Elbasvir/grazoprevir effectively treats patients with compensated cirrhosis

SAN FRANCISCO — Elbasvir/grazoprevir effectively treated both experienced and naive patients with compensated cirrhosis, with an integrated analysis presented at The Liver Meeting 2015 putting forward that treatment-experienced patients may benefit from a longer treatment duration with ribavirin.

“In compensated cirrhotic patients who are either treatment-naive or treatment-experienced, a regimen of elbasivr/grazoprevir was highly effective,” Chief Medical Editor for HCV Next, Ira M. Jacobson, MD, of the department of Medicine at Mt. Sinai Beth Israel in New York, said during his presentation.

Jacobson presented an analysis of the efficacy and safety data for 12 and 16 weeks of therapy with grazoprevir 100 mg and elbasvir 50 mg with or without ribavirin. The cohort included 169 treatment-naive and 233 treatment-experienced patients with compensated cirrhosis from six different studies, including C-SURFER, C-WORTHY, C-EDGE and C-SALVAGE.

Ira M. Jacobson

This analysis showed that 97.8% of treatment-naive patients achieved SVR12 without ribavirin while 90.3% of treatment-naive patients achieved the same result with added ribavirin. Breaking that down further, 96.1% of patients with genotype 1a achieved SVR12, as compared to 100% of both genotype 1b and genotype 4.

In those treated without ribavirin, 97% of those with platelets less than 100 and 99% of those with platelets at 100 or more, achieved SVR12. When cirrhosis was determined by biopsy or APRI plus FibroTest, 100% of patients achieved SVR12. When determined by Fibroscan (Echosens), 98% did the same. Patients at every Fibroscan value achieved at least 97% SVR12.

“The efficacy was high among treatment-naive and treatment-experienced compensated cirrhotic subjects regardless of platelet count or Fibroscan score,” Jacobson said.

In the treatment-experienced cohort treated for 12 weeks, 88.9% of those treated without ribavirin achieved SVR12 while 91.4% of those treated with ribavirin did as well. In those treated for 16 or 18 weeks, 93.9% treated without ribavirin and 100% of those treated with ribavirin achieved SVR12.

“It becomes readily apparent that the optimal treatment seems to be 16 or 18 weeks with ribavirin,” Jacobson said.

Jacobson showed that patients who previously relapsed all achieved SVR12 whether treated for 12 weeks without ribavirin or 16 to 18 weeks with ribavirin. Yet prior nonresponders did not have the same effect at 12 weeks without ribavirin. He showed that 91.9% of those with genotype 1 and 66.7% of those with genotype 4 achieved SVR12 in the shorter treatment duration. When extended to 16 to 18 weeks and also given ribavirin, 100% of nonresponders achieved SVR12.

“Patients with a history of PEG-ribavirin prior nonresponse benefited from extension of therapy to 16 to 18 weeks with ribavirin. This suggests that relapsers may not require extension of therapy,” Jacobson said.

Serious adverse events occurred in only 3%, but only one patient’s serious adverse event seemed associated with the drug. There was only one discontinuation due to alanine aminotransferase concerns.

“In cirrhotic patients, elbasvir/grazoprevir was generally safe and well-tolerated,” Jacobson said. – by Katrina Altersitz and Rob Volansky

Reference:

Jacobson IM, et al. Abstract 42. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: This study was sponsored by Merck. Jacobson reports various financial relationships with AbbVie, Achillion, Alnylam, Bristol-Myers Squibb, Enanta, Gilead Sciences, Janssen Therapeutics, Merck and Tobira. Please see the full study for a list of all other authors’ relevant financial disclosures.