Phase 2 data show treatment efficacy in ‘difficult-to-cure’ hepatitis C patients
April 16, 2016, Barcelona, Spain: A Hepatitis C (HCV) drug currently under investigation, ABT-493 and ABT-530, which is an all-oral once-daily antiviral treatment, helped HCV genotype 3 patients with heavily scarred livers and no previous treatment history to achieve a 100% sustained virologic response after receiving the treatment for 12 weeks (SVR12).
Additional data from this study, also presented at The International Liver CongressTM today in Barcelona, Spain, show that 97% of patients with the same HCV genotype, but without scarred livers, achieved SVR12 after eight weeks on the same treatment without ribavirin (RBV).
As treatments for HCV have evolved, genotype 3 patients have become the most difficult subgroup of patients to cure.1 Although there have been recent advances in direct-acting antiviral therapies for HCV genotype 1, genotype 3 remains a challenge and is a highly prevalent strain of the infection globally, with a particularly high concentration of cases in Asia.1
The current standard of care for HCV genotype 3 is the nucleotide polymerase inhibitor sofosbuvir with weight-based RBV for 24 weeks. This recommendation comes from the Valence study where high SVR rates were seen in those who had no previous HCV treatment history, without or with scarring of the liver, known as cirrhosis (93% and 92%, respectively). However, treatment-experienced genotype 3 cirrhotic patients experienced a lower SVR rate of 60%.2
"We are pleased to see the efficacy of this two direct-acting antiviral investigational, pan-genotypic regimen has been validated for treatment-naïve Hepatitis C genotype 3 patients – with 100% of cirrhotic patients treated for 12 weeks and 97% of non-cirrhotic patients treated for eight weeks achieving sustained virologic response at 12 weeks post treatment," said Dr Paul Kwo from Indiana University School of Medicine, Indianapolis, US and one of the lead study authors. "Clinical trials are ongoing to evaluate the safety and efficacy of the investigational treatment, and we are now focusing on a larger cohort of HCV genotype 3 patients, including treatment-experienced patients."
In the international Phase 2 clinical trial, two study arms enrolled 24 cirrhotic patients each, none who had previously been treated for HCV infection. In the two patient groups taking the investigational combination treatment ABT-493 and ABT-530 with and without once-daily RBV, all achieved SVR12 after 12 weeks on treatment. No patient discontinued the study or experienced virologic failure.
In another trial treatment arm that focused on non-cirrhotic patients, 29 genotype 3-infected patients were enrolled. SVR12 was achieved by 97% (28/29) of patients with no patient experiencing virologic failure. The most common side effects were the same across both studies, including headache, and fatigue.
"These data mark another step forward in continued research efforts to address the unmet medical need among HCV patients," said Professor Frank Tacke, EASL Governing Board member. "We will be watching with close interest to see whether similar efficacy levels can be achieved for treatment-experienced genotype 3 HCV patients – a group known for being hard to cure."
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 6.0
Saturday 16 April, 16:00 – 18:00
Presenter: Paul Kwo, United States
Abstract: LB01, 100% SVR4 with ABT-493 and ABT-530 with or without Ribavirin in Treatment-Naïve HCV Genotype 3-Infected Patients with Cirrhosis
Viral hepatitis C (2), Hall 6.0
Saturday 16 April, 11:30 – 13:30
Presenter: Andrew Muir, United States
Abstract: PS098, High SVR Rates with ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 3 Infection
Author disclosures of interest
Paul Kwo – Advisory board: Abbott, Abbvie, BMS, Gilead, Merck, Janssen. Grant support: Abbvie, BMS, Gilead, Janssen, Merck
Andrew Muir – Research grants: AbbVie, Achilion, BMS, Gilead, GSK, Hologic, Intercept, Janssen, Merck, NGM Biopharm, Roche. Educational activities: Salix. Consulting services: AbbVie, Achilion, BMS, Gilead, Inovio Pharmaceuticals, Intercept, Janssen, Lumena, Merck, Portola Pharmaceuticals, Regulus Therapeutics, Salix, Shire Pharmaceuticals, Theravance.
1 US National Library of MedicineNational Institutes of Health. Review article: HCV genotype 3 – the new treatment challenge. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24612116. Last accessed: March 2016.
2 The Hepatitis C Trust. Genotype 3: One of the Remaining Challenges for Hepatitis C. Available from: http://www.hepctrust.org.uk/news/may-2015/genotype-3-one-remaining-challenges-hepatitis-c. Last accessed: March 2016.
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