Patients with hepatitis C virus (HCV) infection who received transplanted HCV-infected kidneys followed by HCV treatment had good outcomes up to one year later, a recent small industry-funded study found.
Researchers performed a single-center open-label nonrandomized trial in 20 HCV-negative patients to look at 12-month HCV treatment outcomes, estimated glomerular filtration rate (eGFR), and quality of life. All patients received a transplant of a kidney infected with HCV genotype 1 and were treated with elbasvir-grazoprevir on post-transplant day 3. The study's primary outcome was HCV cure, defined as undetectable HCV RNA 12 weeks after completing HCV therapy. Quality-of-life scores on the RAND-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) at enrollment and after the transplant, as well as renal function post-transplant, were exploratory secondary outcomes. The results of the study, which was funded by Merck, were published by Annals of Internal Medicine on Aug. 7.
Of the 20 patients included in the study, 70% were men and 40% were black. The mean age was 56.3 years. HCV was considered cured after treatment in all 20 patients. Five patients experienced transiently elevated aminotransferase levels, and one patient developed proteinuria that was subsequently managed with an angiotensin-receptor blocker. No other serious adverse events were determined to be related to HCV or to HCV treatment, and no patients had allograft rejection. At four weeks post-transplant, mean MCS and PCS quality-of-life scores had decreased, but PCS scores increased above those measured pretransplant as more time passed, while MCS scores returned to baseline. Median eGFR values were similar between study participants and matched recipients of HCV-negative kidneys at six months and at 12 months (67.5 vs. 66.2 mL/min/1.73 m2 and 72.8 vs. 67.2 mL/min/1.73 m2, respectively).
The study authors noted that their trial was small and that its results may not be generalizable to other patient populations or to health care facilities that follow different protocols, among other limitations. However, they concluded that their results “should encourage transplant leaders, organ procurement organizations, and payers to consider infrastructure investments to augment the use of HCV-infected kidneys.” They called for larger trials to confirm their findings and provide more information about complication rates.
An accompanying editorial said the study helps confirm the increasing consensus that it is feasible to transplant HCV-positive kidneys in HCV-negative recipients given the availability of oral direct-acting antivirals. The results “should encourage workable strategies to increase utilization of HCV-positive kidneys (and other organs) in transplant candidates regardless of their HCV serostatus, thereby offering hope to thousands in need of life-saving or life-enhancing transplants,” the editorialist wrote.