Preliminary results from the SOLAR 2 trial show that ledipasvir/sofosbuvir in combination with ribavirin is safe and effective in patients with decompensated liver disease or who have undergone liver transplantation

April 23, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 show that the use of the fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) in combination with ribavirin (RBV) was well tolerated and demonstrated high sustained virologic response rates 12 weeks post treatment (SVR12) in patients with chronic hepatitis C virus (HCV) infection who have decompensated liver disease (cirrhosis) or have undergone liver transplantation.

SOLAR 2 data are presented for 328 HCV genotype-1 or -4 treatment-naive or treatment-experienced patients with decompensated liver disease or recurrent HCV following a liver transplant. More than 75 percent of patients in the study were treatment-experienced.

The participants were randomized to receive either 12 or 24 weeks of LDV/SOF plus RBV. Ten patients were excluded from the analysis because of transplantation (n=7) or because they were pre-transplantation, but not decompensated (n=3); an additional 27 of these patients have not yet reached post-treatment week 12. The number and proportion of genotype 1 patients with available data achieving SVR12 are summarized in the table below:
table 1

Of the 32 genotype 4 patients, 27 (84%) achieved SVR12. Additionally, among patients with cirrhosis and decompensated cirrhosis before and after liver transplantation, virologic response was associated with improvements in Model for End-Stage Liver Disease (MELD) and CPT scores.

“Current treatment options are limited for HCV patients with decompensated liver disease or in those where the virus persists even after having a liver transplant,” said Professor Michael Manns, Professor and Chairman, Department of Gastroenterology, Hepatology and Endocrinology,
Hannover Medical School, Germany. “We are therefore pleased that the combination of LDV/SOF+RBV has proved to be so effective, and consider this a significant step forward in the management of these difficult-to-treat patients,” he added.

“As we constantly seek to improve the lives of people with chronic HCV, results from trials such as SOLAR 2 give hope to those with an advanced form of the disease such as cirrhosis and disease persisting even after a liver transplant,” said Professor Markus Peck, Secretary General, European Association for the Study of the Liver.
In the study, the most common adverse events were fatigue, anaemia, nausea and headache. Sixty-nine patients (21 percent) experienced serious adverse events (SAEs). Nine patients had SAEs considered to be related treatment-related: anaemia (five), fall, diarrhoea, vomiting and hyperbilirubemia. Six patients have discontinued treatment.

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. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.

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Since EASL’s foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

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