Published: Mar 19, 2014
By Michael Smith, North American Correspondent, MedPage Today
The antiviral drug ribavirin can clear chronic hepatitis E virus (HEV) in solid-organ transplant recipients, researchers reported.
In a retrospective case series, 3 months of the drug resulted in a sustained virologic response (SVR) in 78% of patients, according to Nassim Kamar, MD, PhD, of the Centre Hospitalier Universitaire Rangueil in Toulouse, France, and colleagues.
Retreatment of six patients who failed the therapy resulted in four achieving an SVR, Kamar and colleagues reported in the March 20 issue of the New England Journal of Medicine.
HEV infection is usually self-limiting, except in patients with a suppressed immune system, where it can evolve to chronic hepatitis and cirrhosis, Kamar and colleagues noted.
There is no established HEV treatment, they added, and simply reducing immunosuppression in transplant patients with HEV only resulted in clearance in about 30%.
To evaluate the effects of ribavirin, they examined case records for 59 solid-organ recipients in 13 French centers who were treated with ribavirin alone between Sept. 10, 2009, and June 27, 2012.
Ribavirin is a general antiviral that inhibits replication of many RNA and DNA viruses. It has long been used to treat hepatitis C, along with pegylated interferon-alfa and now several direct-acting anti-HCV agents.
In the transplant case series, Kamar and colleagues reported, 37 patients got a kidney, 10 got livers, five got hearts, five got a kidney-pancreas transplant, and two got lungs.
Physicians started ribavirin a median of 9 months after HEV was diagnosed, and it was delivered at a median dose of 600 mg daily, equivalent to 8.1 mg/kg of body weight.
Patients got the drug for a median of 3 months (with a range from 1 to 18 months), but 66% got it for 3 months or less, the researchers reported.
One patient who started ribavirin was lost to follow-up after a month of treatment, and another was withdrawn for psychiatric reasons, Kamar and colleagues reported.
Among the remaining 57 patients, 56 had no detectable virus 3 months after the end of their therapy and, of those, 10 had a recurrence of HEV viremia.
Overall, a sustained virologic response -- defined for this study as no detectable viral RNA 6 months after the end of treatment -- was observed in 46 of the 59 patients, or 78%.
At the most recent follow-up -- a median of 25 months after the end of therapy -- the 46 patients were still free of the virus, Kamar and colleagues noted.
Of the 10 patients with relapse, six were retreated with ribavirin and four achieved an SVR.
Analysis found that a higher lymphocyte count when ribavirin therapy was initiated was the only factor associated with a greater likelihood of SVR, the researchers reported.
The main side effect of the drug was anemia, which necessitated a dose reduction in 29% of patients, erythropoietin in 54%, and blood transfusions in 12%, they found.
Kamar and colleagues cautioned that the study was retrospective and had only a small number of patients. In addition, care was clinically driven so that ribavirin dosing, duration, and monitoring varied from patient to patient. Drug levels were not measured.
Primary source: New England Journal of Medicine
Source reference: Kamar N, et al "Ribavirin for chronic hepatitis E virus infection in transplant recipients" NEJM 2014; 370: 1111-20.