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Clinical Summary

Posttransplant HCV: meta-analysis fails to support add-on ribavirin

Takeaway

  • A meta-analysis suggests limited utility for ribavirin (RBV) in patients receiving sofosbuvir (Sovaldi)-based direct-acting antiviral (DAA) regimens for HCV recurrence after liver transplant.

Why this matters

  • Findings have important implications in the context of HCV+ organ donation.

Key results

  • Pooled sustained virologic response at 12 weeks posttherapy (SVR12) rate, 91% (95% CI, 84%-95%), with high heterogeneity (I2=88%; P<.01) but no evidence of publication bias.
  • SVR12 was similar in patients receiving and not receiving RBV (90% vs 94%; risk ratio [RR]=0.97; P=.35; I2=46%), regardless of:
    • Therapy duration of 12 vs 24 weeks (P=.26).
    • DAA targets (NS3/4A+NS5B vs NS5A+NS5B inhibitors; P=.76).  
    • Studies conducted in the U.S. vs Europe (P=.13). 
  • RBV inclusion was associated with an increased prevalence of anemia (42% vs 10%; RR=5.18; P<.00001; I2=26%).

Study design

  • Meta-analysis of 12 studies involving 1466 liver transplant recipients receiving sofosbuvir-based DAA regimens with (n=502) and without RBV (n=964).
  • HCV-1 was predominant (81%); approximately 58% were treatment-experienced.
  • Primary endpoint: SVR12.
  • Funding: National Natural Science Foundation of China, National Science and Technology Major Project of China, Chongqing Natural Science Commission Foundation.

Limitations

  • Only 1 randomized controlled trial included.
  • No genotype-specific analysis.

References


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