efficacy of this investigational combination for hard-to-treat patients with genotype 1 hepatitis C,” said Dr Eric Lawitz, Clinical Professor of Medicine at the Texas Liver Institute, University of Texas Health Science Centre, San Antonio and lead author of the study. “With the triple combination of three potent drugs, sofosbuvir, velpatasvir and GS-9857, we demonstrated that high SVR12 results were achieved with or without ribavirin.”
Patients previously treated with DAAs were randomised to receive the combination treatment with or without ribavirin for 12 weeks. The primary endpoint of the study was SVR12. SVR12 was achieved in 100% of patients who took sofosbuvir, velpatasvir and GS-9857 without ribavirin and in 96% of patients who additionally took ribavirin.
A total of 49 patients were randomised and treated in the American study. The majority were male (65%), and had HCV genotype 1a (88%). Overall, 41% of patients had previously received an NS5A inhibitor, and 47% of patients had previously received at least two classes of DAA. The triple combination of sofosbuvir, velpatasvir and GS-9857, with or without ribavirin was generally safe and well tolerated. There was one serious adverse event and two patients discontinued treatment with ribavirin due to adverse events. Most frequent adverse events were fatigue and anaemia, which were only observed in patients that received ribavirin.
“This new combination of treatments could add to our arsenal of therapies for patients with Hepatitis C, a disease which could eventually be eradicated. In the hard-to-treat patient population who had previously failed on existing treatment regimens, the combination with GS-9857 could provide these people with another hope,” said Professor Tom Hemming Karlsen, EASL Vice-Secretary.
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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.
About EASL (www.easl.eu)
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.
For more information, please contact the ILC Press Office at:
- Email: ILCpressoffice@ruderfinn.co.uk
- Telephone: +44 (0)7841 009 252
Onsite location reference
Viral hepatitis: Hepatitis C – clinical (new compounds, resistance), Hall 8.0-D1
Thursday 14 April, 16:00 – 18:00
Presenter: Eric Lawitz, United States
Abstract: PS021, High efficacy of sofosbuvir/velpatasvir/GS-9857 with or without ribavirin for 12 weeks in direct acting antiviral-experienced patients with genotype 1 HCV infection
Author disclosures of interest
Research/Grant support: AbbVie, Achillion Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Enanta Pharmaceuticals, Gilead Sciences, GlaxoSmithKline, Janssen, Merck & Co., Roche, Salix, Santaris Pharmaceuticals, Tacere, Theravance
Speaker: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck & Co.
Advisory/Consultation: AbbVie, Achillion Pharmaceuticals, Bristol-Myers Squibb; Enanta, Gilead Sciences, Janssen, Merck & Co., Novartis, Santaris Pharmaceuticals, Regulus, Theravance
1 World Health Organization. Hepatitis C Fact Sheet N°164. Available from: http://www.who.int/mediacentre/factsheets/fs164/en/. Last accessed: February 2016.
2 World Health Organization. Global Alert and Response – Hepatitis C. Available from: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html. Last accessed: March 2016.
3 Messina JP, et al. (2015). Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 61:77-87.