Combination therapy offers new hope for difficult-to-treat patients with chronic hepatitis C
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.
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.
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