In the Journals

Ribavirin May Increase Lactic Acidosis Occurrence for HCV-Related Cirrhosis

New findings published in the Journal of Hepatology show that patients with hepatitis C virus infection-related cirrhosis undergoing antiviral therapy with ribavirin may have increased risk for developing lactic acidosis.

In a retrospective analysis, researchers collected data of 35 patients with chronic HCV with advanced fibrosis, compensated cirrhosis and decompensated cirrhosis before and after liver transplantation  treated with Sovaldi (sofosbuvir, Gilead Sciences)-based antiviral therapy with and without ribavirin. Adverse events were measured over a period of 24 weeks before and during therapy.

Overall, 43% of patients experienced a serious adverse event (n = 15) before 24 weeks and 34% (n = 12) during antiviral therapy. A majority of the adverse events were associated with acute-on-chronic hepatic decompensation.

Lactic acidosis was observed in 14% of patients during therapy (n = 5). No evidence of lactic acidosis was seen prior to the start of antiviral therapy. Severe lactic acidosis, meaning an arterial lactate concentration greater than 20 mg/dL, was found in two patients (pH < 7.3). Ribavirin doses of 200 mg to 1,200 mg per day were being given at the time of diagnosis.

Lactic acidosis was found in patients with more advanced cirrhosis and impaired kidney function compared with patients who did not development lactic acidosis.

The researchers concluded: “Our data indicate a risk for the development of lactic acidosis complicating acute-on-chronic hepatic decompensation during [ribavirin/sofosbuvir]-based antiviral therapy in patients with HCV-associated cirrhosis. … Impaired renal function and higher MELD/Child-Pugh scores were identified as potential risk factors. … Ribavirin should be used with caution in patients with decompensated liver disease.” – by Melinda Stevens

Disclosure: Welker reports financial relationships with Amgen, Bayer, Bristol-Myers Squibb, Gilead Sciences, Astellas, Novartis, Hanssen and Roche. Please see the study for a full list of all other authors’ relevant financial disclosures.

New findings published in the Journal of Hepatology show that patients with hepatitis C virus infection-related cirrhosis undergoing antiviral therapy with ribavirin may have increased risk for developing lactic acidosis.

In a retrospective analysis, researchers collected data of 35 patients with chronic HCV with advanced fibrosis, compensated cirrhosis and decompensated cirrhosis before and after liver transplantation  treated with Sovaldi (sofosbuvir, Gilead Sciences)-based antiviral therapy with and without ribavirin. Adverse events were measured over a period of 24 weeks before and during therapy.

Overall, 43% of patients experienced a serious adverse event (n = 15) before 24 weeks and 34% (n = 12) during antiviral therapy. A majority of the adverse events were associated with acute-on-chronic hepatic decompensation.

Lactic acidosis was observed in 14% of patients during therapy (n = 5). No evidence of lactic acidosis was seen prior to the start of antiviral therapy. Severe lactic acidosis, meaning an arterial lactate concentration greater than 20 mg/dL, was found in two patients (pH < 7.3). Ribavirin doses of 200 mg to 1,200 mg per day were being given at the time of diagnosis.

Lactic acidosis was found in patients with more advanced cirrhosis and impaired kidney function compared with patients who did not development lactic acidosis.

The researchers concluded: “Our data indicate a risk for the development of lactic acidosis complicating acute-on-chronic hepatic decompensation during [ribavirin/sofosbuvir]-based antiviral therapy in patients with HCV-associated cirrhosis. … Impaired renal function and higher MELD/Child-Pugh scores were identified as potential risk factors. … Ribavirin should be used with caution in patients with decompensated liver disease.” – by Melinda Stevens

Disclosure: Welker reports financial relationships with Amgen, Bayer, Bristol-Myers Squibb, Gilead Sciences, Astellas, Novartis, Hanssen and Roche. Please see the study for a full list of all other authors’ relevant financial disclosures.