PI-Based Triple Therapy Improves Virological Response Rates in Liver Transplant Recipients With HCV

Presented at EASL

By Shazia Qureshi

AMSTERDAM, the Netherlands -- April 27, 2013 -- Sustained virological response 4 weeks after the end of treatment (SVR-4) was reached by as many as 65% liver transplant recipients with hepatitis C virus (HCV) genotype 1 who were receiving antiviral triple therapy with pegylated interferon, ribavirin, and a protease inhibitor (PI).

“However, these results must be balanced with high rates of adverse events observed,” said Elizabeth Verna, MD, Columbia University College of Physicians and Surgeons, New York, New York, on April 25 at the 48th Annual Meeting of the European Association for the Study of the Liver (EASL).

The study cohort included 112 liver transplant recipients with HCV who were receiving antiviral triple therapy with pegylated interferon, ribavirin, and a PI (telaprevir or boceprevir).

The median time from liver transplantation to start of triple therapy was 3.7 years. Prior to triple therapy, 96% of patients had undergone a lead-in period with only pegylated interferon plus ribavirin, mainly because the PIs used in the study only recently became available in 2011. Immunosuppression treatment was also administered and included cyclosporine, tacrolimus, steroids, and mycophenolate mofetil (MMF).

From the data collected so far, 64% of patients have shown an extended rapid virological response (eRVR), defined as undetectable HCV RNA levels at weeks 4 and 12.

So far, 48 patients have had the opportunity to reach SVR-4 (48 weeks of treatment plus 4 weeks of follow-up). Among them, 63% have shown eRVR and 65% have shown SVR-4. In addition, SVR-4 rates were 93% among those with eRVR -- which may be an important predictor of response, according to Dr. Verna.

Six percent of patients died (4% liver-related, 2% non-liver-related). Hospitalisation due to serious adverse events occurred in 21% of patients, with the rate being higher among the 30 patients with advanced disease (38%) than among the 82 patients without advanced disease (16%; P = .02).

Renal failure -- defined as an increase in serum creatinine level of >0.5 mg/dl -- was reported in 34% of the whole cohort, again with a difference between patients with and without advanced disease (47% vs 30%).

“The results are preliminary, and improving tolerability and identifying predictors of SVR is critical to optimising the risks and benefits of post-liver transplant triple [antiviral] therapy,” said Dr. Verna.

[Presentation title: A Multicenter Study of Protease Inhibitor-Triple Therapy in HCV-Infected Liver Transplant Recipients: Report From the CRUSH-C Group. Abstract 23]

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