Newly approved all-oral hep C combination drug found more effective in head-to-head comparison

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April 14, 2016, Barcelona, Spain: Findings presented today from a Phase 3 head-to-head study that compared two direct-acting antiviral treatment regimens, demonstrated that the all-oral, once daily combination of elbasvir and grazoprevir was more effective and safer than the combination of sofosbuvir and pegylated interferon with ribavirin, in certain patients with Hepatitis C (HCV).

The results were shared at The International Liver Congress™ 2016 in Barcelona, Spain. The combination of elbasvir and grazoprevir – recently approved by the US Food and Drug Administration and Health Canada in January 2016 – is an all-oral once a day treatment that is taken over a 12 to 16 week course.1,2

The combination of sofosbuvir and pegylated interferon with ribavirin was previously recommended by treatment guidelines, however the guidelines have since been updated and no longer recommend this treatment combination. In the United States, genotype 1 HCV is the most common infection, accounting for approximately 70 to 75% of all HCV infections.3 HCV genotype 4 is less prevalent in the United States, however there is a high frequency of this strain in Egypt and Africa.4

"We have recently seen a great increase in the overall number of studies investigating different direct-acting antiviral treatment regimens for Hepatitis C, but direct comparative studies are lacking," said study lead author Dr Jan Sperl, from the Institute for Clinical and Experimental Medicine, Prague, Czech Republic. "The combination of elbasvir and grazoprevir has shown to be more effective than previously recommended treatment options, giving physicians another treatment option against this damaging infection."

The C-EDGE head-to-head study was a randomised, parallel-group trial that enrolled patients with HCV genotypes 1 and 4 who either had never received treatment or had prior unsuccessful treatment with pegylated interferon and ribavirin. Patients were randomised 1:1 to receive either 12 weeks of the combination of elbasvir/grazoprevir, or the sofosbuvir, pegylated interferon and ribavirin regimen. The primary efficacy endpoint of the study was achievement of a sustained virologic response (negative virus in the blood) at 12 weeks after the end of therapy (SVR12).

Results show that the elbasvir/grazoprevir combination was effective in HCV genotypes 1 and 4 with fewer overall side effects than the sofosbuvir, pegylated interferon combination and ribavirin combination.

The combination of elbasvir and grazoprevir resulted in an SVR12 of 99.2% (128/129) compared to 90.5% (114/126) in the sofosbuvir/pegylated interferon/ribavirin group. Elbasvir and grazoprevir demonstrated superior efficacy especially in subgroups of patients considered as hard-to-treat in the past (in cirrhotics, patients with high initial vireamia and in previous null-responders to pegylated interferon and ribavirin). Furthermore, elbasvir and grazoprevir demonstrated a superior safety profile compared to sofosbuvir/pegylated interferon/ribavirin. This is primarily due to the absence of adverse effects commonly associated with pegylated interferon and/or ribavirin, including low red blood cell count, low white blood cell count, flu-like illness, and pyrexia.

"A great wealth of data now exists on treatment approaches in HCV and these findings give the medical community another effective option in the treatment of this harmful disease," said Professor Laurent Castera, EASL Secretary General.

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C-EDGE Head-to-Head

This is a randomised, parallel-group trial that enrolled genotype 1, 4 or 6 infected treatment-naïve or pegylated interferon and ribavirin experienced patients. Patients were randomised 1:1 to receive either 12 weeks of elbasvir/grazoprevir (50mg/100mg) or sofosbuvir (400mg), pegylated interferon and ribavirin (both weight based). The primary efficacy endpoint of the study was achievement of SVR at 12 weeks (SVR12).

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

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: [email protected]

Telephone: +44 (0)7841 009 252

Onsite location reference

Viral Hepatitis C, Hall 6.0

Thursday 14 April, 16:00 – 18:00

Presenter: Jan Sperl, Czech Republic

Abstract: PS002, C-EDGE head to head: Efficacy and safety of elbasvir and grazoprevir compared with sofosbuvir/pegylated interferon/ribavirin: A Phase 3 randomized controlled trial

Author disclosures of interest

Grants: Gilead, Janssen

Speaker/Advisor: Gilead, Janssen, Merck, AbbVie

References

1 Hepatitis C online. Elbasvir-Grazoprevir (Zepatier). Available from: http://www.hepatitisc.uw.edu/page/treatment/drugs/elbasvir-grazoprevir. Last accessed: March 2016.

2 FDA. FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm. Last accessed: March 2016.

3 Hepatitis C online. Core Concepts. Treatment of HCV Genotype 1. http://www.hepatitisc.uw.edu/go/treatment-infection/treatment-genotype-1/core-concept/all. Last accessed: March 2016.

4 US National Library of Medicine National Institutes of Health. Prevalence and treatment of hepatitis C virus genotypes 4, 5, and 6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16234071. Last accessed: March 2016.

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