MAGELLAN-2: safety and efficacy of glecaprevir/pibrentasvir in liver or renal transplant adults with chronic hepatitis C genotype 1–6 infection

Section: Introductionmentioning

confidence: 99%

Safety and effectiveness of direct acting antivirals for treatment of hepatitis C virus in patients with solid organ transplantation

Mansour

Hill

Kerr

2018

“…Based on the period analyzed, all patients were treated with a SOF‐based regimen. Recently, GLE/PIB was released onto the market and has proven to be safe and efficacious for 12‐week HCV treatment in LT recipients . Since increased TAC dosing requirement is because of a theoretical increase in hepatic metabolism from viral clearance, it is likely that GLE/PIB would provide similar results.…”

Section: Discussionmentioning

confidence: 99%

Impact of direct‐acting antivirals for hepatitis C virus therapy on tacrolimus dosing in liver transplant recipients

Bixby

Fitzgerald

Leek

et al. 2019

Introduction Direct‐acting antivirals (DAAs) have transformed hepatitis C virus (HCV) management post‐liver transplant. As HCV clears during DAA treatment, hepatic metabolism improves, resulting in decreased tacrolimus concentrations that may require dose adjustment. The purpose of this study was to determine appropriate management of immunosuppression in liver transplant recipients during and following treatment of HCV. Methods This study was a single‐center retrospective analysis of 71 liver transplant recipients who were treated for HCV with DAAs. The primary outcome was change in dose‐normalized tacrolimus concentrations from the start of DAA treatment to 12 weeks following therapy. Results The mean change in log‐transformed dose‐normalized tacrolimus concentrations was a reduction of 0.43 ng/mL/mg (95% CI; 0.26‐0.60, P < 0.0001). The greatest decrease occurred in the first 4 weeks of treatment, after which levels stabilized. The overall mean tacrolimus concentration was 4.8 ng/mL (±2.5). Two patients (3%) developed acute cellular rejection and two patients (3%) had graft loss and died. Conclusion From the start of treatment to 12 weeks post‐DAA therapy, liver transplant recipients experienced a significant decrease in dose‐normalized tacrolimus concentrations. In conclusion, close monitoring of tacrolimus concentrations is warranted during and following treatment with DAAs, as dose increases may be indicated in order to maintain therapeutic concentrations to prevent graft rejection.

“…Glecaprevir/pibrentasvir, a combination pill with an NS3/4A protease inhibitor plus an NS5A inhibitor, was selected for its pangenotypic efficacy, minimal drug‐drug interactions (DDIs), and absence of dose adjustments for hepatic or renal impairment . A 12‐week course was proposed based on experience following liver and renal transplantation; however, his insurance covered only 8 weeks . The Food and Drug Administration has since updated the glecaprevir/pibrentasvir label in August 2018 to recommend a 12‐week course for liver and kidney transplant recipients…”

Section: Case Reportmentioning

confidence: 99%

Successful treatment of hepatitis C virus infection with direct‐acting antivirals during hematopoietic cell transplant

Cunningham

Shea

Grgic³

et al. 2019

Current guidelines recommend that hepatitis C virus (HCV) infection be treated completely prior to hematopoietic cell transplantation or delayed until immune reconstitution after transplantation to avoid drug‐drug interactions and treatment interruption. However, these recommendations were informed by outcomes using treatment with ribavirin and pegylated interferon. We report the first case of successful treatment of HCV using direct‐acting antivirals during hematopoietic cell transplantation. This case study suggests that treatment of HCV concurrent with hematopoietic cell transplantation for malignancy may be the best option for some patients in whom it is unsafe to delay treatment for either disease.