April 14, 2016, Barcelona, Spain: New data presented today at The International Liver Congress™ 2016 in Barcelona, Spain, demonstrates a high sustained virologic response (SVR) at 12 weeks from the all-oral combination of sofosbuvir/velpatasvir and experimental compound GS-9857 in patients with the Hepatitis C virus (HCV).
This triple combination treatment was generally safe and effective, even in patients who had been unsuccessfully treated with direct acting antivirals (DAAs, medicines which have been used to treat and cure almost all patients with HCV). The study showed that 99% of patients with HCV genotype 1, 2, 3, 4 and 6 who had previously received treatment, achieved SVR 12 weeks after treatment using this triple combination.
Hepatitis C is a virus carried via the blood, which infects and damages the liver.1 HCV infects liver cells, resulting in inflammation and fibrosis.1 In chronic HCV cases, such symptoms may continue to increase and result in liver cirrhosis, scarring of the liver.1 Despite the high overall SVR rate achieved with currently approved DAA therapies, approximately 5% of patients treated with DAAs will not be cured.2 According to the study authors, for this small proportion of patients who are not cured, retreatment options are significantly limited.
"Our study demonstrates that for HCV patients whose prior treatment has failed with the use of DAAs, this triple combination provides a high rate of sustained virologic response across HCV genotypes," said Dr Eric Lawitz, Clinical Professor of Medicine at the University of Texas Health Science Center, San Antonio and lead author of the study. "Furthermore, the study indicates that the treatment combination is generally safe and well tolerated by patients, providing a promising alternative for HCV sufferers who have limited re-treatment options."
Two global, open-label Phase 2 studies were conducted among chronic HCV-infected patients that had failed prior HCV treatment. Genotype 1 HCV-infected patients enrolled in the study had previously been treated with an NS5A-inhibitor or multiple classes of DAAs, and genotype 2-6 HCV-infected patients had previously been treated with pegylated-interferon (Peg-IFN) plus ribavarin and/or any DAA. All patients received the triple combination of sofosbuvir/velpatasvir plus GS-9857 for 12 weeks. Frequently reported adverse events (AEs) were headache, fatigue, diarrhea and nausea; most were mild or moderate in severity.
"Having offered promising results, this three drug combination is being further evaluated in Phase 3 trials as a single tablet regimen in DAA-experienced patients," said Professor Laurent Castera, EASL Secretary General.
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Additional study results
A total of 128 patients were treated: 75% were male, 82% were white, 73% with non-CC IL28B genotypes, and 48% with cirrhosis. 49% of patients had genotype 1, 16% had genotype 2, 27% had genotype 3, 5% had genotype 4 and 2% had genotype 6.
Overall, 27% of patients had been previously treated with NS5A-inhibitors, 52% had been previously treated with other DAAs, and 21% had failed interferon-based treatment without a DAA. Baseline resistance-associated variants (RAVs) were detected in 60% of patients (20% with RAVs to NS5A-inhibitors and 23% with RAVs to multiple classes).
The most commonly reported AEs (>10%) were headache, fatigue, diarrhea, and nausea; most were mild or moderate in severity. One patient (<1%) experienced a serious AE of gastroenteritis (<1%) and 1 patient discontinued treatment early due to an AE of gastritis at Week 9 and achieved SVR12; both AEs were not considered related to the study drugs. No clinically significant laboratory abnormalities were observed.
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.
Contact
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 C, Hall 6.0
Thursday 14 April, 16:00 - 18:00
Presenter: Eric Lawitz, USA
Abstract: PS008, High efficacy of sofosbuvir/velpatasvir plus GS-9857 for 12 weeks in treatment-experienced genotype 1-6
HCV-infected patients, including those previously treated with direct-acting antivirals
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
References
1 British Liver Trust. Hepatitis C. Published March 2015. Available from: http://www.britishlivertrust.org.uk/liver-information/liver-conditions/hepatitis-c/. Last accessed: March 2016.
2 Tamori A, et al. Recent Advances in Antiviral Therapy for Chronic Hepatitis C. 2016. Available from: http://www.hindawi.com/journals/mi/2016/6841628/. Last Accessed: March 2016.