December 17, 2013
Atif Zaman, MD, MPH reviewing Liu CH et al. Ann Intern Med 2013 Dec 3.
Until next-generation drugs become approved for this population, adding low-dose ribavirin to standard peginterferon therapy improves sustained virologic response.
Although the next-generation regimens for hepatitis C virus (HCV) are effective, currently, the standard approved regimen for patients receiving hemodialysis is still peginterferon plus low-dose ribavirin (200 mg/day). The addition of low-dose ribavirin was approved by the FDA in August 2011. However, that approval was based on small studies that were very heterogeneous with regard to treatments, HCV genotypes, and endpoints. Therefore, the efficacy and safety of combination therapy compared with monotherapy in this population is unclear.
In the current open-label, randomized, controlled trial, 205 treatment-naive patients with genotype 1 HCV infection receiving hemodialysis were randomized to receive either peginterferon alone (135 µg weekly) or in combination with ribavirin (200 mg daily) for 48 weeks. Outcomes were sustained virologic response (SVR) rate and adverse event–related withdrawal rate.
SVR was significantly higher in the combination group compared with the monotherapy group (64% vs. 33%, respectively; P<0.001). As expected, significant anemia (hemoglobin level <8.5 g/dL) was higher among the patients receiving ribavirin (72% vs. 6%; P<0.001), who also required higher doses of erythropoietin (P=0.006) for a longer duration (P=0.004). Adverse event–related withdrawal rates were similar in the combination and monotherapy groups (7% and 4%).
In this large treatment study, sustained virologic response was higher with combination peginterferon and ribavirin compared with monotherapy in patients with genotype 1 hepatitis C virus infection receiving hemodialysis. Using the very low dose of 200 mg daily of ribavirin not only achieved an SVR rate comparable to that reported in patients who were not receiving hemodialysis, but also kept the discontinuation rate due to adverse events low. While we wait for the safety and efficacy data of the new HCV regimens in patients receiving hemodialysis, peginterferon plus low-dose ribavirin is a viable option.
Liu CH et al. Pegylated interferon-α2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 1 receiving hemodialysis: A randomized trial. Ann Intern Med 2013 Dec 3; 159:729. (http://dx.doi.org/10.7326/0003-4819-159-11-201312030-00005)