Provided by Healio
June 14, 2013
Chronic hepatitis C-infected renal transplant recipients receiving interferon-based therapy experienced modest efficacy rates but were not at elevated risk for allograft rejection, according to recent results.
In a prospective, multicenter, open-label trial, researchers evaluated 32 adult patients with chronic HCV genotypes 1 (62.5%) or 4 (37.5%) and significant fibrosis who had undergone renal transplantation (RT) between November 2007 and December 2011. Participants received 135 mcg or 180 mcg pegylated interferon alfa-2a (PegIFNa-2a) weekly and between 200 mg and 1,200 mg ribavirin (RBV) daily for 48 weeks. Patients’ renal safety was compared with that of 31 matched, untreated historical controls.
Sustained virologic response (SVR) was achieved by 37.5% of treated participants, 12.5% experienced rapid virologic response (RVR) and 56.3% achieved early virologic response (EVR). Patients who received 135 mcg/week peginterferon had a numerically higher SVR rate than 180 mcg patients (50% vs. 33.3%; P=.432). Of all evaluated factors, only EVR was found to be independently predictive of SVR via binary logistic regression (OR=20.4; 95% CI, 2.2-192.6).
After 72 weeks, 16.1% of controls and 6.3% of treated participants experienced sustained, incremental creatinine elevations (P=.148). Mean creatinine levels did not change significantly from baseline levels among treated participants (113.4 ± 62.8 vs. 106.8 ± 32 at baseline; P=.14), but were higher at 72 weeks among controls (142.5 ± 93 vs. 106.6 ± 35.6; P=.013). Acute allograft rejection did not occur among any treated patients, though two patients experienced graft dysfunction unrelated to rejection.
Two patients experienced serious adverse events unrelated to the kidneys, including high serum-albumin gradient ascites and perforated duodenal ulcer. Treatment discontinuation occurred in 12.5% of cases, while 34.4% of patients required a peginterferon dose reduction and 78.1% required a ribavirin reduction.
“PegIFNa-2a and RBV combination therapy may be safe in RT recipients infected with HCV at low risk for allograft rejection, albeit with modest efficacy rates,” the researchers concluded. “The results of this study provide an impetus for conducting a larger, randomized controlled trial aiming at defining the optimal dosage of PegIFNa-2a and RBV and identify predictors of graft dysfunction.”
Disclosure: The researchers reported numerous financial disclosures.